Job Information
Novel Laboratories, Inc. Senior Scientist, Technical Service in Somerset, New Jersey
Duties: Novel Laboratories, Inc. seeks a Senior Scientist, Technical Service in Somerset, New Jersey to support pharmaceutical development and product launches. Be responsible for the new product launch, process improvement, and life cycle management of pharmaceutical products. Develop and review master production and packaging records based on the product and process development studies. Initiate and compile GMP documents including change control, CAPA, annual product review, standard operating procedures, risk assessments, gap analysis, scale up reports, and justification reports. Developing pharmaceutical products leading to NDA/ANDA filings and approval. Review and analyze patents deal with Reference Listed Drug and provide the technical approaches for ANDA product development. Characterize API, excipients, and compatibility studies. Conduct formulation trials and compile and review scientific data to support pharmaceutical development. Develop technology transfer, scale-up, and process validation plans for oral solid dosage drug products. Supporting the formulation development, stability studies, method development, method validation, troubleshooting, and method transfer for pharmaceutical development. Write and record pharmaceutical development work and draft technical reports to support product development, specifications, and stability in NDAs/ANDA and regulatory submissions. Handle the MFG equipment and analytical related interventions and evaluations during new pharmaceutical products execution. Annual salary: $111,161.96.Requirements: Master’s degree in Chemistry, Pharmacy, or a related field plus one year of pharmaceutical development experience. Must have at least one year of experience in each of the following: 1. Developing pharmaceutical products leading to NDA/ANDA filings and approval; 2. Supporting the formulation development, stability studies, method development, method validation, troubleshooting, and method transfer for pharmaceutical development; 3. Developing technology transfer, scale-up, and process validation plans for oral solid dosage drug products; 4. Characterizing API, excipients, and compatibility studies; 5. Conducting formulation trials and compiling and reviewing scientific data to support pharmaceutical development; and 6. Drafting technical reports to support product development, specifications, and stability in NDA/ANDA and regulatory submissions.To apply, please send resume to USACareers@lupin.com and cite requisition number 00153 or apply at www.lupin.com/US/ .