Senior Quality Control Manager - GMP API Testing & Leadership

Bachem; Vista (CA); On-site; USD 109,000 - 183,000; Full time

Benefits offered by this job

Annual performance bonus

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation

Job summary

Bachem Americas seeks a Manager/Sr. Manager, Quality Control to oversee stability testing, raw material qualification, testing and release, and validation projects in API manufacturing.

You will coordinate in-house and contract labs and support data review and reporting for the Director of Quality Control. The role requires GMP expertise, strong leadership of QC teams, SOP development, and advancing analytical capabilities.

Qualifications

• Bachelor's degree in a relevant scientific field with a minimum of 8 years’ industry experience.
• Master's degree in a relevant scientific field with a minimum of 5 years’ industry experience (preferred)
• PhD in a relevant scientific field with a minimum of 2 years’ industry experience (preferred)
• 1-3 years’ experience in managing projects (preferred)
• Extensive GMP laboratory testing experience across IPC, HPLC, GC, TLC, UV-Vis, Karl Fischer, FTIR, MS, LAL, bioburden etc.
• Thorough knowledge of analytical chemistry including USP materials testing.
• Excellent communication and leadership skills.

Responsibilities

• Manage and oversee 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 and revise specifications and sampling plans for IPC, raw materials and final product
• Develop and optimize new and existing analytical methods for qualification and release testing
• Coordinate stability program and testing to meet stability endpoints
• Manage IPC release activities, raw material and API release to meet manufacturing deadlines
• Write, review, and approve QC SOPs
• Evaluate and implement new analytical technologies and instrumentation
• Investigate OOS results and implement CAPAs
• Manage external contract laboratories for testing
• Review test data for completeness and accuracy
• Provide timely responses to inquiries
• Stay updated on new analytical developments
• Improve laboratory operations for GMP compliance

Skills

Leadership

Project management

Analytical chemistry

Communication

Problem solving

Team collaboration

Multitasking

Documentation

Education

Bachelor's degree in a relevant scientific field

Master's degree in a relevant scientific field

PhD in a relevant scientific field

1-3 years’ management experience

1-3 years’ project management experience

Tools

HPLC

GC

TLC

UV-Vis Spectrophotometer

Karl Fischer Titrator

FTIR

MS

LAL

Bioburden testing

Job description

Bachem Americas seeks a Manager/Sr. Manager, Quality Control to oversee stability testing, raw material qualification, testing and release, and validation projects in API manufacturing.

You will coordinate in-house and contract labs and support data review and reporting for the Director of Quality Control. The role requires GMP expertise, strong leadership of QC teams, SOP development, and advancing analytical capabilities.