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Cmc Msat Director Jobs (NOW HIRING)

Madrigalpharma

Director, MSAT API Lead

Indiana, PA · On-site

$200 - $250/hr

## Director, MSAT API LeadApplylocations: Zug - Switzerland - Officetime type: Full timeposted on ... Coordinates with CMC and Quality to execute tech transfers, ensuring readiness criteria, milestones ...

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Cmc Msat Director information

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How much do cmc msat director jobs pay per year?

As of Sep 9, 2026, the average yearly pay for cmc msat director in the United States is $127,543.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,000.00 and $150,500.00 per year, depending on experience, location, and employer.

What is a CMC MSAT Director?

CMC MSAT Directors are senior leaders responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) and Manufacturing Science and Technology (MSAT) functions within pharmaceutical and biotechnology companies. They ensure that drug manufacturing processes are consistent, efficient, and compliant with regulatory standards. Their role involves leading teams that optimize production processes, resolve technical issues, and support technology transfer from development to commercial manufacturing. CMC MSAT Directors also play a vital role in cross-functional collaboration with quality, regulatory, and R&D departments to ensure product quality and successful market delivery.

How does a CMC MSAT Director typically collaborate with cross-functional teams during process development and tech transfer projects?

A CMC MSAT Director plays a pivotal role in bridging process development, manufacturing, and quality teams to ensure seamless technology transfer and process scale-up. They lead cross-functional meetings, coordinate with regulatory affairs, and work closely with analytical, quality assurance, and engineering departments to resolve technical issues and maintain compliance. This collaboration ensures robust manufacturing processes and timely delivery of clinical and commercial products. Effective communication, leadership, and project management are critical to successfully driving these multidisciplinary efforts.

What are the key skills and qualifications needed to thrive as a CMC MSAT Director, and why are they important?

To thrive as a CMC MSAT Director, you need deep expertise in chemistry, manufacturing, and controls (CMC), process development, and regulatory requirements, typically supported by an advanced degree in a scientific field. Familiarity with tools such as process analytical technologies (PAT), quality management systems, and regulatory submission platforms is essential. Strong leadership, cross-functional collaboration, and problem-solving skills help drive technical teams and projects forward. These competencies ensure robust product development, regulatory compliance, and efficient technology transfer in the pharmaceutical or biotech industry.

What is the difference between Cmc Msat Director vs Cmc Msat Manager?

AspectCmc Msat DirectorCmc Msat Manager
ResponsibilitiesOversees global CMC MSAT strategies, leads cross-functional teams, and ensures regulatory compliance at a senior level.Manages daily MSAT operations, coordinates project activities, and supports senior leadership in CMC activities.
Required CredentialsTypically requires advanced degrees (PhD, MSc) and extensive industry experience.Requires relevant bachelor's or master's degree with significant industry experience.
Work EnvironmentStrategic, leadership-focused, often in corporate or global settings.Operational, team-oriented, often in laboratory or manufacturing settings.

The Cmc Msat Director focuses on strategic leadership and global oversight, while the Cmc Msat Manager handles day-to-day operations and project management. Both roles require industry-specific knowledge, but the director role involves higher-level decision-making and broader scope.

What does a Cmc Msat Director do?

A CMC MSAT Director oversees the Chemistry, Manufacturing, and Controls (CMC) activities related to drug development and manufacturing. They coordinate cross-functional teams to ensure regulatory compliance, manage technical documentation, and support product approval processes. Strong knowledge of regulatory requirements, project management skills, and experience with quality systems are essential for this role.

What are popular job titles related to Cmc Msat Director jobs?

For Cmc Msat Director jobs, the most frequently searched job titles are:

Infographic showing various Cmc Msat Director job openings in the United States as of September 2026, with employment types broken down into 2% As Needed, 84% Full Time, 12% Part Time, 1% Temporary, and 1% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $127,543 per year, or $61.3 per hour.

Director, MSAT, CMC and Process Validation

San Diego, CA • On-site

Artiva Biotherapeutics Inc.
Biotechnology Research and Development • 11 - 50 employees
Learn more about Artiva Biotherapeutics Inc.external

$200 - $250/hr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 20 days ago

Job description

About Artiva:

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, create an opportunity to generate potentially transformative therapies.


Lead. Validate. Transform Cell Therapies.


Drive the manufacturing future of allogeneic NK cell therapy.


Artiva is seeking a Director, MSAT, CMC & Process Validation to lead end-to-end process validation as we advance toward Phase 3. Own the journey from process characterization through PPQ and continued process verification, partnering across MSAT, CMC, Quality, and GMP Manufacturing. Late-stage development experience and hands-on PPQ execution are must-haves. Join a nimble biotech. Lead critical work. Make a difference for patients.


For more information, visit www.artivabio.com.


As the Director, MSAT & CMC Process Validation, you will lead process validation strategy and execution for Artiva's allogeneic manufacturing processes. As a senior member of the MSAT (Manufacturing Science & Technology) organization, you will own the end-to-end validation lifecycle for our biopharmaceutical plant - from process characterization through PPQ and continued process verification - and serve as a key technical leader at the intersection of MSAT, CMC, and GMP manufacturing operations.


Duties/Responsibilities

  • Own the process validation strategy and lifecycle for Artiva's manufacturing processes - Stage 1 (process design/characterization) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification) - in alignment with FDA, EMA, and ICH expectations.

  • Lead the planning, authoring, execution, and disposition of process validation protocols and reports, including studies demonstrating the suitability and robustness of manufacturing processes.

  • Provide hands-on technical leadership for PPQ campaigns, including protocol design, acceptance criteria, real-time execution support on the manufacturing floor, deviation triage, and report closure.

  • Define and maintain control strategy elements, process monitoring plans, and CPV trending programs; drive data-driven decisions on process capability (Cpk/Ppk) and process performance.

  • Support day-to-day manufacturing operations through master batch record (MBR) review and revision, authoring of deviations and investigations, and development of effective, sustainable CAPAs with verified effectiveness checks.

  • Own process data management for validation and CPV, including data integrity, structured data capture from manufacturing runs, and governance of validation datasets.

  • Build and maintain dashboards and data tracking tools for real-time visibility into process performance, CQA/CPP trending, and validation program status; establish statistical trending and alert/action limits to enable proactive process monitoring.

  • Direct the management of technical risks associated with process validation, ensuring project completion in alignment with program milestones and regulatory filing timelines.

  • Author and own CMC sections of regulatory filings (IND, BLA, MAA) and the technical content of validation reports; serve as validation SME during regulatory inspections and health authority interactions.

  • Partner cross-functionally with QA, QC, PD, Manufacturing, Supply Chain, and Regulatory Affairs to ensure critical process and technical information flows to the right stakeholders on the required timelines.

  • Ensure timely, rigorous assessment of change requests and validation-related deviations within the GMP quality system; drive disposition-enabling technical assessments.

  • Build, mentor, and develop validation and MSAT talent; establish validation lifecycle strategies, standards, and best practices as the organization scales toward commercial readiness.

  • Champion continuous improvement initiatives across MSAT, and manufacturing operations.

  • Generously share information and knowledge across teams and functions. Demonstrate high integrity.


Requirements

  • Bachelor's, Master's, or PhD in biotechnology, chemical engineering, or related discipline.

  • Minimum 5 years of experience in process validation, MSAT, and/or manufacturing within a cGMPregulated biopharmaceutical environment, including leadership of technical teams and complex crossfunctional programs.

  • Late-stage development experience with hands-on PPQ execution is a must - candidates must have directly led or executed PPQ campaigns, not solely in an oversight capacity.

  • Strong working knowledge of CMC and GMP operations, including quality systems (change control, deviations, CAPA), batch disposition, and regulatory filing strategy.

  • Strong technology transfer experience required; cell therapy or other complex biologics experience strongly preferred.

  • Deep understanding of ICH, FDA, and EMA guidelines, including the FDA process validation lifecycle framework and process capability expectations.

  • Excellent technical writing skills, with demonstrated authorship of validation documents and CMC regulatory sections.

  • Excellent communication, stakeholder management, and executive presence; able to represent validation strategy to senior leadership and health authorities.


In addition to a great culture, we offer:

  • A beautiful facility

  • An entrepreneurial, highly collaborative, and innovative environment

  • Comprehensive benefits, including:

    • Medical, Dental, and Vision

    • Group Life Insurance

    • Long-Term Disability (LTD)

    • 401(k) Retirement Plan

    • Employee Assistance Program (EAP)

    • Flexible Spending Account (FSA)

    • Paid Time Off (PTO)

    • Company-paid holidays, including the year-end holiday week

    • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.



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