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, experienced, and curious individual to join our growing team. This scientist will be responsible for designing, running, and reporting experiments related to sustained release of small molecule drugs to the eye using drug / medical device combinations. This will include utilizing polymer science expertise and engineering principles to help design formulations, prepare manufacturing prototypes, and will help guide the development of the selected product candidate to development and clinical stage. The selected candidate will help characterize the sustained release formulations and will evaluate their dissolution and stability utilizing analytical techniques such as HPLC and dissolution apparatus.
The successful candidate will be collaborative, highly motivated, and possess the desire to improve processes, while being flexible and adaptable to changing needs of the projects.
This position is full-time and will be based at our laboratory in San Diego, CA. Preference will be given to candidates who are open to contract to hire.
Roles 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 for preclinical and clinical use, manufacture prototype dosage forms, and conduct drug product process development and process optimization activities in-house. Candidate should have a strong polymer science background to help with selection and optimization of polymer-based sustained release formulations.
- Design and conduct pre-formulation, formulation development of ophthalmic formulations and related drug delivery systems such as polymer/drug implants and hydrogels. Experimental scope will include characterizing sustained release ophthalmic formulations, including but not limited to release profile, solubility, loading capacity, degradation, and stability.
Design and execute laboratory experiments with particular emphasis on DOE principles, make detailed observations, perform data analyses and report results. Responsibilities will include preparing experimental protocols and writing formal reports of experimental results, including in electronic lab notebook format.
Participate in the management of CDMOs as well as other external vendors supporting formulation activities, including working with CDMO to transfer selected formulation for GMP production.
- Perform development and validation of test methods for drug products.
- Comfortable with analytical sample prep techniques including HPLC-UV, long term dissolution and performing sample prep for related experiments.
- Working with the regulatory advisors, this role will contribute data, data analysis and related write ups to CMC section of IND submissions.
- Demonstrate scientific creativity, initiative and contribution to the team and company goals.
- Maintain laboratory documentation in accordance with required scientific, regulatory and intellectual property requirements.
Key Qualifications & Competencies
- MS in Material Sciences, Polymer Sciences, Chemistry or related technical field; PhD preferred but not required.
- Minimum 4 years' experience in formulation development in a pharmaceutical company and proven ability to identify and develop innovative ideas.
- Experience in performing formulation/process development of sterile dosage forms for small molecules. Hands-on experience with polymer/drug systems and modified release formulations.
- Experience working in GMP and/or GxP environment.
- 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.
- Experience with drug/device combinations and quality systems is strongly preferred.
- Strong communication and technical writing skills, including communicating and summarizing data in a regulated environment. 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 (required to visit certain preclinical labs and hospitals).
- High personal integrity and strong work ethic.
- Ability to operate with substantial latitude in a fast-paced environment.
- Candor (address the 'elephant in the room')
- Humility (desire the success of others)
- Communication (listen to be heard)
- Agility (reflect patiently, pivot rapidly)
- Leadership (act to build trust).
San Diego, CA
This position is a full-time position that is based at our laboratory.
Perceive Core Values
Benefits
For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa.
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