The CMC & Supply Chain Compliance Specialist is responsible for establishing, addressing and ensuring compliance of Corbus' GMP activities occurring at Contract Manufacturing Organizations. This position will work closely with CMC, Clinical Supply Chain and Quality Assurance representatives to ensure compliance with all activities for GMP materials. The CMC & Supply Chain Compliance Specialist will also provide quality support for the various functions under its responsibility which include Process Chemistry, Pharmaceutics R&D, Analytical R&D, Clinical Supply Operations and includes quality system support. The successful candidate is self-motivated, independent, highly organized and able to work in a small team environment. Due to the critical nature of this role in Corbus' success, this position reports directly to the Vice President, CMC Operations
Responsible for liaising with Quality Assurance on internal and external investigations, deviations and other quality system events to assess impact, root cause analysis and CA/Pas.
Track and drive CMC related quality items to closure on-time (investigations, deviations, CAPA, gap assessments, risk assessments, process change controls)
Provide regular updates to Quality Assurance in support of monthly reporting and metrics generation
Create and implement workflows, processes and/or procedures for approving, organizing and archiving CMC related documents in manual and electronic systems.
Creation of CMC and Supply Chain SOP's related to Quality and Compliance.
Recommend and influence for changes in practices to bring about a Quality Centric CMC and Supply Chain organization
Review of stability protocols, reports and data
Tracking, authoring and closing all CMC related investigations, deviations and CAPAs
SKILLS & REQUIREMENTS:
Bachelor's Degree in related field and minimum 5 years of experience in Pharmaceutical Industry in a related CMC, Supply Chain or Quality Assurance role, or the equivalent combination of education, training and experience.
Experience with reviewing and dispositioning GxP materials
Ability to identify technical problems and suggest resolution of the issues
Excellent organizational, interpersonal and decision-making skills, as well as verbal and written communication skills
Knowledge of FDA and international regulations and GxP guidelines
Comfortable in a fast-paced environment and able to navigate changing priorities
Corbus is a close-knit team of over 100 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 "family" atmosphere where each person's 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.
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
Corbus Pharmaceuticals Holdings, Inc.