Associate Director, Drug Product Development - Biotech - Boston

Boston Permanent USD155,000 - USD175,000
  • Cross-functional work to support clinical/commercial drug product manufacturing
  • Lead selection and management of Drug Product CMOs

About Our Client

Our client is a clinical-stage biopharmaceutical company focusing on neuromuscular and rare diseases. Their mission is to discover and develop these differentiated therapeutics which treat patients that do not have a current alternative. This publicly traded company was founded in the past decade and has massive growth potential.

Job Description

  • Lead selection and management of Drug Product CMOs
  • Collaborate with Drug Substance team to plan for Drug Product manufacturing needs, timelines, and Drug Product supply
  • Collaborate with Supply Chain to assure Drug Product manufacturing plans meet the needs of multiple programs
  • Collaborate with process development to deliver manufacturing processes that meet the speed, yield, and product quality requirements of the development programs
  • Development of different drug product presentations (ie liquid fills in vials, pre-filled syringes etc)
  • Lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place
  • Lead Drug Product process characterization studies to ensure design spaces, define control strategy for validation and routine manufacturing operation
  • Review and approve technical documentation including protocols, master batch records, and reports related to engineering, GMP and PPQ runs
  • Lead manufacturing process validation activities and transfers with external CDMOs ensuring design of validation strategy is in alignment with business needs, regional & global regulatory compliance and support continued process verification post validation
  • Support continuous process improvement and scale up activities to increase yield while maintaining quality attributes for manufacturing process lifecycle management
  • Collaborate cross-functionally to support clinical and commercial drug product manufacturing processes, tech transfer, validation, supply/supply chain, quality/ compliance, change management and product life cycle management
  • Ensure regulatory inspection readiness and product compliance with regional regulatory requirements
  • Partner with product development, manufacturing, quality and regulatory, lead quality investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place
  • Cultivate excellent working relationship with stakeholders to deliver successful manufacturing campaigns

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • MS with 15+ years of experience in biologics process development; process scale-up; process characterization; technology transfer; process validation; cGMP manufacturing support; and regulatory submissions for protein therapeutics
  • PhD with 10+ years of experience listed above
  • Experience in managing drug product manufacturing vendors including tech transfer, process characterization, process validation of biological products is required
  • Experience in scale up, lifecycle management and commercial planning is required
  • Experience with prefilled syringe development and manufacturing
  • Thorough understanding of product development lifecycle from IND to BLA
  • Experience in managing a team of scientists and associates at different levels
  • Experience with authoring and reviewing CMC documents for multiple regulatory submissions (IND to BLA)
  • Excellent collaboration skills and ability to work cross functionally to achieve objectives
  • Strong work ethic, motivation, and scientific curiosity

What's on Offer

  • Amazing Stock options
  • Annual bonus
  • Excellent benefits package
  • Novel drug portfolio with strong pipeline
  • Start up culture
  • Contribute to development of cutting edge treatments for rare diseases
Faith Emery
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Faith Emery
Job Reference