Manager / Sr. Manager, Quality Control

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
• Carefully 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
• Able to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Able 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
• Able to work independently and manage one’s time
• Able to drive projects to success under time constraints
• Communicate effectively and able to function well in a team environment

Base Salary Range

• Manager: $109,396 - $164,095
• Sr. Manager: $133,304 - $183,293

Total Rewards

• Competitive pay
• Annual performance bonus
• A generous benefit package with comprehensive Medical/Dental/Vision coverage
• 401(k) plan with employer contribution
• 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

Equal Opportunity Employer

• Bachem Americas is an Equal Opportunity Employer