Assistant Manager, Formulation Development & Tech Transfer

Assist Associate Director in activities and projects related to formulation development of new products and alternate source API products. Develop and lead project plans, timelines, and milestones to support development, scale up, and commercialization. Monitor project milestones and deliverables. Handle technology transfers new and existing products from development or other sites to the manufacturing facility, including all process validation activities. Support lifecycle management of commercial products, including process improvements, troubleshooting, and quality enhancement initiatives. Assist in identifying, installing, and qualifying new equipment required for development and manufacturing activities. Propose and oversee all phases of development and transfer activities, including research, scale up, exhibit/registration batches for ANDA submissions, component changes, and process validation batches. Prepare, review, and approve required documentation such as SOPs, batch records, protocols, reports, QOS, strategy documents, deviations, change controls, investigations, and CAPAs in compliance with regulatory requirements. Implement Quality by Design (QbD) principles for new and existing products. Assist Regulatory Affairs with information and documentation needed for regulatory submissions. Coordinate cross functionally with Production, QA, QC, Engineering, and Regulatory Affairs to ensure smooth technology transfer and project execution. Conduct periodic reviews and updates of SOPs and procedures. Handle inventory and prepare quarterly and annual reports for DEA controlled substances. Initiate and monitor stability studies for development products, including data analysis and reporting. Support new product launches, contract manufacturing activities, and logistical planning. Perform other duties as assigned by management. Applicant must have a Master's Degree in Pharmaceutical Manufacturing, Pharmaceutics, Project Management or closely related occupation. Two (2) years' experience in Generic Manufacturing Science & Technology (MSAT). Experience in formulation development of solid oral dosage forms (tablets and capsules). Ability to perform technology transfer for ANDA products and site transfer projects. Proficiency operating manufacturing equipment such as high shear granulators, fluid bed dryers, blenders, tablet presses, coaters, encapsulation machines, and imprinting machines. Experience executing manufacturing and packaging of exhibit, validation, and site transfer batches. Ability to troubleshoot commercial manufacturing issues and support production teams. Experience preparing qualification protocols, process validation protocols, and validation reports. Knowledge of FDA regulations and cGMP for solid oral and controlled substance products. Ability to prepare regulatory documentation for ANDA submissions. Knowledge of labeling lifecycle management and incorporating updates from RLD or FDA guidance. Strong technical writing, documentation, and communication skills. Ability to work cross functionally with QA, QC, Production, Engineering, and Regulatory Affairs. Strong organizational skills and attention to detail. Demonstrable acceptable skills in problem solving and adhering to timelines.