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

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.

• 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 work streams, 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.

• 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 (am , 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…