Quality Control Manager, GMP Analytics

Bachem Holding AG; Vista (CA); On-site; USD 109,000 - 164,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem Americas is seeking a QC Manager to lead quality control testing across IPC, API, raw materials, and final product release. You will guide a team of QC scientists, develop specifications, and optimize analytical methods to ensure GMP compliance and timely product release.

The role requires strong analytical chemistry knowledge, SOP writing, and project leadership within a fast-paced biotech environment in California. Competitive benefits and total rewards apply.

Qualifications

• GMP laboratory testing experience including IPC, HPLC, GC, TLC, UV-VIS.
• Strong knowledge of analytical chemistry and USP materials testing.
• Experience writing SOPs and test methods.

Responsibilities

• Manage execution of QC testing including IPC, API, raw material, validation, release, EM and microbial testing.
• Supervise QC Scientists; provide training, scheduling, mentoring, and coaching.
• Establish specifications and sampling plans for IPC, raw materials and final product.
• Develop and optimize analytical methods for qualification and release testing.
• Coordinate stability program and testing to meet endpoints.
• Manage release activities to meet manufacturing deadlines.
• Review test data for completeness and accuracy; respond to inquiries.
• Write, review, and approve QC SOPs; implement CAPA when needed.
• Investigate OOS results and drive corrective actions; manage external labs.

Skills

GMP laboratory testing

Analytical chemistry

Project management

SOP writing

Quality systems

Communication

Problem solving

Team leadership

Education

Bachelor's degree in a relevant scientific field

Master's degree in a relevant scientific field

PhD in a relevant scientific field

Tools

HPLC

GC

TLC

UV-VIS Spectrophotometer

Karl Fischer Titrator

FTIR

MS

LAL

Job description

Bachem Americas is seeking a QC Manager to lead quality control testing across IPC, API, raw materials, and final product release. You will guide a team of QC scientists, develop specifications, and optimize analytical methods to ensure GMP compliance and timely product release.

The role requires strong analytical chemistry knowledge, SOP writing, and project leadership within a fast-paced biotech environment in California. Competitive benefits and total rewards apply.