Contract | Biotechnology / Vaccine Development
Viltis is seeking an experienced Senior Scientist, Downstream Process Development – Vaccines to support a biotechnology client with late-stage vaccine process development, scale-up, technology transfer, and commercialization activities.
This role is ideal for a downstream process development professional who has supported vaccine programs through Phase III and into commercial manufacturing and can take ownership of critical downstream technical workstreams. The Senior Scientist will work as part of an established process development team and collaborate closely with internal cross-functional groups and external CMO/CDMO manufacturing partners.
Key Responsibilities
- Lead and support downstream process development, optimization, characterization, scale-up, and technology transfer for vaccine manufacturing processes.
- Support late-stage/Phase III vaccine programs through PPQ, licensure, and commercial manufacturing readiness.
- Lead significant portions of downstream technical execution and technology transfer with external CMO/CDMO partners and manufacturing sites.
- Support pilot-scale and manufacturing-scale execution, including on-site scale-up, troubleshooting, process evaluation, and transfer activities.
- Provide technical expertise for downstream unit operations, including tangential flow filtration (TFF), UF/DF, membrane filtration, and purification operations.
- Define, evaluate, and troubleshoot critical downstream process parameters and process performance.
- Support process characterization, validation, and Process Performance Qualification (PPQ) activities.
- Develop, review, and execute technical documentation associated with process development, scale-up, validation, and technology transfer.
- Identify technical and manufacturing risks and develop appropriate solutions during scale-up and commercial transfer.
- Partner with Process Development, Manufacturing, MSAT, Quality, Regulatory, and other cross-functional groups to ensure successful program execution.
- Participate in technical investigations, troubleshooting, and decision-making with internal teams and external manufacturing partners.
- Ensure downstream processes are appropriately transferred, understood, validated, and executable at receiving manufacturing sites.
- Independently own assigned downstream technical workstreams while operating effectively within a broader project team.
Required Qualifications
- 10+ years of experience in biopharmaceutical process development, with substantial experience in downstream processing.
- Demonstrated experience supporting vaccine development programs, preferably in late-stage clinical development.
- Experience supporting a vaccine program through Phase III, process validation/PPQ, and transition into commercial manufacturing.
- Strong technical expertise in downstream process development, process characterization, scale-up, and technology transfer.
- Demonstrated experience transferring downstream processes to manufacturing facilities and/or CMO/CDMO partners.
- Hands-on technical experience with TFF/UF-DF, membrane filtration, and downstream purification processes.
- Experience supporting pilot-scale and/or manufacturing-scale downstream operations.
- Strong understanding of downstream process parameters, scale-up considerations, process robustness, troubleshooting, and manufacturing execution.
- Experience working within a regulated GMP biologics or vaccine manufacturing environment.
- Ability to independently lead technical workstreams and effectively collaborate with multidisciplinary teams.
- Strong technical communication, documentation, problem-solving, and stakeholder-management skills.
Preferred Qualifications
- Direct experience with Phase III-to-commercial vaccine development and manufacturing.
- Experience with PPQ, process validation, BLA/licensure support, and commercial launch/readiness.
- Experience supporting licensed or commercially manufactured vaccines.
- Experience with glycoconjugate, recombinant protein, antigen, or other biologic vaccine manufacturing processes.
- Previous experience working directly with CMOs/CDMOs on process transfer, scale-up, validation, and manufacturing execution.
- Experience transitioning downstream processes from development through clinical and commercial manufacturing.
- Advanced degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, Chemistry, or a related scientific/engineering discipline preferred; equivalent relevant industry experience will be considered.
What We're Looking For
The strongest candidates will have personally supported a vaccine program from late-stage/Phase III development through scale-up, technology transfer, PPQ or validation, and commercial manufacturing.
We are particularly interested in candidates who can clearly demonstrate ownership of downstream activities such as TFF/UF-DF, membrane filtration, purification, process characterization, scale-up, troubleshooting, CMO/CDMO technology transfer, and PPQ execution.
Position Details
- Position: Senior Scientist, Downstream Process Development – Vaccines
- Employment Type: Contract
- Function: Process Development / Manufacturing Sciences / Technology Transfer
- Industry: Biotechnology / Vaccine Manufacturing
About Viltis
Viltis provides specialized consulting and workforce solutions to organizations across the biotechnology, pharmaceutical, medical device, and life sciences industries. We connect experienced technical professionals with projects where their expertise can make an immediate impact.
Candidates with direct Phase III-to-commercial vaccine process development experience are strongly encouraged to apply.
Pay: $120,182.64 - $200,327.48 per year
Work Location: In person
