Associate Director of Technical Services
About The Position
The Associate Director of Technical Services is responsible for providing technical expertise to develop, validate, and enhance manufacturing processes. Transfer technology for new products from the development site(s) to the manufacturing site Transfer technology to Manufacturing during the process validation of submitted/approved products Plan and manage successive phases of developmental and transfer activities including production of research, Scale-Up, Exhibit/Registration for ANDA submission, component changes and process validation batches. Provide technical support to manufacturing (i.e. review SOPs, Protocols, reports, etc.) Perform all supervisory duties including for exempt level scientists and hourly technicians. Assigning daily work, hiring, performance management, training and other managerial duties. Write and manage department SOPs, training, etc. to ensure regulatory compliance and operations enhancement. Coordinate investigation and closure of incidents. Coordinate media fills and related SOPs
Requirements
- Bachelor's Degree in Science, Engineering or related field required. Master Degree desired.
- Minimum 10 years of related experience required
- Supervisory and Managerial experience required.
- Pharmaceutical and FDA Regulated Industry experience required.
- Advanced vocational/specialized knowledge required
- Microsoft Word, Excel, and PowerPoint experience required
- Exposure to allergens Working in aseptic areas required
- Prolonged sitting and standing required
Nice To Haves
- Master Degree desired.
Responsibilities
- Transfer technology for new products from the development site(s) to the manufacturing site
- Transfer technology to Manufacturing during the process validation of submitted/approved products
- Plan and manage successive phases of developmental and transfer activities including production of research, Scale-Up, Exhibit/Registration for ANDA submission, component changes and process validation batches.
- Provide technical support to manufacturing (i.e. review SOPs, Protocols, reports, etc.)
- Perform all supervisory duties including for exempt level scientists and hourly technicians. Assigning daily work, hiring, performance management, training and other managerial duties.
- Write and manage department SOPs, training, etc. to ensure regulatory compliance and operations enhancement.
- Coordinate investigation and closure of incidents.
- Coordinate media fills and related SOPs
Benefits
- Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
- Life, AD&D, Short and Long Term Disability
- 401(k) with company match
- Generous paid time off plan
- Employee Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Industry
Chemical Manufacturing
Number of Employees
5,001-10,000 employees
