The Manager, Formulation Research and Development will be responsible to manage all formulation activities to support development of generic products in timely manner. This includes managing daily laboratory activities, oversight of formulation development for various topical, semi-solid and sterile dosage forms, supporting ANDA filings and deficiency letter responses. This individual will also be responsible to maintain GMP compliance in the lab and accountable for helping set and achieve department objectives
Management of the formulation development team. Review/approve and/or prepare technical reports/summaries for all work performed formulation R&D group Direct, coordinate and prioritize activities of group; assign staff to ensure assigned project timeline are met. Present data and communicate issues related to projects to upper management for review and discussion Work in collaboration with and provide technical assistance to other departments, e.g. Analytical Method Development/Method Validation/Stability, Regulatory Affairs, Production, QA and QC, etc. to support timely new product development/submission of new ANDAs. Review technical documentation in support of regulatory filings. Troubleshoot/improve existing development methods when necessary. Participate in and recommend the setting of product specifications. Participate in CMC deficiencies responses to support project approvals. Monitor currents systems and facilitate necessary changes to increase efficiency and accuracy to achieve the objectives. Ensure all formulation development work within group is in accordance with cGMP, SOP, FDA, ICH guidelines. Audit and review procedures, processes, data and laboratory preparedness for inspections. Participate in FDA and internal audits. Work with contract laboratories when necessary. Participate in selection, evaluation and development of new personnel. Perform staff annual performance evaluation.
PhD with a minimum of 8 years of experience or Master's degree with a minimum of 15+ years of experience in the pharmaceutical formulation development or related sciences, with hands-on knowledge of current techniques, and a proven 5+ years supervisory experience. Delegates work assignments; matches the responsibility to the person; gives authority to work independently; sets expectations and monitors delegated activities; provides recognition for results. Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.