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Director Of Process Development Jobs in California

Solidigm

Process Development Engineer

Rancho Cordova, CA · On-site

$139.52K - $223.30K/yr

Established track record of innovation and results Preferred Qualification * The ideal candidate will have direct experience in 3D NAND process development. * Willing to travel and work 25% of time ...

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Director Of Process Development information

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

To thrive as a Director Of Process Development, a strong background in process engineering, project management, and a relevant advanced degree (such as in chemical engineering or biotechnology) is essential. Expertise in process simulation software, Six Sigma/Lean methodologies, and regulatory compliance systems is typically required. Leadership, strategic thinking, and effective cross-functional communication are vital soft skills for driving innovation and aligning teams. These competencies ensure successful process optimization, regulatory adherence, and achievement of organizational goals in a dynamic industry.

How does a Director of Process Development typically collaborate with cross-functional teams to drive process improvements?

A Director of Process Development regularly partners with R&D, manufacturing, quality assurance, and regulatory teams to develop and refine processes. This collaboration involves leading cross-functional meetings, aligning project goals, and ensuring that new or improved processes meet both technical and compliance standards. Effective communication and project management skills are essential, as the director often serves as a bridge between technical staff and executive leadership, ensuring that process initiatives support broader business objectives.

What does a Director of Process Development do?

A Director of Process Development oversees the design, optimization, and implementation of processes within an organization, often in manufacturing, biotechnology, or pharmaceuticals. They lead teams to improve efficiency, ensure quality standards, and drive innovation from concept to production scale. This role involves collaborating with cross-functional departments, managing budgets and timelines, and staying updated on industry trends and regulatory requirements. Their ultimate goal is to streamline operations and support the company's strategic objectives.

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

AspectDirector Of Process DevelopmentProcess Engineer
CredentialsBachelor's/Master's in Engineering, often with experience in process developmentBachelor's or higher in Engineering or related field
Work EnvironmentLeadership role overseeing process development teams, strategic planningHands-on technical role focusing on process design and optimization
Industry UsageCommon in manufacturing, pharmaceuticals, biotechFound across similar industries, often reporting to Directors or Managers

The main difference is that the Director Of Process Development leads and strategizes process development initiatives, while Process Engineers focus on executing technical process improvements. The director role involves higher-level planning and team management, whereas Process Engineers are more involved in technical implementation.

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Director Of Process Development jobs near you

Assoc Director/Director of Process Development - Drug Substance

Programmable Medicine Operatin

Redwood City, CA • On-site

$185K - $230K/yr

Full-time

Medical, Dental, Vision

Posted 3 days ago

Job description

Who we are
Programmable Medicine is a pre-revenue, clinical-stage biotechnology company focused on discovering and developing innovative therapies for patients with serious diseases. The company operates across multiple legal entities and partners with external CROs, CMOs, and research institutions globally. Backed by leading venture capital investors, Programmable Medicine is building a scalable finance function to support rapid growth and pipeline advancement.
Role Summary
We are looking for a dynamic and experienced Associate Director/Director, Process Development/Drug Substance to guide late-stage development and ensure adequate supply for launch/commercialization. This newly created role requires a leader with deep understanding of CMC principles, manufacturing, regulatory requirements, and a proven track record of success in guiding late-stage candidates through development. The candidate will engage with internal Med Chem and CDMO(s) for process development, scale up that enables robust production of Drug Substance (DS) and payload for dendrimer-based drug candidates. This is a hands-on individual contributor position located at our Redwood City facility. Candidates must be able to work on site 3 days per week.
Key Responsibilities
  • Build development strategy to advance clinical assets from Phase 2 through launch and commercialization
  • Develop phase-appropriate product understanding and control strategies using QbD framework
  • Lead risk assessments and integrate output into QbD-based development study
  • Support manufacture of clinical GMP DS and payload throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
  • Review/approve master and execute batch records, support investigations, and resolve deviations
  • Analyze process and manufacturing data to understand and optimize process performance
  • Author and support regulatory submissions (IND, IMPD, amendments)
  • Improve production models that enable granular connectivity with clinical supply
  • Develop cost of good models that describe process and enable sensitivity analyses for process improvements
  • Guide the organization in improving business processes to support effective CMC management and communication
  • Collaborate closely with colleagues including Med Chem, and Analytical R&D to support all process development activities of all programs
  • Author and review internal procedures, reports, and presentations
  • Significant contributor to defining goals and strategic vision for the TechOps organization

Requirements
  • PhD in relevant discipline (e.g., chemistry, chemical engineering, or relevant field)
  • At the Director level, 15+ years process development and manufacturing experience is required. Candidates with less experience may be considered but at a lower level position.
  • Well-developed understanding of drug development, including collaborating with Chemistry, Analytical R&D, CDMOs, and commercial organizations.
  • Experience with late-stage development and commercialization of small molecules, payloads, and dendrimers is needed.
  • Demonstrated ability in collaborating strategically with various functional areas including analytical development, Manufacturing, QA, RA, and Supply Chain.
  • Substantial experience leading Tech Transfer to CDMOs and supporting DS campaigns
  • Excellent communication skills with an ability to interact effectively with stakeholders and partners
  • Ability to multi-task and keep pace with a fast-moving organization
  • Availability to take part in calls across multiple international time zones
  • Ability and willingness to travel
  • Must be able to work 3 full days on site at our Redwood City facility.

What we can offer you
This is a unique opportunity to join a team focused on a new class of precision medicines that selectively treat diseased cells in regions of inflammation. By making precision medicine even more precise, our nanomedicine technology has the potential to change the standard of care across ophthalmology, neurology, inflammatory diseases and neuro-oncology.
We have a comprehensive total compensation package including fully paid medical, dental, and vision benefits for you and your family. The Company also offers participation in the annual bonus program. The salary range for PhD, Director level candidates located in the Bay Area is $185,000 - $230,000 annually. We consider various factors when determining the base compensation, including market survey data, experience, qualifications,which means the actual compensation may vary. Candidate's who do not meet the requirements for a Director level position, may be considered for an Associate Director level role at a lower base salary.

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