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Director Process Development Jobs in North Carolina

Ergon

Process Technical Services Manager

Severn, NC · On-site

... development. * Ensure all departmental training and qualification needs are met for all direct ... Process Technical Services Manager Location: Severn, NC Employment offer contingent upon pre ...

AskBio

Process Engineer II

Durham, NC · On-site

Speak with your direct manager to discuss your interest and alignment with your development goals ... Position Summary AskBio is seeking a Process Engineer II to join our MSAT Process Engineering team ...

AskBio

Process Engineer II

Durham, NC

Speak with your direct manager to discuss your interest and alignment with your development goals ... Position Summary AskBio is seeking a Process Engineer II to join our MSAT Process Engineering team ...

Prysmian Group

Fiber R&D Director

Claremont, NC · On-site

Make Your Mark at Prysmian - Join Us Fiber R&D Director, North America About the Role You will ... Technical Skills • Strong knowledge of fiber manufacturing processes and material properties. • ...

Safeguard Medical

Senior Process Engineer

Huntersville, NC

$97K - $126K/yr

Description Job Summary Responsible for leading and executing the development, sustainment, and ... directed, demonstrating ownership and accountability Demonstrates the ability to plan, execute ...

Selby Jennings

Director of Development

Raleigh, NC · On-site

This individual will be responsible for all phases of the development process, including sourcing ... The Director of Development will build and lead the development team, establish scalable systems ...

Merck & Co.

The Associate Director, Technical Operations will be responsible for providing technical leadership ... records, process development, and process performance qualification.Lead, facilitate and ...

Kymanox

(Contract) Senior Process Engineer

Sanford, NC · On-site

$130 - $180/hr

... team and lead the design, development, and optimization of manufacturing processes for ... In addition to support from a direct, functional manager, work will also be done under the guidance ...

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Director Process Development information

What does a director of process development do?

A Director of Process Development is responsible for overseeing the design, implementation, and optimization of processes within an organization, typically in manufacturing, biotech, or pharmaceutical industries. They lead teams to develop efficient, cost-effective, and scalable processes for producing products or delivering services. This role often involves coordinating cross-functional teams, ensuring regulatory compliance, and driving continuous improvement initiatives. The Director also collaborates with R&D, quality, and production departments to bring new products from concept to commercial scale.

What are the key skills and qualifications needed to thrive as a director of process development?

To thrive as a Director of Process Development, you need deep expertise in process engineering, project management, and a strong background in chemistry, biochemistry, or a related field, often supported by an advanced degree. Familiarity with process modeling software, statistical analysis tools, and industry-specific quality standards such as GMP or Six Sigma certifications is typically required. Exceptional leadership, strategic thinking, and cross-functional communication skills set top performers apart in this role. These abilities are essential for driving efficient process innovation, ensuring regulatory compliance, and leading teams toward operational excellence.

How does a director of process development typically collaborate with cross-functional teams to drive project success?

As a Director of Process Development, you will regularly work alongside R&D, Quality Assurance, Manufacturing, and Regulatory Affairs teams to ensure new processes are scalable, compliant, and align with business goals. This collaboration often involves leading cross-departmental meetings, aligning on project milestones, and troubleshooting process bottlenecks together. Strong communication and leadership skills are crucial, as you’ll be responsible for integrating feedback, managing diverse perspectives, and ensuring that project deliverables are met on time and within budget.

What is the difference between Director Process Development vs Process Engineer?

AspectDirector Process DevelopmentProcess Engineer
CredentialsBachelor's/Master's in Engineering or related field, often with leadership experienceBachelor's or Master's in Engineering or related field
Work EnvironmentStrategic planning, team leadership, cross-department collaborationHands-on process design, optimization, and troubleshooting
Industry UsageCommonly used in biotech, pharma, and manufacturing industriesUsed across similar industries for process development and improvement

The main difference is that the Director Process Development oversees strategic process initiatives and manages teams, while the Process Engineer focuses on executing process improvements and technical tasks. The director role involves higher-level planning and leadership, whereas the engineer role is more hands-on and technical.

What are the most commonly searched types of Process Development jobs in North Carolina?

The most popular types of Process Development jobs in North Carolina are:

What are popular job titles related to Director Process Development jobs in North Carolina?

For Director Process Development jobs in North Carolina, the most frequently searched job titles are:

What job categories do people searching Director Process Development jobs in North Carolina look for?

The top searched job categories for Director Process Development jobs in North Carolina are:

What cities in North Carolina are hiring for Director Process Development jobs?

Cities in North Carolina with the most Director Process Development job openings:

Director Process Development jobs near you
Infographic showing various Director Process Development job openings in North Carolina as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 15% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

Senior Manager -Manufacturing Programs- Process Owner Organization

Amgen

Holly Springs, NC

$90K - $116K/yr

Full-time

Re-posted 25 days ago

Job description

Career CategoryManufacturingJob Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Manager -Manufacturing Programs

Live

What you will do
We are seeking a Senior Manager ofManufacturing Programsto lead the Process Owner organization within Manufacturing Support at ANC. This leadership role is responsible for providing technical process stewardship, manufacturing support, process governance, and manufacturing changecontrolsupport for Upstream, Downstream, and Services Drug Substance Unit Operations.
The Process Ownerteamserves as the technical process steward for manufacturing operations, partnering closely with Manufacturing Operations and cross-functional support functions to ensure manufacturing processes are effectively governed, implemented, maintained, and continuously improved throughout their lifecycle.
Process Owners serve as the primary technical liaisons between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, Commissioning & Qualification (C&Q), Supply Chain, and Digital Manufacturing. Through floor presence,hypercaresupport, process ownership, operational readiness activities, and manufacturing change implementation, the team enables reliable, compliant, and efficient manufacturing execution.
The Senior Manager will lead a growing organization of Process Owners responsible for process ownership, floor support andhypercareactivities, operational readiness assessments, dry and water run execution, electronic batch record implementation support, manufacturing change implementation, BOM support, and procedural governance. This role will also be responsible for expanding organizational capabilities, including establishing and leading a swing-shift Process Owner team to provide enhanced operational support and manufacturing coverage.

What You Will Do

  • Lead and develop the Process Owner organization responsible for providing technical process stewardship and manufacturing support for Upstream, Downstream, and Services Drug Substance Unit Operations.

  • Provide direct management, coaching, mentoring, and career development for Process Owners.

  • Develop and implement a swing-shift Process Owner organization to provide expanded manufacturing support and floor coverage.

  • Foster a culture of safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.

  • Provide strategic leadership for process ownership, operational readiness, manufacturing change implementation,manufacturing procedures, manufacturing CAPAs,and technical process stewardship.

  • Coordinate with site scheduling to ensure Process Owners provide timely hyper-care support and technical assistance during manufacturing campaigns, startup activities, process changes, first-time executions, and routine operations.

  • Serve as the primary interface between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.

  • Oversee execution of dry runs, water runs, engineering runs, and operational readiness activitiessupporting manufacturing.

  • Own manufacturing-relatedCAPAs andchange controls associated with process, procedural, and operational improvements.

  • Provide leadership andinputfor electronic batch record (EBR) and manufacturing execution system (MES) implementation activities impacting manufacturing operations.

  • Partner withTechnologyteams to ensure manufacturing processes are effectively translated into digital workflows and manufacturing execution platforms.

  • Partner with Supply Chain organizations to ensure manufacturing processes, material strategies, and Bill of Materials(BOM) support efficient manufacturing execution.

  • Provide process ownership oversight for BOM creation, maintenance, and updates associated with manufacturing process changes.

  • Ensure creation, revision, maintenance, and periodic review of GMP documentation supporting manufacturing operations.

  • Drive strategic initiatives to improve process reliability, manufacturing efficiency, operator experience, and operational performance.

  • Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections as required.

Win

What We ExpectofYou

Basic Qualifications:

Doctorate degree and 2 years of biotechnology or pharmaceutical industry experience
OR
Master's degree and 6 years of biotechnology or pharmaceutical industry experience
OR
Bachelor's degree and 8 years of biotechnology or pharmaceutical industry experience
OR
Associate's degree and 10 years of biotechnology or pharmaceutical industry experience
OR
High school diploma / GED and 12 years of biotechnology or pharmaceutical industry experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

  • 8+ years related work experience in biotechnology or pharmaceutical manufacturing with progressively increasing responsibility.

  • Prior people leadership experience managing and developing technical teams.

  • Strong understanding of GMP manufacturing operations supporting Upstream, Downstream, and Services Drug Substance Unit Operations.

  • Experience with process ownership, manufacturing support, and technical process stewardship.

  • Experience supporting digital manufacturing systems, electronic batch records (EBRs), manufacturing execution systems (MES), and associated process implementation activities within a GMP manufacturing environment.

  • Experience authoring, approving, and governing manufacturing SOPs and GMP documentationwithinQuality Systems (i.e. Veeva,Documentum, etc.).

  • Experience leading manufacturingCAPAs/change controls and implementation activities.

  • Experience supporting operational readiness activities, including dry runs, water runs, process implementation, and startup support.

  • Experience partnering with Supply Chain organizations to support BOM management, material readiness, and manufacturing execution.

  • Excellent organizational, written, verbal communication, and cross-functional leadership skills.

.

Salary Range

154,173.00USD -208,587.00USD

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