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

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.

Number of Years of Experience in the Function and in the Industry:

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