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Vice President Process Development Cmc Jobs (NOW HIRING)

Attaineo

VP, Research and Development

Round Rock, TX · On-site

$250/hr

VP, Research and Development at Attaineo The VP of Research & Development will define and execute ... Understand overall drug development process, regulatory guidelines, and CMC strategy in US, with ...

AskBio

VP, GDNF Clinical Development

... CMC. They will be responsible for establishing and overseeing global clinical development ... The VP, GDNF Clinical Development will partner with AskBio's Safety and Pharmacovigilance teams to ...

AskBio

VP, GDNF Clinical Development

Durham, NC · On-site

... CMC. They will be responsible for establishing and overseeing global clinical development ... The VP, GDNF Clinical Development will partner with AskBio's Safety and Pharmacovigilance teams to ...

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$65.5K

$147.4K

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How much do vice president process development cmc jobs pay per year?

As of Sep 9, 2026, the average yearly pay for vice president process development cmc in the United States is $147,428.00, according to ZipRecruiter salary data. Most workers in this role earn between $115,000.00 and $175,500.00 per year, depending on experience, location, and employer.

What is a vice president process development CMC?

A Vice President of Process Development CMC (Chemistry, Manufacturing, and Controls) is a senior executive responsible for overseeing the development, optimization, and scale-up of manufacturing processes for pharmaceutical products. They ensure that all processes comply with regulatory standards, lead cross-functional teams, and collaborate with research, manufacturing, and quality departments. Their primary goal is to ensure that drug products are developed efficiently, safely, and in accordance with all industry and regulatory requirements.

What are some typical challenges faced by a vice president process development CMC when scaling up new pharmaceutical products?

A Vice President of Process Development CMC often encounters challenges such as ensuring process scalability while maintaining product quality and compliance with regulatory standards. Coordinating cross-functional teams—including R&D, manufacturing, quality assurance, and regulatory affairs—can be complex, especially when integrating new technologies or adapting to evolving guidelines. Additionally, managing timelines and budgets amid shifting project requirements and global supply chain constraints requires strong leadership and agile problem-solving. Building robust processes that are both efficient and adaptable is key to overcoming these challenges.

What are the key skills and qualifications needed to thrive as a vice president process development CMC, and why are they important?

A Vice President Process Development CMC typically requires advanced expertise in chemical, biological, or pharmaceutical process development, along with a relevant advanced degree such as a Ph.D. or MS in a scientific discipline. Familiarity with regulatory guidelines (such as FDA and EMA), quality management systems, and industry-standard software (like LIMS or process modeling tools) is essential. Exceptional leadership, strategic thinking, and cross-functional communication skills help drive teams and manage complex projects. These competencies ensure robust process development, regulatory compliance, and the successful advancement of products from research to commercial production.

What is the difference between Vice President Process Development Cmc vs Director Process Development Cmc?

AspectVice President Process Development CmcDirector Process Development Cmc
ResponsibilitiesStrategic leadership, overall process development, and cross-functional oversightOperational management, project execution, and team supervision
Required CredentialsAdvanced degree (PhD/MS), extensive industry experience, leadership skillsRelevant degree (MS/PhD), significant process development experience
Work EnvironmentExecutive-level, strategic planning, collaboration with senior managementTeam management, project-focused, hands-on process development

The Vice President Process Development Cmc holds a higher strategic and leadership role, overseeing the entire process development function, while the Director Process Development Cmc focuses on managing projects and teams within that function. Both roles require strong technical credentials, but the VP is more involved in setting long-term strategies and cross-departmental coordination.

What are popular job titles related to Vice President Process Development Cmc jobs?

For Vice President Process Development Cmc jobs, the most frequently searched job titles are:

Infographic showing various Vice President Process Development Cmc job openings in the United States as of September 2026, with employment types broken down into 80% Full Time, 10% Temporary, and 10% Contract. Highlights an 90% In-person, and 10% Hybrid job distribution, with an average salary of $147,428 per year, or $70.9 per hour.

Director, CMC - Precursor Development & Manufacturing

Boston, MA • On-site

AdvanCell
See more jobs at AdvanCellexternal

$170K - $230K/yr

Full-time

Posted 5 days ago

Job description

The Director, CMC - Precursor Development & Manufacturing is responsible for the development, optimization, manufacturing, and lifecycle management of precursor molecules and related reference standards used in the Company's radiopharmaceutical products. This role provides technical leadership across synthetic chemistry, process development, analytical development, and GMP manufacturing of complex small molecules, including peptide-based and chelator-containing precursors.

The successful candidate will work closely with external contract development and manufacturing organizations (CDMOs) to build process understanding, support analytical method development and validation, and ensure alignment with global regulatory expectations (e.g., ICH, GMP). This work enables the timely delivery of high-quality drug substance and reference standards for clinical and commercial manufacturing. The Director also supports CDMO selection and shipping logistics for precursor materials.

The role also includes leading CMC regulatory writing and documentation to support regulatory submissions for precursors and related reference standards.

Key Responsibilities and Duties

  • Lead process development, optimization, and scale-up for precursor molecules and reference standards, including small molecules and peptide-based constructs

  • Provide subject matter expertise in synthetic organic and process chemistry, including route design, impurity control, and process robustness

  • Partner with the Associate Director of Analytical Development to guide analytical development activities and ensure methods are GMP-ready, fit for intended use, and capable of supporting manufacturing, release, and stability programs.

  • Ensure GMP-compliant manufacturing of precursor materials at CDMOs

  • Support technology transfer and scale-up activities for clinical and commercial manufacturing

  • Ensure CMC activities align with ICH guidelines and global regulatory requirements for drug substance development

  • Prepare and review CMC documentation for regulatory submissions (e.g., IND/CTA/MAA)

  • Partner with Quality Assurance on deviations, investigations, change controls, and audit readiness

  • Drive continuous improvement in process efficiency, robustness, and cost of goods

  • Support material specifications, control strategies, and impurity fate and purge assessments

  • Provide technical input to supply chain planning and risk mitigation strategies

  • Mentor and develop CMC staff and foster a strong technical culture

Other Responsibilities

  • Observe the Company's workplace, health and safety, and regulatory policies and procedures

  • Engage and communicate with other AdvanCell business unit staff to ensure that activities are coordinated seamlessly and effectively

  • Adhere to the Company's quality management system processes and policies

  • Other tasks as requested by the VP, CMC and Supply Chain

Essential Skills, Qualifications, Industry and Educational Requirements

  • Ph.D. in Chemistry (preferably Organic or Process Chemistry) or related discipline

  • Significant industry experience (typically 6+ years) in CMC, process development, or technical operations

  • Strong expertise in synthetic chemistry, including multi-step synthesis and impurity control

  • Working knowledge of analytical development and validation (e.g., HPLC, LC-MS, stability-indicating methods)

  • Advanced knowledge of GMP manufacturing and regulatory expectations

  • Strong understanding of ICH guidelines and global regulatory requirements

  • Demonstrated experience selecting and managing CDMOs and external partners

  • Excellent problem-solving, communication, and leadership skills

  • Ability to operate independently and effectively in a fast-paced, development-stage environment

  • Demonstrated ability to deliver to timelines in high-pressure environments

Desirable Skills, Qualifications, Industry and Educational Requirements

  • Experience in radiopharmaceutical or radiochemistry environments

  • Familiarity with chelator chemistry and metal complexation

  • Experience supporting regulatory submissions (e.g., IND/CTA/NDA/MAA)

  • Knowledge of CMC strategies for early- and late-phase development

$170,000 - $230,000 a year
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