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Socotra, Inc.

$150 - $200/hr

Support the development and lead Welch's enterprise external manufacturing strategy, expanding the co-manufacturing network to support long-term business growth, innovation, and operational ...

Celldex Therapeutics

Overview The Manager, Biologics Drug Substance External Manufacturing works cross-functionally with internal and external teams to support drug substance (DS) GMP external clinical and commercial ...

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How much do external manufacturing jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for external manufacturing in the United States is $18.46, according to ZipRecruiter salary data. Most workers in this role earn between $15.14 and $20.91 per hour, depending on experience, location, and employer.

What are some typical challenges faced by professionals in external manufacturing roles, and how can they be addressed?

Professionals in External Manufacturing often encounter challenges related to managing supplier relationships, ensuring product quality, and coordinating timelines across multiple partners. Navigating different time zones, regulatory requirements, and production capabilities can create complexity. Proactive communication, clear documentation, and regular audits are essential strategies for addressing these challenges and maintaining smooth operations. Building strong partnerships with external vendors also helps in mitigating risks and supporting continuous improvement.

What are the key skills and qualifications needed to thrive in external manufacturing, and why are they important?

To thrive in External Manufacturing, you need strong project management skills, a solid understanding of manufacturing processes, and often a degree in engineering, supply chain, or a related field. Familiarity with ERP systems, quality management tools, and regulatory compliance standards is commonly required. Excellent communication, problem-solving, and relationship-building abilities help professionals effectively coordinate with external partners and internal teams. These skills are crucial for ensuring product quality, on-time delivery, and successful collaboration with third-party manufacturers.

What is the difference between External Manufacturing vs Contract Manufacturing?

AspectExternal ManufacturingContract Manufacturing
DefinitionOutsourcing production to a third-party company to produce goods on behalf of a brand or company.Engaging a third-party manufacturer to produce specific products or components under a contractual agreement.
FocusOverall production process management and supply chainSpecific product or component manufacturing
RelationshipTypically ongoing partnership with multiple projectsProject-based or short-term agreement
Common CredentialsManufacturing certifications, quality standardsManufacturing certifications, quality standards

External Manufacturing and Contract Manufacturing both involve outsourcing production to third parties, but External Manufacturing generally refers to managing the entire manufacturing process, while Contract Manufacturing focuses on producing specific products or components under contractual terms. Understanding these differences helps companies choose the right outsourcing strategy for their production needs.

What is external manufacturing?

External manufacturing involves outsourcing the production of goods to third-party manufacturers outside a company’s internal facilities. It allows companies to focus on design, marketing, and distribution while relying on specialized manufacturers for production, often requiring coordination, quality control, and supply chain management skills.
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External Manufacturing jobs near you
Infographic showing various External Manufacturing job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 85% Full Time, 11% Part Time, and 2% Contract. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $38,403 per year, or $18.5 per hour.

Director / Senior Director, External Manufacturing Operations

Bothell, WA

Immunome, Inc.
Biotechnology Research and Development • 11 - 50 employees
Learn more about Immunome, Inc.external

Full-time

Posted 7 days ago

Job description

Position Overview

The Director / Senior Director, External Manufacturing Operations provides strategic leadership and oversight of Immunome's external manufacturing network to ensure supply requirements and business objectives are met. The Director leads and develops a team of external manufacturing professionals, establishes and maintains effective supplier governance, and partners closely with Technical Operations leadership and cross-functional stakeholders to drive operational performance and successful execution of clinical and commercial programs.  

This role also plays a key part in developing and executing external manufacturing and supply strategies, strengthening supplier relationships, and evolving Immunome's external manufacturing capabilities as the company's portfolio and manufacturing network continue to grow.  

Responsibilities

  • Provide overall leadership for Immunome's External Manufacturing Operations function, with responsibility for the performance, development, and effectiveness of the team overseeing CDMOs and other external service providers.  
  • Lead, coach, and develop a team of external manufacturing professionals. Establish clear priorities, expectations, and accountabilities; support staff development and the continued growth of organizational capabilities as the portfolio and manufacturing network expand.  
  • Ensure Virtual Management Teams (VMTs) are empowered and operate effectively, collaboratively, and consistently across programs. Provide leadership in resolving significant risks, delays, and competing priorities that could affect supply or key program milestones.  
  • Establish and maintain effective governance across the external manufacturing network. Ensure business reviews, steering committees, and executive-level meetings are conducted at appropriate frequencies and with the right level of engagement. Serve as a senior escalation point for significant operational, contractual, supply, and relationship matters.  
  • Develop strong cross-functional relationships internally, partnering closely with Technical Operations leadership, Legal, Finance, Regulatory, and other key stakeholders to align activities and ensure business objectives are met.  
  • Provide senior leadership with clear and timely updates regarding manufacturing performance, supply risks, network capacity, financial considerations, and other matters requiring management attention or decision-making.  
  • Contribute to the development and execution of Immunome's external manufacturing and supply network strategy, and business continuity planning.  
  • Support regulatory submission activities and regulatory inspections, as required.  
  • Contribute to the continuous improvement of Technical Operations processes, governance frameworks, and ways of working to support the continued growth of Immunome's product portfolio and external manufacturing network. 

Qualifications

  • Bachelor's degree in biotechnology, biology, chemistry, chemical engineering, pharmaceutical sciences, or a related field; advanced degree preferred.  
  • Minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, including significant responsibility for cGMP manufacturing operations and oversight of external manufacturing partners.  
  • Demonstrated experience leading external manufacturing activities supporting clinical and commercial products.  
  • Proven ability to build and manage strategic relationships with CDMOs, including engagement with senior business leaders, site heads, and executive management.  
  • experience contributing to manufacturing network strategy, supply planning, technology transfer, commercial readiness, and risk management.  
  • Position requires domestic and international travel of up to approximately 25%, with occasional evening and/or weekend commitments based on manufacturing activities and business needs.  

Knowledge and Skills

  • Strong leadership and people-management skills, with a demonstrated ability to coach, develop, and retain high-performing professionals.  
  • Demonstrated success managing complex external manufacturing organizations and supplier relationships across development and commercial stages.  
  • Strong strategic thinking and business judgment, with the ability to balance technical, operational, financial, quality, regulatory, and supply considerations. Demonstrated ability to identify and manage manufacturing and supply risks, resolve complex issues, and drive cross-functional decision-making.  
  • Broad technical understanding of biotechnology/pharmaceutical manufacturing and process development. Hands-on experience in process development and/or cGMP manufacturing is strongly preferred. Experience with highly potent products is desirable.  
  • Strong understanding of cGMP requirements and pharmaceutical Quality Systems, including deviations, investigations, change controls, CAPAs, and batch disposition activities.  
  • Strong executive communication, influencing, and negotiation skills, with the ability to effectively engage internal and external senior leadership. Expert knowledge of supply agreements, service agreements, statements of work, and other commercial terms relevant to external manufacturing.  
  • Ability to operate effectively in a fast-paced and evolving environment, manage ambiguity, and adjust priorities while maintaining focus on critical business objectives.  

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