Job Description

A brief overview

The Director of Quality Control will lead the Quality Control and Analytical functions for release, stability, raw material testing and method validation/transfer functions in compliance with FDA and other international regulatory requirements for research, pre-clinical, clinical and commercial pharmaceutical products at Bachem.

What you will do

• Maintain the quality control laboratories and stability program per FDA cGMP parts 210 and 211, ICH Q7 and Q9 requirements for drug substances and ISO 13485 for raw materials used in device and diagnostics
• Develop annual master analytical validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations and analytical test method validation
• Ensure continuous improvement and effectiveness of the quality control labs
• Oversee and conduct cGMP, ICH and ISO stability programs to comply with regulatory requirements
• Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees
• Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records
• Investigate and document out-of-specification results and deviations during product testing
• Assure and oversee QC laboratory testing and documentation under cGMP conditions
• Maintain laboratory performance matrices and other activities as assigned.

Qualifications

• Master’s degree in chemistry or chemical engineering (or equivalent) with a minimum of 5 years’ work experience in GMP manufacturing
• Bachelor’s degree in chemistry or chemical engineering (or equivalent) with a minimum of 8 years’ work experience in GMP manufacturing
• PhD in Chemistry/Chemical Engineering (or equivalent) with a minimum 1 year of relevant work experience
• At least 4 years management experience including people management at a leadership role.
• Experience with peptides and oligomer manufacturing processes (preferred)
• Experience with Master Control (preferred)
• Experience with SAP (preferred)
• Knowledge of cGMP and FDA regulations
• Knowledge in Method Qualification/Validation and Analytical Transfers
• Knowledge in routine QC functions including OOS/OOT, Deviations, CAPA’s and Change Controls.
• Experience with overseeing regulatory audits (preferred)
• Exhibit detail-oriented documentation skills
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Familiarity with laboratory electronic systems including LIMS/ELN
• 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 complex scientific problems
• Ability to work independently and manage one’s time effective time management
• Communicate effectively and ability to function well in a team environment

Base Salary Range: $149,360 - $205,370

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 Platinum Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

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

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