Sr. Director, Drug Substance (small molecules)

EyePoint Pharmaceuticals•Watertown, MA

3d•Hybrid

About The Position

At EyePoint , leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our: focus on science and innovation, we aim to offer a lifetime of clearer vision commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases. We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. Based in Watertown, MA and reporting to the VP, CMC, this position is responsible for providing leadership in drug substance development of small molecules from preclinical through clinical development and commercialization and ensuring high quality outsourcing of small molecule drug substances and related materials. There will be a significant contribution expected from this role to enable regulatory filings . In addition, the successful candidate will have demonstrated capabilities in working cross-functionally with internal stake holders and effectively managing development activities at external vendors. Supervisory experience is a must. The position holder needs to have a broad range of knowledge across the various functional areas in pharmaceutical development, understand manufacturing technologies, people and organizational structures. The role enables high performing internal and external development teams to successfully develop, commercialize, and file products. This position is located at our Watertown, MA site and we offer a hybrid work schedule.

Requirements

Expert in synthesis of small molecules and in developing and optimizing chemical manufacturing processes.
Experience in late-stage drug substance development (Phase III to commercialization, especially validation).
Knowledge of current regulatory guidance and experience in managing IND/IMPD and NDA filings.
Excellent interpersonal, technical writing, and oral communication skills.
Strong business acumen and problem-solving skills.
Able to identify key performance metrics, generate actionable reports and communicate complex information clearly to internal stakeholders.
Possesses high integrity and exceptional work ethic.
Ability to travel domestically and/or internationally to achieve goals, when required.
Supervisory experience is a must.
PhD or MS in Organic Chemistry with 15+ years of related industry experience.
At least 15 years of relevant experience in the pharmaceutical industry.

Nice To Haves

Experience in pre-formulation development/crystal form optimization is a plus.
Experience with solid-state characterization (PLM, PXRD, TGA, DSC, DVS, etc.).
Understanding of pharmaceutical dosage forms with a focus on physicochemical properties and how they impact dosage form development.

Responsibilities

Provide strategic leadership and oversight to the drug substance group, aligning with the company's overall goals and objectives.
Provide leadership for all outsourced activities for starting materials and drug substances at CDMOs, ensuring timely progression and high-quality outcomes.
Responsible for high level planning and budgeting of all drug substance related activities from preclinical to commercial.
Responsible for business review meetings with drug substance CDMOs.
Mentor and develop a team of internal and external chemists, fostering a collaborative and innovative work environment.
Work closely with cross-functional teams, including regulatory, formulation, analytical, project management, quality and discovery.
Ensure all activities comply with relevant regulatory requirements and industry standards.
Provide leadership to ensure high quality process documentation and batch records for cGMP small molecule drug substance manufacturing.
Review and approve drug substance reports based on CDMO results, data and documentation required for regulatory submissions including review and approval of CMC sections of regulatory filings
Ensure that all work is conducted in accordance with applicable policies and procedures, cGMP and regulatory standards and guidelines.
Maintain an understanding of current laws & regulations applicable to the pharmaceutical/biotechnology industry.