Quality Control Laboratory Manager

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 is partnered with a rapidly growing biologics CDMO looking to hire a QC Manager, Analytical to lead analytical testing activities supporting biologics development and manufacturing programs.

This is a hands-on leadership role where you'll combine strong technical expertise with people management responsibilities, overseeing analytical operations while supporting method transfer, validation, investigations, and continuous improvement initiatives across the QC organization.

You'll work closely with QA, Manufacturing, Process Development, and client teams to ensure analytical programs are scientifically sound, inspection-ready, and capable of supporting complex biologics products from development through commercial manufacturing.

What you'll be doing:

• Leading and developing a team of QC Analysts and Scientists within the analytical testing group
• Providing technical oversight for analytical testing of biologics, vaccines, cell and gene therapies, and related products
• Supporting analytical methods including HPLC/UPLC, CE, ELISA, qPCR, spectroscopy, bioassays, and compendial techniques
• Driving method transfers from Process Development, Protein Characterization, and external clients into QC operations
• Overseeing method qualification, validation, and lifecycle management activities
• Reviewing analytical data, reports, protocols, and investigations to ensure scientific integrity and GMP compliance
• Leading OOS, OOT, and atypical result investigations, performing root cause analysis and implementing effective CAPAs
• Acting as a QC Analytical SME during client meetings, regulatory inspections, and internal audits
• Supporting stability programs and stability-indicating method development
• Collaborating cross-functionally with QA, Manufacturing, and Technical Operations teams to resolve complex analytical challenges
• Driving continuous improvement initiatives focused on efficiency, data integrity, and laboratory performance

What we're looking for:

• Bachelor's, Master's, or PhD in Analytical Chemistry, Biochemistry, Biological Sciences, or a related discipline
• Extensive experience within GMP-regulated biopharmaceutical, biologics, or CDMO environments
• Previous supervisory or people management experience within a QC Analytical laboratory
• Strong expertise across analytical methodologies including HPLC/UPLC, CE, ELISA, qPCR, mass spectrometry, and other biologics characterization techniques
• Experience with method transfer, qualification, validation, and lifecycle management
• Strong understanding of FDA, ICH, and GMP requirements
• Proven experience leading investigations including OOS, OOT, and deviation management
• Ability to mentor, develop, and build high-performing technical teams
• Strong communication skills with experience interacting directly with clients, auditors, and regulatory agencies

This role would suit a QC leader who enjoys balancing technical problem solving with team development and wants to play a key role in shaping analytical capabilities within a fast-growing CDMO environment.