Analytical Scientist, Protein Therapeutics & CMC

BioTalent; Collegeville (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

BioTalent is partnering with an innovative regenerative biologics company to add an Analytical Scientist to their Process & Analytical Development team in Collegeville, PA.

You will lead analytical method development for recombinant protein characterization, collaborating across CMC, process development and formulation teams to support development from early research through clinical milestones.

Qualifications

• BSc or MSc in Analytical Chemistry, Biochemistry, Biotechnology or related discipline with experience in biopharma.
• Strong hands-on experience with protein characterization and analytical method development.
• Expertise in chromatographic, electrophoretic and mass spectrometry techniques.
• Experience with GMP/GLP environments and method qualification/validation.

Responsibilities

• Develop, optimize and validate analytical methods for recombinant protein characterization.
• Lead protein analytics across purity, identity, potency and structural characterization.
• Apply HPLC/UPLC, CE-SDS, icIEF, LC-MS and spectroscopy techniques.
• Support formulation, process development and stability studies with analytical insight.
• Manage assay transfers and qualification with external CDMOs/CROs.
• Author technical reports, SOPs, validation protocols, and CMC documents.
• Support IND/BLA submissions and regulatory interactions as required.

Skills

Analytical chemistry

Biopharmaceutical experience

Method development

Data interpretation

Regulatory understanding

Education

MSc in Analytical Chemistry

Tools

HPLC/UPLC

SEC

RP

IEX

LC-MS

CE-SDS

Job description

BioTalent is partnering with an innovative regenerative biologics company to add an Analytical Scientist to their Process & Analytical Development team in Collegeville, PA.

You will lead analytical method development for recombinant protein characterization, collaborating across CMC, process development and formulation teams to support development from early research through clinical milestones.