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Director Process Chemistry Jobs (NOW HIRING)

Director of CMC

El Segundo, CA ยท On-site

$200K - $230K/yr

... molecule) including process chemistry, drug product, analytical, and formulation from lead ... Experience in leading and direct management of research, analytical laboratories, process ...

This position will support manufacturing and process chemistry activities through analytical method ... Participate, support and facilitate site audits as directed and required. * Perform other related ...

Ensure that processes for identifying and correcting sentinel events are in place. * Direct the clinical chemistry proficiency testing program to ensure the following: (1) The laboratory is enrolled ...

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Director Process Chemistry information

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$41K

$84.8K

$131K

How much do director process chemistry jobs pay per year?

As of Jun 22, 2026, the average yearly pay for director process chemistry in the United States is $84,782.00, according to ZipRecruiter salary data. Most workers in this role earn between $59,000.00 and $105,000.00 per year, depending on experience, location, and employer.

What does a Director of Process Chemistry do?

A Director of Process Chemistry leads teams responsible for developing and optimizing chemical processes used in the production of pharmaceuticals or other chemicals. They oversee process development from laboratory scale to full manufacturing, ensuring efficiency, safety, and regulatory compliance. This role involves collaboration with R&D, manufacturing, and quality teams to deliver scalable and cost-effective chemical synthesis solutions. Directors also manage budgets, mentor staff, and may interact with regulatory agencies to support product approval.

What are the key skills and qualifications needed to thrive as a Director of Process Chemistry, and why are they important?

A Director of Process Chemistry typically requires a Ph.D. in chemistry or chemical engineering, extensive experience in process development and scale-up, and a strong foundation in organic synthesis. Familiarity with analytical instrumentation, process safety systems, and regulatory compliance, as well as proficiency in software for data analysis and project management, are commonly expected. Exceptional leadership, communication, and problem-solving skills help foster innovation and guide multidisciplinary teams effectively. These competencies are vital for ensuring efficient, safe, and cost-effective chemical manufacturing processes that meet organizational goals and industry standards.

What is the difference between Director Process Chemistry vs Process Development Manager?

AspectDirector Process ChemistryProcess Development Manager
CredentialsAdvanced degree in Chemistry or Chemical Engineering, extensive industry experienceSimilar educational background, often with several years of industry experience
Work EnvironmentStrategic leadership, overseeing multiple projects and teamsHands-on process development, project management, and team coordination
Industry UsageUsed in pharmaceutical, chemical, and biotech industries for high-level oversightCommonly found in R&D and manufacturing settings for process optimization

The main difference is that the Director Process Chemistry focuses on strategic leadership and overall process chemistry direction, while the Process Development Manager handles day-to-day process development and project execution. Both roles require similar credentials but differ in scope and responsibilities.

How does a Director of Process Chemistry typically collaborate with cross-functional teams during drug development?

A Director of Process Chemistry works closely with teams such as Analytical Development, Formulation, Quality Assurance, and Regulatory Affairs to ensure smooth progression of drug candidates from lab to manufacturing scale. Collaboration involves regular meetings to align on project timelines, address technical challenges, and implement process improvements. This role often leads technology transfer discussions and troubleshooting sessions, ensuring process scalability and compliance with regulatory requirements. Effective communication and interdisciplinary teamwork are essential for success in this leadership position.
More about Director Process Chemistry jobs
What cities are hiring for Director Process Chemistry jobs? Cities with the most Director Process Chemistry job openings:
What states have the most Director Process Chemistry jobs? States with the most job openings for Director Process Chemistry jobs include:
Infographic showing various Director Process Chemistry job openings in the United States as of June 2026, with employment types broken down into 4% Locum Tenens, 84% Full Time, and 12% Part Time. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $84,782 per year, or $40.8 per hour.
Associate Director, Process Validation and Risk Management

Associate Director, Process Validation and Risk Management

Vaxcyte

San Carlos, CA โ€ข On-site

Full-time

Posted 19 days ago


Job description

Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
The Associate Director, Process Validation and Risk Management will lead and facilitate commercial process validation and risk management activities across Vaxcyte's end-to-end manufacturing processes. This role focuses on technical strategy, execution, and cross-functional coordination to support commercial readiness, regulatory compliance, and lifecycle management.
The incumbent will provide leadership to ensure the organization is equipped to effectively design, execute, and communicate process validation and risk management strategies to internal stakeholders, external partners, and regulatory agencies.
This position will report to the Sr. Director of Process Validation within the Global MSAT organization and will collaborate on overall validation strategy, with primary responsibility for process validation execution and risk management frameworks supporting commercial manufacturing.
Essential Functions:
Process Validation Leadership
  • Provide strategic and scientific leadership for process validation (PPQ, CPV, lifecycle validation) across commercial programs.
  • Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch.
  • Ensure alignment of validation activities with regulatory expectations and lifecycle management plans.

Risk Management
  • Develop and implement risk management frameworks, tools, and processes in collaboration with Quality.
  • Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks.
  • Monitor and communicate risk trends and key risk indicators to stakeholders.

Commercialization & Lifecycle Support
  • Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state.
  • Contribute to lifecycle management activities, including process improvements and continued process verification.

Cross-functional Interface
  • Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity.
  • Partner with internal teams and external CMOs to ensure alignment on validation and risk strategies.

Technical Oversight
  • Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization.
  • Support deviation investigations, ensuring timely resolution and sustained compliance.

Regulatory
  • Contribute to authoring and reviewing regulatory filings and responses to health authorities.
  • Effectively communicate the scientific and commercial rationale for validation and risk management strategies.

Process Validation & Comparability
  • Provide leadership for execution of process validation and comparabilityactivities, ensuring data integrity and compliance.

Raw Material & Network Support
  • Provide guidance on raw material qualification strategies to ensure supply reliability.
  • Support validation activities across internal and external manufacturing networks.

Communication & Leadership
  • Communicate process validation performance and risk insights to key stakeholders.
  • Build strong working relationships and influence across a matrixed organization.
  • Contribute as a key member of the Global MSAT organization to enable successful commercialization.
  • Travel - 10-30% domestic and international travel required.
Requirements:
  • Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A.
  • Strong experience in biologics/vaccine manufacturing, including:
    • Process validation (PPQ/CPV)
    • MSAT, technical operations, or late-stage development
  • Technology transfer and commercialization
  • Experience in quality risk management (ICH Q9) and regulatory expectations
  • Demonstrated leadership in matrixed or cross-functional team environments
  • Ability to apply deep technical knowledge to develop strategies and drive execution
  • Strong problem-solving, organizational, and strategic planning skills
  • Excellent communication and stakeholder engagement skills
  • Ability to analyze data and align stakeholders with organizational strategy
  • Innovative and entrepreneurial mindset to drive continuous improvement
  • An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Reports to: Senior Director, Process Validation
Location: San Carlos, CA or North Carolina
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $174,000 - $203,000 (SF Bay Area). Salary ranges for non-California locations may vary.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013