QC Project Manager
Millipore Corporation

Job Info

---

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

The Quality Control Project Manager at Millipore Sigma in St. Louis, MO (Cherokee) supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice guidelines (ICHQ7) and Drug Products. In this role, you will be overseeing projects/products status and serve as liaison between QC and customer/clients. The position is also accountable for the on-time delivery of QC actions to Clients. The position reports to Head of QC and typical work hours from 8 am to 5 pm. There are no direct reports for this role.

• Lead QC in global client/customer meetings (various time zones).
• Work closely with QC analysts, supervisors, data reviewer, QA, PAD, and client project managers (CPM) on all QC projects and track on time deliveries (OTD).
• Escalate delays, and potential risks to QC management.
• Communicate to CPM and clients on QC status and any potential risks to products and or deliverables. .
• Plan, schedule, and track the QC instrument qualifications (IQ/OQ/PQ) with validation, instrumentation, and QA team.
• Work with clients, technical operation team and PAD for ADC GMP readiness (method, specifications, and method qualification reports including Chromeleon templates etc).
• Design and implement laboratory efficiency/operational excellence initiatives.
• Work on QC capacity models for client delivery.
• Provide customer support and communications for rapid and effective resolutions pertaining to QC and non-conforming issues to customer.
• Communicate with OSL (outside laboratory) of QC testing needs and tracking.
• Additional duties as assigned by QC Management.

About You

You're a fit for the role if your background includes:

• Strong knowledge of project management methodologies, including proficiency in developing comprehensive project plans and risk management strategies
• Proven ability to build and maintain effective stakeholder relationships, with exceptional communication and interpersonal skills
• Demonstrated expertise in creating high-quality deliverables, such as detailed reports and presentations, tailored to client needs
• Strong analytical and problem-solving skills, with a track record of identifying and mitigating risks and issues
• Proficiency in driving change management initiatives and collaborating with cross-functional teams to achieve cohesive project execution.

Who You Are:

Minimum Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Biology, or other life science discipline
• 5+ years of work experience in a cGMP (QC) testing laboratory environment.

OR

• Associate degree in Chemistry, Biochemistry, Biology, or other life science discipline.
• 10+ years of experience working in a cGMP (QC) laboratory environment.

Preferred Qualifications:

• 5+ years of experience handling with customers/clients.
• Outstanding written and verbal communication and customer interface skills.
• Strong computer skills, including proficiency in Word, Excel, and PowerPoint.
• API manufacturing and testing knowledge and/or experience desired.
• Experience writing technical documentation and reports.
• Demonstrate strong technical knowledge.
• Familiar with scientific/regulatory principles.
• Experience with Trackwise, Chromeleon, LIMS and SAP.
• GDP, Data integrity and ALOCA.
• Antibody drug conjugate (ADC) experience.
• Familiar with GMPs, FDA, ICH and OSHA requirements.
• Highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Experience in multi-disciplinary project management, along with laboratory efficient improvements.
• Experience with CGE, ICIEF, HPLC, Solo VPE, and LC-MS.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

---