Vaccine Drug Substance Process Development Lead - Contract

Company Description

Sia Partners is a next-generation consulting firm focused on delivering superior value and tangible results to its clients as they navigate the digital revolution. Our global footprint and expertise in more than 40 sectors and services allow us to enhance our clients’ businesses worldwide. We guide their projects and initiatives in strategy, business transformation, IT & digital strategy, and Data Science.

Job Description

This role will contribute to our client’s mission through a range of activities from developability assessments through Drug Substance and Drug Product development, manufacturing for pre-clinical and early/late phase clinical studies, to establishing a commercially viable process and product design. The client works in an outsourced model, so this role will partner collaboratively with a network of trusted partners and manage activities through this network. Your ability to establish and maintain productive relationships will be a key part of your success and your opportunity in this role.

With our goal of providing affordable solutions, innovation in manufacturing technology is not optional, it is key to our client’s mission. This role will work with colleagues across the CMC department (Biologics, Pharmaceuticals, Analytical, Clinical Supply and Operations) on the planning and execution of activities to support DS Vaccine Development including QbD activities, technical risk assessment, and control strategy. The role calls for an individual who combines deep vaccine process development expertise with the willingness to roll up their sleeves and address the issue of the day.

Location: Remote, Cambridge, MA preferred

Project Length: 8 Months

Compensation Range: This role's compensation is contingent depending upon years of experience, education, and relevant certifications

Responsibilities 

• Provides Upstream and Downstream Drug Substance (DS) CMC operational oversight to vaccine pre-PPQ development programs consisting of process development, in process controls and testing, release and characterization, scale-up, and commercial scale development.
• Support late-phase process development and QBD control strategy.
• Facilitates technical risk assessment evaluations and manages archiving of related documents.
• With a focus on access and affordability support DS commercial process development.
• Authors DS CMC sections for regulatory filings in collaboration with SMEs and quality documentation.
• Provide support to queries from Client regulatory for DS CMC sections authored.
• Support leadership in corporate strategy and planning exercises related to vaccine DS development and commercial manufacturing.
• As needed: Provide in-person support (including potential Person In Plant) to late phase DS process development at CDMO in Europe.

Qualifications

• Degree in engineering or a scientific discipline with demonstrable experience in biologic process development:
  • PhD or equivalent degree plus 6 years of relevant industry experience in vaccine Drug Substance development, release, characterization, scale-up and technology transfer, including experience with Phase 3 development programs.
  • Masters degree plus 9 years of relevant industry experience.
• Applied to upstream/downstream process development in preparation for PPQ, experience with:
  • Design of Experiment (DOE) and
  • Quality By Design (QBD)
• Experience in CDMO/CMO management and oversight is strongly preferred.
• Experience in technical risk assessment including cause and effect (C&E) and failure mode evaluation assessment (FMEA).
• Late phase (Phase 3) process development experience.
• CMC analytical experience is plus. Good understanding of manufacturing efficiency and manufacturing cost structures.
• cGMP experience – especially with Phase 3 CMC product development.
• Willingness to travel as required to Europe or Cambridge, MA (estimated 0-3 trips)
• Willingness to be a hands-on problem solver.

Additional Information

At this time, Sia Partners does not intend to pursue employment with applicants who require/will require sponsorship for work authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa, or any other non-immigrant status). Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for work authorization.  

Our Commitment to Diversity

Diversity, equity, inclusion, and belonging (DEIB) are part of Sia Partners’ DNA. Thanks to our expertise in several sectors and our international growth, our teams include a variety of experiences and cultures. We’re confident that promoting DEIB creates an en