Senior Manager, Pharmaceutical Development Lead

2 days ago

New Bedford, Massachusetts, United States Ocular Therapeutix Full time
Job Summary

As a Senior Manager, Pharmaceutical Development, you will lead the design, build, and management of commercial scalable drug product prototypes with the Pharmaceutical Development team. Your focus will be on the commercial development of a sustained release hydrogel based drug product for ophthalmic indications.

You will work closely with direct reports and broader company team members to design and implement program plans in line with team and corporate goals. Effective communication with team members and management is essential to present concepts, activities, plans, and updates on program status to gain alignment of strategy towards project goals.

Key Responsibilities
  • Manage, develop, build, and demonstrate highly scalable reproducible implant production processes incorporating rapid automated inspection processes to meet intravitreal implant commercial demand projections.
  • Direct and manage junior team members in the design, execution, and scale-up of a sustained release hydrogel based drug product currently in Phase 3 clinical studies.
  • Build scalable prototype processes incorporating in-process inspection control strategies (PAT) demonstrating critical process parameters at scale to define in-process controls to establish process robustness.
  • Create and evaluate processes and work with outside vendors, when necessary, in the development of custom equipment to support manufacturing scale-up efforts.
  • Communicate needs, plans, and technical study information with team members defining project milestones, tasks, timelines, resources, and costs.
  • Serve as a team member on a cross-functional project team working towards the development of increased commercial production capacity.
  • Document work in technical reports in support of scale-up strategies and future regulatory submissions.
  • May assist in the evaluation of drug product performance in nonclinical studies.
  • Manage, motivate, and mentor junior team members working towards project goals and career development.
Qualification Requirements
  • MS or PhD in a relevant pharmaceutical discipline.
  • 6+ years' experience in drug product research, development, or manufacturing.
  • Experience in CMC drug product development.
  • Experience managing a team of early career scientists and engineers.
  • Experience in drug product formulation development and process scale-up supporting CMC elements towards regulatory submissions.
  • An understanding of phase-appropriate drug product requirements and applicable GMP manufacturing regulations including batch records, raw materials, product specifications, and pertinent documentation supporting regulatory submissions.
  • Demonstrated ability to apply scientific skills to evaluation of processes and development of practical solutions to technical challenges towards production scale-up activities.
  • Experience in sustained release formulations, tyrosine kinase inhibitors, and ophthalmic indications is a plus.
  • A collaborative, hard-working, passionate about science team player that can effectively work in a dynamic, cross-functional team environment.
  • Strong presentation skills and written communications skills supporting regulatory submissions.

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