Manager / Sr. Manager, Quality Control

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

A brief overview

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com .

What you will do

• Manage and oversee execution of QC testing including IPC, API, raw material, validation, release, EM and microbial testing
• Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel
• 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 the testing to meet stability endpoints, as needed
• Manage IPC release activities, raw material and API release activities to meet deadlines tied to manufacturing schedules
• Write, review, and approve QC Standard Operating procedures (SOP’s) as needed
• Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, final product, In process, microbial, environmental, and water testing
• Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent recurrences
• Manage external test laboratories for contract testing of raw materials and other related testing
• Review test data for completeness and accuracy
• Provide timely responses to internal and external inquiries
• Stay abreast of new developments in analytical technologies
• Contribute to improvements in laboratory operations to increase efficiency and GMP compliance

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’ management experience (preferred)
• 1-3 years’ experience in managing projects (preferred)
• Extensive experience in GMP laboratory testing such as IPC, HPLC, GC, TLC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, LAL, bioburden, etc.
• Thorough knowledge and understanding of analytical chemistry, including USP materials testing
• Creativity to solve technical and compliance problems
• Comply with good housekeeping and safety practices
• Experience in writing standard operating procedures (SOP’s) and test methods
• Excellent written and oral communication skills
• Excellent computer knowledge, including Microsoft Word, Excel, Power Point and Access
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one’s time
• Ability to drive projects to success under time constraints
• Communicate effectively and ability to function well in a team environment

Base salary range

Manager: $109,396 - $164,095

Sr. Manager: $133,304 - $183,293

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you’ll find a diverse, multicultural team. The (a)in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.