Sr. Scientist, Downstream and Biologics Formulation Development

Avid Bioservices•Tustin, CA

5d•Onsite

About The Position

Avid Bioservices 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. 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.

Requirements

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-developability assessment
Proven record of strong technical writing and communication skills.
Ability to thrive in a dynamic, cross-functional environment.

Nice To Haves

Demonstrated experience in formulation development for complex biologic modalities—including antibody–drug conjugates (ADCs)—with understanding of modality-specific stability and developability challenges is highly advantageous.
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.
Prior line management or informal leadership experience is advantageous.
Ph.D. in Biochemistry, Chemistry, or related field with 4-6 years of industry experience, or M.S. with 6-10 years of experience.
Prior experience in formulations process development and/or downstream process development of biologics is a plus.
Experience mentoring or leading scientific staff preferred.
Candidates with strong expertise in either biologics formulation development or downstream process development will be considered, with opportunities to contribute across both areas.
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Responsibilities

Lead formulation development for biologics, including pre-formulation assessments, excipient screening, and stability studies.
Lead downstream process development for biologics, including capture chromatography, polishing chromatography, viral inactivation/filtration, and tangential flow filtration (TFF).
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.
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.
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.