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Direct message the job poster from Prinston Pharmaceutical Inc. Human Resources Head at HuaHai US and Subsidiaries Job Title: Associate Director, Analytical Research & Development (Generic Pharmaceuticals) Location: Somerset, New Jersey ABOUT US Prinston Pharmaceutical, Inc. is a fully-integrated pharmaceutical company engaged in product development, registration, manufacturing, marketing and sales of high quality affordable generic prescription products to customers. We deliver and maintain high quality and integrity in all of our products, which are manufactured in world-class cGMP manufacturing facilities. We currently have an immediate opening for Associate Director of Analytical R&D, located in our Somerset, New Jersey headquarters. This role will report to Executive Director, Analytical R&D and provide technical guidance within and outside of R&D to support product development and management from analytical and quality’s perspectives'. PRIMARY RESPONSIBILITIES: 1) Lead the AR&D team for method development, method pre-validation, stability studies of developmental batches to support product development. Effectively follow through with the downstream sites to ensure successful method validation. 2) Identify critical quality attributes, propose specifications with justifications for finished drug product, work closely with formulation and technical operations for the final product specifications toward regulatory submissions. 3) Author/review dossiers for ANDA filings, work with Regulatory Affairs and other departments/sites, provide inputs and responses to the FDA deficiencies related to ANDA submissions. 4) Collaborate with the API sourcing team, identify API sources by looking into the process control, impurity profiling, and the quality risk management. 5) Establish strong communication and collaboration with CRO/CDMO companies, specify requirements, and follow up with the actions from various communications to make sure products are developed and manufactured in a both regulatory and compliant manner. 6) Maintain effective management over the AR&D laboratory, including but not limited to: EHS, instrument qualification, lab supplies ordering, material management, documentation, electronic data management, SOPs and training. 7) Manages staff and recruits new hires to develop the analytical teams. Lead training on analytical method development, method execution, compliance and regulations. KEY QUALIFICATIONS: 1) Must have advanced degree in Organic Chemistry, Analytical Chemistry or related fields, Ph.D. preferred; 2) At least 8 years of experience in pharmaceutical industry, preferably in generic pharmaceutical industry; 3) Oral solids dosage forms experience (i.e., immediate release, delayed release and extended release) required. Injectables and complex generic experience (i.e., injectables, topicals) are a plus. 4) In depth understanding and knowledge of FDA and ICH guidelines for drug product development. Good knowledge of cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA) regulations and guidelines. Job Type: Full-time 401(k) Health insurance Paid time off Vision insurance Schedule: 8 hours shift Supplemental Pay: Bonus opportunities Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Prinston Pharmaceutical Inc. by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Associate Director Research Development jobs in Somerset, NJ . 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