Sr. Scientist I (Pre-formulation and Solid State Characterization)

Initial Therapeutics, Inc.; Watertown (MA); On-site; USD 146,260 - 184,713; Full time

Job summary

EyePoint Pharmaceuticals in Watertown, MA is seeking a Sr Scientist I to lead formulation/process development of intravitreal drug products and drug-device combinations. The candidate will advance pre-formulation and solid-state characterization with cross-functional collaboration across Drug Substance, Analytical Development, and Formulation Development.

The role requires a PhD or Master with extensive industry experience; responsibilities include pre-formulation studies, crystallization

Qualifications

• PhD or Master in Material Sciences, Pharmaceutical Sciences or related discipline.
• PhD: at least 5 years of relevant industry experience; Master: at least 10 years.

Responsibilities

• Work with Drug Substance, Analytical Development, and Formulation Development to progress API from discovery to manufacturing.
• Conduct pre-formulation studies/solid-state characterization of APIs and ensure timelines align with project goals.
• Design and execute crystallization processes focusing on form control, particle size, yield and purity.
• Prepare pre-formulation and development reports for regulatory submissions.
• Maintain compliance with policies, procedures, and regulatory standards.

Skills

Pre-formulation development

Solid-state characterization

Cross-functional collaboration

Project planning

Technical writing

Oral communication

Education

PhD in Material Sciences

Master in Pharmaceutical Sciences

Tools

PLM

SEM

PXRD

TGA

DSC

NMR

FTIR

Raman

UV-Vis

Job description

The Discovery & Development team is driven by our patient-first commitment to advancing a retinal disease-focused pipeline. This function leads end-to-end R&D, from early discovery through product development, leveraging cutting-edge ophthalmology and biotechnology platforms to deliver innovative therapeutics that protect vision. By developing best-in-class, durable retinal therapies that can potentially improve outcomes and reduce treatment burden, the team plays a critical role in disrupting the treatment paradigm for serious retinal diseases.

Based in Watertown, MA and reporting to the Senior Director of Formulation Development, this position is responsible for the formulation/process development of high value intravitreal drug products and drug-device combinations. The individual we are seeking will have a well-established track record of successfully developing innovative formulations and processes of small molecules. In addition, the successful candidate will have demonstrated capabilities in working cross-functionally with internal stakeholders and effectively managing internal formulation teams as well as 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. The role enables high performing internal and external development teams to successfully develop, commercialize, and file products.

Primary responsibilities include, but are not limited to, the following:

Work in close partnership with Drug Substance, Analytical Development, and Formulation Development to progress API from discovery to manufacturing. With expertise in pre-formulation research and solid-state characterization, play a crucial role in advancing our discovery pipeline.

Individual Responsibilities

• Conduct pre-formulation studies/solid-state characterization of active pharmaceutical ingredients (APIs) and ensure pre-formulation timelines are aligned with project goals.
• Contribute to a thorough understanding of drug substance attributes, such as solubility, polymorphism, morphology, and stability and conceive formulation strategy.
• Design and execute crystallization process with a focus on form control, particle size/morphology, yield, purity, and process understanding.
• Identify and deploy new solid state characterization technologies as needed.
• Prepare pre-formulation and pharmaceutical development reports and other technical documentation required for regulatory submissions.
• Ensure that all work is conducted in accordance with applicable policies, procedures, regulatory standards and guidelines.
• Maintain an understanding of current laws & regulations applicable to the pharmaceutical/biotechnology industry.

Primary skills and knowledge required include, but are not limited to the following:

• Expertise in pre-formulation development of small molecules.
• Strong lab skills with a Can-Do attitude; independently carry out pre-formulation research.
• Highly skilled in characterization techniques such as PLM, SEM, PXRD, TGA, DSC, DVS, NMR, FTIR, Raman, and UV/Vis.
• Skilled in independently organizing project goals and completing long-term projects on time.
• Flexible, adaptable and collaborative style with a willingness to take on new challenges and positively respond to changes.
• Possess high integrity and exceptional work ethic.
• Excellent interpersonal, technical writing, and oral communication skills.
• A team player, collaborating effectively with a broad range of internal functions.
• Versatile, driven and curious to take on new and challenging roles and responsibilities

Level of Education Required:

• PhD or Master in Material Sciences, Pharmaceutical Sciences or related discipline.

Sr Scientist I:

• PhD: at least 5 years of relevant experience in pharmaceutical industry
• Master: at least 10 years of relevant experience in pharmaceutical industry

Pay range

$146,260 - $184,713 USD

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindnessby developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

Transformational Innovation

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.

Unwavering Integrity

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.

Compassionate Excellence

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.

Inclusive Collaboration

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.

EyePointis 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.