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Vice President Process Development Cmc Jobs (NOW HIRING)

AskBio

VP, GDNF Clinical Development

Durham, NC · On-site +1

... 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

... 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 ...

The Michaels Organization

VP Development

Camden, NJ · Hybrid

The VP will support the Regional Vice President in the early stages of the development process including business development, community relations and building partnerships. * The role will entail ...

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Vice President Process Development Cmc information

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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 Jun 7, 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 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 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 of 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.
Infographic showing various Vice President Process Development Cmc job openings in the United States as of May 2026, with employment types broken down into 6% Internship, 22% As Needed, 66% Full Time, and 6% Part Time. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution, with an average salary of $147,428 per year, or $70.9 per hour.
SVP/VP, Technical Development Operations (TDO) & Strategy

SVP/VP, Technical Development Operations (TDO) & Strategy

Kelonia Therapeutics

Boston, MA

$304K - $381K/yr

Full-time

Posted 15 days ago

Job description

At Kelonia Therapeutics, our ambitions are bold: to dramatically expand the benefit and reach of genetic medicines. Our goal is to change what’s possible for genetic medicine by building the capabilities, experience, and commitment to bring life-saving medicine to every patient in need. We are a human-first company, driven by a mission to develop transformative genetic medicines for patients and their loved ones.
 
We have brought together pioneers in cell and gene therapy, guided by extraordinary scientific founders and a team committed to turning breakthrough science into real-world impact. As we grow, we are building a culture that values rigor, collaboration, and care for one another.

Are you ready to be a part of our remarkable journey? We're looking for someone exceptional to join our growing team as SVP/VP, Technical Development Operations & Strategy. We’re seeking an inspiring leader to architect and scale Technical Operations across the development lifecycle, including process, analytical, formulation development, internal manufacturing and MSAT, and CDMO management, while ensuring cGMP compliance and advancing critical regulatory submissions. This is an opportunity to shape groundbreaking therapies, build a company from the ground up, and make a transformative impact on patients’ lives. The ideal candidate pairs deep technical expertise with strategic vision and a collaborative spirit. Join us at the forefront of innovation and help write the next chapter in gene therapy.

What You Will Do
  • Drive the overall TDO Strategy, Vision and Strategic Growth to enable success, ensuring alignment with program and corporate milestones including control strategy, PPQ/validation path, and BLA/MAA readiness.
  • Establish trusted Partnership and Collaboration with Regulatory CMC and Quality.
  • Lead upstream, downstream, analytical, formulation and fill-finish activities; oversee tech transfer to CDMOs, set phase-appropriate specs/method lifecycle/stability, and lead comparability/bridging.
  • Own and optimize clinical supply (DS/DP/F&F, packaging/labeling, release/testing, cold-chain distribution) to ensure on-time, in-spec lots.
  • Own the preparation, review, and submission of CMC sections for global filings (IND/IMPD/CTA, NDA/BLA); author/defend content and lead FDA/EMA/HA meetings.
  • Partner with QA to run change control, deviations/CAPA, data integrity, and inspection readiness across internal and external sites.
  • Lead a high-performing, collaborative TDO Strategy team, fostering accountability, speed, and quality.
  • Cultivate and manage relationships with CDMOs/CMOs via QTAs/TTAs, audits, and KPI dashboards to ensure best-in-class capabilities.
  • Govern the TDO Strategy budget; model options for throughput, COGS, and yield improvements; communicate trade-offs and recommendations to the exec team and Board.
What You Will Bring
  • Ph.D. or M.S. in Chemistry, Pharmaceutical Sciences, Biochemical Engineering, or related field with 12–15+ years in CMC/Tech Ops, including small-company leadership through early clinical.
  • Proven success optimizing established teams/systems: tech transfer, control strategy, stability, comparability, and phase-appropriate validation/PPQ planning.
  • Expertise in cell & gene therapy/viral vectors or complex biologics; potency/viral safety analytics and chain-of-identity/custody highly preferred.
  • Regulatory leadership authoring/defending CMC; experience preparing for BLA/MAA strongly preferred.
  • Deep knowledge of cGMP and ICH Q-series, change control, deviations/CAPA, and inspection readiness, including oversight of external partners.
  • Excellence in CDMO/CMO governance and running an externalized manufacturing model with measurable KPI improvement.
  • Clear, concise communicator who aligns cross-functionally (QA, Regulatory, Clinical, Finance) and steers the team with data and judgment.
  • Strategic and operational mindset, able to balance long-term vision with day-to-day execution
Kelonia does not accept unsolicited resumes from any source other than directly from candidates. 
 
The anticipated salary range for candidates for this role if hired at VP Level will be $274,000 – 353,000
The anticipated salary range for candidates for this role if hired at SVP Level will be $304,000 - $381,000.
The final salary offered will depend on several factors, which may include, but is not limited to, relevant years of experience, skills, qualifications, job knowledge, and educational background.
 
 

At Kelonia, we’re serious about balance and growth. We offer Flexible Time Off and flexible scheduling aligned with team objectives, a competitive benefits package (health, commuter, and more), and on-site perks including free parking, a state-of-the-art gym, and a food hall, all within a collaborative, inclusive team that invests in your development.
 
Kelonia Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.
 
Kelonia does not accept unsolicited resumes from any source other than directly from candidates. 

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.