Sr. Scientist, Pharmaceutical Development

Founded in October 2019, We are a clinical-stage pharmaceutical company focused on developing innovative ophthalmic therapies to improve vision for people around the world. Our lead program is BRIMOCHOL™, an investigational drug designed to be a once-daily eye drop to correct for the loss of near vision associated with presbyopia.

The Senior Scientist, Pharmaceutical Development is responsible for planning, designing, coordinating and executing experiments and studies leading to the development and characterization of small molecule and peptide drug substances and ophthalmic and dermal formulations. The individual will also assist with advancing the programs through the drug development stages, meeting all CMC technical and regulatory requirements appropriate for the stage of development.

This position requires an in depth understanding of chemistry, pharmaceutics, formulation development, drug substance and materials characterization and analytical techniques. A key component of this position is the ability to integrate data and information from various sources, critically evaluate and utilize it to develop drug products meeting global regulatory requirements. The position operates in the early development stages, but should have line of sight to later stages of development including in depth developability assessment, critical quality and material attribute determination, process development and identifying critical process parameters for robust technical transfers.

An essential component of this position is the interaction with contract research and contract manufacturing organizations. Effective communication skills are required. The candidate will need to be proactive and diligently follow-up on third party commitments and quality.

Responsibilities:

• Designs, plans and coordinates or executes experiments leading to the characterization of drug substances (small molecules and peptides) and drug product (dermal, ophthalmic and complex drug delivery systems). Drug substances, drug products and processes will meet all required regulatory guidance and requirements for the given stage of development. Works with CROs to ensure the necessary characterization data is generated to move -products through the development stages
• Coordinates and works with CMOs on the design and characterization of manufacturing processes for topical ophthalmic and dermal formulations as well as complex dosage forms. Identifies the critical quality and material attributes of the drug product and excipients and the critical process parameters of the manufacturing processes. ----Participates in the tech transfer from us to third parties or between third parties.
• Coordinates internally and with external CROs and CMOs to generate the required analytical, process and stability data to support regulatory filings at all stages of development. Identifies, initiates and maintains contacts with CROs and CMOS to facilitate the development of our drug products and their characterization. The candidate will have the ability to represent the company on a technical level with CROs and CMOs.
• Provides drug substance and formulation test articles and analysis in support of all our R&D groups. Forecasts, plans and prepares justification for future capital, equipment or facility needs such as the University Lab Partners lab (ULP) space. Forecasts and monitors spend on laboratory and research consumables. Serves as the Safety Officer for
• Writes and reviews reports and memos summarizing research for senior management and to document development. Authors relevant sections of regulatory documents including module 3 of the eCTD. Participates in internal and external meetings with CROs and CMOs to communicate the results

Qualifications:

• Master degree in Physical Chemistry, Pharmaceutical Sciences, Polymer Sciences, Chemical Engineering or related field with four (4) years of relevant experience. A PhD plus two (2) years of relevant experience is preferred.
• Thorough understanding of inorganic and organic chemistry, physical chemistry and analytical chemistry.
• Previous experience in drug product development.
• Good analytical and assessment skills, judgement, and problem-solving skills.
• Ability to work independently at a high technical level, including the ability to independently pull from the primary research and reduce that knowledge to practice in drug delivery system development and characterization.
• Strong working knowledge of analytical techniques and instrumentation including HPLC, UV, FTIR, UV-Vis, as well as knowledge in particle size analysis and molecular weight determination of biomaterials.
• Knowledge of peptide characterization and formulation development is a plus.
• Strong oral and written communication skills.