- Leads the development of novel extended-release of small molecule drug product formulations and drug-device combinations.
- Ensures drug product development activities and timelines are aligned with project goals
- Designs and executes experiments to evaluate formulation for performance, stability, and manufacturability.
- Manages drug product development activities at external vendors with applicable regulatory and quality requirements including providing input into the design of experiments, managing timelines, reviewing technical and batch manufacturing documentation and ensuring that EyePoint's business needs are met by the vendor
- Identify and implement improvements to existing EyePoint technologies.
- 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, and other filings.
- Works collaboratively across internal stakeholder functions such as Project Management, Pre-Clinical and Device development, 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.
- Maintains an understanding of current laws & regulations applicable to the pharmaceutical/biotechnology industry.
- Solid understanding of pharmaceutical and engineering principles in drug development
- Experience in solid dosage formulation development of small molecules
- Proven experience in successfully leading drug product development and manufacturing activities
- Experience in ocular drug product is a plus
- Experience in development of injectable product is a plus
- Experience in extrusion is a plus
- Strong problem-solving skills with a Can-Do attitude
- Hands-on experience with physicochemical and analytical techniques such as DSC, TGA, XRPD, HPLC, SEM, PSD, KF, and Dissolution.
- 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/IMPD filings
- Excellent interpersonal, technical writing, and oral communication skills
- A team player who is able to collaborate effectively with a broad range of internal functions
- High integrity and exceptional work ethic
- PhD in Pharmaceutical Sciences, Chemical Engineering or related discipline with 5+ years of related industry experience or Masters with 8+ years of related industry experience.
- At least 5 years of relevant experience in pharmaceutical development
- Success begins with our People
- Patients First
- Integrity
- Results-Driven
- Innovation
- Team Focus
- Diversity & Inclusion
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Senior Scientist II/Principal Scientist-Formulation Development/Innovative Drug Delivery - Watertown, United States - EyePoint Pharmaceuticals
Description
OverviewBe 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:
* developing therapeutics to improve the lives of patients with serious retinal disease
* advancing best-in-class proprietary drug delivery technologies
* innovative pipeline of sustained delivery products
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 Director, Formulation Development, this position is responsible for the formulation and process development of innovative drug delivery platform/drug product device combination for peptides/small molecules.
The individual we are seeking will have a well-established track record of successfully developing peptide/small molecule formulations and processes from concept to late-stage across multiple modalities.
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.
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.
This position is based in Watertown, MA and offers flexible work hours.
Responsibilities
Primary responsibilities include, but are not limited to, the following:
Individual responsibilities
Primary skills and knowledge required include, but are not limited to the following:
Level of Education Required Field of Study:
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.
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.
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