We are excited to offer a one-of-a-kind opportunity for a talented, experienced, and inquisitive individual to join our dynamic team. This scientist will be at the forefront of pioneering experiments in the sustained release of small molecule drugs using drug / medical device combinations. The role will involve applying material science expertise and engineering principles to design formulations and prepare manufacturing prototypes, guiding the development of the selected product candidate to the clinical stage. The selected candidate will be instrumental in characterizing the sustained release formulations and evaluating their dissolution and stability using analytical techniques such as HPLC and dissolution apparatus.
The successful candidate will be collaborative, highly motivated, and a critical thinker. They will possess the desire to improve processes while being flexible and adaptable to the changing needs of the projects. We seek team players who can contribute to our collaborative work environment.
Responsibilities
We are seeking a candidate with a robust scientific acumen, who can independently plan, design, execute, and interpret experiments to tackle problems of medium/high complexity. The ability to work independently and solve intricate problems is a key requirement for this role.
- Formulation Development: Create and optimize prototype dosage forms, focusing on polymer-based sustained-release formulations. A strong polymer or material science background is essential for selecting and enhancing these formulations.
- Drug Delivery Systems: Lead pre-formulation and formulation development efforts for advanced drug delivery systems, including polymer/drug implants and hydrogels. You will characterize sustained-release formulations, analyzing release profiles, solubility, loading capacity, degradation, and stability factors.
- Laboratory Experimentation: Design and execute laboratory experiments focusing on Design of Experiments (DOE) principles. You will conduct detailed observations, perform data analyses, and prepare comprehensive reports, including formal documentation in electronic lab notebooks. Managing Contract Development and Manufacturing Organizations (CDMOs) and other external vendors involved in formulation activities. Key responsibilities include:
- Collaborating with CDMOs to facilitate the transfer of selected formulations for Good Manufacturing Practice (GMP) production.
- Ensuring seamless communication and coordination with external partners to support formulation development and production processes.
- 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 the CMC section of IND submissions.
Requirements
- MS in Material Sciences, Polymer Sciences, Chemistry, or related technical field; PhD preferred but not required. Candidates with formulation experience are strongly preferred.
- Minimum four 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 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.