WuXi Biologics / WuXi AppTec Job Openings: New England, New Jersey and Southern California in the US. Wuxi, Shanghai, Wuhan, Tianjin and Suzhou in China
药明生物 WuXi Biologics
药明生物（WuXi Biologics）是药明康德的生物制药一体化服务平台，由无锡药明康德生物技术股份有限公司、苏州药明康德检测检验有限责任公司和上海药明生物技术有限公司组建而成。
目前，公司研发团队规模达到1200多人，有120多位拥有海外高等学位和工作经验的海归科学家，拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验，打造了世界一流的生物药研究、开发及生产（CDMO）团队，诚挚欢迎同样优秀的你。
若您对以下职位感兴趣，可将个人中英文简历和应聘意向发送至 HR_Biologics@wuxiapptec.com，并在邮件标题注明“应聘岗位+姓名”。
WuXi Biologics ’most valuable resources are our employees. We strive to provide every employee with a strong company culture and a working environment for which they can learn and improve as working professionals.
Our approach to employee development and career progression focuses on developing well-rounded technical and business leaders through multiple career paths. We offer progression as an individual contributor, a technical expert or through a managerial career path.
WuXi Biologics’ employees build depth and breadth in the organization through a variety of experiences including cross functional teams, stretch assignments, key projects and initiatives, and rotational assignments. We partner this with strong mentorship and on-going training programs to provide every employee with the opportunities to develop and grow their career at WuXi.
As a global company with employees around the world, we operate across cultures and serve a broadly diverse client base. We believe that success in our global marketplace requires that we create a corporate culture and an inclusive business environment of talented individuals, with varied perspectives, skills, and experiences. The collaboration of varied cultures and perspectives in our organization differentiates us as an employer and a company well positioned to meet the needs of our global clients.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics Discovery（Shanghai , China）
Job Title：Immunology Group senior scientist
KEY ACCOUNTIBILITIES：
We are seeking a highly motivated and skilled research scientist to join the Biologics Discovery – Immunology Group at WuXi Biologics in Shanghai, China. You will be responsible for designing, executing and reporting the results of experiments to support projects from target identification and validation through to clinical candidate selection. You will use a wide range of advanced methodologies to probe mechanisms and test drugs, primarily through in vitro and ex vivo cell-based immunological assays. The successful candidate will have excellent oral and written communication skills, work well independently and as part of a team, and be able to execute on multiple projects simultaneously. With limited supervision, the role includes developing and optimizing methodologies and assays and making decisions using good scientific judgment. The position is a hands-on, laboratory based role with no direct reports
REQUIREMENTS：
Ph.D. in Immunology, cell biology or related field with a minimum of 3 years’ experience in pharmaceutical/biotech industry or in an academic setting.
Outstanding candidates with a Master’s degree with a minimum of 7 years’ industry experience will also be considered
Solid training and background in cellular immunology, preferably with expertise in immune-oncology, autoimmunity, and associated rodent pre-clinical models.
Ability to independently design, perform and interpret data derived from cellular immune function assays.
Broad expertise and familiarity with assays and technologies commonly used to assess immune endpoints (e.g., MLR, antigen-specific T/APC cultures; ELISA/ELISPOT, qPCR); solid cell line and primary immune cell tissue culture skills.
Experience in multi-parameter FACS analysis and proficiency in downstream FACS data analysis using FlowJo.
Ability to organize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds.
Basic understanding of statistics, data analysis, and assessment of reproducibility and reliability of experimental data.
Ability to contribute at a scientific and strategic level to drug discovery research programs in immunology, including proposal and identification/validation of novel targets.
S/he should be a strong team player with excellent oral and written communication skills and a demonstrated ability to work independently to design experiments, generate and interpret data, troubleshoot, and suggest next steps
Demonstrated project lead experience in an academic or industrial research setting.
Demonstrated experience mentoring and training junior scientists.
Proven experience with biologics drug discovery and demonstrable knowledge of multiple large molecule formats and associated technologies.
Experience with in vivo immune-mechanistic or autoimmune/cancer disease models in the mouse system and their application towards pharmacological assessment of drug efficacy and mode-of-action.
Demonstrable experience with in vitro pharmacology assays involving large or small molecule drugs, e.g., experimental design and replication, titration and potency value determination, etc.
Experience with isolation, characterization, and functional testing of primary human immune cells from healthy donors or disease patient-derived materials.
Genetic engineering of reporter cell lines and/or primary cells: molecular biology skills (e.g., plasmid manipulation and transfection, clonal selection) and experience with gene editing technologies (e.g., si/shRNA and CRISPR/Cas9 via transfection or retroviral delivery)
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics Discovery （Shanghai , China）
Job Title :(Associate/Senior) Director Protein Engineering and Material generation
KEY ACCOUNTIBILITIES：
Lead a team for antibody generation and optimization, protein engineering, including optimizing vector, cell line and culture process.
Lead integrated projects from target identification to lead optimization
Has a solid research skill in molecular biology, vector design and construction, and proficient in using various gene database
Has deep understanding of recombinant protein, therapeutic antibody, and protein engineering.
Able to effectively prioritize team efforts, summarize data, write and present report.
Other responsibilities may be added at the company's discretion.
REQUIREMENTS：
Ph.D. in molecular biology, protein chemistry, structural biology, or related field.
Managerial experience in biotech or pharmaceutical companies
A strong motivation in pursue science in drug discovery.
Adaptable and productive in a fast-paced environment
Good communication skills required, including writing and presentation in English.
Strong team-working spirit and excellent communication and inter-personal skills
Doctor degree in related Life Science subject with > 3 years related experience
Knowledge of bispecific antibody engineering/directed evolution methods
Experience in structural characterization of protein-protein complexes, preferably antibody-antigen complexes is a plus
Knowledge of regulation and IND filing
Experience in patent search and filing
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics Discovery（Shanghai , China）
Job Title：Sr. Scientist/Assistant Director -Antibody Discovery (Phage Display)
KEY ACCOUNTIBILITIES：
We are seeking a highly motivated scientist/group leader to join our Antibody Discovery group in Shanghai. The successful candidate will lead a team on the development of therapeutic antibodies.
Performs antibody phage library construction，selection， and screening.
Performs antibody lead isolation tasks including solid, liquid, and cell-based panning of antibody phage libraries, screening and analysis of selection outputs, IgG conversion, and lead characterization .
Operates and maintains equipment and instruments.
Analyzes, interprets, summarizes, compiles data and presents internally.
Keeps appropriate experimental records and documentation.
Other responsibilities may be added at the company's discretion
REQUIREMENTS：
Hands-on experience in phage display and antibody engineering.
Strong skills in molecular biology, biochemical, and immunochemical techniques (restriction cloning, SDS-PAGE, ELISA, western blot) are highly desirable.
Thorough understanding of antibody display technologies and antibody engineering concepts.
Experience with project/grant management including keeping aggressive timelines and troubleshooting experiments.
Ability to direct and motivate the team of junior and experienced scientists
High degree of motivation and strong English communication skills required
PhD or Masters Degree in Molecular Biology, Cell Biology or a related discipline.
PhD - minimum 2 years relevant experience, MS – minimum 5 years relevant experience in biopharmaceutical sector or academia.
Excellent organizational and communication skills, a keen attention to details and controlling the development from a holistic viewpoint.
Safety procedures must be strictly followed at all times.
Signing and compliance with the company’s Confidentiality and Non-compete Agreement is a condition of employment.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics Discovery（Shanghai , China）
Job Title：Senior Scientist or Associate Director_Molecular Biology and Antibody Engineering
KEY ACCOUNTIBILITIES：
Lead a small group of scientists to conduct molecular biology-related tasks. Test different antibody formats, search and design novel formats
Lead integrated projects from target research to lead optimization
Has a solid research skill in molecular biology, vector design and construction, and proficient in using various gene database
Has basic understanding of recombinant protein, therapeutic antibody, and protein engineering.
Able to effectively prioritize team efforts, summarize data, write and present report.
Other responsibilities may be added at the company's discretion.
REQUIREMENTS：
Ph.D. in molecular biology, protein chemistry, structural biology, or related field.
Experience in biotech or pharmaceutical companies is preferred
A strong motivation in pursue science in drug discovery.
Adaptable and productive in a fast-paced environment
Good communication skills required, including writing and presentation.
Strong team-working spirit and excellent communication and inter-personal skills.
Doctor degree in related Life Science subject with > 1 year related experience
Knowledge of bispecific antibody engineering/directed evolution methods
Experience in structural characterization of protein-protein complexes, preferably antibody-antigen complexes is a plus
Knowledge of bioinformatics
Experience in patent search and filing
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics And Bioprocess （Shanghai , China）
Job Title：Scientist/Senior Scientist of Functional Assays
KEY ACCOUNTIBILITIES：
Research on literature, propose assay strategies, design assay validation plans and perform assay development and screening studies for biochemical and cell based assays
Analyze, interpret, summarize and compiles data independently. Keep appropriate experimental records and documentation,
Lead various assay development and antibody screening efforts preferably through active bench work.
Function as a project representative to coordinate and perform assays within timeline and quality requirement, be able to communicate effectively both internally or externally
Train and manage junior scientists to fulfill desired duties satisfactorily
Keep compliance with all company and departmental policies.
Other responsibilities may be added at the company's discretion.
REQUIREMENTS：
Ph.D. or M.S. Degree in cell biology, biochemistry, molecular biology or a related discipline.
Experience in cell-based or biochemical assay development
Experience in antibody discovery and characterization, and background in signal transduction and cancer biology is a strong plus.
Project management and communication skills including English proficiency
High degree of motivation and team work spirit required.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics Discovery（Shanghai , China）
Job Title：Antibody Engineering
KEY ACCOUNTIBILITIES：
Performs antibody engineering tasks including antibody library construction, affinity maturation, humanization, germlining, and Fc-engineering.
Performs molecular cloning tasks including PCR amplification, restriction cloning, bacterial culture, and sequence analysis.
Operates and maintains equipment and instruments.
Analyzes, interprets, summarizes, compiles data and presents internally.
Keeps appropriate experimental records and documentation.
Other responsibilities may be added at the company's discretion.
REQUIREMENTS：
Master’s Degree in Molecular Biology, Cell Biology or a related discipline.
Minimum 2 years relevant experience in academia or biopharmaceutical sector.
Excellent organizational and communication skills, a keen attention to details and controlling the development from a holistic viewpoint.
Hands-on experience in antibody engineering and antibody library construction
Strong skills in molecular biology, biochemical, and immunochemical techniques (restriction cloning, SDS-PAGE, ELISA, western blot) are highly desirable.
Thorough understanding of antibody structure/function and antibody engineering concepts.
High degree of motivation and strong communication skills required
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Project Manager（Shanghai , China）
Job Title：Group Leader/Assistant Director/Associate Director, Project Management
KEY ACCOUNTIBILITIES：
Develop project plans and timeline for the project while working closely with the project CMC leader.
Identify the critical path activities in the timeline and keep the internal staff and the client informed.
Coordinates the internal resources and leads WuXi's efforts for timely completion of projects by interacting with the client and internal technical staff
Holds regular meetings with team members and with clients to update progress as appropriate.
Keep clients updated in a timely manner regarding progress of project, decision points, and events through teleconferences, e-mails, site visits or other suitable means.
Monitor timeline and contract for accuracy and follows up on any discrepancies with clients and/or internal personnel.
Confirm the completion of work by stage with client and ensures invoices are sent to client for processing.
Act as a team leader and provide the training, guidance, feedback and review to the team members as needed
REQUIREMENTS：
PHD degree in science/engineering field with 2 years of industrial working experience or master degree with at least 5 years of working experience in the pharmaceutical or biotech field.
Some experience in project management preferred.
Good English skills, both written and oral.
Ability to work independently with limited supervision in a fast-paced environment.
Excellent verbal and written communication skills.
Ability to work as a team member and as a leader.
Good multi-tasking and prioritization skills
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics And Bioprocess（Shanghai , China）
Job Title：Scientist of Therapeutic Antibody Bioassay Development
KEY ACCOUNTIBILITIES：
To develop and perform the cell-based assays and immunoassays in support of therapeutic antibody or other biotech product portfolio
To conduct sample testing for lot release, in-process, stability and R&D samples
To ensure compliance to regulatory requirement, including instrument maintenance, personnel training, document drafting, review and archiving
To participate in the qualification or validation of cell-based assays and immunoassays under a GMP environment until established as part of a clinical or commercial control system
Transfer, training and trouble-shooting of cell based assays to collaborating QC labs
REQUIREMENTS：
BS or MS in Biochemistry/Biotechnology, Cell Biology, Immunology or related field
Previous mammalian cell culture experience required
Previous working experience in biochemical and cell-based assay preferred
Working knowledge of regulatory requirement preferred
Detail-oriented and quality-driven.
Being able to read and write SOP and lab notebook in English
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics And Bioprocess （Shanghai , China）
Job Title：Scientist of Therapeutic Antibody Characterization
KEY ACCOUNTIBILITIES：
Skills in characterization assays development in support of therapeutic biotech products.
Good knowledge in regulatory requirements, including instrument maintenance, lab notebook recording, review and archiving.
To support timely sample testing for in-process, release-lots characterization, stability and R&D activities
REQUIREMENTS：
BS/MS in Analytical chemistry, chemistry, biotechnology or related field.
1-3 years of industrial experience in protein characterization. Previous working experience in biochemical and cell-based assay preferred
Strong technical performance and trouble-shooting skills
Good knowledge with protein characterization.
Good in spoken and written communication in English.
Self-motivated to strive for better results
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics And Bioprocess （Shanghai , China）
Job Title：Biologics FFF E&L Senior Scientist
KEY ACCOUNTIBILITIES：
Optimize platform to provide Extractables/Leachables evaluation and trace level analytical support for parenteral product development programs.
Develop and validate E&L analytical methods (GC/MS, LC/MS, HPLC, FT-IR, ICP-MS and etc.) with minimal supervision.
Conduct routine analytical testing.
Provide leadership for various operational tasks within laboratory including use and maintenance of modern analytical instrumentation such as GC/MS, LC/MS, HPLC, FT-IR, ICP-MS and etc.
Possess good judgment and awareness to recognize and solve laboratory/data issues to assure high quality data.
Write validation protocols, validation reports, technical reports, investigations, and documents for regulatory submissions.
Other duties as assigned
REQUIREMENTS：
M.S. or Ph.D. degree in analytical chemistry, Pharmacy, biochemistry, or related science areas.
MS with at least 5 years, or PhD with at least 2 years of relevant experience.
Analytical problem-solving skills, utilizing and maintaining modern analytical instrumentation such as GC/MS, LC/MS, HPLC, FT-IR and etc.
Chromatographic method development and validation experience.
Lab experience including research in GMP environment is desirable.
Must be self-motivated; possess good interpersonal skills, and the ability to handle a wide variety of work assignments while meeting tight timelines.
Excellent communication skills, including technical writing and oral communication in both Chinese and English;
Computer skills (Excel, Word, PowerPoint, Minitab), Experience with Empower and ChemStation chromatographic data systems)
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics And Bioprocess （Shanghai , China）
Job Title：Cell Culture Senior Scientist
KEY ACCOUNTIBILITIES：
we are seeking a candidate with PhD degree and at least 4 years industry experience, or with MS degree and at least 8 years industry experience. He/she must have hands-on mammalian cell culture process development experience for protein therapeutics (preferably monoclonal antibodies), and have strong expertise in process optimization, scale-up and technology transfer. Experience with medium optimization, DoE studies, regulatory submission to the FDA/EMEA and personnel management is preferred. Key aspects of the position include coaching, mentoring and managing junior staff members, technical oversight of study design, execution and results interpretation
REQUIREMENTS：
PHD/MS in biotechnology or related field.
1-3 years of industrial experience in Cell Culture.
Strong technical performance and trouble-shooting skills
Good knowledge with Cell Culture.
Good in spoken and written communication in English.
Self-motivated to strive for better results
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics And Bioprocess （Shanghai , China）
Job Title：Down Stream Senior Scientist
KEY ACCOUNTIBILITIES：
Design the downstream processes that are efficient, robust and scalable for the clinical manufacturing.
Assist the director to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
Oversee the process scale-up and technology transfer between the process development team and manufacturing team.
Coach the group leads and staff on the process development and validation.
Manage the activities for the validation of the downstream processes
REQUIREMENTS：
MS with 5+ years, or PhD with 3+ years downstream process development experience.
At least 4 years’ people management experience
Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
Experience in downstream process cGMP production.
Experience in downstream process validation
Experience in working with the cross-functional teams.
Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
Experience in regulatory submission to FDA/EMA
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：CMC (Shanghai/Wuxi, China)
Job Title: Director, CMC Management
KEY ACCOUNTIBILITIES：
Lead CMC activities of protein based drug development and manufacturing. Provide leadership to all aspects of CMC Team activity.
Ensure alignment of CMC activities with development and manufacturing plans. Chart the course, track progress against goals and outline key strategic events for project.
Serve as the center of solution. Address any challenges and issues that arise. Make hard decisions.
Engage with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines.
Build a solid communication with client senior management to ensure alignment
between WuXi Biologics and clients. Coordinate efforts and facilitates communication of team members to address client’s needs timely and effectively.Coach and evaluate performance of CMC team members. Recognize and reward members of good performance.
Enhance CMC related business processes. Develop & update a strategy in response to changing business needs. Manage matrix of all aspects of CMC Team activity.
Keep senior management and committee informed of project status. Monitor external scientific information and serve as a key link to external Key Opinion Leaders in area(s) of focus.
Enhance current service offering and develop new clients. Assess business development opportunities which could impact program. Develop future perspectives.
REQUIREMENTS：
Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Science or related major with 5+ years of applicable work experience.
Strategic view and leadership abilities as well as hands on problem solving skills. Experience in managing projects is required.
Excitement about the vision and mission of WuXi Biologics.
Experience in two or more functional areas in cell line development, cell culture, purification, analytical, formulation, MFG/MFG support, QC, QA, project management in the biologics industry.
Experience with staff management and/or CMC team management.
Ability to effectively work across all levels, functions, sites and companies. Excellent verbal and written communication skills in both English and Chinese.
Experience in writing regulatory documents and submissions and ability to work on multiple CMC projects at a time.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department: Cell Culture Process Development (Shanghai/Wuxi, China)
Job Title: (Associate/Senior) Director, Cell Culture Process Development
KEY ACCOUNTIBILITIES：
1) Lead tech transfer activities and provide on-site and on-floor cell culture support for the cGMP facility in Wuxi city;
2) Develop & optimize cell culture processes for IND-enabling projects per China/US/EU regulatory requirements;
3) Develop & optimize late-stage (Phase II/III) cell culture processes, including design and execution of process characterization and validation studies.
4) Key aspects of the position include hiring/coaching/mentoring and managing junior staff members; technical oversight of study design, execution and results interpretation; interaction with manufacturing groups and development groups in Shanghai; and managing budgets etc.
REQUIREMENTS：
PhD degree and at least 4 years industry experience, or MS degree and at least 8 years industry experience.
He/she must have hands-on mammalian cell culture process development experience for protein therapeutics (preferably monoclonal antibodies), and have strong expertise in process optimization, scale-up and technology transfer.
Experience with medium optimization, DoE studies, regulatory submission to the FDA/EMEA and personnel management is a plus.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Biologics And Bioprocess （Shanghai/Wuxi, China）
Job Title：(Associate/Senior) Director of Protein Analytical Sciences
KEY ACCOUNTIBILITIES
Lead analytical group for biologics service at Shanghai and interact with Biologics sites at Wuxi and Philadelphia
Develop and improve analytical platforms for biologics to meet increasing demands of clients
Provide technical oversight (guidance) to staff in the Protein Analytical Sciences groups. Ensure ongoing training programs for continuous growth of key personnel. Recruit, train and retain a high performance team to ensure best quality services.
Provide technical leadership for all aspect of analytical services for a broad portfolio of biologics (mabs, ADCs, therapeutic proteins)
Contribute to growth of biologics business by using existing contacts and establishing contacts with new customers.
Build new capabilities and enhance current service offering of bioanalytical service and develop new clients by building up team and by evaluating new technologies/ equipment which can bring value to the customers
Contribute to budgeting process of Biologics Development and ability to operate within budget by maximizing efficiencies and pioneering innovative techniques
Work closely with Biologics Development department head to meet project timelines, departmental goal, and customer request.
Coordinate with the customer for new projects, preparing technical proposals addressing their needs and drawing up cost estimates for project work. Coordinate with customer service on project proposals for customers.
Participate in telecons, prepare update reports on ongoing projects to keep customers briefed on progress of projects , also prepare and review final reports for closing of projects
REQUIREMENTS
MS or Ph.D. degree in a relevant biopharmaceutical science discipline with 15+ years of industrial experience in the fields of biologics analytical release and characterization assay development, qualification, validation and transfer
Demonstrated record of accomplishments and in depth technical experience in the biologics analytical assay development intended for clinical trials and commercialization. Must be able to work in a team-oriented manner in order to accomplish objectives.
Must be proficient with the requirements of the FDA/EMA cGMP regulations, ICH guidelines. Familiarity and understanding of the CFDA cGMP regulations preferred.
Excellent written and verbal communication, negotiation, problem solving and decision making skills, and outstanding interpersonal skills
Demonstrated leadership and capability for strategic analysis and conflict resolution, organizational and project management skills preferred.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Protein Analytical Science （Wuxi , China）
Job Title：LC/MS Scientist/Group leader for Characterization of Protein Therapeutics
KEY ACCOUNTIBILITIES：
Planning, design and execute experiments for LC/MS characterization of monoclonal antibodies (mAbs) and protein therapeutics;
Operates and maintains LC-MS instrument;
Create and follows written instructions (e.g. SOPs) to execute experiments independently or with minimum supervision;
Keeps appropriate experimental records and documentation;
Analyzes, interprets, summarizes, compiles data and presents results at internal meeting;
Prepare and write/deliver documents including data summaries, technical and analytical reports;
Training and orientating new lab members;
Lead projects as analytical and characterization function leader
REQUIREMENTS：
Ph.D. (preferred) or M.S. with 2-years and more experience in protein chemistry, analytical chemistry, biochemistry/biophysics, or a related discipline with dedicated training in protein mass spectrometry or biologic LC/MS;
Solid knowledge on the HPLC and MS theories and technologies, and hands-on experience in operating, calibrating, maintaining and troubleshooting of advanced LC/MS systems;
Responsible for developing and utilizing mass spectrometry (such as Q-Exactive) to characterize proteins, such as protein intact mass/reduced mass, deglycosylated mass, PTMs characterization, disulfide bond mapping, peptide mapping, and glycan mapping, etc.;
Demonstrated analytics knowledge and experience in analytical testing method development & validation, protein stability studies, product-related impurity profiling, etc.;
A good team player with excellent interpersonal and communication skills (both written and verbal) and able to present data effectively;
An independent researcher with can-do manner and strong problem solving and troubleshooting capabilities; proactive and self-motivated; able to manage multiple tasks at one time;
Experience and knowledge with other protein analytical and characterization skills (e.g. LC, CE, SDS-PAGE, Western Blot, CD, DLS, Optical Spectroscopy) and knowledge on biopharmaceutical development and manufacturing is a plus
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Cell Culture Process Development （Wuxi , China）
Job Title：Scientist/Group leader for Cell Culture Process Development
KEY ACCOUNTIBILITIES：
Design experiments for cell culture process development for service projects. Technical oversight of study design, timely execution and results interpretation.
Communicate professionally and effectively with clients.
Prepare study reports and technology transfer documents.
Coach, mentor and manage junior staff members
REQUIREMENTS：
We are seeking a candidate with PhD degree and 0-2 years industry experience, or with MS degree and at least 3 years industry experience.
The candidate should have background in one of the following fields: biochemical or biological engineering, cell/molecular biology, biochemistry, or microbiology.
Hands-on experience in mammalian cell culture or microbial fermentation using bioreactors is preferred, and experience with recombinant protein expression is a plus.
Strong written and verbal communication skills are required, as well as ability to take on multiple tasks simultaneously.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Downstream Process Development （Wuxi , China）
Job Title：Associate Director/Director, Downstream Development
KEY ACCOUNTIBILITIES：
Design the downstream processes that are efficient, robust and scalable for the clinical manufacturing.
Assist the director to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
Oversee the process scale-up and technology transfer between the process development team and manufacturing team.
Coach the group leads and staff on the process development and validation.
Manage the activities for the validation of the downstream processes.
REQUIREMENTS：
MS with 12+ years, or PhD with 8+ years downstream process development experience.
At least 4 years’ people management experience
Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
Experience in downstream process cGMP production.
Experience in downstream process validation
Experience in working with the cross-functional teams.
Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
Experience in regulatory submission to FDA/EMA.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：BioManufacturing （Wuxi , China）
Job Title：Director of upstream Manufacturing
KEY ACCOUNTIBILITIES：
Supervise daily upstream manufacturing activities and ensure production timelines are met.
Collaborate with Process Development and Project Management groups technical transfer and process validation
Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
Provides working knowledge and technical leadership in purification operations.
Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
Motivate, retain, develop existing group members and recruit new staffs to build a strong upstream manufacturing team
Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear.
Communicate operational status regularly to senior director, as required, at the appropriate level of detail.
Assist the director to coordinate the work between the upstream groups and other functional groups to meet the production objectives and timelines
REQUIREMENTS：
BS/MS in a scientific discipline or equivalent is preferred.
Minimum 6-8 years working in a cGMP biological manufacturing environment with previous experience managing subordinates and/or leading project teams.
Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
Experience in working with the cross-functional teams.
Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
Must possess good interpersonal skills and the ability to communicate well, both verbally and written. Fluent in both Chinese and English.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Bio Manufacturing （Wuxi , China）
Job Title：Director of Downstream Manufacturing
KEY ACCOUNTIBILITIES：
Supervise daily downstream manufacturing activities and ensure production timelines are met.
Collaborate with Process Development and Project Management groups technical transfer and process validation
Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
Provides working knowledge and technical leadership in purification operations.
Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
Motivate, retain, develop existing group members and recruit new staffs to build a strong downstream manufacturing team
Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear.
Communicate operational status regularly to senior director, as required, at the appropriate level of detail.
Assist the director to coordinate the work between the downstream groups and other functional groups to meet the production objectives and timelines.
REQUIREMENTS：
BS/MS in a scientific discipline or equivalent is preferred.
Minimum 6-8 years working in a cGMP biological manufacturing environment with previous experience managing subordinates and/or leading project teams.
Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
Experience in working with the cross-functional teams.
Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
Must possess good interpersonal skills and the ability to communicate well, both verbally and written. Fluent in both Chinese and English.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Quality Control （Wuxi , China）
Job Title： Assistant Director/Associate Director/Director of AST
KEY ACCOUNTIBILITIES
Lead QC functional group(s) to perform analytical method development/ optimization, qualification/validation, and QC testing under cGMP.
Schedule resources, coordinate laboratory activities, improve data and document quality to regulatory requirements/expectations.
Author, review and approve technical documents such as SOPs, methods, protocols, reports, etc.
Provide technical leadership for problem solving and laboratory investigations.
Enhance current service offering and develop new capabilities
Communicate with other functional areas and clients to ensure timely completion of QC activities to meet project timeline.
Interact with regulatory CMC group to support IND and BLA filing.
REQUIREMENTS：
Graduate degree in analytical chemistry, biochemistry, molecular/cell biology, immunology, microbiology or related fields.
Experience in Pharmaceutical/Biopharmaceutical industry and team management experience are highly desirable.
Extensive knowledge and hands-on experience in one of the following areas are required.
Biochemical assays such as ELISA, cell based assay, qPCR, gel electrophoresis, Western blot, enzyme activity testing
Instrumental analysis such as HPLC, CE, Ion-chromatography, Mass Spectrometry
Strong oral and writing communication skills in both English and Chinese are required.
Knowledge in FDA/EMA cGMP regulations, Pharmacopoeias, and ICH guidelines is preferred.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Project Management （Wuxi , China）
Job Title： Project Manager or DOE
KEY ACCOUNTIBILITIES：
Leads the project team to fulfill the contract requirement and meet the client’s need for CMC development or manufacturing projects as appropriate.
Racks the progress of projects and coordinates WuXi's staff and resources to meet project deadlines in a timely and efficient manner.
Disseminates and facilitates information flow/exchange among WuXi departments and between the client and WuXi.
Manage scope change in project execution and assist to sign supplementary agreement for it.
Holds regular internal project meetings to discuss and plan the projects.
Holds regular meetings with clients to update progress via teleconference or site visits as appropriate.
Maintains records to document all relevant communications related to projects.
Copies files and mails final reports.
Help Service Department to generate invoices and send them to the client.
Maintains the WuXi standard quality and format of communications (e.g. letters, proposals, reports, etc.) and overall harmonization of documentation at the corporate level.
Monitors timeline and contract for accuracy and follows up on any discrepancies with clients and/or internal personnel.
Assists with training of team members as appropriate.
Tracks and confirms client materials transfer information.
Performs other duties as required.
REQUIREMENTS：
BS/MS/PhD with major in Biological Sciences, Chemical engineering, or equivalent training plus 1 or more years project management experience or equivalent training and/or experience.
Ability to accomplish the described duties through the use of appropriate computer equipment and software (i.e. Microsoft Word, Excel, PowerPoint, Project and Outlook) and general office equipment (i.e. photocopier, fax machine and phone equipment).
Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages.
Ability to use judgment as dictated by complexity of situation.
Ability to work under limited supervision and to handle problems of a more difficult nature.
Ability to interpret written instructions and to write form letters and routine correspondence.
Ability to understand and follow verbal or demonstrated instructions.
Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
Ability to prioritize tasks in fast paced work environment.
Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
Ability to build rapport with internal co-workers and clients in such a way as to maximize quality of client service.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
Department：Process Engineering & Validation （Wuxi , China）
Job Title： CSV & ERES Compliance Director
KEY ACCOUNTIBILITIES：
Automation and CSV for WuXi Biologics in general and the Wuxi Bio MFG2 facility in particular.
Establishing ERES and CSV/computerized system ERES compliance part of QMS (QM part, QSGs, SOPs and CSV validation/compliance documents).
Working closely with QA, QC, MFG/FFF, ENG, Operation and IT to achieve and maintain Computerized Systems and ERES compliance.
Lead and act as the key contact person / SME for all issues related to Computerized Systems and ERES compliance during routine quality operation, internal/external audits, health authority (HA) inspections and client communication.
Serve as a Computerized System Validation Subject Matter Expert and provide strategic guidance. Determine and establish validation requirements for computerized systems based on SOPs and regulatory standards (FDA, EMA) to ensure compliance and maintain an inspection ready state.
Lead the development of system specific validation plans and strategy using a risk-based approach.
Provide (modular) training of validation engineers and / or consultants to effectively produce validation deliverables following CSV SOPs and FDA 21CFR Part 11 requirements.
Provide regular updates related to key accountabilities and scope of the job to senior management.
Ensure quality of CSV deliverables for regulated systems and quality of non-regulated
REQUIREMENTS：
BS in Engineering, Computer Sciences, or related field.
At least 10 years of working experiences in the field of computerized system validation in the pharmaceutical industry. Additionally, have more than 5 years of working experiences in engineering fields.
An expert in related regulatory requirements and industry standards, such as 21 CFR Part 11/210/211, Annex 11 of EU GMP, GAMP 5, ICH Q9/Q10.
Proficiency in: Trackwise, SAP, LIMS, MES, DCS, Empower, automation, and other pharmaceutical IT systems; Data Management Systems.
Proficient speaking and writing in English. Having similar skills in Chinese is a plus. Excellent technical writing skills in English is required.
Excellent training skills for providing both classroom training and on the job training of CSV and ERES compliance.
To apply please send the CV to HR_Biologics@wuxiapptec.com.
药明康德 WuXi AppTec
药明康德新药开发有限公司，是全球领先的制药、生物技术以及医疗器械研发外包服务公司，在中美两国均有运营实体。作为一家以研究为首任，以客户为中心的公司，药明康德向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务，服务范围涵盖从药物发现到推向市场的全过程。
WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device outsourcing company with operations in China and the United States. We provide a broad and integrated portfolio of laboratory and manufacturing services and play an ever-expanding role in helping our customers discover and develop life-saving medicines and products for patients. Since its establishment in 2000, WuXi AppTec has grown to over 3 million square feet of laboratory and manufacturing space, with more than 7,000 talented, dedicated employees. Our rapid business expansion has opened up many exciting positions across the company and around the world.
Positions available in the USA
If interested in applying for any of these roles, please apply at www.wuxiapptec.com
Job Title: Account Executive, Laboratory Testing Division / New England
Summary of Job:
Responsible for driving the company’s continued growth in the U.S. markets and carrying the revenue targets from a spectrum of service offerings from the Testing Division, including chemistry & biology services at both discovery and clinical stage. Serves as the primary commercial point of contact for the Division: with key Pharma & Biotech stakeholders and decision makers, as well as key opinion leaders.
Customary Education and Experience:
Minimum 3 years of experience developing key accounts and driving top line CRO, Pharma, Biotech services revenue growth, through collaboration or independent efforts in a territory.
Minimum Bachelor’s degree in Life Science fields, MBA, M.S., or PhD from Life Science fields a plus.
Minimum 3 years of direct sales experience in CRO, Pharma & Biotech services, or related health care industries; International business or cross-cultural experience, ability to work with international teams.
50% travel with some international travel required.
Commercial background in Chemistry services and Bioanalysis services strongly preferred
Job Title: Project Manager / New Jersey or Southern California
Summary of Job:
Responsible for project management function within STA, WuXi’s API development and manufacturing division. Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting STA’s services in conferences/trade shows.
Customary Education and Experience:
Masters (MS) or PhD in chemistry
A minimum of 10 years pharmaceutical or CRO/CMO industry experience preferably in process R&D, API development and manufacturing area.
Prior experience in project management or managing external research collaborations.
Bilingual – English and Mandarin
Positions available in the People’s Republic of China
Job Title: Scientist, Chemistry /Chemistry Services Unit / Shanghai, Wuhan or Tianjin
Summary of Job:
Responsible for the design and synthesis of molecules on milligram to multi-gram scale.
Customary Education and Experience:
PhD in organic or medicinal chemistry, 2-3 years postdoctoral or industry experience, a solid background in synthetic / medicinal chemistry. Good communications skills in both English and Chinese and be a team player with great problem solving ability.
To apply email Haiyan Luo luo.haiyan.hr@wuxiapptec.com
Job Title: Associate Director to Director of Bioanalysis / WGQ / Suzhou
Summary of Job:
Leads a team responsible for development, validation and implementation of immunoassays in support of pre-clinical and clinical studies under GLP and non-GLP compliance.
Customary Education and Experience:
PhD with 2-3 years or MS with 3-5 years of relevant industrial experience.
Minimum Bachelor’s degree in Life Science fields, MBA or PhD from Life Science fields preferred.
Work experience in the CRO industry is helpful
International business or cross-cultural experience and ability to work with international teams.
To apply email Michael Xing - xing_shaoguo@wuxiapptec.com
Job Title: Continuous Processing (flow chemistry) Scientist / Shanghai
Summary of Job:
Responsible for the support of process development, optimization and scale up of continuous processes (flow chemistry processes) for intermediate and final API solids from lab to kilo lab and pilot plant.
Customary Education and Experience:
MSc with degrees in chemistry, chemical or process engineering with 2 years of experience in continuous processes, or reaction kinetics, or reaction engineering in Pharmaceutical R&D environments; OR
PhD degree in chemistry, chemical or process engineering with research in continuous processes, or reaction kinetics, or reaction engineering.
A postdoc experience in these areas is a plus.
Lab experience and willingness to work with organic chemists and plant engineers to develop continuous processes.
Job Title: Director / Sr. Director Process Research Development / Shanghai
Summary of Job:
Responsible for the support of process development, optimization and scale up of continuous processes (flow chemistry processes) for intermediate and final API solids from lab to kilo lab and pilot plant.
Customary Education and Experience:
PhD in organic chemistry or equivalent degree.
Be proficient in organic chemistry, process R&D and GMP regulations.
Excellent in presentation and communication in English.
10 years or above experience in organic synthesis or process R&D; 5 years or above work experience after PhD graduation; 3 years or above project management experience.
Demonstrate ability in problem solving, communications, project management and coordination, and team cooperation.
