Scientist, Analytical Development

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 partnered with an innovative regenerative biologics company looking to add an Analytical Scientist to their growing Process & Analytical Development team.

This is an opportunity to play a key role in the development of next-generation recombinant protein therapies, leading analytical method development and serving as a key technical interface with external CDMOs and CROs.

You'll work across CMC, process development and formulation teams to build and implement analytical strategies that support development from early-stage research through clinical and regulatory milestones.

What you'll be doing:

• Developing, optimizing and validating analytical methods for recombinant protein characterization
• Leading protein analytics across purity, identity, potency and structural characterization
• Applying techniques including HPLC/UPLC (SEC, RP, IEX), CE-SDS, icIEF, LC-MS and spectroscopy methods
• Supporting formulation, process development and stability studies through analytical insight and data interpretation
• Managing assay transfers, qualifications and validations with external CDMOs and CROs
• Authoring technical reports, SOPs, validation protocols and CMC documentation
• Supporting IND/BLA submissions and regulatory interactions where required
• Collaborating closely with Process Development, Formulation, Quality and Manufacturing teams

What we're looking for:

• BSc or MSc in Analytical Chemistry, Biochemistry, Biotechnology or a related discipline, alongside relevant experience in the Biopharmaceutical industry
• Strong hands-on experience with protein characterization and analytical method development
• Expertise across chromatographic, electrophoretic and mass spectrometry-based techniques
• Experience with method qualification and validation within GMP/GLP environments
• Strong understanding of protein chemistry, aggregation, degradation pathways and post-translational modifications
• Familiarity with biologics CMC development and regulatory expectations (FDA, EMA, ICH)
• Previous experience in a biopharmaceutical or CDMO environment is highly desirable

This role would suit an analytical scientist who enjoys working in a fast-moving development environment and wants broad exposure across protein therapeutics, CMC development and external partner management.