Senior Specialist, External Manufacturing

Merck; Durham (NC); Hybrid; USD 104,000 - 164,000; Full time

Job summary

A leading pharmaceutical company is seeking an External Manufacturing Operations Senior Specialist to manage relationships with external partners and ensure compliance with quality and safety standards. Candidates should hold a BS or MS in relevant fields and have experience in pharmaceutical manufacturing. This role involves strategic initiatives, operation oversight, and effective communication skills. A hybrid work model is available, and the salary range is competitive based on experience.

Benefits

Comprehensive benefits package

Annual bonus eligibility

Flexible work arrangements

Qualifications

• 4 years' experience in commercial/business and pharmaceutical manufacturing for BS holders.
• 2 years' experience for MS holders.
• Experience with leadership opportunities required.

Responsibilities

• Manage relationships with external partners.
• Drive risk assessments and ensure compliance.
• Support strategic initiatives for World Class Supply.

Skills

Adaptability to work in remote settings

Understanding of GMP and EHS compliance

Lean Six Sigma skills

Business and financial acumen

Strategic thinking

Interpersonal communication

Education

Bachelor of Science (BS) degree in Engineering, Science, Business or related field

Master of Science (MS) degree in Engineering, Science, Business or related field

Job description

Overview

The External Manufacturing Operations Senior Specialist (ExMOSrS) is accountable for meeting customer demand at the External Partner (EP) they support by achieving excellence in Compliance, Supply, Continuous Improvement & Cost through their leadership and coaching of our company’s responsible cross-functional teams and their work in partnership with those EPs while leveraging our company's Production System principles (MPS) and the E2E supply chain. The ExMOSrS serves as a point of contact for dealings between our manufacturing division and the EP and supports a strong business partnership as well as boundaries and ground rules of engagement.

Primary Activities

• ExMOSrS is Virtual Plant Management support within ExM. They support our manufacturing division's relationship with the external partner.
• Leads / supports our manufacturing division cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).
• Work with VCM (Value Chain Management) Lead and team (where applicable) and Product Technical Steward (where applicable) to support the designated products.
• Is accountable for operational related activities such as
• Ensuring 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 ExM funcional rep should be deployed to the External Party’s (EP) 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 whole value chain and work closely together with Focus Factory team and EP to manage and mitigate risks to aim at zero interruption of the supply chain and to ensure 100% compliance in quality and in environment, health and safety
• Builds a strong interdependent relationship with the site’s leadership team and can (“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 ExM Procurement, ExM Quality, and ExM Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The ExMOSrS 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 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. The ExMOSrS will ensure there is a plan with clear actions and timelines in place to deliver this SOS or NPI.
• The ExMOSrS works with the external partner to understand EP capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required etc.) and future capacity based on agreed improvements
• 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 our manufacturing division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
• Is accountable for inventory control. Depending on the location of goods (at External Party or at our company), ExMOSrS 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.
• Supports our company's Production System improvements internally and with EPs.
• Supports the external partner periodic Business and Operations Review Meetings. Based on our company and ExM’s strategy the ExMOSrS develops with their cross functional team and their external partner the annual Priorities for the relationship with clear goals and targets. The ExMOSrS also supports EP / company presentations for the relationships they manage.
• Supports strategic initiatives of network actions to enable World Class Supply.
• Participates in the maintenance of an External Manufacturing Organization information containing Global ExM policies, procedures, templates, etc.

Minimum Education Requirements

• Bachelor of Science (BS) degree in Engineering, Science, Business or related field with four (4) years’ experience in commercial/business and pharmaceutical manufacturing (operations, quality, technology, planning), roles required with experience with leadership opportunities. OR
• Master of Science (MS) degree in Engineering, Science, Business or related field with two (2) years’ experience in commercial/business and pharmaceutical manufacturing (operations, quality, technology, planning), roles required with experience with leadership opportunities.

Required Experience and Skills

• Work Environment – Adaptability to work in remote setting with remote teams.
• 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 experience with 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

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.

EEO and Privacy

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. We comply with 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 the following resources: EEOC Know Your Rights; EEOC GINA Supplement; privacy information and rights under state acts.

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, with specifics varying by site. This guidance does not apply to roles that are remote or require in-person presence on-site. Hybrid arrangements may differ by role and location.

The salary range for this role is

104200.00 - 163900.00

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 education, qualifications, certifications, experience, skills, location, and business needs.

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

We offer a comprehensive benefits package. Information about benefits is available on the company benefits page.

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

Additional Notes

Travel Requirements: 25%

Flexible Work Arrangements: Hybrid

Shift: 1st - Day

VISA Sponsorship: No

Relocation: No