This position will be part of pharmaceutical research and development. The incumbent will be responsible for development of parenteral formulations, alternate drug delivery systems, and manufacturing processes (such as technology transfer and scale up) to enable the successful development of mammalian and microbial fermentation derived candidate molecules.
The Principal Scientist, Formulations Pharmaceutical Research and Development is responsible for developing parenteral formulations, alternate drug delivery systems, and manufacturing processes (such as technology transfer and scale up) to enable the successful development of mammalian and microbial fermentation derived candidate molecules. The position will involve rapid, comprehensive, characterization of candidate molecules to determine the stability profile, and applying this information to develop an appropriate dosage form to meet clinical and commercial needs. The incumbent is responsible for developing/identifying new technologies and procedures to accelerate the development process. The incumbent, working with Tech transfer group, is responsible for the development and scale-up of processes from bench top to pilot-scale and, as required, technology transfer to clinical or commercial plants.
The Principal Scientist, must be able to interact effectively with a multi-disciplinary team of staff scientists for formulation optimization and overall candidate progression. Effective communication and personal leadership skills are desirable for interactions with laboratory scientists and associates, serving on multi-disciplinary project teams, and for project reviews with leadership team.
- 4 years with Ph.D. or 10 years with BS. of industrial or Post-Doc experience in parenteral formulation and process development of protein/peptide therapeutics. Demonstrated capability to perform independent research.
- Extensive knowledge of protein and/or vaccine and/or oligonucleotide chemistry, degradation pathways, analytical characterization and stabilization techniques.
- Experience in biotherapeutic parenteral formulation and process development of mammalian and microbial fermentation derived candidate molecules.
- Knowledge of drug development processes for progression of a biological candidate.
- Demonstrated leadership skills.
- PhD in Biochemistry, Chemistry or equivalent with Post-Doc experience. Knowledge of drug development processes for progression of a biological candidate.
- Theoretical and practical knowledge of lyophilization and lyophilization cycle development is preferred.
- Familiarity with parenteral manufacturing requirements, including media fills, environmental monitoring, container/closure integrity, and commercial unit operations.
- Familiarity with GLP/GMP requirements.
- Familiarity in scale-up and technology transfer to pilot/commercial scale.
- Knowledge of protein drug delivery technologies is preferred.
- Experience with state-of-the-art analytical and bio-analytical methods.
- Excellent oral and written communication skills and ability to mentor junior staff and peers.
- Demonstrated leadership skills.
- Familiarity with Intellectual Property (IP) and IP strategy development.
- Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA).
- Familiarity with combination product development and design control.
- Understanding of biophysical attributes of biotherapeutics.
- Experience in vaccines formulation and process development.
- Ability to mentor and develop colleagues.