QC Analytical Leader — Biologics, Methods & QA Impact

BioTalent; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

BioTalent, partnered with a rapidly growing biologics CDMO, seeks a QC Manager, Analytical to oversee analytical testing activities supporting biologics development and manufacturing programs.

This hands-on leadership role blends technical excellence with people management, overseeing method transfer, validation, investigations, and continuous improvement across QC operations to ensure GMP-compliant analytics from development through commercial production.

Qualifications

• GMP-regulated biopharmaceutical, biologics or CDMO experience.
• Supervisory experience in a QC Analytical lab.
• Expertise across analytical methods including HPLC/UPLC, CE, ELISA, qPCR, MS and related techniques.
• Experience with method transfer, qualification, validation, and lifecycle management.
• Strong knowledge of FDA, ICH and GMP requirements.
• Proven ability to lead investigations including OOS, OOT and deviation management.

Responsibilities

• Lead and develop a team of QC Analysts and Scientists within the analytical testing group.
• Provide technical oversight for analytical testing of biologics, vaccines, cell and gene therapies, and related products.
• Support analytical methods including HPLC/UPLC, CE, ELISA, qPCR, spectroscopy, bioassays, and compendial techniques.
• Drive method transfers from Process Development, Protein Characterization, and external clients into QC operations.
• Oversee method qualification, validation, and lifecycle management activities.
• Review analytical data, reports, protocols, and investigations for GMP compliance.
• Lead OOS, OOT, and atypical result investigations with root-cause analysis and CAPA implementation.
• Act as a QC Analytical SME during client meetings, regulatory inspections, and internal audits.
• Collaborate cross-functionally with QA, Manufacturing, and Technical Operations to resolve challenges.
• Drive continuous improvement in efficiency, data integrity, and laboratory performance.

Skills

Leadership

People management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's, Master's, or PhD in Analytical Chemistry, Biochemistry, Biological Sciences or related

Tools

HPLC/UPLC

CE

ELISA

qPCR

Mass spectrometry

Spectroscopy

Job description

BioTalent, partnered with a rapidly growing biologics CDMO, seeks a QC Manager, Analytical to oversee analytical testing activities supporting biologics development and manufacturing programs.

This hands-on leadership role blends technical excellence with people management, overseeing method transfer, validation, investigations, and continuous improvement across QC operations to ensure GMP-compliant analytics from development through commercial production.