A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
Supervise the Microbiology/Cell Culture Quality Control laboratory to ensure raw materials and finished goods are tested according to approved procedures in timely manner to allow delivery to be met. Provide subject matter expertise for microbiology related issues for the manufacturing plant.
ESSENTIAL JOB FUNCTIONS
Oversees and directs raw material and finished product sampling, testing, peer review, and disposition, assuring timely completion and GMP testing documentation.
Oversees and provides direction for laboratory log-in of samples and aliquot for testing.
Reviews raw material and finished product test requirements to confirm scientifically sound and ability to perform in-house or need to have performed by contract testing laboratory.
Supervises Microbiology staff including manpower direction, performance review, staff development, and scientific coaching.
Assures timely execution of stability testing, raw material qualification/requalification testing, and ad hoc testing with appropriate documentation and failure resolution.
Ensures laboratory has sufficient lab instruments and/or qualified contract testing suppliers to meet microbiological, cell culture, and virus testing demands for release of raw material and finished product.
Participates in Raw Material Review Board where raw material quality discussion and decisions are made.
Participates as Subject Matter Expert on project teams and investigations.
Oversees test method and other QC SOP generation in support of microbiology, cell culture, and virus testing and other related laboratory activities.
Ensure test methods comply with appropriate compendia including but not limited to USP, EP, ACS, etc.
Ensure test methods are validated or verified as appropriate to the method.
Ensures Analysts and Technicians are trained consistent with corporate policy including complete and accurate documentation and content addressing: job skills, quality awareness, cGMPs, ISO, Job Skills, and training in compliance related areas.
Participates in establishment of QC policies in conjunction with Site Quality Manager.
Participates as lead for microbiology, cell culture, and virus test methods and data during customer audits. Facilitates closure of customer and supplier audit observations.
Leads and/or participates in Out-of-Specification and other problem solving activities assuring timely resolution of issues and ensuring corrective actions have been taken and documented.
Lead continuous improvement efforts for the laboratory.
Performs “lead escort” activities for regulatory and customer audits.
Establishes goals and objectives for the QC Microbiology/Cell Culture group.
Ensures laboratory costs are within budget or justifies excursions.
Performs other activities as may be directed from time to time by Site Quality Manager.
Who You Are:
- Bachelor’s degree in Microbiology or Life Sciences with 2+ years industry microbiology laboratory experience
Attention to detail
Problem solving and organizational skills
Knowledge of method development and validation
Knowledge of industry microbiology practices
- Knowledge of cell culture practices
Experience in method transfer
Knowledge of virology testing
Knowledge of teamwork and coaching techniques
Knowledge of cGMP, 21CFR, and 9CFR
Knowledge of general laboratory procedures
Knowledge of on the job training techniques
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.