- Lead and manage the technical services department at site.
- Manage Technical Services activities such as Product Transfers (within DRL Site and External to DRL Site), vendor development, new products (ANDAs) scale up and process optimization, routine process validation, cleaning validation and equipment qualification activities.
- Guide preparation of master documents
- Plan and monitor the routine validations programs
- Provide technical inputs on trouble shooting during commercial manufacturing
- Conduct root cause analysis (RCA) and develop corrective action plan for non-recurrence of problems
- Technical evaluation of alternate vendors
- Develop transfer plans; guide team on troubleshooting during transfer; and build technical competencies in team members
- Support site in quality and compliance, active participation in FDA and DEA inspections
Education & Experience:
Bachelor's degree in an engineering/pharmacy/scientific field. (Biological sciences, Chemical Engineering, or Pharmacy). MBA helpful. Prior supervisor/managerial experience leading and developing employees. Prior pharma experience with 10 or more years in the industry in Manufacturing (oral dosage forms), Process and Formulation Development and Product Transfer is must.