Senior Scientist, Biologics Analytical Development

TalentBurst, an Inc 5000 company; San Francisco (CA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, dental, vision benefits

Retirement plan

Job summary

TalentBurst is seeking a Senior Scientist, Biologics Analytical Development in San Francisco, CA. This 4-month contract role focuses on analytical method development for recombinant proteins, characterization using HPLC, MS, and biophysical techniques, and supporting process development activities in microbial and mammalian systems.

The candidate will manage CRO/CMO activities, contribute to GMP documentation, and collaborate with cross-functional teams to advance innovative biologic therapies.

Qualifications

• 5+ years in biotechnology or pharmaceutical industry; process development preferred.
• Strong analytical and problem-solving skills; ability to interpret complex data.
• Excellent written and verbal communication; able to present technical data clearly.

Responsibilities

• Develop, qualify, and optimize analytical methods for biologics.
• Characterize proteins and conjugates; perform QC-support and tech transfers.
• Oversee CRO/CMO activities and ensure GMP-compliant documentation.
• Review data, write/approve technical reports and regulatory sections as needed.
• Lead and mentor junior staff; collaborate across cross-functional teams.

Skills

Analytical method development

Protein characterization

Data analysis

Scientific communication

Team collaboration

Tools

HPLC

CE

Mass Spectrometry

Biophysical characterization

Job description

Job Title: Senior Scientist, Biologics Analytical Development

Duration: 4 Months

Location: San Francisco, CA (Remote)

Duties

The Senior Scientist, Biologics Analytical Development, supports the development of recombinant protein production processes and analytical strategies for biologic therapeutics. This role is responsible for analytical method development, product characterization, and analytical support for process development activities involving microbial and mammalian expression systems. The position contributes to the advancement of innovative therapies addressing unmet medical needs.

Key Highlights

• Analytical method development and optimization


• Protein and conjugate characterization using HPLC, CE, Mass Spectrometry, and biophysical characterization techniques


• Support of upstream and downstream process development


• CRO/CMO oversight and technology transfer activities


• GMP manufacturing support and regulatory documentation contributions

Essential Duties & Responsibilities

• Support extended characterization studies of recombinant proteins and protein conjugates using a variety of analytical techniques including LC-MS peptide mapping, U/HPLC, SEC, IEX, CE-SDS, iCIEF, GC/GC-MS, and biophysical techniques


• Process and review analytical data utilizing modern chromatographic and mass spectrometry CDS/MS software platforms


• Write and approve technical reports, SOPs, and method protocols; Develop, optimize, and qualify analytical methods for biologic products.


• Characterize and quantify product and process related impurities; Support upstream and downstream process development programs.


• Manage analytical activities performed by CROs and support analytical transfers to CROs and CMOs.


• Review analytical data and reports supporting GMP manufacturing activities.


• Author and/or review CMC sections of regulatory submissions.


• Independently design, execute, and 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.


• Lead projects, mentor team members, and provide training as needed.

Skills

• Minimum 5 years of experience within the biotechnology or pharmaceutical industry, preferably in process development. Applicable postdoctoral experience may be considered toward the experience requirement.


• Demonstrated technical expertise, scientific creativity, and independent thinking.


• Strong problem-solving, organizational, and analytical abilities.


• Excellent written and verbal communication skills.


• Ability to effectively communicate scientific concepts to both technical and non-technical audiences.


• Strong interpersonal and collaboration skills.


• Proficiency with Microsoft Word, Excel, and PowerPoint.


• Ability to work effectively in a fast-paced, team-oriented environment.

Preferred Qualifications

• Experience working in an FDA-regulated environment.


• Knowledge of current GMP requirements and laboratory practices.


• Experience contributing to regulatory submissions.


• Prior leadership or management experience.

Why TalentBurst?

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

• We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.