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:
Lead and provide direction and strategy to Pharmaceutical Development team members and direct reports 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 executive level 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:
- Direct and assign Pharmaceutical Development team members in the design, execution and scale up of a sustained release hydrogel based drug product currently in Phase 3 clinical studies.
- Plan and critically evaluate scalable drug product manufacturing processes using risk assessment and DOE approaches to define in-process controls and establish commercial process robustness.
- Communicate needs, plans and technical study information with senior leadership defining project milestones, tasks, timelines, resources, and costs.
- Incorporate rapid automated inspection processes to meet drug product commercial demand projections.
- Serve as a senior team member on a cross-functional project team and provide guidance and direction with emphasis on CMC drug product development towards at commercial production.
- Contribute to the writing and reviewing of CMC sections of regulatory submissions.
- May assist in the design and/or evaluation of drug product performance in nonclinical studies.
- This position will lead a team of creative managers, scientists, and engineers to build a commercial process for a sustained release ophthalmic drug product.
- Manage, motivate, and mentor scientists and engineers towards project goals and career development.
Supervisory Responsibilities:
Supervise a team of managers, scientists and/or engineers.
Qualification Requirements:
- MS or PhD in relevant pharmaceutical discipline.
- 10+ years’ experience in drug product research, development, or manufacturing.
- Experience in CMC drug product development towards commercialization.
- Experience managing a team of scientists and engineers.
- Experience in drug product formulation development and process scale-up supporting CMC elements towards commercialization.
- 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 strong fundamental scientific skills to evaluation of processes and development of practical solutions to technical challenges.
- Experience in sustained release formulations, tyrosine kinase inhibitors, and ophthalmic indications is a plus.
- A hard-working, passionate about science, leader and team player that can effectively collaborate in a dynamic, cross-functional team environment.
- This individual must have excellent oral presentation skills and strong written communications skills to support of regulatory submissions.
Knowledge/Skill: Identify specific knowledge and /or minimum skill
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- Experience 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 completion
- Excellent multi-tasking and prioritization skills
Working Conditions:
- Work in both a laboratory and an environmentally controlled GMP environment
Ocular 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 https://www.ocutx.com/privacy-policy/.