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Sr. Scientist, Downstream and Biologics Formulation Development

Job in Tustin, Orange County, California, 92681, USA
Listing for: avidbio
Full Time position
Listed on 2026-07-09
Job specializations:
  • Research/Development
    Biotech Research, Research Scientist, Pharmaceutical Science/ Research, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 147200 - 184000 USD Yearly USD 147200.00 184000.00 YEAR
Job Description & How to Apply Below

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Your Role:

Avid is seeking a highly motivated and technically strong Sr. Scientist, Downstream and Biologics Formulation Development to lead biologics formulation development while contributing to integrated downstream process development within a fast-paced, client-facing environment. This role is responsible for defining formulation strategies, executing technical studies, and supporting cross-functional integration as the capability expands. Additional responsibilities include designing downstream purification processes for protein-based biologics, viral clearance studies, scale-down and scale-up activities, and technology transfer to manufacturing.

The individual will collaborate closely with Cell Line Development, Upstream Process Development, Analytical Sciences, MSAT, DS/DP Manufacturing, Program Management, and external partners to support client programs.

Key Responsibilities:
  • Lead formulation development for biologics, including pre-formulation assessments, excipient screening, and stability studies. Demonstrated experience in formulation development for complex biologic modalities—including antibody–drug conjugates (ADCs)—with understanding of modality-specific stability and develop ability challenges is highly advantageous.
  • Lead downstream process development for biologics, including capture chromatography, polishing chromatography, viral inactivation/filtration, and tangential flow filtration (TFF).
  • Extensive hands‑on experience with analytical techniques for protein characterization, including DLS, DSF, SEC, CE, rheology, and spectroscopy. Design and interpret analytical testing strategies including HPLC (SEC & IEX), CE‑SDS, SDS‑PAGE, UV spectroscopy, and other biophysical assays to support process development and formulation studies.
  • Expertise in developing high concentration protein formulations and resolving issues such as aggregation, viscosity, and solubility. Able to identify and mitigate formulation risks including precipitation and chemical degradation.
  • Design experiments, analyze data, and prepare technical protocols, reports, and development summaries.
  • Establish and drive scientific strategy, workflows, and best practices for early‑to‑late‑stage biologics formulation development, with the ability to operate independently in a dynamic, fast‑paced, client‑facing environment with evolving priorities.
  • Serve as a technical subject matter expert (SME) in client engagements, including proposals, presentations, and project reviews; prior line management or informal leadership experience is advantageous.
  • Collaborate effectively with cross‑functional teams to align project timelines, priorities, and resource planning.
  • Mentor and develop junior scientists and technical staff, and support onboarding of new team members.
  • Evaluate and implement new technologies and platform approaches to enhance internal capabilities and drive innovation.
  • Ensure compliance with applicable quality, regulatory, and safety standards.
  • Perform additional responsibilities as required to support evolving business and project needs.
  • Occasional travel may be required (by land or air) to attend conferences, seminars, off‑site client meetings, and marketing events as needed.
Minimum Qualifications:
  • Master’s degree/PhD degree in Biochemistry, Chemistry, or related field and minimum 4‑6 years of relevant experience and demonstrated working knowledge of scientific principles.
  • Prior experience in formulation development, stability studies, and analytical characterization of biologics or strong background in biochemical and biophysical characterization of proteins with deep understanding of protein structure and function.
  • Experience in development of ultra‑high concentration and pre‑develop ability assessment.
  • Proven record of strong technical writing and communication skills.
  • Ability to thrive in a dynamic, cross‑functional environment.
Preferred…
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