Director, External Manufacturing Operations Drug Product
Location:
West Point , Pennsylvania
Posted:
November 09, 2016
Reference:
PLA000181
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

External Manufacturing Drug Product Operations Director, North America Lead, will lead all ExM sterile operations in North America with direct engagement through Line Of Business and Supply Chain Management/ Regional Operations and serve as ExM point of contact for all regional Tier, S&OP, Regional Marketing, LOB meetings. The leader in this position will drive boundary less collaboration, influence and connectivity by working directly with key stakeholders (VP SM LOB, VP Quality, AVP Supply Chain). This role will engage in strategy development and early engagement on due diligence and business development work occurring in the region. The role is accountable for meeting customer demand at the Contract Manufactures by achieving excellence in Compliance, Supply, Continuous Improvement & Cost through its leadership and coaching of the responsible MSD cross functional teams and their work in partnership with those CMO's while leveraging MPS and the E2E supply chain.
  1. Serve as "Virtual Plant Manager" within ExM. They oversee MMD's relationship with the contract manufacturer. The ExMOD serves as the air traffic controller of all information/interactions between MMD and the contract manufacturer and establishes boundaries and ground rules of engagement.
  2. Is the leader of regional ExM crossfunctional teams (Supply Chain, Quality, Technical Ops, Procurement...) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).
  3. Is accountable for all operational related activities:
    • Compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand
    • Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management (MRP entries, Logistics); Technology issues; Oversight of shop floor production (determining when an EM functional rep should be deployed to the External Party's (EP) facility); OpEx and Continuous Improvement activities; Linking E2E (upstream and downstream) and with SCM in the Supply Chain to ensure and optimize flow of materials
  4. Builds a strong interdependent relationship with the sites leadership team and is able to ("read a site") assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site and formulate in partnership with the external partner and the MSD cross-functional team action orientated and time bound improvement plans
  5. Partners with ExM Procurement, ExM Quality, and ExM Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required.
  6. Participates and represents ExM on the cross-functional teams with SCM/Product Source Management/Procurement/IDST for due diligence ahead of siting approval & post siting approval to support SOS/NPI changes at an external party and assume primary ownership of the new relationship.
  7. Works with the external partner to understand EP capacity (e.g. stated capacity, firm capacity, future capacity plans, time horizon / lead times required, comments/concerns, etc.) and future capacity based on agreed improvements
  8. Is accountable for maintaining the integrity of the MSA(Master Supply Agreement) ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms agreed upon by MMD and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
  9. Is accountable for inventory control. Depending on the location of goods (at External Party or at Merck), ensures adequate documentation of material disposition. In some markets, ExM Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
  10. Acts as a Merck Production System (LSS) leader & coach for own team and works with external partner and MPS resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
  11. Leads with the external partner periodic Business and Operations Review Meetings. Based on MSD and ExM strategy to ensure cross functional team and their external partner the annual Hoshin Kanri Plan for the relationship with clear goals and targets.
  12. Lead strategic initiatives of network actions, World Class Supplier, Hoshin Kanri.
  13. Participates in the creation and maintenance of an External Manufacturing Organization Handbook containing Global ExM policies, procedures, templates, etc. The Ops Director prepares customized materials per product type where appropriate and also ensures training and adherence by Operations Managers within his/her area.
  14. Plans strategically and understands the broad CMO business environment and specific opportunities & potential partners in their operations area



Qualifications:
Education:
  • Required: Bachelors degree (preferably in the Engineering, Science or Business)

Required:
  • Minimum 12 years' experience in commercial /business and manufacturing (operations, quality, technology, planning), roles required with a significant portion in management/leadership positions.
  • Compliance - Has experience and ability to achieve compliance goals, through a risk based approach has a deep understanding of GMP and EHS compliance and compliance risk in modality (API, Drug Product, Sterile). Direct Health Authority Audit experience desirable.
  • World Class Supplier Mindset - Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time
  • Business &Financial Acumen - Has skills to understands and intelligently apply economic, financial and industry data to make e business decisions that drive value for Merck and our customers.
  • Depth of Manufacturing Knowledge - Has proven skills and expertise at management level in modality (API, Drug Product, Sterile)
  • Strategic Thinking - Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain
  • Working Across Boundaries - Must possess excellent interpersonal, communication, collaboration, negotiation to work outside boundaries as a norm
  • Business Outcomes /Drive Results - Ability to use deep knowledge and expertise in production operations to drive results and business outcomes
  • End to End Mindset - Ability to apply understanding of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute supply chain optimization


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

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