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.
Your Role: The extractables and leachables (E&L) lab manager is responsible for direct oversight of all E&L laboratory operations and personnel. Daily laboratory operations are focused primarily on performing routine and custom testing according to client-approved protocols which are designed to satisfy generally accepted industry expectations and regulatory requirements, and which are executed to meet best-in-class quality standards. The manager’s scope of responsibilities also includes supporting the development of technical lab staff with a wide range of technical skills and with varying depth of industry experience.
Key functions and duties:
- Review and approve test protocols and reports
- Schedule testing to maximize capacity, equipment utilization and throughput
- Coordinate on-time completion of equipment/instrument calibration, qualification and maintenance activities according to laboratory procedures and plans
- Lead, support and/or approve laboratory investigations and CAPA activities related to deviations, complaints and audit observations
- Periodic evaluation of external suppliers
- Establish/Assign learning plans and monitor training completion status for staff
- Coordinate on-time periodically reviews of E&L SOPs
- Managing change to continuously improve cycle time, right first time and rerun rate key performance indicators
- Participate in world-wide harmonization projects, goals and initiatives among other BioReliance Validation Services E&L laboratories
Who You Are
- BS/MS in Analytical, Organic or Polymer Chemistry
- Min 5+ years of experience working in a regulated/accredited laboratory (i.e. GMP/ISO) with 2 years supervising or leading a team.
- Previous laboratory experience with one or more of the following techniques; GCMS, LCMS, ICP-MS, HPLC and FTIR
- Previous experience with sample preparation techniques including solid phase and liquid-liquid extraction
- Ability to prioritize high visibility projects to meet aggressive timelines
- Accurately forecast spending and deliver within financial target
- Excellent interpersonal, presentation, listening and communication skills
- Working knowledge of USP standards and BPOG methodology
- Analytical expertise in GCMS, LCMS, ICP-MS, HPLC and FTIR techniques
- Experience using Trackwise
- Write and/or review laboratory equipment/software validation protocols and reports according to FDA CFR Part 11, EU Annex 1 and GAMP standards
- Lean & Six Sigma certification
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil 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.