Scientist, Downstream Process Development

BioTalent; Tustin (CA); On-site; USD 124,000 - 155,000; Full time

Benefits offered by this job

Annual bonus

Medical coverage

401(k) match

Paid time off

Job summary

BioTalent in the United States (Tustin, CA) seeks a Scientist, Downstream Process Development to advance purification programs for biologics. You will design, optimize, and transfer downstream processes, lead chromatography and filtration studies, and collaborate with multi-disciplinary teams from development through commercial manufacturing.

Qualifications include a PhD or MS with relevant experience, strong knowledge of downstream purification, and GMP experience.

Qualifications

• Ph.D./MS/BS with relevant biopharma industry experience.
• Experience in downstream purification process development for biologics.
• GMP-regulated environment experience preferred.

Responsibilities

• Design, develop, and optimize downstream purification processes for monoclonal antibodies and biologics.
• Lead chromatography, filtration, buffer optimization, viral clearance, and scale-up studies.
• Analyze data, prepare technical reports, and present findings to teams and stakeholders.
• Troubleshoot purification challenges and recommend scientifically sound solutions.
• Support technology transfer and manufacturing within GMP environments.
• Collaborate with Process Development, Analytical Sciences, Manufacturing, MSAT, and clients.

Skills

Downstream purification

Process development

Scale-up studies

GMP experience

Data interpretation

Chromatography

Team collaboration

Education

PhD in Chemical Engineering or Biochemical Engineering

MS with 5+ years experience

BS with 8+ years experience

Tools

PAT

High-throughput methods

Automation technologies

Digital data systems

Job description

Scientist, Downstream Process Development

Are you passionate about advancing innovative biologic therapies and making a meaningful impact on patient lives? Our client, a leading CDMO in the biopharmaceutical industry, is seeking a Scientist, Downstream Process Development to join their growing team in Tustin, CA.

In this role, you will contribute to the development, optimization, and transfer of downstream purification processes for a variety of protein-based biologics. You'll work alongside multidisciplinary teams to support programs from early development through commercial manufacturing.

What You'll Do

• Design, develop, and optimize downstream purification processes for monoclonal antibodies, recombinant proteins, and other biologic products.
• Lead chromatography, filtration, buffer optimization, viral clearance, and process scale‑up studies.
• Analyze and interpret experimental data, prepare technical reports, and present findings to internal teams and external stakeholders.
• Troubleshoot complex purification challenges and recommend scientifically sound solutions.
• Support technology transfer activities and manufacturing implementation within GMP‑regulated environments.
• Collaborate closely with Process Development, Analytical Sciences, Manufacturing, MSAT, Program Management, and client teams.
• Provide scientific guidance and mentorship to junior team members when needed.
• Contribute to process characterization, experimental design, and continuous improvement initiatives.

Preferred Experience

• Strong expertise in downstream process development for biologics, including purification, process characterization, and scale‑up.
• Solid understanding of protein purification principles and biopharmaceutical development workflows.
• Experience working in regulated environments supporting clinical and commercial manufacturing programs.
• Familiarity with PAT, high‑throughput process development, automation technologies, process intensification, and digital data systems is advantageous.
• Ability to effectively communicate technical concepts to diverse audiences, including clients and senior leadership.

Qualifications

Required

• Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, Biological Sciences, or a related field with 0–3 years of industry experience; OR
• M.S. degree with 5+ years of relevant experience; OR
• B.S. degree with 8+ years of biopharmaceutical industry experience.

Preferred

• Ph.D. in Biochemistry, Chemistry, or a related scientific discipline.
• Previous experience leading downstream process development projects for biologics.
• Experience mentoring, coaching, or leading scientific staff.

Base Salary: $124,000 – $155,000 annually (based on experience and qualifications)

In addition to competitive compensation, the company offers:

• Annual performance bonus opportunities
• Comprehensive medical, dental, and vision coverage
• 401(k) with company match
• Generous paid time off
• Career growth and professional development opportunities
• Collaborative and inclusive work environment

Applicants must be legally authorized to work in the United States for any employer. Sponsorship is not available for this position now or in the future.