Associate Director, External Manufacturing

Job Description

The Global Pharmaceutical Organization (GPO) at our company is excited to invite passionate individuals to join our dynamic team!

GPO is a diverse global organization committed to bringing a compliant, reliable supply of life-saving and affordable medicines to patients around the world. Our organization is responsible for the manufacturing and supply of all pharmaceutical products, packaging of the entire Human Health portfolio and commercialization of the small molecule new product pipeline. GPO manages a wide range of products serving communities in more than 175 markets around the globe with more than 7 billion doses of vital medicine distributed each year. Collaborating with other operating units and functions, GPO's commitment to enhancing the patient experience and improving access to life-saving treatments is achieved through a network of internal and external sites that support the enterprise and division's strategic priorities.

Our company's Small Molecule External Manufacturing organization is responsible for management of third party manufactures of our Company's products across drug substance, drug product and packaging operations.- The organization helps launch and supply our critical medicines and vaccines around the world. The role of the Integrated Launch Excellence (ILE) platform within the organization is focused on the introduction/demonstration/validation of new products at EPs.

External Manufacturing Operations Associate Director (Ops AD), in partnership with the respective functional representatives, is responsible for ensuring the reliable supply of quality products at competitive costs from external manufacturing partners (EPs) and to integrating these EP into our company's supply chain appropriately and is the owner and primary point of contact for all interactions between our Manufacturing Division and EPs.

The successful candidate is responsible to establish boundaries and ground rules for engagement with the EPs, while ensuring compliance/quality readiness of these suppliers at all times through the implementation of risk assessments and frequent walkthroughs.- The number of EPs an Ops AD is accountable for will depend upon factors such as: product type, size and/or complexity of supply agreement, geography, etc.; however will typically manage relationships that are highly complex in nature and of strategic importance.

Primary Responsibilities

• Dispute resolution with appropriate escalation
• Balancing our company's delivery requirements with contract manufacturer's production plan. Materials Management (ERP transactions, Logistics)
• Oversight of shop floor production (determining when an ExM functional rep should be deployed to the contract manufacturer's facility)
• Continuous Improvement activities
• Partners with Procurement in the Identification/Selection of new contract manufacturers and Negotiation/Termination of Supply Agreements, as required
• Facilitates the collection of contract manufacturer's capacity information (e.g. stated capacity, firm capacity, future capacity plans, time horizon/lead times required, comments/concerns, etc.), presents the information to Supply Chain Management and drives recommendations for capacity expansion at contract manufacturers, as required
• Ensuring alignment of the Supply and Quality agreements
• Executing ERP transactions associated with receipt and movement of company owned inventory, book-to-physical reconciling of company owned inventory at contract manufacturers, and documenting and witnessing destruction of company owned inventory
• Ensuring contract terms agreed upon by our company and the contract manufacturer including, but not limited to, purchase orders, forecasts, deliveries, and invoice payments are executed in compliance with the Supply Agreement
• Partners with the ExM Company Production System experts and other functionalities supporting ExM (e.g. technical, quality, procurement, etc.) to identify continuous improvement opportunities at contract manufacturers and supports
• Project management support to the -DP NA regional team, and to ensure a greater coordination of ongoing projects within the region
• This position will require travel up to 50%

Education Minimum Requirement

• Bachelor degree minimum in the Engineering, Medical, Science, Business, or related areas of study

Required Experience and Skills

• No less than eight (8) years combined experiences in commercial/business and manufacturing (operations, project management, or quality, technology, supply chain etc.) function in pharmaceutical, chemical or related industry required (or equivalent combination of education/experience)
• Knowledge of Drug Substance manufacturing, including common unit operations and shop floor activities.
• Must possess excellent interpersonal, communication, project management, collaboration, negotiation, analytical and influencing skills
• Has demonstrated strong leadership in a teamwork environment and with strong team coordination abilities
• Cultural awareness and sensitivities
• Fluency in English both verbal and written

Preferred Experience and Skills

• Recent ExM Operations or site operations
• Conversant on domestic and foreign regulations and compendia governing manufacturing operations
• Lean project implementation
• Strong influencing skills demonstrated at various levelsThe Ops AD is the owner and primary point of contact for all interactions between our Manufacturing Division and the assigned EPs. S/he is responsible to establish boundaries and ground rules for engagement with the EPs.- This role will support management of critical site(s) in the U.S. for the Integrated Launch Excellence team.- The number of sites an Ops AD is accountable for will depend upon factors such as: product type, size and/or complexity of supply agreement, geography, etc.."

Required Skills:
Adaptability, API Manufacturing, Business Management, Contract Management, Cultural Awareness, Decision Making, Interpersonal Relationships, Inventory Management, Invoice Processing, Operational Strategies, Process Improvements, Procurement, Production Scheduling, Project Coordination, Project Management, Project Manufacturing, Regulatory Compliance, Risk Assessments, Safety Management, Supply Change Management, Team Leadership, Teamwork, Vendor Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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The salary range for this role is
$129,000.00 - $203,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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.-

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Remote

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
06/11/2026
*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: R400096