Category: Scientific & Clinical
Job ID: 153345
Date Posted: 06/30/2020
Job Title: CONSULTANT, GLOBAL REGULATORY CMC BIOLOGICS/CELL THERAPY
Location: Summit, NJ
Contract Length: 12 mos
Number of Openings: 1
COMPANY is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture
The Consultant will be based in Summit, NJ and will assist the Regulatory-CMC Biologics/Cell Therapy team with projects to support department goals and objectives. Job Responsibilities require the following skills: Attention to detail, excellent organization skills, good verbal and written communication skills are required. Ability to work independently on routine assignments with daily check-ins and to work cooperatively with senior staff providing key assistance on complex assignment. Computer experience must include familiarity with Word, Excel and PowerPoint.
• Support Regulatory CMC Biologics & Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
• Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic/Cell Therapy Regulatory CMC experience, including the preparation of Biologic/Cell Therapy CMC dossiers
• At least a bachelor’s degree required. Master’s Degree or PhD preferred
• Extensive experience with Biologic/Cell Therapy CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
• Experience with CMC regulations for biological compounds
• Experience with Gene/Cell/CAR T Cell therapy CMC regulations
• Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
• Practical knowledge of rest of world post approval guidelines
• Have a solution-oriented approach to problem solving
• Expertise in the drug development process and post approval activities
• Ability to work on complex projects and within cross-functional teams
COMPANY is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. COMPANY complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for COMPANY in the U.S.