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:
Ocular Therapeutix is seeking a highly motivated CMC (Chemistry, Manufacturing, and Controls) Program Manager to join its Program Management team. This individual will play a key role in advancing our clinical-stage programs by overseeing CMC-related activities across the development lifecycle—from early development through regulatory submission and commercialization.
The CMC Program Manager will lead cross-functional teams to ensure the CMC strategy is aligned with corporate objectives, and that key deliverables are executed on time and in compliance with applicable standards. This role involves managing complex, cross-functional initiatives across Pharmaceutical Development, Manufacturing, Supply Chain, Regulatory Affairs, Quality, Validation, and Facilities, requiring strategic thinking and strong leadership. The ideal candidate will be a collaborative leader who demonstrates strong team-building skills, clear communication, openness to diverse perspectives, and a proven ability to drive cross-functional alignment.
- Principal Responsibilities:
- Program Management: Participate in sub-teams consisting of experienced subject matter experts to define and document integrated program plans including the long-term and short-term timelines in accordance with the strategic goals and priorities of the organization and Program Management.
- Develop, manage, and track CMC project plans, including timelines and risk management strategies.
- Ensure alignment across cross-functional teams, including Manufacturing, Pharm-Dev, Regulatory Affairs, Quality, Validation, Facilities, and Supply Chain.
- Collaborate with team members to create and deliver informative, audience-focused presentations for the program/core team, CMC sub-teams, and other stakeholders.
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Coordination and Communication:
- Act as the primary point of contact for CMC-related activities within assigned programs.
- Facilitate cross-functional team meetings, track progress, and provide regular status updates to stakeholders.
- Identify risks, develop mitigation strategies, and escalate critical issues as needed.
- Regulatory Support: Track the preparation and review of CMC sections for regulatory submissions (e.g., INDs, NDAs, CTAs).
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Collaboration:
- Partner with internal and external stakeholders, including contract manufacturing organizations (CMOs) and testing labs, to meet program objectives.
- Monitor and manage performance of external vendors to ensure deliverables are met on time and within scope.
- Performance Monitoring: Track project progress against milestones and objectives, providing regular updates to Program Management and relevant sub teams. Proactively adjust plans as needed to ensure project success.
- Continuous Improvement: Drive process improvements within the program management function, identifying opportunities to enhance efficiency, reduce costs, and improve outcomes.
- Supervisory Responsibilities:
- Qualification Requirements:
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Education: Bachelor’s or Master’s degree in a relevant scientific discipline (e.g., Chemical/ Biomedical/ Mechanical Engineering, Chemistry, Pharmaceutical Sciences, or related field).
- Experience: 5+ years of experience in CMC, Program Management, or related fields within the pharmaceutical or biotech industry.
- A solid understanding of the pharmaceutical development lifecycle—from discovery through commercialization—and the ability to navigate regulatory requirements and industry standards is highly desirable.
- Certifications: PMP (Project Management Professional) or equivalent certification is optional.
- Technical Skills: Strong understanding of pharmaceutical development processes, including process & formulation development, manufacturing, quality control, and regulatory requirements. Proficiency in project management tools (e.g., MS Project, Smartsheet) is desired.
- Communication Skills: Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely to a variety of audiences.
- Problem-Solving: Strong analytical and problem-solving abilities, with a focus on delivering solutions that meet project objectives and stakeholder needs.
- Time Management: Ability to manage multiple priorities and projects simultaneously, ensuring deadlines are met without compromising quality.
- Working Conditions:
- A hybrid work model combining in-office and remote work. Regular on-site presence is highly encouraged to foster collaboration and build strong relationships with our CMC team.
- This role may involve occasional travel to attend conferences or oversee project-related activities. The position may also require extended hours to meet critical project deadlines.
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/.
