Director, Formulation Process Development

Overview

Be Seen and Heard at EyePoint Pharmaceuticals

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:

 

• Preventing blindness through vision-saving medications
• Delivering best-in-class proprietary pharmaceutical technologies
• Transforming ocular drug delivery

 

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 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.

Responsibilities

Primary 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.

Qualifications

Primary 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 goals
• Flexible, 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 ne