Corbus Pharmaceuticals – Norwood, MA
The Pharmaceutical Development & Manufacturing function of Corbus Pharmaceuticals is currently seeking innovative, impactful, and highly talented individuals in our Formulation Development group. These positions are offered at the Scientist/Research Investigator level and will report to the Head of Formulation Development. Our organization is focused on developing novel enabling science, exceptional processes and disruptive innovation in the pursuit of safe, efficient, green and industry leading manufacturing routes to Corbus assets. Cross-functional collaboration and a mindset of innovation and growth are critical to these roles. Our department offers an excellent opportunity for those who want to learn and grow their career while continuing to develop our shared culture of excellence.
The successful candidates will be working for phase appropriate solid oral dosage formulations for small molecules from exploratory development through commercialization.
The candidate will possess:
- Hands-on experience developing manufacturing processes for various oral solid dosage formulations (tablets, capsules, HME, SDD, lipid delivery, etc.), to meet phase appropriate requirements of the clinic and the commercial target product profiles.
- Experience in pharmaceutical unit operations, e.g. mixing, wet and dry granulation, drying, milling, encapsulation, tableting, coating, etc.
- Solving critical manufacturing process parameters and come up with suggested improvements
- Proven track record of applying fundamental scientific and engineering principles to formulation design, development, and process understanding.
- Drive development activities working in a cross-functional environment
- Experience with directing and working on drug product development and manufacturing with CDMOs, which will encompass the development and scale-up activities with subsequent GMP manufacture.
- Excellent career accomplishments.
- Excellent oral and written communication skills.
- Deliver and oversee the development of drug product formulations and processes through the understanding of the API and excipients physical properties.
- Design rational single variable and multivariable (DoE) experiments, ensure proper execution of the experiments and provide clear data interpretation and recommendations.
- Develop strategies for formulation and process development and the corresponding regulatory submissions.
- Collaborate within the CMC team and actively contribute to deliverables and engage in team discussion on issue resolution. Serve as the Formulation person in CMC teams.
- Execute and oversee development, scale-up, clinical and commercial manufacture at external drug product GMP facilities.
- Draft and review presentations relevant to formulation development activities and present to various management levels.
- Author and review technical reports, regulatory filings, source documents, patents and external publications.
- Accountable for troubleshooting and resolving high complexity formulation challenges.
Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering or related field with at least 2-5 years of directly relevant industry experience or MS with over 7 years of directly relevant experience. Demonstrated hands-on and virtual industrial experience in small molecule oral solid dose formulation development from exploratory development (pre-clinical formulations) and experience in Phase 1/2 drug product development. Commercial manufacturing experience would be a plus.
All your information will be kept confidential according to EEO guidelines.