The Process Development Scientist, Analytical Methods (iNeST) is part of the Individualized NeoAntigen-Specific Immunotherapy team in the Pharma Technical organization (PT-iNeST) based in South San Francisco. iNeST is an RNA-based individualized cancer immunotherapy.
In this role, the Process Development Scientist, Analytical Methods (iNEST) will ensure relevant analytical methods are developed, validated and implemented from early development through product licensure. Responsibilities will include characterization, method development and qualification, supporting process development, release and stability testing of novel drug substance and drug products. The Process Development Scientist, Analytical Methods (iNEST will report to the Analytical Lead and interact closely with the dedicated, cross-functional iNeST team members in South San Francisco, Hillsboro, and Basel, as well as with our collaborators in Germany.
- Development and qualification of release, stability and characterization assays needed to support process development, clinical and commercial manufacturing
- Design, execution and analysis of experiments to support process development activities within the PTD labs. Presentation of results to cross-functional teams and corporate partners
- Support the implement of a novel control strategy for iNeST to enable high quality control (QC) throughput and minimum turnaround time for product release
- Author technical reports in support of analytical development and process development activities
- Support analytical method validation and transfers to commercial manufacturing site(s).
- Collaborate and/or author sections of documents to be reviewed by health authorities (e.g. INDa, IMPDa, BLA)
Who You Are
- PhD, Bachelor or Master degree in chemistry, biochemistry, chemical engineering or a related discipline and 8 - 10 years relevant experience in the pharmaceutical industry within analytical development.
- Candidates must have a strong background in protein analytical chemistry, experience in chromatography (HPLC, UPLC), capillary electrophoresis, mass spectroscopy, and/or other analytical techniques.
- Experience with individualized therapies or in field of RNA therapeutic products a strong plus.
- High flexibility and strong problem solving skills to meet business objectives. A ‘can-do’ attitude, with the ability to deal with ambiguity and to “think out of the box” and challenge the status quo
- Demonstrated ability to independently manage complex situations as well as to coordinate multiple tasks and manage priorities
- Strong verbal and written communication skills including the ability to present scientific results clearly and concisely
- A strong desire to work in a collaborative, multi-disciplinary environment; demonstrated ability to effectively interact in small teams.
- Customer-focused, motivated, detail-oriented, with excellent organizational skills
- German language proficiencies (verbal and written) a plus
- This position requires up to 10% international travel