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.
St. Louis - 2nd Street
The Cherokee Quality Control group in St. Louis, MO supports manufacturing of custom products including active pharmaceutical ingredients, excipients, and raw materials used within the health care industry. In this Supervisor position within Quality Control department you will be responsible for the management of a team of chemists that perform analytical testing of test samples of raw materials, intermediates, stability and finished goods per ICH / cGMP / 21CRFR guidelines and regulations. You will also be tasked with building out 2nd shift operations as the business expands. This is a 2nd shift position.
· This is a second shift position.
· Manage a team of 3-10 scientists responsible for the analytical testing of test samples to support commercial API and DP manufacturing.
· Draft and review analytical method or equipment procedures and protocols as assigned.
· Perform technical review of assays and other GMP documentation.
· Works in accordance with current GMPs and demonstrates / champions proper laboratory safety and housekeeping practices.
· Lead in technical troubleshooting and process improvements to improve laboratory performance.
· Prepare technical reports as assigned.
· Manage project milestones for internal and external customers to ensure on quality and on time success.
· Provide training, coaching and development opportunities to direct reports.
· Additional duties as assigned by QC Management.
Who You Are:
The ideal candidate has a broad range of experience performing, reviewing, troubleshooting analytical methods to support bio-organics, protein, or bio-conjugate products. These techniques may include HPLC, GC, LC-MS, CGE, iCE, and ELISA. Additional requirements for the position include the following attributes.
- MS Office, Knowledge of ICH/ cGMP/ 21CFR guidelines
- BS/BA or MS degree in chemistry, biochemistry, biology, or related life science.
- 5+ years of GMP experience in pharmaceutical, biopharmaceutical or similar industry desired.
- 2+ years of managing GMP QC chemists desired.
- Experience with technical writing, root cause analysis and scientific reasoning.
- Experience in lean lab practices and continuous improvement initiatives.
- Chemical environment-Must be able to perform tasks while wearing personal protective equipment.
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.