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Director Process Chemistry Jobs (NOW HIRING)

Enliven Therapeutics

Director, Process Chemistry

$190K - $238K/yr

Director, Process Chemistry Job Status: Exempt, Full Time Location: Remote Department: CMC Company Overview Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery ...

Aralez Bio

Scientist, Process Chemistry

Berkeley, CA · On-site

$95K - $120K/yr

As a teammate on the Process Chemistry and Manufacturing team, your work will be a significant ... Exceptional interpersonal and management skills to collaborate with and direct the work of others ...

Aralez Bio

Scientist, Process Chemistry

Berkeley, CA · On-site

$95K - $120K/yr

As a teammate on the Process Chemistry and Manufacturing team, your work will be a significant ... Exceptional interpersonal and management skills to collaborate with and direct the work of others ...

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How much do director process chemistry jobs pay per year?

As of May 30, 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 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.

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.

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 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.

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Director Process Chemistry jobs near you
Director, Process Chemistry

Director, Process Chemistry

Enliven Therapeutics

Remote

$190K - $238K/yr

Full-time

Posted 15 days ago

Job description

Job Type
Full-time
Description
Position Title: Director, Process Chemistry
Job Status: Exempt, Full Time
Location: Remote
Department: CMC
Company Overview
Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs.
Summary
Enliven is seeking a Process Chemistry Lead to serve as the drug substance/API subject matter expert, defining and executing phase-appropriate CMC strategy to advance product candidates through late-stage development, pivotal trials, and potential commercial launch. Establish and maintain the API control strategy, including specifications and process controls, ensuring they are locked for pivotal studies and regulatory submission. Review and approve technical reports and GMP documentation such as batch records, protocols, campaign reports, specifications, and regulatory filing content. Oversee drug substance scheduling and manufacturing campaigns, ensure cGMP compliance and inspection readiness, and represent drug substance/API priorities on core cross-functional teams. Partner closely with CMOs and internal teams across Quality, Supply Chain, Regulatory CMC, Formulation, and Analytical Development to drive operational excellence and timely release of drug substance for clinical use.
Responsibilities:
  • Oversee late-stage drug substance/API development and manufacturing activities to support pivotal studies, regulatory submission, and commercial launch readiness
  • Help define and execute phase-appropriate API strategy for late-stage development, ensuring alignment with program milestones and submission goals
  • Ensure process design and control strategy are sufficiently established to support pivotal trials, registration, and commercial manufacturing readiness
  • Oversee external CDMO/CMO activities for late-stage API manufacturing, process performance, and supply continuity
  • Lead technology transfer activities between manufacturing sites to support scale-up, validation, and long-term commercial supply
  • Drive process characterization, CPP identification, validation planning, and PPQ readiness/execution for late-stage programs
  • Establish, maintain, and refine API control strategy, specifications, and supporting documentation for regulatory submission and commercial readiness
  • Oversee drug substance manufacturing campaigns, scheduling, site readiness, and operational execution to ensure timely supply for clinical and registration-enabling activities
  • Author, review, and approve technical reports and GMP documentation, including batch records, protocols, specifications, campaign reports, and regulatory CMC submission content
  • Partner closely with Quality, Regulatory CMC, Supply Chain, Analytical, Formulation, Legal, and external manufacturers to ensure cGMP compliance, inspection readiness, and successful health authority interactions
  • Help represent CMC/DS/API needs to core development team

Requirements
  • MS or PhD in Organic Chemistry, Chemistry, Chemical Engineering, or a related scientific discipline
  • 10+ years of relevant experience in the pharmaceutical or biotechnology industry, including significant hands-on experience in small molecule drug substance/API development and commercialization
  • Strong late-stage development experience supporting Phase 3 programs through NDA/BLA or equivalent regulatory submission
  • Deep technical expertise in small molecule API process chemistry, development, and scale-up
  • Demonstrated experience leading drug substance manufacturing activities in support of late-stage development and commercial readiness
  • Experience with process performance qualification, process validation, and commercial launch preparation
  • Deep understanding of impurity control strategies, including ICH Q3A/Q3B and ICH M7
  • Strong working knowledge of cGMP requirements and global regulatory expectations, including ICH Q7, Q11, and Q2
  • Experience authoring, reviewing, or contributing to Module 3 and other CMC documentation for regulatory submissions
  • Proven readiness to support regulatory inspections, ensure reliable API supply, and deliver successful outcomes across PPQ, submission, and commercial manufacturing

The annual salary range Enliven reasonably and in good faith expects to pay for this position at the time of this posting is $190,000 - $238,000. The actual salary offered will be determined based on factors such as experience, qualifications, skills and expertise, geographic location, and other job-related factors permitted by law. Benefits are included and other incentives such as bonus and equity may be provided. This range is subject to change based on business needs, job scope changes, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying.
Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.
Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.

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