Senior Manager, Drug Product Development

Role Summary

The Senior Manager, Drug Product Development is a key member of the Manufacturing and Process Technology Team. The candidate should be able to work collaboratively in a fast-paced environment, navigate ambiguities, and drive results forward. The role reports to the Senior Director of Process Technologies and Manufacturing and serves as a business partner to other parts of the organization.

Responsibilities

• Lead formulation, Device, and Drug Product deliverables to support pre-clinical, clinical/pivotal studies leading to IND, BLA/MAA and commercial launch
• Evaluate molecules for CQAs by accelerated conditions and stress exposures, characterizing molecule variants and degradants
• Plan, design and execute univariate/multivariate formulation and DP process characterization/validation studies with external testing sites, and drive timely execution with quality oversight
• Guide CRO in analytical testing with chromatographic and biophysical methods (e.g. SEC-MALS, DLS, spectroscopy) to support product and process characterization
• Devise the DP and Device process technology transfer, qualification, and validation strategy, for clinical/commercial product site transfer
• Provide ongoing fill-finish manufacturing support to Drug Product sites/CMOs: including technology transfers and impact assessments, during quality investigations to ensure product and process consistency
• Partner with internal/external manufacturing and quality for process improvement, transfers, compilation and review of batch records, master production records and technical support to resolve investigations, deviations, corrective/preventative actions
• Author and review technical protocols and reports to document study findings in support of IND, IND amendments, BLA/MAA and other global regulatory filings
• Participate in CMC/project teams for functional representation as well as support teams’ objectives and project deliverables
• Evaluate biochemical and biophysical methods suitable for MaB and fusion protein molecular assessment and product characterization
• Collaborate with full-time employees, contractors, and consultants to deliver organizational goals

Qualifications

• Ph.D. in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and 5+ years of product development experience in industry, or BS/MS with 10+ years of experience
• Experience with biologics formulation development, Drug Product process design, Device development, and manufacturing Fill/Finish, is highly desirable

Skills

• Experience with MaB or fusion protein process/formulation/analytical development is a plus
• Sound understanding of analytical methods for formulation characterization (e.g. qPCR/ddPCR, UV-vis, H/UPLC, capillary electrophoresis and biophysical techniques (e.g. SEC-MALS, DLS, AUC, Fluorescence, particle analysis, etc.))
• Experience in QbD methodologies and statistical analysis using JMP
• Good knowledge of FDA guidance as well as cGMP and ICH requirements
• Experience or contribution to regulatory submissions, through any phase of product development
• Excellent communication (oral and written) and attention to detail, ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

Education

• Ph.D. in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and 5+ years of product development experience in industry, or BS/MS with 10+ years of experience

Additional Requirements

• Travel may be required for up to 25% of time worked