Associate Director, External Manufacturing Operations

Job Description

An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.

You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.

You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).

Bring energy, knowledge, innovation to carry out the following:

• Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party’s (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials

• Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (“read a site”) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information

• Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc

• Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.

• Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI

• Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.

• 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 established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.

• Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.

• Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.

• Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets

• Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc

Minimum education required:

• Bachelor’s degree preferably in the Engineering, Science or Business

Required experience and skills:

• Minimum 8 years’ experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)

• Role requires a portion in management/leadership positions or project management.

• At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women’s Network, LEAD or mentoring.

• Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.

• Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.

• Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.

• Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.

• Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.

• Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.

• Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.

• Direct Health Authority Audit experience is desirable.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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.

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Relocation:

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Requisition ID:R333541