Lead Formulation Scientist

Overview

LEAD FORMULATION SCIENTIST

Perceive Biotherapeutics is an exciting early-stage company, funded by Deerfield Management, with a team focused on improving human health by developing breakthrough neuroprotective therapeutics. We are using novel approaches to treat highly prevalent, blinding diseases that currently have no good therapeutic alternatives. Our unique approach is leading to first-in-class and best-in-class small molecule and gene therapy solutions that will significantly impact patients’ lives.

Position SummaryWe are looking for a talented and experienced individual to join our growing team as our Lead Formulation Scientist. The Lead Formulation Scientist will be responsible for understanding the small molecule chemistry, degradation pathways, characterization, and stabilization techniques. The selected candidate will be designing and screening formulations for optimizing solubility and stability of drug candidates for ophthalmic and injectable drug products. The candidate will also manage external vendors that support the formulations and fill/finish.

The successful candidate will be collaborative, highly motivated, and possess the desire to constantly improve processes with an emphasis towards operational best practices.

Qualifications

Location

San Diego, CA

Key Qualifications & Competencies

• Bachelor’s in Chemistry or related technical field; MS and/or PhD preferred but not required.
• Minimum 5 years’ experience in early-stage formulation development of small molecules.
• Must have pharmaceutical development experience and proven ability to identify and develop innovative ideas.
• Experience in performing early phase formulation/process development of sterile dosage forms for small molecules. Hands-on experience in solubilization and stabilization of small molecules as well as understanding of mechanisms of degradation and stabilization of molecules.
• Demonstrated excellence in independently designing and conducting experiments and analyzing data
• Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems.
• Excellent verbal and written communication skills
• Strong interpersonal skills and ability to work and communicate effectively at all levels within and external to the organization.
• Vaccinated against COVID-19 per CDC guidelines.
• High personal integrity and strong work ethic.
• Ability to operate with substantial latitude in a fast-paced environment.

Perceive Biotherapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

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Responsibilities

Role And Responsibilities

• Exhibit strong scientific acumen, with ability to solve problems of medium/high complexity via independent planning, design, execution, and interpretation of experiments.
• Design and develop robust, scalable formulations, manufacture prototype dosage forms, and conduct drug product process development and process optimization activities in-house.
• Prepare experimental protocols and write formal reports of experimental results.
• Design and conduct pre-formulation, formulation development, process development and process optimization of parenteral and ophthalmic formulations and related alternate drug delivery systems such as solutions, lyophilized products, sterile injectable suspensions etc.
• Experience with crystallization experiments (via outsourced vendor) and NMR.
• Develop formulations for pre-clinical and clinical studies.
• Design and execute different laboratory experiments, make observations, perform data analyses and report results.
• Manage contract manufacturing vendor for fill/finish as well as other external vendors supporting formulation activities.
• Support the development of robust scalable manufacturing processes and contribute to technology transfers to commercialization partners.

• Perform development and validation of methods for drug products, and prototype formulations
• Operate analytical equipment including HPLC-UV, LC-MS.
• Design and conduct experiments to characterize ophthalmic formulations, drug delivery systems, and drug-eluting formulations, including but not limited to release profile, solubility, loading capacity, degradation, and stability.

• Work with regulatory team in preparing Pre-IND meeting request and support IND submissions.
• Prepare and review of product development reports and related documents including regulatory filings for Pre-IND, IND.
• Demonstrate scientific creativity, initiative and contribution to the team and company goals.
• Maintain laboratory documentation in accordance to required scientific, regulatory and intellectual property requirements
• Support the development and advance of sterile formulation best practices, new technology development and operational excellence