More jobs:
Scientist, Biologics Formulation Development
Job in
Costa Mesa, Orange County, California, 92626, USA
Listed on 2026-06-03
Listing for:
Avid Bioservices
Full Time
position Listed on 2026-06-03
Job specializations:
-
Research/Development
Research Scientist, Biotechnology
Job Description & How to Apply Below
Your Role:
The Scientist, Biologics Formulation Development will establish and lead formulation development activities within the Process Development department while also driving downstream process development of biologics programs. 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 Upstream Process Development, Analytical Sciences, MSAT, Manufacturing, Program Management, and external partners to support client programs.
Essential Functions:
(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
* Lead formulation development for biologics, including pre-formulation assessments, excipient screening, and stability studies.
* Extensive hands-on experience with analytical techniques for protein characterization, including DLS, DSF, SEC, CE, rheology, and spectroscopy.
* 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.
* Design and interpret analytical testing strategies including HPLC (SEC & IEX), CE-SDS, SDS-PAGE, UV spectroscopy, and other biophysical assays to support formulation studies.
* Establish scientific strategy, workflows, and best practices for early to late stage biologics formulation development.
* Proven ability to work independently in dynamic, fast-paced environments with evolving priorities.
* Serve as a technical subject matter expert (SME) during client proposals, presentations, and project reviews.
* Collaborate with cross-functional teams to align timelines and resource planning.
* Mentor junior scientists/staff and support onboarding of new team members.
* Evaluate new technologies and contribute to internal capability-building initiatives.
* Ensure compliance with relevant quality and safety standards.
* Perform other duties as assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The job description, shown above, is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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.
* Hands-on experience with biophysical and analytical techniques such as DSC, DLS, DSF, CD, HPLC, CE-SDS, UV spectroscopy, etc.
* Proven record of strong technical writing and communication skills.
* Ability to thrive in a dynamic, cross-functional environment.
Preferred Qualifications:
* Ph.D. in Biochemistry, Chemistry, or related field with 4-6 years of industry experience, or M.S. with 6-8 years of experience.
* Prior experience in downstream process development of biologics is a plus.
* Experience mentoring or leading scientific staff preferred.
Position Type/Expected…
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