Senior Scientist Analytical Development

TalentBurst•San Francisco, CA

22h•Remote

About The Position

The Senior Scientist, Biologics Analytical Development supports development of recombinant protein production processes and analytical strategies for biologic therapeutics. The role focuses on analytical method development, product characterization, and analytical support for process development activities involving microbial and mammalian expression systems. The position contributes to advancing therapies addressing unmet medical needs. The Senior Scientist develops, optimizes, and qualifies or validates analytical methods; characterizes recombinant proteins and protein conjugates; and supports upstream and downstream process development. The role also manages analytical activities performed by CROs, supports analytical transfers to CROs and CMOs, reviews data and regulatory materials, and collaborates with internal teams and external partners. The position authors and approves scientific documentation, maintains regulatory and quality compliance, and supports resource planning and organizational initiatives.

Requirements

At least 5 years of experience in the biotechnology or pharmaceutical industry; process development experience is preferred.
Demonstrated technical expertise, scientific creativity, and independent thinking.
Strong problem-solving, organizational, and analytical abilities.
Excellent written and verbal communication skills, including the ability to explain scientific concepts to technical and non-technical audiences.
Strong interpersonal and collaboration skills.
Proficiency with Microsoft Word, Excel, and PowerPoint.
Proficiency with Waters Empower software or other appropriate analysis software.
Ability to work effectively in a fast-paced, team-oriented environment.

Nice To Haves

Experience working in an FDA-regulated environment.
Knowledge of current GMP requirements and laboratory practices.
Applicable postdoctoral experience may be considered toward the experience requirement.

Responsibilities

Develop, optimize, and qualify or validate analytical methods for biologic products.
Characterize recombinant proteins and protein conjugates using analytical techniques.
Support upstream and downstream process development programs.
Manage analytical activities performed by CROs and support analytical transfers to CROs and CMOs.
Review analytical data supporting GLP and GMP manufacturing activities.
Review CMC sections of regulatory submissions.
Contribute to patent application activities as appropriate.
Independently analyze laboratory experiments.
Evaluate complex scientific data and apply sound technical judgment.
Collaborate with cross-functional teams and external partners.
Author and approve technical reports, protocols, and scientific documentation.
Maintain compliance with applicable regulatory and quality requirements.
Support resource planning, equipment identification, and organizational initiatives.