Director - Biologics Integrated Product Team Leader, Biologics External Manufacturing:
Merck

MAN004713-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: MAN004713

Merck & Co., Inc. Kenilworth, N.J., U.S.A.known as Merck in the United States and Canada, is a global health care leaderwith a diversified portfolio of prescription medicines, vaccines and animalhealth products. The difference between potential and achievement lies in thespark that fuels innovation and inventiveness; this is the space where Merckhas codified its legacy for over a century. Merck’s success is backed byethical integrity, forward momentum, and an inspiring mission to achieve newmilestones in global healthcare.


Merck Manufacturing Division, MMD, is a team of dedicated, energeticindividuals who are committed to being the most trusted supplier ofpharmaceuticals and health products worldwide. Our facilities, along with ourexternal contractors, suppliers, and partners, comprise an interdependentglobal manufacturing network that’s committed to delivering a compliant,reliable supply to customers and patients on time, every time, across theglobe. 


The Biologics IPT leader is accountable for reliable, compliant supply of Merck’s Biologics drug substance at established Contract Manufacturing Organizations (CMOs).  The IPT leader will lead the cross-functional team within Merck and across the CMO partner to effectively manage the Biologics product in terms of compliance, supply planning and strategy, financial and performance targets and metrics.  


The IPT leader provides leadership to the team in the areas of:

  • Production Planning
  • Materials Management (MRP entries, Logistics)
  • Quality issues (Deviation Management, Product Release, Change Control)
  • Technology issues (Technology transfers, Investigations, Process Improvements, etc.)
  • Oversight of shop floor production (determining when a  Quality or Technology representative should be deployed to the External Party’s facility)
  • Financial transactions
  • Inventory management
  • Operational Excellence and Continuous Improvement activities (MPS application)
  • Dispute resolution (w/ appropriate escalation)

Additionally, the successful candidate will lead cross- functional team and supportive areas (e.g. Procurement, Quality, Technology, Finance, Legal, HR, etc.) to address broader business issues, customer needs and opportunities.  She or he will also participate in the annual capacity and profit planning process, and work with the organization to continuously improve/optimize, always monitoring industry and policy changes to assess implications and opportunities for their area of responsibility.

Qualifications

Education:
  • Bachelor of Science Degree or higher in Engineering or Biotechnology, or related field
Required:    
  • A minimum of ten (10) years of experience in Biologics or Vaccines,  Upstream and Downstream processing/manufacturing 
  • A minimum of two (2) years of experience in Operations with internal or external manufacturing sites with deep understanding of compliance/cGMPs/EHS/OpEx, technology transfer/process validation experience with Biologics products
Preferred:
  • Experience in Quality and/or Technical Operations in Biologics bulk, working with external parties (contracts, operational oversight), Six sigma black belt certification

Your role at Merck is integral to helping theworld meet new breakthroughs that affect generations to come, and we’recounting on your skills and inventiveness to help make meaningful contributionsto global medical advancement. At Merck, we’re inventing for life. 

 

If you need an accommodation for the applicationprocess please email us at staffingaadar@merck.com.

  

Search Firm Representatives Please ReadCarefully: 

Merck & Co., Inc. is not acceptingunsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.  All resumes submitted by search firmsto any employee at Merck via email, the Internet or in any form and/or methodwithout a valid written search agreement in place for this position will bedeemed the sole property of Merck.  No fee will be paid in the event thecandidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for thisposition.

 

For more information about personal rights underEqual Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Manuf./Operations Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement