Sr. Scientist, Pharmaceutical Development

Biologics Drug Product Development Scientist About the Role

We are seeking a highly motivated Biologics Drug Product Development Scientist to support formulation development, analytical characterization, process development, and clinical manufacturing activities for protein-based therapeutics. This individual will play a key role in advancing biologics programs through hands-on laboratory execution, data analysis, and cross-functional collaboration in a fast-paced pharmaceutical development environment.

Key Responsibilities

+ Execute and support biologics drug product development activities, including formulation development, characterization, stability studies, and process optimization.

+ Perform analytical testing using a variety of characterization techniques, including HPLC/UPLC-based methods and protein analysis assays.

+ Generate, review, and maintain accurate laboratory documentation, including electronic and paper records, in compliance with GMP and pharmaceutical industry standards.

+ Analyze experimental data, identify trends, investigate atypical results, and communicate scientifically sound conclusions.

+ Collaborate closely with Analytical Development, Quality, Manufacturing, Program Management, and external partners to achieve project milestones.

+ Support technology transfer initiatives and clinical manufacturing activities, including fill-finish operations for biologics drug products.

+ Contribute to the development and execution of characterization strategies for protein therapeutics.

+ Manage multiple projects simultaneously and prioritize competing deadlines in a dynamic development environment.

+ Author and review technical documents including SOPs, protocols, study plans, and technical reports.

Required Qualifications

+ Bachelor's degree in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline with 4+ years of industry experience, OR Master's degree with 2+ years of relevant experience.

+ Hands-on experience with biologics drug product development and protein-based therapeutics.

+ Strong expertise with HPLC/UPLC techniques, including:

+ SEC

+ Reverse Phase (RP)

+ Hydrophobic Interaction Chromatography (HIC)

+ Ion Exchange Chromatography (IEX/CEX)

+ CAD

+ CE-SDS

+ Experience operating, maintaining, and troubleshooting chromatography systems.

+ Required experience performing imaged capillary isoelectric focusing (iCiEF) analysis.

+ Strong understanding of protein chemistry, biologics characterization, and analytical method execution.

+

Experience with charge variant analysis and particle characterization of biologic drug products.

+ Ability to interpret complex analytical data and present findings effectively.

+ Experience working within regulated pharmaceutical or biotechnology environments.

Preferred Qualifications

+ Experience supporting clinical manufacturing and technology transfer activities.

+ Knowledge of biologics fill-finish operations and drug product manufacturing processes.

+ Familiarity with broader analytical development strategies and CMC activities.

+ Strong project management and organizational skills.

+ Excellent written and verbal communication skills.

+ Proven ability to thrive in a highly collaborative, cross-functional environment.

Work Environment

+ Fully onsite laboratory position.

+ Monday through Friday, approximately 8:00 AM to 5:00 PM.

+ Collaborative pharmaceutical development environment with exposure to Analytical Development, Manufacturing, Quality, and Program Management teams.

+ Opportunity to work with state-of-the-art analytical instrumentation and contribute to the advancement of innovative biologics programs.

+ Contract engagement anticipated to last approximately 5-7 months.

+ Two-step interview process.

Ideal Candidate

The ideal candidate brings strong hands-on experience in biologics formulation and drug product development, advanced protein characterization expertise, and a proven ability to independently drive laboratory studies while collaborating effectively across multidisciplinary teams.

Experience with iCiEF, HPLC/UPLC-based characterization methods, and protein therapeutics is highly desired.

Job Type & Location

This is a Contract position based out of San Diego, CA.

Pay and Benefits

The pay range for this position is $43.00 - $43.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and…