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Director Process Development Jobs in North Carolina

Catalent, Inc.

Development Scientist II

Greenville, NC · On-site

... process problems. * Directly support with writing batch records, SOPs, IQ/OQ/PQ documents, development/technical reports, and CMC sections for regulatory submissions as directed. * Ensure that all ...

MedPharm

Process Technician

Durham, NC · On-site

Direct Reports: No * Indirect Reports: No Key Relationships (examples: Depts or Individual ... Process Development/ Formulation R&D * Facilities Travel requirements: • No Education and ...

MedPharm

Process Technician

Durham, NC · On-site

Direct Reports: No * Indirect Reports: No Key Relationships (examples: Depts or Individual ... Process Development/ Formulation R&D * Facilities Travel requirements: · No Education and ...

KBI Biopharma, Inc.

Senior Director, MS&T

Durham, NC · On-site

$180 - $240/hr

The Director or Senior Director will manage a multi-disciplinary team of Engineers and Scientists and will collaborate with Process Development, Quality, Supply Chain, Facilities, Engineering, and ...

Cesna Group

Process Engineer

Tarboro, NC · On-site

$50K - $100K/yr

... in the development and/or improvement of production methods, processes, machines, equipment ... Direct and/or coordinate capital expenditure projects and work closely with supervisor and various ...

KBI Biopharma, Inc.

Senior Director, MS&T

Durham, NC · On-site

The Director or Senior Director will manage a multi-disciplinary team of Engineers and Scientists and will collaborate with Process Development, Quality, Supply Chain, Facilities, Engineering, and ...

KBI Biopharma, Inc.

Senior Director, MS&T

Durham, NC · On-site

The Director or Senior Director will manage a multi-disciplinary team of Engineers and Scientists and will collaborate with Process Development, Quality, Supply Chain, Facilities, Engineering, and ...

Elevait Solutions

Process Engineer

Newton, NC · On-site

$60 - $65/hr

Strong statistical analysis skills applied to process development and control * Strong technical ... Direct experience with ribbon manufacturing, SZ stranding, jacketing extrusion, or high fiber count ...

Elementia

Process Engineer

North Wilkesboro, NC · On-site

... development and implementation. The Process Engineer maintains existing plant processes, plant ... Highly self-motivated and self-directed * Must have excellent written/verbal skills as well as ...

Elementia

Process Engineer

North Wilkesboro, NC · On-site

$85 - $115/hr

... development and implementation. The Process Engineer maintains existing plant processes, plant ... Highly self-motivated and self-directed * Must have excellent written/verbal skills as well as ...

Teach For America

Director, Development

Charlotte, NC · On-site

The Development Director will lead stewardship systems, fundraising campaign execution, donor follow-up processes, portfolio tracking, and development operations that support revenue growth and ...

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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.

Associate Director or Director, CMC Regulatory Affairs

Atsena

Durham, NC • On-site

$180 - $260/hr

Other

Re-posted 19 days ago

Job description

Position Summary

The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.

The individual will work cross-functionally with process development, analytical development, manufacturing, quality, and program leadership to ensure that CMC development plans meet regulatory expectations for gene therapy products. The role will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.

Key Responsibilities CMC Regulatory Strategy
  • Develop and implement global CMC regulatory strategies for gene therapy programs from early development through clinical stages and commercialization.
  • Provide regulatory guidance on viral vector manufacturing, process development, analytical characterization, and product comparability.
  • Assess regulatory risks related to manufacturing changes and propose mitigation strategies.
Regulatory Submissions
  • Lead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates
  • Ensure submissions meet regulatory expectations for gene therapy products.
Health Authority Interactions
  • Prepare CMC regulatory briefing documents and support agency meetings.
  • Serve as the subject matter expert for CMC topics during interactions with agencies including the FDA and EMA.
  • Coordinate and author responses to regulatory agency questions related to CMC.
Cross-Functional Collaboration
  • Partner closely with internal teams including: Process Development, Analytical Development, Manufacturing, Quality
  • Serve as the CMC regulatory representative on cross-functional program teams.
  • Provide regulatory guidance for manufacturing changes, comparability strategies, and lifecycle management.
Regulatory Intelligence & Compliance
  • Monitor evolving regulatory guidance related to gene therapy and advanced biologics.
  • Interpret regulatory requirements and communicate implications to internal teams.
  • Support development of internal regulatory policies and processes.
Qualifications Education
  • PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field.
Preferred Qualifications
  • Direct experience with AAV, lentiviral, or other gene therapy platforms.
  • Experience supporting late-stage development or BLA/MAA submissions.
  • Familiarity with global regulatory frameworks for advanced therapy medicinal products (ATMPs).
  • Prior experience participating in regulatory meetings.
Associate Director Experience
  • 7–10 years of experience in regulatory affairs and CMC.
  • Experience contributing to CMC sections of IND/CTA submissions.
Director Experience
  • 10–15+ years of experience in regulatory affairs with leadership responsibility for CMC regulatory strategy.
  • Demonstrated experience leading CMC regulatory submissions and health authority interactions.
Knowledge & Skills
  • Strong knowledge of global CMC regulatory requirements for biologics and gene therapies.
  • Understanding of viral vector manufacturing processes.
  • Experience with analytical characterization, comparability, and manufacturing changes.
  • Excellent regulatory writing and communication skills.
  • Ability to work effectively in a fast-paced startup environment.
Key Competencies
  • Strategic thinking and problem solving
  • Strong scientific and regulatory expertise
  • Cross-functional leadership
  • Excellent communication and collaboration skills
  • Ability to manage multiple programs and timelines
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