Quality Control Lead

In the Quality Control Lead role, you will assume responsibility for managing the QC activities that are pivotal in ensuring the quality and compliance of our new emerging therapy services. This includes the new GMP Phase 1 clinical production facility in Marlborough MA with the focus on novel modalities including allogenic stem cell, cell and gene therapy, extracellular vesicles, using advanced manufacturing methods.

Sartorius is one of the world‘s leading technology providers to the life sciences and biopharma industries, and is actively shaping dynamic, innovative and high-growth markets. To drive the creation of new innovative solutions, Sartorius has formed an initiative to discover new trends and cutting-edge opportunities for rapid conversion towards next generation technology solutions. This exciting initiative enables the research, development and clinical production of novel modalities using next generation manufacturing platforms, in partnership with key customers.

The QC Lead ensures that all QC activities comply with regulatory standards and contribute to the consistent production of high-quality biotechnological products. The role involves close collaboration with research and development, manufacturing, and regulatory teams to uphold and enhance quality standards.

What you will accomplish together with us:

QC Microbiology:

• You will oversee and execute microbiological testing, including but not limited to bioburden, endotoxin, sterility tests, and microbial identification.
• One of your tasks will be to ensure that microbiological methods are appropriately validated, and that testing complies with cGMP regulations.

Environmental Monitoring:

• Manage the environmental monitoring program to ensure the manufacturing environment is controlled and complies with cGMP requirements.
• Analyze environmental monitoring data to identify trends and implement corrective actions when necessary.

Quality Metrics and Reporting:

• Establish and track QC metrics to evaluate laboratory performance, identify areas for improvement, and ensure compliance with quality objectives.
• Compile and present QC reports to management, detailing testing activities, compliance status, and any significant quality issues.

Quality Control Leadership:

• Provide leadership, direction, and support to the QC team, ensuring that all members are adequately trained and equipped to perform their duties.
• Develop and implement standard operating procedures (SOPs) and QC policies to maintain high-quality standards and regulatory compliance.
• Promote a culture of continuous improvement within the QC department.

Regulatory Compliance:

• Stay abreast of regulatory guidelines and industry best practices related to QC in biotechnology cGMP manufacturing.
• Lead the QC department in preparation for regulatory inspections and audits, and coordinate responses to audit findings.
• Ensure that all QC activities are documented in accordance with cGMP standards and that records are maintained for regulatory review.

Sample Control:

• You will be responsible for overseeing Sample Control, instrument qualification, assay validation, method qualification, QC Microbiology, QC analytical testing, and environmental monitoring.
• In this role, you will execute and manage the sample management system, ensuring the proper receipt, identification, storage, and tracking of samples for QC testing.
• One of your tasks will be to coordinate with production and other departments to ensure timely and efficient sample flow through the QC laboratory.
• You will manage and review external QC sample requisition and testing for key accounts including assessment of methods and lot testing.
• You will lead and perform the qualification and requalification of QC laboratory instruments and equipment, ensuring compliance with cGMP and industry standards.
• Develop and maintain a schedule for routine calibration, maintenance, and performance checks of laboratory equipment.

Assay Validation and Method Qualification:

• You will design, execute, and document validation studies for new assays and qualification of existing methods to ensure they are suitable for their intended use.
• On an as needed basis, you will approve validation and qualification protocols and reports, ensuring that all methods are robust, reproducible, and compliant with regulatory requirements.

QC Analytical Testing:

• Supervise the execution of analytical testing for raw materials, in-process samples, finished products, and stability studies.
• Confirm that all QC analytical methods are validated and that test results are accurate, reliable, and reported in a timely manner.

What will convince us:

• You have completed a bachelor’s degree in a Biology, Microbiology, Chemistry, Biochemistry, or a related scientific field.
• Completion of master's degree or PHD in a Life Sciences discipline a plus.
• You have a minimum of 5+ years of experience in a QC role within the biotechnology or pharmaceutical industry, with at least 1 years in a leadership or supervisory capacity preferred.
• Extensive knowledge of cGMP regulations and experience with QC testing in a biotechnology manufacturing environment.
• Demonstrated expertise in Sample Control, instrument qualification, assay validation, method qualification, QC Microbiology, QC analytical testing, and environmental monitoring.
• Up to 10% domestic and international trav

We Value:

• Strong leadership and team management skills.
• Excellent communication, organizational, and analytical skills.
• Proficiency in data analysis and reporting.
• Ability to work in a laboratory setting, which may include standing for extended periods and handling various chemicals and biological materials.
• May require occasional lifting of laboratory supplies and equipment.
• May require occasional travel to assess/ manage external service providers.
• Identification with our core values: Sustainability, Openness, Enjoyment

Work Environment: The QC Lead will work in a controlled laboratory setting that requires adherence to safety protocols and cGMP regulations. The role may involve exposure to chemicals, biological materials, and controlled environments, necessitating the use of personal protective equipment.

Note: This job description is intended to provide a broad overview of the responsibilities and qualifications for the QC Lead position in biotechnology cGMP manufacturing. It is not exhaustive and may be subject to modifications to align with the specific needs of the organization and regulatory changes.

What We Offer

As a growing global life science company, with our stock listed on the German DAX and TecDAX , Sartorius offers a wide range of benefits:
Personal and Professional Development: Mentoring, leadership programs, LinkedIn Learning, internal seminar offerings
Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules
Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform
Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.

Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate

Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service

All qualified applicants will be considered for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

Please view equal employment opportunity posters provided by OFCCP here.

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Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.

We look forward to receiving your application.

www.sartorius.com/career

Sartorius is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. 

All employment decisions are based on valid job-related requirements. 

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by calling +1 631 254 4249 ext 8330 or via e-mail at [email protected]
 

About Sartorius 

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. 

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application. 
www.sartorius.com/careers