Senior/Principal Scientist of Drug Product Engineering

Location
Foster City, California, United States
Posted
Jul 25, 2021
Ref
1095606790
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Vaxcyte is looking for an energetic and talented individual to join the Formulation and Drug Product Development team. The primary responsibility for the incumbent will be to support the late stage activities of the Drug Product (DP) team in readiness for phase 3 clinical studies and through commercial launch.

Due to the number of antigens and the suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. This is a senior position and will require the candidate to have a high level of independence, scientific judgement, and leadership abilities.

Essential Activities:

• Aid in evaluation, selection, and oversight of an appropriate fill finish CMO service

provider to support early, late, and commercial stage manufacturing deliverables

• In concert with the CMC team and external guidance, design and oversee late-stage process

characterization and process validation strategies consistent with CMC-regulatory

guidance

• Provide engineering guidance, in conjunction with the CMO to generate the appropriate

solutions for successful commercial mixing of the DP intermediates that allows

compounding of 24 Drug Substances (DS)

• Scaleup of mixing solutions for the DP bulk suspension mixture to ensure adequate

homogeneity during the DP final fill and facilitation of internal development work.

• Generation, testing, and validation of the above mixing solutions for the DP bulk

suspension mixture to ensure adequate homogeneity during the DP final fill.

• Participate cross-functional process risk analysis using appropriate tools such as FMEA,

leading to the identification of CPPs and CQAs, in conjunction with other Regulatory/CMC

leaders

• Ultimately establish supply chain logistics for the shipping of DS/intermediates/DP bulk

under liquid or frozen conditions with suitable container closure systems

• Experience of the specifics in transferring from a vial to pre-filled syringe solution from

an engineering perspective

Requirements:

• BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development

preferred, with >10 year of industrial experience; or PhD with >7 years.

• Experience in late-stage clinical manufacturing within fill finish sites under GMP

regulations; it is mandatory that the successful candidate be entirely conversant with GMP

manufacturing

• Experience of chemical engineering in the biological manufacturing space, leading to

custom engineering solutions

• Experience in the progression of such engineering solutions from early to late clinical stage

and through commercial launch, preferably in the fill/finish arena

• Experience in the development of scaleup/down models and how they pertain to mixing of

DP bulk, preferably suspension systems

• Experience in validation of DP processes, including the use of QbD as required

• Experience in leading the evaluation, selection and oversight of CMOs that perform DP fill

finish activities

• An understanding of the design and management of logistical supply chains to enable

bespoke fill finish activities

• Strong interpersonal and leadership skills; ability to communicate effectively both verbally

and in written formats

• Ability to work within in a fast-paced, cross functional environment, multitasking as

needed