Associate Scientist/Scientist of Drug Product Engineering

Location
Foster City, California, United States
Posted
Jul 25, 2021
Ref
1518188323
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 (DP) team. The primary responsibilities for the incumbent will be to support the DP process development of pre-clinical programs through to the phase 3 and commercial readiness of the lead program. This position will require the candidate to develop scalable and scaled manufacturing process for Vaxcyte's vaccine portfolio, being highly complex biological products.

Due to the high number Drug Substances (24) within the DP 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. The candidate will need to relish the scope and size of this unique challenge

Essential Activities:

• Generate early stage DP manufacturing processes that allow for accurate multivalent Drug Substance (DS) mixing, aseptic handling and homogeneity of the final suspension mixture prior to fill.

• Enable the team in general process design, including contact material selection, hardware design/construction, filter selection/sizing, mixing and filling activities at the phase 1 scale and in down scaled models

• Play a significant role in the build out of an in-house near full-scale production process for development and trouble shooting of the phase 3 process

• Aid in oversight of the fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables

• In concert with the CMC team and external guidance, aid in late-stage process characterization and process validation

• Provide engineering support, in conjunction with the CMO to generate the appropriate solutions for successful commercial mixing of the DP intermediates that allows compounding of the 24 DSs

• Scaleup and validation of mixing solutions for the DP bulk suspension mixture to ensure adequate homogeneity during the DP final fill and facilitation of internal development work.

• Participate in 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

• Aid in establishing supply chain logistics for the shipping of DS/intermediates/DP bulk under liquid or frozen conditions with suitable container closure systems

Requirements:

• BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development preferred, with >4 year of industrial experience; or PhD with >2 years.

• Experience in early and/or late-stage clinical manufacturing within fill finish sites under GMP regulations

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

• 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

• 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