The Pharmaceutical Development & Manufacturing function of Corbus Pharmaceuticals is currently seeking an experienced, innovative, impactful, entrepreneurial and highly talented individual to lead our Formulation Development efforts. This position is offered at the Associate Director level and will report to the Head of Pharmaceutical 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 mind-set of innovation and growth are critical to this role. Our department offers an excellent opportunity to those who want to learn and grow their career while continuing to develop our shared culture of excellence.
The successful candidate with be responsible for advancing fit for purpose solid oral dosage formulations for small molecules from exploratory development through commercial line extension in a Quality by Design (QbD) environment.
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.
- 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 drug product development and manufacturing with CDMOs, which will encompass development and scale up activities with subsequent GMP manufacture.
- Excellent leadership skills as evidenced by significant career accomplishments.
- Excellent oral and written communication skills.
Key Responsibilities:
- Deliver and oversee the optimization of drug product formulations and processes through understanding of the materials physical properties.
- Design rational single variable and multivariable (DoE) experiments, ensure proper execution of the experiments and provide clear data interpretation and recommendations, with a heavy dependence on statistical analysis.
- Develop strategy 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 expert for Formulation 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.
Minimum Qualifications
Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering or related field with at least 7 years of directly relevant industry experience or MS with over 10 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) through to commercial manufacturing.
Corbus Culture:
Corbus is a close-knit team of almost 140 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.
You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our âfamilyâ atmosphere where each personâs contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist, company-paid classes with Title Boxing, and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.
About Corbus:
Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company’s lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer
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