Manager / Sr. Manager, Quality Control

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

Job summary

Bachem Americas, Inc. is seeking a Manager/Sr. Manager of Quality Control to lead analytical testing operations for API, raw materials and final products.

You will coordinate internal and external lab activities, review data, and drive method development and GMP compliance. The role requires strong supervisory skills, SOP writing, and effective communication to ensure timely release and continuous improvement of QC processes.

Qualifications

• Bachelor's degree in a relevant scientific field and 8+ years in the industry.
• Master's degree in a relevant field with 5+ years in the industry (preferred).
• PhD in a relevant field with 2+ years in the industry (preferred).
• Management experience and project management experience preferred.
• GMP laboratory testing experience and analytical chemistry knowledge.

Responsibilities

• Oversee QC testing including IPC, API, raw materials, validation and release.
• Supervise QC scientists; provide training, scheduling, mentoring and coaching.
• Establish specifications and sampling plans for IPC and materials.
• Develop and optimize analytical methods for qualification and release testing.
• Coordinate stability programs and ensure endpoints are met.
• Manage release activities to meet manufacturing deadlines.
• Author and review QC SOPs and test methods.
• Evaluate new analytical technologies and instrumentation.
• Investigate OOS results and implement CAPA actions.
• Manage external labs for contract testing and data reviews.

Skills

Excellent written and oral comms

Attention to detail

Project management

Team leadership

Problem solving

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field (preferred)

PhD in a relevant field (preferred)

1-3 years management experience (preferred)

Tools

HPLC

GC

TLC

UV-VIS Spectrophotometer

Karl Fisher Titrator

FTIR

MS

LAL

bioburden testing

Job description

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status

Bachem Americas, Inc.

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.

A brief overview

The Manager / Sr. Manager, Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations. This individual is responsible for managing and coordinating stability testing, raw material qualification, testing and release, and validation projects. The Manager / Sr. Manager coordinates both in-house and contract laboratory testing activities. Additionally, this individual supports the Director, Quality Control in reviewing data and reports. This role also serves to advance analytical capabilities and contributes to the development of the Quality Control department.

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.

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