Senior Manager, 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

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.