Manager, Quality Control (Microbiology)

Merck•Saint Louis, MO

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: As Quality Control Manager (Microbiology) you will be accountable for management of a GMP Quality Control Microbiology and Environmental Monitoring department supporting microbiological testing of APIs according ICH Q7 and 21CFR regulations; oversee the Quality Control activities associated with microbiological method validation and transfer; testing of product; Environmental monitoring; training on aseptic technique and test methods; OOS/OOT investigations; deviation and CAPA management. Management and development of Quality Control microbiology department, consisting of 2 groups totaling 20+employees. Accountable to meet business and quality performance metrics through continuous process improvement initiatives. Provide scientific guidance on complex manufacturing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results and ensure data integrity. Detect quality problems w/in the department, prepare investigation reports, and implement corrective actions in a timely manner. Manage test deviation as necessary with QA and notify it to management. Collaborate cross functionally as needed to ensure the Quality Management System processes are implemented in accordance with established procedures. Attend project team meetings as the QC microbiology representative and works closely with the team to ensure on-time delivery. Interface with internal and external customers on a regular basis to communicate project status, resolve issues; implement methods, techniques and evaluation criteria for products and processes. Develop and manage the department budget and capital expenditure budget Interact with internal and external customers on regular basis. Participates and supports regulatory/customer audits. Other duties as required. Who You Are: Minimum Qualifications: Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required. Master's degree in a scientific discipline or related discipline desired but not required. 10+ years of successful demonstration of the key responsibilities as presented above with in biologics or pharmaceuticals and previous people leadership experience. Demonstrated experience working in a highly matrixed, GMP manufacturing setting. Strong understanding of microbiology (Endotoxin and Bioburden testing); contamination control; Cleanrooms and Aseptic manufacturing; Environmental monitoring etc. Strong understanding of microbiological methodology and laboratory techniques, specifically USP<85>; USP<61> and USP<62>. Knowledge of Laboratory Information Management System (LIMS). Preferred Qualifications: Demonstrated leadership, people development and team building skills. Requires prior managerial experience. Solid track records in method development, method verification and validation Strong written and verbal communication skills. Strong problem solving skills. Strong computer skills, including word processing, and Quality systems databases. Knowledge of GMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP). Knowledge of FDA practices and guidelines. Knowledge of pharma/biotech bulk and finished product manufacturing and microbiological testing requirements. Expertise in aseptic principles and practices Knowledge of ICH Q7A, 21CFR, Eudralex GMP regulations, USP and EP pharmacopeia requirements Pay Range for this position: $134,400-$201,600 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here . What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Requirements

Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required.
10+ years of successful demonstration of the key responsibilities as presented above with in biologics or pharmaceuticals and previous people leadership experience.
Demonstrated experience working in a highly matrixed, GMP manufacturing setting.
Strong understanding of microbiology (Endotoxin and Bioburden testing); contamination control; Cleanrooms and Aseptic manufacturing; Environmental monitoring etc.
Strong understanding of microbiological methodology and laboratory techniques, specifically USP<85>; USP<61> and USP<62>.
Knowledge of Laboratory Information Management System (LIMS).

Nice To Haves

Master's degree in a scientific discipline or related discipline desired but not required.
Demonstrated leadership, people development and team building skills.
Requires prior managerial experience.
Solid track records in method development, method verification and validation
Strong written and verbal communication skills.
Strong problem solving skills.
Strong computer skills, including word processing, and Quality systems databases.
Knowledge of GMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP).
Knowledge of FDA practices and guidelines.
Knowledge of pharma/biotech bulk and finished product manufacturing and microbiological testing requirements.
Expertise in aseptic principles and practices
Knowledge of ICH Q7A, 21CFR, Eudralex GMP regulations, USP and EP pharmacopeia requirements

Responsibilities

Accountable for management of a GMP Quality Control Microbiology and Environmental Monitoring department supporting microbiological testing of APIs according ICH Q7 and 21CFR regulations
Oversee the Quality Control activities associated with microbiological method validation and transfer
Oversee testing of product
Oversee Environmental monitoring
Oversee training on aseptic technique and test methods
Oversee OOS/OOT investigations
Oversee deviation and CAPA management
Management and development of Quality Control microbiology department, consisting of 2 groups totaling 20+employees
Accountable to meet business and quality performance metrics through continuous process improvement initiatives
Provide scientific guidance on complex manufacturing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results and ensure data integrity
Detect quality problems w/in the department, prepare investigation reports, and implement corrective actions in a timely manner
Manage test deviation as necessary with QA and notify it to management
Collaborate cross functionally as needed to ensure the Quality Management System processes are implemented in accordance with established procedures
Attend project team meetings as the QC microbiology representative and works closely with the team to ensure on-time delivery
Interface with internal and external customers on a regular basis to communicate project status, resolve issues
Implement methods, techniques and evaluation criteria for products and processes
Develop and manage the department budget and capital expenditure budget
Interact with internal and external customers on regular basis
Participates and supports regulatory/customer audits
Other duties as required