VP, Analytical Research & Development, Vaccines

We are a rapidly growing and dynamic organization that is founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health. Our goal is to build a company that equalizes opportunity for people around the world by removing barriers of health inequity, and we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases.

Objectives / Overview:

The Vice President of Analytical Development will work in partnership with the Senior Vice President of Technical Operations to provide leadership and management of the 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 for the program at the CDMOs.

In this role, an individual 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.

We are looking for a team player with strong leadership skills and ability and passion for mentoring and working along with others in a laboratory setting. Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior written and oral communications skills. A track record of delivering impactful solutions to complex analytical problems, and evidence of strong cross-functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy is a must.

This leader will ensure that the network of contract manufacturing organizations responsible for product supply is well managed, fully compliant and operating effectively and efficiently.



Responsibilities:

·       Support the SVP in the development, evaluation and implementation of strategies and initiatives to advance the vaccine program

·       End to end stewardship for establishing a robust analytical control strategy for the vaccine program 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

·       Cultivate a cohesive, innovative and nimble team environment

·       Ensure quality, compliance and robust method establishment at the CDMOs

·       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.

·       Work and collaborate effectively in a multidisciplinary team environment and provide technical input to enable team decisions.

·       Be an advocate for Analytical excellence with the senior leaders within The company and with external partners as needed

·       Establish operational excellence and performance goals at the CDMOs

Education, Experience & Skills:

·       Ph.D. in Chemistry/ Analytical chemistry/Biochemistry with 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.

·       Demonstrated ability for taking initiative, creativity and innovation in problem solving.

·       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.

·       Exceptional interaction, leadership and command skills with results-oriented focus is required.

·       Demonstrated change agility to successfully manage a high degree of complexity and multiple priorities.

·       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.

·       Established scientific reputation supported by publications and external presentations.

Travel Requirements:

●      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%.

The company is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.