Director – Pharmacokinetics – Early Development Vaccines
| Company | Inventing for Life |
|---|---|
| Location | Ambler, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- A Ph.D. or doctoral level degree in Biology, Immunology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related area with 8+ years, a MS degree with 10+ years, or BS degree with 14+ years of relevant experience
- 8+ years of experience in molecular biology, immunogenicity and cell-based assay development and optimization
- Actively working with staff to encourage and facilitate their personal and scientific development
- A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent
- Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence and curiosity
- Setting future strategies and bringing new technologies into the regulated labs
- Partner with our Outsourcing team to provide scientific oversight at our Clinical Research Organizations (CROs) to ensure data quality and accuracy is aligned with our company’s expectations
- Has in-depth understanding of the drug discovery and/or development process and comprehensive knowledge of the principles and concepts of bioanalytical and/or vaccine clinical testing/regulatory filing
- Strong technical expertise in bioanalytical assay design, development, and execution in support of antiviral, antibacterial, cell and gene therapy, and/or vaccine discovery
- Has advanced knowledge in multiplexed immunogenicity and cell-based assays
- Candidate must be trained in GLP and GCLP requirements and must have experience working in a regulated laboratory environment
- Proven ability to lead the development of new, innovative bioanalytical techniques including experience in new assay technology evaluation and optimizing these technologies to garner health authority approval
- Established external scientific reputation (e.g. publication record, leadership in consortia, external presentations)
Responsibilities
- Lead a team to support vaccine early development (Phase 1 and 2)
- Contribute to drug discovery and development teams within the Infectious Disease and Vaccines therapeutic areas
- Oversee a broad portfolio of molecular and cell-mediated based serology assays
- Collaborate with CROs for assays that are outsourced
- Help teams develop a clinical assay strategy for data-driven decision-making
- Mentor, scientifically supervise, and train scientists to become future leaders
Preferred Qualifications
- Experience with immunoassay platforms such as MesoScaleDiscovery, Luminex, ELISA, AphaLISA is a plus
- Experience in cell-based functional assays to monitor immunogenicity
- Familiar with liquid handlers and other automation/robotic platforms for sample preparation and assay process
- Working knowledge and proponent of developing a strategy to utilize a standardization process for Data Analysis and strong supporter of using the Design of experts to improve robustness in bioanalytical
- Experience in authoring and responding to communications with regulatory agencies