Scientist, Process Engineering (Drug Product)
Alder Biopharmaceuticals is seeking a highly motivated individual to join the Pharmaceutical Operations Process Engineering department. This position will be filled at a level commensurate with experience. This individual will ensure drug product processes are robust, scalable, well-characterized, and economical for pipeline molecules. The successful candidate will interact with internal product development groups and with Alder's external CMOs/contract labs. Primary responsibilities may include developing process characterization studies, data analysis utilizing statistics, and providing reports to enable process validation for drug product.
In this newly created position, you will lead a wide variety of process development activities including:
- Design process characterization protocols and lead studies internally / externally to meet commercialization timelines 2017.
- Communicate to stakeholders current late-stage commercialization requirements for laboratory studies supporting process characterization of unit operations and developing acceptance criteria for these studies.
- Author regulatory sections for investigational new drug applications and marketing authorization regulatory filings.
- Perform on-site troubleshooting during process scale-up (international travel required).
- Interpret analytical results and write technical reports independently.
- Represent process development on one or more internal project teams and interact with CMO/external project teams to enable successful process validation.
- BS or MS in a relevant scientific discipline (such as engineering, chemistry, biochemistry, or analytical chemistry) and a minimum 5 years’ relevant experience.
- Experience scaling-up drug product, with a working knowledge of GMP requirements and ICH guidelines is required.
- The ability to work independently, and to proactively prioritize and accomplish multiple tasks simultaneously is required.
- The candidate should also have demonstrated experience with leading process characterization / process development efforts, including independent design of protocols and developing acceptance criteria.
- Experience authoring of regulatory filings is a plus.
- The candidate must be willing to periodically travel to contract manufacturing sites for on-site support.