Job Description

Position Overview – Basic Functions & Responsibility

The External Manufacturing Operations Senior Specialist is accountable for meeting customer demand at the External Partners by achieving excellence in Compliance, Supply, Continuous Improvement & Cost through their leadership and coaching of the responsible cross functional teams within our company and their work in partnership with those External Partners while leveraging Lean Six Sigma principles and the end to end supply chain.

The role serves as the main point of contact for dealings between our company and the External Parter and ensures a strong business partnership as well as managing boundaries and the ground rules of engagement.

Primary Activities

The role is to be a “Virtual Plant Manager” within External Manufacturing. They oversee the companies relationship with the External Partner ;The role serves as the air traffic controller of all information/interactions between our company and the External Partner,  establishing boundaries and the ground rules of engagement ;Is the leader of the Focus Factory Team, a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s). Champions diversity, equity, and inclusion programs with their Focus Factory Team and enables participation in events ;Based on our company's strategy the role develops the annual relationship priorities with clear goals and targets for the Focus Factory Team and External Partners ;Is accountable for all external partner business related activities including:Ensuring compliance (Quality Risk management, Deviation Management, Product Release, Change Control) ;Driving Execution Excellence at our partner sites for effective production planning, materials / resource management & meeting demands / delivering on priorities ;Meeting Demand, Production Planning, Materials Management ;Dispute resolution (w/ appropriate escalation) ;Technology issues ;Oversight of shop floor production (determining when an External Manufacturing functional rep should be deployed to the External Partners facility) ;OpEx and Continuous Improvement activities, Linking E2E (upstream and downstream) and with SCM (Supply Chain Management) to ensure and optimize flow of materials.Proactively drive risk assessment across the value chain (operations, quality & compliance, safety, raw materials, resources) and work closely together with Focus Factory team and External Partner to manage and mitigate risks, aiming for zero interruption of the supply chain and ensuring 100% compliance in quality and in environment, health and safety ;Is frequently present at their external partners site on the production floor, conducts GEMBA of manufacturing facility for understanding the equipment trains / layouts w.r.t. ease of operations, housekeeping & hygiene; review piping layouts from GEP perspective i.e., having proper slopes, no dead legs etc. & from safety perspective to ensure availability of all required safety installations, earthing & grounding provisions etc. ;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 our company's cross-functional team action orientated and time bound improvement plans ;Partners with External Manufacturing Procurement, Quality and Technology on commercial aspects of relationship, including new External Party Identification, Selection, Negotiation and Re-negotiate/termination ;The role may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept appraised of status/resolutions, etc. ;Participates and represents External Manufacturing on the cross-functional teams with Supply Chain Management / Product Source Management / Procurement / Product Teams for due diligence ahead of siting approval & post siting approval to support source of supply and new product introduction changes at an external partner and assume primary ownership of the new relationship. The role will ensure there is a plan with clear actions and timelines in place to deliver this source of supply or New Product ;The Role works with the external partner to understand our company’s requirements and the External Partners capacity  (e.g. stated capacity, firm capacity, future capacity plans, time horizon / lead times required for raw materials, manufacturing & shipping etc.) and future capacity based on agreed improvements ;Is accountable for maintaining the integrity of the 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 Manufacturing Division and the External Partner are executed including purchase orders, forecasts, deliveries, and approving invoice payments ;Is accountable for inventory control. Depending on the location of goods (at External Partner or at our company), the role ensures adequate documentation of material disposition. In some markets, the role may need to witness the destruction of goods (to prevent counterfeiting) or have the External Partner certify the destruction and provide supporting documentation ;Supports lean six sigma improvements internally and with External Partners, identifying improvement opportunities and supporting implementation once approved for implementation ;Supports with the external partner periodic Business and Operations Review Meetings ;The prepares an annual “state of the union” presentation for the relationships they manage which includes successes and lessons learned ;Supports strategic initiatives such as New Product Introduction, Network actions, Due Diligence etc. ;Is active in Person in Plant Activities for cause or to support new product introductions / tech transfer projects ;Participates in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc.

Skills/Qualification

Bachelor's degree preferably in Engineering and/or Science ;Minimum 5 years’ experience in commercial / business and manufacturing preferred (operations, quality, technology, planning), roles required with a portion in management/leadership positions ;Minimum of 3 years of operational experience is manufacturing environment ideally in Active Pharmaceuticals manufacture or equivalent (Food, Chemical, Other), driving Execution Excellence ;Compliance – Has experience and ability to achieve compliance goals, through a risk based approach has a deep understanding of GMP and EHS compliance and quality compliance risk. 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 business decisions that drive value for our company 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 skills 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 ;Between 25% to 50% travel required for the role when supporting new product introduction. This may include working in shifts and / or working on weekends as per project requirements.

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Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/16/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R324820