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

Merida Biosciences; Cambridge (MA); On-site; USD 165,000 - 200,000; Full time

Benefits offered by this job

Comprehensive benefits package

Transparent hiring range

Job summary

Merida Biosciences is seeking a Sr. Manager / Associate Director to lead late-phase drug substance PD/MSAT, interfacing with a CDMO and the CMC team to drive strategy and execution. You will guide process characterization, PPQ development, and regulatory deliverables in collaboration with upstream and downstream SMEs.

The role requires a Ph.D. or MS with extensive experience in biologics, DoE and multivariate analysis, and hands-on bioreactor leadership.

Qualifications

• Ph.D. in Chemical Engineering or related field with 5+ years of upstream biologics 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.

Responsibilities

• Lead late-phase PD/MSAT for fusion protein program, coordinating with CDMO and CMC teams.
• Define upstream/downstream late-phase activities, DoE and design space to drive control strategies; develop PPQ protocols.
• Oversee CDMO governance and ensure on-time execution of development and manufacturing workstreams.
• Collaborate with SMEs to define integrated CMC strategy across development, manufacturing, and regulatory deliverables.
• Author study reports, MBRs and CMC sections for regulatory filings.
• Support early-phase upstream development activities as bandwidth allows.

Skills

Upstream Biologics

Process Development

CDMO Management

DoE

Statistical Modeling

Scale-up Bioreactors

Regulatory Submissions

Education

Ph.D. in Chemical Engineering

M.S. in Chemical Engineering

Tools

JMP

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.