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: In this exciting role you will manage a global team of Validation Project Managers in our fast-growing Extractables and Leachables organization and support the team in providing best-in-class services to our biopharmaceutical customers. You will lead the E&L Project Management team to achieve business objectives, deliver customer satisfaction at the highest level, and continuously improve processes and workflows to support growth expectations and increase business performance. The scope of responsibilities also includes supporting the development of project manager staff with a wide range of skills and with varying depths of industry experience.
As a self-motivated Manager, E&L Project Management, you will also be responsible for supporting global customer delivery and for the design, conduct, and reporting of the study results to the external biopharmaceutical customer. This includes protocol design & report writing, assisting in raw data review & related investigations, and the overall coordination of validation studies for MilliporeSigma global customers. Testing includes but is not limited to Extractables and Leachables analysis incorporating NVR, TOC, FTIR, RP-HPLC, LCMS, and GCMS separation and identification techniques. The purpose of the position is to support MilliporeSigma products in customer applications and to provide technical consultancy for the validation aspect of customer filtration & single-use processes.
- Manage & provide oversight for external customer E&L projects
- Establish/assign learning plans and monitor training completion status for staff
- Coordinate on-time periodic 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 global BioReliance Validation Services E&L laboratories
- Coordinate on-time completion of customer projects & prioritize high visibility projects to meet aggressive timelines
Who You Are:
- Bachelor’s Degree
- 5+ years of experience working in regulated biotech/biopharmaceutical industry
- A high-energy leader - able to drive a team to execute our mission and to coach team members to collectively achieve excellent results in their respective areas of responsibility
- Clear communicator, both internally and towards our customers, working in a team environment and interfacing with various departments/geographies
- Very strong organizational skills & project management experience
- Degree preferred in chemistry or related science discipline
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.