<p>Overview</p> <p>Be Seen and Heard at EyePoint</p> <p>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 success for:</p> <ul> <li>preventing blindness through vision-saving medications </li><li>delivering best-in-class proprietary pharmaceutical technologies </li><li>transforming ocular drug delivery </li></ul> <p>We See You.</p> <ul> <li>Your wellbeing </li><li>Your professional worth </li><li>Your future at EyePoint </li></ul> <p>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.</p> <p>Based in Watertown, MA and reporting to the VP, CMC, this position is responsible for the drug substance development of small molecules from preclinical through clinical development and commercialization and for overseeing CDMO activities related to development, optimization, scale-up, technology transfer, development manufacture and commercial manufacture 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 plus.</p> <p>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.</p> <p>Responsibilities</p> <p>Primary responsibilities include, but are not limited to, the following:</p> <p>Individual responsibilities</p> <ul> <li>Oversight of CDMO activities related to synthetic route development, process optimization, scale-up, technology transfer, development manufacture, and commercial manufacture of small molecule drug substance and related materials. </li><li>Review, verify and approve process documentation and batch records for cGMP small molecule drug substance manufacturing. </li><li>Provide on-site monitoring of drug substance manufacturing at contract sites, and support of deviations and investigations. </li><li>Write and review drug substance development reports based on CDMO results, data and documentation required for regulatory submissions including authoring, review and approval of CMC sections of regulatory filings </li><li>Direct isolation and identification of impurities at a CDMO and recommend process modification to control impurity levels. </li><li>Conduct comprehensive Failure Mode and Effect Analysis (FMEA) of manufacturing processes. </li><li>Conduct fate and purge studies to support regulatory submissions. </li><li>Regularly report work status and prepare presentations for team meetings. </li><li>Cooperatively work with CMC teams and personnel from other departments such as Analytical Development, Formulation Development, Quality Assurance, Regulatory Affairs, and Project Management. </li><li>Ensure that all work is conducted in accordance with applicable policies and procedures, cGMP and regulatory standards and guidelines. </li><li>Maintain an understanding of current laws & regulations applicable to the pharmaceutical/biotechnology industry. </li></ul> <p>Qualifications</p> <p>Primary skills and knowledge required include, but are not limited to the following:</p> <ul> <li>Expert in synthesis of small molecules and in developing and optimizing chemical manufacturing processes. </li><li>Able to design synthetic routes and complex procedures for defined compounds. </li><li>Experience in late-stage drug substance development (Phase III to commercialization). </li><li>Experience in managing drug substance CDMOs/CMOs. </li><li>Hands-on experience with laboratory research and development, pilot plant scale-up and/or larger scale chemical synthesis is desirable. </li><li>Experience in pre-formulation development/crystal form optimization is a plus. </li><li>Understanding of physical organic chemistry and materials science/engineering. </li><li>Experience with solid-state characterization (PLM, PXRD, TGA, DSC, DVS, etc.) </li><li>Understanding of pharmaceutical dosage forms with a focus on physicochemical properties and how they impact dosage form development. </li><li>Strong project management skills and the ability to prioritize and align drug substance development activities with broader project goals. </li><li>Flexible, adaptable and collaborative style with a willingness to take on new challenges and positively respond to changes. </li><li>Knowledge of current regulatory guidance and experience in managing IND/IMPD and NDA filings. </li><li>Excellent interpersonal, technical writing, and oral communication skills. </li><li>Strong business acumen and problem-solving skills. </li><li>Able to identify key performance metrics, generate actionable reports and communicate complex information clearly to internal stakeholders. </li><li>A team player who is able to collaborate effectively with a broad range of internal functions. </li><li>Possesses high integrity and exceptional work ethic. </li><li>Ability to travel domestically and/or internationally to achieve goals, when required. </li><li>Supervisory experience is a plus. </li></ul> <p>Level of Education Required:</p> <ul> <li>PhD or MS in Organic Chemistry with 10+ years of related industry experience. </li></ul> <p>Number of Years of Experience in the Function and in the Industry:</p> <ul> <li>At least 10 years of relevant experience in the pharmaceutical industry. </li></ul> <p>Envision Your Future</p> <p>With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.</p> <p>The collective power of our values influences everything we do, and everything we do for you.</p> <p>Transformational Innovation</p> <p>We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.</p> <p>Unwavering Integrity</p> <p>We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.</p> <p>Compassionate Excellence</p> <p>We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.</p> <p>Inclusive Collaboration</p> <p>We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.</p> <p>EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.</p> <p>#LI-Onsite</p>