Senior Manager, Analytical Development (Bioassay/Potency)
Our organization is seeking a highly motivated Senior Manager to lead and manage our cell-based potency assay activities within the Vaccines Analytical Development team at our Company’s location in San Diego, CA. The candidate will lead the development and optimization of cell-based assays for the lot release and characterization of both adjuvanted and unadjuvanted vaccines for protection against viral and microbial diseases. The successful candidate will have hands-on experience with development and validation of in-vitro potency assays and familiarity with in vivo potency correlation studies.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- The qualified candidate will be responsible for leading and managing the development of phase-appropriate cell-based potency assay efforts to support our vaccine pipeline; responsibilities include development of new assay platforms and benchmarking current approaches/techniques to the industry standards to a degree ready to transfer to QC for late phase and commercial programs.
- The Senior Manager will lead and manage 2-6 individuals, as well as intra-company and external (CRO, CDMO) collaborations, in developing cell-based methods that assess antigen-specific potency of vaccine candidates, either directly or from immune response in animal models.
- The successful candidate will have hands-on experience with developing these assays along with demonstrated project leadership experience to develop and execute strategies to support regulatory approval of in vitro potency assays.
- The candidate must have a passion for mentoring and enjoy working on projects requiring close collaboration with groups such as discovery research, product sciences, process development, and QC.
- The successful candidate will be enthusiastic about developing novel vaccines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists.
- Preferably, the candidate would also have experience in engineering reporter gene assays, viral plaque and ID50 assays, and experience in assay qualification/validation according to ICHQ2 guidelines.
- The candidate will be expected to work independently, communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate in cross-functional teams.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
Minimum Education, Experience and Skills
- B.S degree with 10+ years’ experience or M.S. degree with 8+ years or Ph.D. degree with 6+ years of experience in virology, cell biology, immunology, or related field in the biopharmaceutical industry.
- GxP experience in a CMC group (QC/Analytical Development) in analytical method development and qualification under ICH/FDA guidelines is required.
- Expertise in developing cell-based potency assays to reflect mechanism of action of vaccine candidates and relative potency determination, with good understanding of the statistical approaches, e.g. USP1034 and EP5.3.
- Experience in viral infectivity assays such as plaque or immune-plaque assays, or TCID50, etc.
- Experience working with a variety of cell lines used in cell-based assays, e.g. Vero, HEK293, etc.
- Prior experience in bringing and applying new technologies suitable for bioassay development such as cell line engineering, stable clone generation, cell banking and cell imaging.
- Experience with in vitro and in vivo study designs statistical analysis of data, e.g. parallel line analysis and relative potency determination
- Experience establishing the range, accuracy, intermediate precision, and repeatability of an assay.
- Working knowledge of regulatory and industry guidelines for Chemistry Manufacturing and Controls (CMC).
- A strong team leader and player with excellent oral and written communication skills; ability to work independently and as a team lead.
- Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
- Strong verbal and written communication skills and effective interpersonal, technical discretion and troubleshooting skills are essential
- Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines
- Strong attention to detail supported by excellent time management and organizational skills