Director, Formulation Process Development

OverviewBe Seen and Heard at EyePoint PharmaceuticalsAt 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 : Preventing blindness through vision-saving medicationsDelivering best-in-class proprietary pharmaceutical technologiesTransforming ocular drug deliveryWe See You.Your wellbeingYour professional worthYour future at EyePointEyePoint 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 of CMC, this position is responsible for the process development of dosage forms for in vitro and in vivo nonclinical and clinical studies including drug product-device combinations. The individual we are seeking will have a well-established track record of successfully developing drug product formulations and processes from concept to commercialization across small molecules. 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.This person will have direct reports.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. Late-stage experience in process development and commercialization of small molecules are a must.  The role enables high performing internal and external development teams to successfully develop, commercialize, and file products.ResponsibilitiesPrimary responsibilities include, but are not limited to, the following : Individual responsibilities Leads the process development of drug product formulations.Leads and implements Quality by Design (QbD) principles in drug product development programs including technical risk assessments, identification of critical quality attributes and process parameters, and manufacturing control strategies.Performs formulation and process development studies and testing in the laboratory.Ensures drug product development activities and timelines are aligned with project goals.Prepares pharmaceutical development reports and other technical documentation required for regulatory submissions including authoring, review and approval of requisite sections of the IND, CTA, IMPD, NDA, MAA or other filings.Works collaboratively across internal stakeholder functions such as Project Management, Manufacturing Operations, Clinical, and Regulatory to meet program goals, including representation on CMC development teams.Ensures that all work is conducted in accordance with applicable policies and procedures, cGMP and regulatory standards and guidelines.Leads and participate in strategic initiatives for improving functional processes within Technical Operations.Maintains an understanding of current laws & regulations applicable to the pharmaceutical / biotechnology industry.QualificationsPrimary skills and knowledge required include, but are not limited to the following : Experience in successfully leading drug product and process development and manufacturing activities for small molecules from Phase 2 / 3 to commercialization, understanding GMP manufacturing. Expert in Quality by Design (QbD) principles, statistical design and proficient use of relevant statistical software like JMP or Minitab.Experience in developing complex formulations and processes. Experience in development of extended-release formulations.Experience in combination products or devices is a plus.Experience in development of ophthalmic products is a plus.Strong project management skills and the ability to prioritize and align drug product development activities with broader project goalsFlexible, adaptable and collaborative style with a willingness to take on new challenges and positively respond to changes.Knowledge of current regulatory guidance and experience in managing IND and NDA filings.Excellent interpersonal, technical writing, and oral communication skills.Proven track record for bringing a high degree of insight, creativity and listening to patient and provider needs to develop and deliver patient services in a high impact, innovative and cost-effective way.Skilled at independently organizing project goals, completing long-term projects on time and within budget and fully integrating them into the work of other functionsStrong business acumen and problem-solving skills.Able to identify key performance metrics, generate actionable reports and communicate complex information clearly to internal stakeholders.Excellent leadership and managerial skills and dedication to mentoring.A team player who is able to collaborate effectively with a broad range of internal functions. Versatile, driven and curious to take on new and challenging roles and responsibilitiesPossesses high integrity and exceptional work ethic.Travel required to our Northbridge, MA site as needed. Level of Education Required : PhD in Chemical Engineering (preferred), Pharmaceutical Sciences or related discipline.Number of Years of Experience in the Function and in the Industry : At least 7 years of relevant experience in pharmaceutical development in late-stage process development.Envision Your FutureWith 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.The collective power of our values influences everything we do, and everything we do for you.Transformational InnovationWe 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.Unwavering IntegrityWe 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.Compassionate ExcellenceWe 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.Inclusive CollaborationWe 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.EyePoint Pharmaceuticals 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.#LI-OnsiteJob Summary