WuXi BiologicsRemote
VP, Head of Analytical Science and Quality Control, MVP Business
United States of America
Full Time
4 weeks ago
H1B Sponsor Likely
Key skills
Ph.D in Analytical ChemistryMass spectrometry techniquesBiopharmaceutical analysis experienceAnalytical assay developmentBiopharmaceutical CMC knowledgeRegulatory requirements knowledgeDigital management mindsetTeam management experienceRStrategic PlanningCommunication
About this role
WuXi Biologics is seeking a VP, Head of Analytical Science and Quality Control for their MVP Business. The role involves leading a large analytical and quality control team to develop and execute strategic plans for analytical services, ensuring compliance and enhancing business growth.
Responsibilities:
- Lead analytical and QC functions (> 150 people) to provide a full spectrum of analytical services for products from microbial/mRNA/HEK293 platforms from pre-IND to commercial manufacturing. Develop long - term strategic plans for the expansion and optimization of services in accordance with prevailing industry trends
- The scope of the ASQC team includes but not limited to analytical assay development, transfer, qualification and validation; GMP batch release; raw material testing and release; stability program management; EM in BSL1/BSL2 and GMP facility; MFG investigation support; work closely with RA and QA for global regulatory filing; support and host quality auditing; testing outsourcing management. Continuously evaluate and adjust the strategic direction to ensure maximum efficiency and effectiveness
- Serve as CMC leader and alliance key contact for critical projects and clients. Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients. Develop and execute client - centric strategies to enhance partnerships and drive business growth
- Represent ASQC functions in the CMC management review committee. Collaborate with CMC functional areas to ensure successful execution of various CMC projects, and delivery of results on time and within budget. Contribute to the overall CMC strategic planning by providing insights from the ASQC
- Oversee team management, project delivery and support new technology development. Recruit, train and retain high performance teams to ensure best quality services
- Develop and manage operational budgets and supervise teams to ensure IP and EHS compliance. Incorporate cost - effectiveness and risk - management strategies into budget planning
- Assist or lead (if necessary) in BD efforts. Enhance current service offering and develop new clients. Develop and implement strategies to enhance existing service offerings and actively develop new clients. Assist the head of MVP to identify and pursue strategic business opportunities to expand the company's market share in microbial/mRNA/LNP/HEK293 sections
- Establish solid documentation systems within the organization, to record and document all studies to support regulatory filings and inspections, as well as business development and financing projects
- Adopt and/or develop new technologies for improvement of quality, speed, and/or cost effectiveness. Identify emerging technologies and trends in the AS/QC field and integrate them into the strategic plan for continuous improvement
Requirements:
- Ph.D in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related fields; strong academic background with biopharmaceutical analysis major is preferred
- Over 15 years of experience in biopharmaceutical analysis, including at least 8 years team management experience (hold technical management experience at least 100/team size)
- Proficient in mass spectrometry techniques (LC-MS, GC-MS, etc.), biopharmaceutical physicochemical characterization methods (e.g., SEC-MALS, CE-SDS, DLS), and bioactivity assay development at the non-GMP stage
- Hands-on experience in the mRNA/LNP and complex protein therapeutics
- Familiar with the entire biopharmaceutical R&D process (early discovery → process development → pre-clinical)
- Deep understanding of analytical technical requirements and industry regulations (e.g., ICH, FDA guidelines) at the non-GMP stage
- Proficient in analytical assay development, transfer, qualification and validation; GMP batch release; raw material testing and release; EM, stability program management etc
- Proficient in biopharmaceutical analysis and relevant regulations; Excellent in biopharmaceutical CMC knowledge
- Familiar with biopharmaceutical industry practices and regulatory requirements; possesses digital management mindset
- Fluent language capabilities, excellent communication skill