Senior Manager, Pharmaceutical Development

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.Position Summary:Design, build, and manage the production of commercial scalable drug product prototypes with the Pharmaceutical Development team working towards the commercial development of a sustained release hydrogel based drug product for use in the treatment of an ophthalmic indication.  Work with direct reports and broader company team members to design and implement program plans in line with team and corporate goals.  Communicate with team members, and management to present concepts, activities, plans, and updates on program status to gain alignment of strategy towards project goals. Principal Duties and Responsibilities include the following: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.Supervisory Responsibilities:Supervise scientists and/or engineers.Qualification Requirements:MS or PhD in 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 submissionsDemonstrated 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.Knowledge/Skill: Identify specific knowledge and /or minimum skillExperience in medical device and/or pharmaceutical development.Knowledge of medical device and/or pharmaceutical product development practices and regulatory requirements.Knowledge of safe laboratory practices.Able to drive projects through to completionExcellent multi-tasking and prioritization skillsWorking Conditions:Work in both a laboratory and an environmentally controlled GMP environmentOcular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at .