Our clinical-stage Vaccine Client based in Boston, MA is growing and looking to add a VP, Analytical Development (remote/hybrid) to their team! VP will work in partnership with the SVP of Technical Operations to provide leadership and management of their lead vaccine program with regard to developing the Analytical method development and characterization strategy for the Virus like particles and the drug product. In particular, the successful candidate will demonstrate a strong focus on technical leadership of vaccine program and guide the internal and external CDMO teams on scientific and technical development topics required for establishing the analytical control strategy. VP will lead a team of scientists and work closely with the Technical Operations team to design and develop the Analytical strategy for solving complex analytical problems to facilitate vaccine process characterization and formulation development. The ideal candidate will have in-depth knowledge in protein chemistry, structural biology, and biochemistry to characterize virus like particles, adjuvanted drug substance and drug product using an array of biophysical and biochemical tools.
As a member of the Technical Operations Leadership Team, the VP is accountable for successful implementation of the analytical control strategy, including method development, qualification and validation to enable product release, extended characterization and stability for GMP batch manufacture at the CDMOs in alignment with Technical Operations vision and strategies. This individual will also drive strategy for management of critical reagents including reference standards, develop and justify product specifications and ensure analytical robustness over the life cycle of the program.
- Support the SVP in the development, evaluation and implementation of strategies and initiatives to advance the lead vaccine program.
- End to end stewardship for establishing a robust analytical control strategy; including resource planning, team productivity and timeline management of the deliverables.
- Provide strategic, tactical and technical leadership in the development of analytical methods for characterization of critical raw materials, process intermediates, virus like particles, adjuvanted drug substance and drug product.
- Provide scientific and technical leadership and oversight for the ongoing vaccine program at the CDMOs.
- Responsible for establishing specific objectives and timelines at the CDMOs, identify key scientific issues and critically assess scientific data to drive resolutions
- Lead and manage a team of scientists applying analytical methods to support vaccine process development and characterization, formulation development, root cause investigations, method qualifications and transfers.
- Ensure characterization methods developed and implemented at the CDMOs are technically sound, robust and support regulatory filings.
- Evaluate and establish contracts with CDMOs and CROs for characterization, method development or stability studies.
- Drive analytical innovation and stay current on the cutting-edge analytical technology to drive life cycle management initiatives.
- Provide technical direction, mentorship and coaching to the analytical team.
- Deliver against business metrics to implement continuously improve operations at the CDMOs.
- Proactively anticipate and pan to ensure rapid and effective resolution of analytical challenges at the CDMO.
- Guide the team in authoring and reviewing scientific documents including development reports, analytical method protocols, qualification protocols, and electronic notebooks.
- Ph.D. in Chemistry/ Analytical chemistry/Biochemistry & a minimum of 12+ years of relevant experience in the pharmaceutical industry or a Masters with 15+years of experience in Pharma/biotech industry experience is required.
- Ideal candidate will have proven track record of heading Analytical Development function for Vaccines or parenterals. Experience with alum adjuvanted formulations is a strong plus.
- Must possess a strong understanding of protein chemistry and biochemistry, particularly of various analytical chemistry methodology principles with a successful track record of method development, trouble shooting and validation for GMP release as well as extended characterization analysis
- Extensive experience in Mass spectrometry, U/HPLC, Biophysical methods (DLS, SEC MALS, FTIR, PFI) is preferred.
- Familiar with ICH guideline of analytical procedure validation and transfer.
- Experience with assay robustness evaluation, method validation or qualification.
- Experience with method transfer.
- Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment. Excellent verbal and written communication skills.
- Capable of multi-tasking and managing multiple projects.
- Knows and understands Quality compliance processes and regulations pertaining to production of sterile injectables (vaccines).
- Demonstrated ability to establish collaborative, effective relationships with key external partners, including executive leaders of key CMOs and alliance partners.
- Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise) and makes the best decisions for the whole.
- Excellent influencing and negotiating experience and capabilities in a matrix environment.
- Strong project management and execution skills and can manage multiple projects and prioritize as needed. Ability to plan and conduct projects within a multi-disciplinary environment.
- Ability to travel to the Boston office monthly for 3-4 days.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Approximately 10-20%.