WuXi AppTec Biologics Is Hiring
WuXi AppTec Biologics Is Hiring
Established in December 2000, WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device outsourcing company with operations in China and the United States. Our services are designed to help our worldwide customers shorten the time and lower the cost of drug and medical device R&D through cost-effective and efficient outsourcing solutions. WuXi is a NYSE-listed company (ticker symbol: WX) with more than 7,000 employees. More information about WuXi is available on the company website: http://www.wuxiapptec.com/index.html.
WuXi AppTec has invested substantially in building its capabilities and capacities in biologics in the past few years. The recent startup of its biologics manufacturing facility in Wuxi, the first in China to meet GMP standards of the United States, the European Union and China, marked another milestone for the company. This facility also is the first one globally to utilize 100% disposable equipment for biologics drug substance manufacturing. The company announced three deals in biologics: a collaboration with Open Monoclonal Technology to use OmniRat™, the first fully human monoclonal antibody platform based on transgenic rats, to develop novel human antibodies for global clients; a contract with TaiMed Biologics to produce the HIV compound ibalizumab for global phase II and III clinical trials; and a joint venture agreement with MedImmune, the global biologics arm of AstraZeneca, to develop MEDI5117, an IL-6 inhibitor for rheumatoid arthritis and autoimmune disorders in China.
We are actively recruiting experienced talents who are interested in joining our growing and vibrant organization dedicated to biologics development. Currently, we have the following open positions. If you are interested, please contact Haodi Dong at haodi.dong@wuxiapptec.com.
Upstream Cell Culture Process Development
Director/Senior Director, Cell Culture Process Development
This is a newly created position that will lead the cell culture process development (CCPD) group in Wuxi city. The group is being set up with the following main responsibilities: 1) to lead tech transfer activities and provide on-site and on-floor cell culture support for the cGMP facility in Wuxi city; 2) to develop & optimize cell culture processes for IND-enabling projects per China/US/EU regulatory requirements; 3) to develop & optimize late-stage (Phase II/III) cell culture processes, including design and execution of process characterization and validation studies.
Key Responsibilities
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.
Managing budgets, etc.
Qualifications
PhD degree and at least 6 years industry experience, or MS degree and at least 10 years industry experience.
Hands-on mammalian cell culture process development experience for protein therapeutics (monoclonal antibodies and recombinant proteins).
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.
Location
Wuxi city
Associate Director, Cell Culture Process Development
Key Responsibilities
1. Coaching, mentoring and managing junior staff members.
2. Technical oversight of study design, execution and results interpretation.
Interaction with manufacturing groups and development groups in Shanghai.
Qualifications
1. PhD degree and at least 4 years industry experience, or with MS degree and at least 8 years industry experience.
2. Hands-on mammalian cell culture process development experience for protein therapeutics, and have strong expertise in process optimization, scale-up and technology transfer.
3. Experience with medium optimization, DoE studies, regulatory submission to the FDA/EMEA and personnel management is preferred.
Location
Wuxi city
Senior Scientist, Cell Culture Process Development
Key Responsibilities
1. Study design, execution and results interpretation.
Qualifications
1. PhD degree and 0-2 years industry experience, or with MS degree and at least 3 years industry experience.
2. Background in one of the following fields: biochemical or biological engineering, cell/molecular biology, biochemistry, or microbiology.
3. Hands-on experience in mammalian cell culture or microbial fermentation using bioreactors is preferred, and experience with recombinant protein expression is a plus.
4. Strong written and verbal communication skills are required, as well as ability to take on multiple tasks simultaneously.
Location
Shanghai or Wuxi city
Downstream Purification Process Development
Director/Senior Director, Downstream Process Development
Downstream Process Development is responsible for purification process development, purification technology development, process scale-up, technical transfer and support for pre-clinical and clinical manufacturing of biologics derived from mammalian cell cultures. The scope of downstream process development includes cell culture clarification (centrifuge and depth filtration), column chromatography, viral inactivation/removal, and ultrafiltration/diafiltration.
Key Responsibilities
1. Designing the downstream processes that are efficient, robust and scalable for the clinical manufacturing.
2. Assisting the Senior Director to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
3. Overseeing the process scale-up and technology transfer activities between the process development team and manufacturing team.
4. Coaching the group leads and staff on the process development and validation.
5. Establishing the robust purification development and scale-up platform.
Qualifications
1. MS with 10+ years, or PhD with 6+ years downstream process development experience.
2. Experience in developing the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal.
3. Experience in working with the cross-functional teams.
4. Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
5. People management experience preferred.
Location
Shanghai or Wuxi city
Assistant/Associate Director, Downstream Development
Downstream Process Development Wuxi subdivision is responsible for the purification process development, scale-up, technical transfer and support for the pre-clinical and clinical manufacturing at WuXi AppTec biologics facility in Wuxi, China. The scope of downstream process development includes the cell culture clarification (centrifuge and depth filtration), column chromatography, viral inactivation/removal, and ultrafiltration/diafiltration. The Assistant/Associate Director is responsible for managing a downstream development sub-team to develop the scalable protein purification processes for the pre-clinical and cGMP clinical manufacturing, troubleshoot the issue of manufacturing, and execute downstream process validation.
Key Responsibilities
1. Designing the downstream processes that are efficient, robust and scalable for the clinical manufacturing.
2. Assisting the Director to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
3. Overseeing the process scale-up and technology transfer between the process development team and manufacturing team.
4. Coaching the group leads and staff on the process development and validation.
5. Managing the activities for the validation of the downstream processes.
Qualifications
1. MS with 8+ years, or PhD with 4+ years downstream process development experience.
2. Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal.
3. Experience in working with the cross-functional teams.
4. Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
5. At least 2 years people management experience.
Location
Wuxi city
Protein Analytical Sciences
Director/Senior Director, Analytical Development
This position is within the Protein Analytical Sciences (PAS) and located in the Wuxi city, China.
Key Responsibilities
Managing a PAS team to provide analytical support for cell culture and purification process development, process characterization, tech transfer and cGMP clinical manufacturing.
Qualifications
1. MS or Ph.D. degree in a relevant biopharmaceutical science discipline with 8+ years of industrial experience in the fields of biologics analytical release and characterization assay development, qualification, validation and transfer.
2. 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.
3. Must be proficient with the requirements of the FDA/EMA cGMP regulations, ICH guidelines. Familiarity and understanding of the CFDA cGMP regulations preferred.
4. Excellent written and verbal communication, negotiation, problem solving and decision making skills, and outstanding interpersonal skills
5. Demonstrated leadership and capability for strategic analysis and conflict resolution, organizational and project management skills preferred.
Location
Wuxi city
Director, Product Characterization
This position is within the Protein Analytical Sciences (PAS), which is responsible for developing methods for characterization of therapeutic protein drug candidates, hands on development experience with LC-MS and LC-MS/MS. We are seeking a motivated and experienced candidate with advanced degree in chemistry, analytical chemistry, biological sciences or related field, who exhibits a broad analytical aptitude and can function as a leader in a highly collaborative multidisciplinary team environment to perform characterization of proteins and peptides using state of the art LC-MS and LC-MS/MS based techniques and some other biophysical methods.
Key Responsibilities
Utilizing LC-MS techniques to analyze proteins and peptides to support therapeutic protein drug discovery and development.
Performing intact mass and peptide mapping analyses of proteins and peptides.
Operating, maintaining and troubleshooting of liquid chromatography, mass spectrometers and auxiliary instruments.
Designing and performing experiments, reviewing and analyzing data, and independently interpreting experiment results for qualitative and/or quantitative analyses of degradation and post-translational modifications (PTMs) of protein samples.
Presenting analytical results at group/project team meetings.
Writing analytical reports and updates to customers.
Managing a group of four scientists and provide technical supervision.
Qualifications
MS with 10+ years, or PhD with 6+ years of relevant experience as demonstrated by hands-on experience in protein analysis with LC-MS technique.
Knowledge of protein chemistry including PTMs and degradation pathways.
Understanding of LC-MS methods in protein characterization and hands-on experience in intact mass analysis and peptide mapping analysis of proteins.
Location
Shanghai
Protein Formulation Development
Principal Scientist / Assoc. Director / Director, Protein Formulation Development
The person in this function will lead the development of formulation and fill/finish process for monoclonal antibody, recombinant proteins, and other biologics.
Key Responsibilities
Leading a formulation team in Shanghai, China to support formulation, stressed studies, container closure system selection and process development for protein drugs or other parenteral drugs.
Leading preformulation studies to characterize candidate molecule and elucidate degradation pathways to gain understanding of stability challenges and develop strategies for stabilization.
Collaborating with analytical, cell culture and purification teams to lead the development and transfer of biosimilar, new formulation, container closure systems and fill-finish technology to support clinical development, tech transfer, and process validation for internal or external partners.
Hands-on some analytical instruments and methods such as DSC for liquid, DLS, CD, FTIR, SEC, IEX, SDS-PAGE, IEF, CE, UV spectroscopy, Karl Fischer coulometer, cIEF, Osmometer, particle counter and be able to interpret analytical data.
Collaborating with vendors, draft and then execute IQ/OQ/PQ of formulation and fill/finish instruments and equipments.
Planning, assigning, directing and evaluating the work of technical staff when assigned to the project to meet aggressive project timelines.
Supervising junior level scientists and evaluating their performance.
Presenting results internally and externally at weekly and monthly meetings with customers as well as industrial and scientific conferences.
Qualifications
PhD degree preferably in pharmaceutical chemistry, biochemistry, biophysics or engineering discipline.
PhD with 2 or more years of experience or BS/MS with 8 or more years in formulation development in biotechnology industry.
Hands-on and in-depth understanding of different protein chemistry characterization and stabilization techniques, as well as pharmaceutics relevant to drug product development including lyophilized, liquid and suspension dosage forms.
Good understanding of GMP, pharmacopea testing and regulatory requirements for filing and registration of biologics with some knowledge of Quality by Design approach.
Able to effectively partner with diverse team members from various functions at various levels in organizations.
Able to work with minimal supervision in a matrix environment and effectively manage multiple projects.
Location
Shanghai
