Principal Scientist/Manager, Formulation
4 weeks ago
LEAD FORMULATION SCIENTIST
(Level: Manager or Principal Scientist)
Location: San Diego Lab
We are a small biotech located in South San Francisco and San Diego. We are bringing multiple programs forward in major ophthalmic indications based upon novel science underlying protective biologies in the eye. We are backed by strong funding partners and a growing pipeline. Our team is mission driven, expert, agile and pragmatic.
Position Summary
We are looking for a talented and experienced individual to join our growing team. This scientist will be responsible for helping to design, run, and report experiments related to the small molecule chemistry, degradation pathways, characterization, and stabilization techniques. The selected candidate will be screening formulations to characterize solubility and stability of drug candidates for ophthalmic drug products.
The successful candidate will be collaborative, highly motivated, and possess the desire to constantly improve processes with an emphasis towards operational best practices.
This position is full-time and will be based at our laboratory in San Diego, CA.
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.
- Familiarity with crystallization experiments and API characterization via NMR.
- Develop formulations for pre-clinical and clinical studies.
- Design and execute different laboratory experiments, make observations, perform data analyses and report results.
- Manage CDMO 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.
- Experience with sample prep and method development for analytical testing including experience with 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.
- Opportunity to manage one scientist, depending on experience and interest of candidate.
Key Qualifications & Competencies
- BS in Chemistry or related technical field; MS and/or PhD preferred but not required.
- Minimum 7+ 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.
- High personal integrity and strong work ethic.
- Ability to operate with substantial latitude in a fast-paced environment.
Further Details
San Diego, CA
This position is a full-time position that is based at our laboratory.
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