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Cmc Msat Director Jobs (NOW HIRING)

FUJIFILM Biotechnologies

Position OverviewThe Associate Director, Drug Substance MSAT, leads end-to-end process stewardship ... CMC review of regulatory submissions, site inspections, and health authority inquiries, as ...

Servier

Assoc Director, Oral Solid Drug Product

Boston, KY · On-site

$198K - $207K/yr

Role Summary Within MSAT, the Oral Solid Drug Product team is responsible for providing technical ... Support Regulatory CMC in responding to health authority questions related to commercial ...

Kelly Services

Sr MSAT Engineer

Stafford, TX · On-site

$60/hr

... manufacturing and CMC-GMP operations. This is a unique opportunity to join a cutting-edge ... Direct cell therapy manufacturing experience required * Strong experience owning deviations ...

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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 12, 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 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $127,543 per year, or $61.3 per hour.

Sr. Manager / Associate Director, Late-Phase Drug Substance PD/MSAT

Cambridge, MA

Merida Biosciences
See more jobs at Merida Biosciencesexternal

Full-time

Re-posted 6 days ago

Job description

Description

Sr. Manager / Associate Director, Late-Phase Drug Substance PD/MSAT 

At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively eliminate the root causes of autoimmune and allergic diseases, achieving deep, durable responses while preserving essential immunity. We are passionate about transforming treatment paradigms across the spectrum of antibody-driven diseases and we are looking for equally passionate individuals to join our mission.


We are seeking a technically driven and strategically minded Sr. Manager / Associate Director to serve as our late-phase drug substance PD/MSAT lead, reporting to the Head of Drug Substance . This individual will own the CMC execution strategy for a fusion protein drug substance program from late-phase development, PC through PPQ and will serve as the primary technical interface with our CDMO partner for operations. Working closely with our upstream and downstream process development SMEs and Head of Drug Substance, this person will help shape the broader CMC strategy and ensure disciplined, on-schedule execution of late-phase plans.


The candidate will also participate in late-phase CDMO vendor evaluation, contribute to early-phase process development work, and gain hands-on experience defining work packages that advance molecules from candidate selection to IND. This is an opportunity for a seasoned upstream engineer to operate with high autonomy and real ownership in a lean, science-first startup environment.


Key Responsibilities

Serve as the primary drug substance technical lead for a fusion protein drug substance program, driving activities from late-phase process development, pivotal supply, characterization through PPQ.

Working closely with CDMO partners and CMC team to define upstream and downstreaM late phase activities such as process characterization studies with qualified SDM to establish proven acceptable ranges (PARs) and design space, applying QbD principles and statistical modeling (DoE, multivariate analysis) to drive control strategies. Develop and oversee execution of the PPQ protocols and serve as PIP as needed.

Manage day-to-day technical relationships with the CDMO partner; oversee execution of development and manufacturing workstreams, ensure alignment on timelines and deliverables, ensure cross-functional alignment on process interfaces, in-process sampling, and release testing strategy and lead technical governance meetings.

Collaborate closely with existing upstream and downstream SMEs and the Head of Drug Substance to define an integrated CMC strategy and ensure consistency across drug substance development, manufacturing, and regulatory deliverables.

Author and review relevant documents including study reports, TTP, PD, MBRs, EBRs, CMC sections for regulatory filings. 

Contribute to early-phase upstream process development activities and broadly to CMC team as bandwidth allows.


Requirements

Qualifications


Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with 5+ years of upstream biologics industry experience; or M.S. with 8+ years.

Deep upstream SME expertise in mAb and/or fusion protein process development: cell culture process design, CPP/CQA characterization, control strategy, and tech transfer.

Hands-on bioreactor experience across scales (ambr, 2L/10L, pilot, manufacturing); demonstrated scale-down model development and qualification.

Proven late-phase track record (Phase II/III through PPQ): process characterization studies, process validation protocols, and commercial-readiness documentation.

Proficiency in statistical modeling for process development: DoE, multivariate analysis, process capability, and statistical software (JMP or equivalent).

Working knowledge of downstream unit operations (chromatography, filtration, viral clearance) sufficient for cross-functional process interface alignment.

Experience authoring CMC regulatory sections (IND, IMPD, BLA).

Demonstrated CDMO management: technical oversight, deliverable governance, and manufacturing partner relationship management.


Preferred

Direct experience with Fc-fusion proteins or other complex biologics modalities.

Background in a startup or clinical-stage biotech where breadth and independent judgment are essential.


Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.


Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we're sharing our hiring range for this role upfront: typically for the  Senior Manager/Associate Director  we target $165,000 to $200,000. The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we're proud to offer a comprehensive benefits package designed to support you both personally and professionally.


Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

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