Scientist

BioTalent; Tustin (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BioTalent is seeking an experienced Scientist, Analytical Development to support development, characterization, validation, and transfer of analytical methods for large-molecule biologic products.

The role emphasizes hands-on experience with HPLC, CE, and ELISA, strong GMP knowledge, and leadership across QC, Manufacturing, and Process Development.

Qualifications

• BS in Biochemistry, Chemistry, Biology, or related scientific discipline.
• 8+ years of biotech industry experience in Analytical Development, QC, or a related analytical laboratory environment.
• Demonstrated large-molecule / protein biologics analytical experience.
• Hands-on experience with HPLC, CE and/or Potency/ELISA.
• Experience with protein characterization, chromatography, electrophoresis, and assay validation/qualification.
• Experience developing, troubleshooting, validating, and transferring analytical methods.
• Strong understanding of GMP/cGMP environments and regulatory expectations.
• Ability to review analytical data, investigate issues, prepare technical documentation, and provide scientific leadership.
• Experience collaborating cross-functionally with QC, Manufacturing, Process Development, Project Management, and/or external clients.

Responsibilities

• Developing and troubleshooting analytical methods.
• Leading method development and validation activities.
• Supporting stability and process-development studies.
• Serving as an analytical SME.
• Authoring/reviewing methods and SOPs.
• Transferring methods into QC.

Skills

Analytical development

HPLC

CE

ELISA

GMP knowledge

Scientific leadership

Data review

Education

Bachelor's degree in Biochemistry, Chemistry, Biology, or related scientific discipline

Tools

HPLC

CE

ELISA

Chromatography

Electrophoresis

Assay Validation

Job description

We’re looking for an experienced Scientist, Analytical Development to support the development, characterization, validation, and transfer of analytical methods for large-molecule / protein biologic products.

Candidates whose experience is primarily in small molecules without hands-on biologics/protein experience will not be a fit for this position.

What we’re looking for:

• BS in Biochemistry, Chemistry, Biology, or related scientific discipline
• 8+ years of biotech industry experience in Analytical Development, QC, or a related analytical laboratory environment
• Demonstrated large-molecule / protein biologics analytical experience
• Hands-on experience with HPLC, CE and/or Potency/ELISA
• Experience with protein characterization, chromatography, electrophoresis, and assay validation/qualification
• Experience developing, troubleshooting, validating, and transferring analytical methods
• Strong understanding of GMP/cGMP environments and regulatory expectations
• Ability to review analytical data, investigate issues, prepare technical documentation, and provide scientific leadership
• Experience collaborating cross-functionally with QC, Manufacturing, Process Development, Project Management, and/or external clients

Key responsibilities include developing and troubleshooting analytical methods, leading method development and validation activities, supporting stability and process-development studies, serving as an analytical SME, authoring/reviewing methods and SOPs, and transferring methods into QC.

Competitive compensation , depending on experience and qualifications, plus bonus and benefits.