Responsibilities:
- Management of the Process Development & Manufacturing group responsible for technology development, demonstration & scale-up and manufacture of small molecule Active Pharmaceutical Ingredients in support of clinical studies and commercial distribution
- Management of projects, staff and facility, to achieve client deliverable & organization's financial targets
- Compliance with Quality Management Systems (GMP/ICH Q7) & EHS policies
- Establish & monitor KPI's to drive continuous improvement
- Manage staffing resources & expenses to achieve organizational goals
- Manage organization to support evaluation & development of proposals with direct responsibility for establishing timing
- Maintain strong working relationship with analytical chemistry, quality control, EHS & quality assurance to achieve deliverables & targets
- Maintain technical/ business relationships with clients
Required Qualifications
- B.S. or M.S. in Chemical Engineering with strong knowledge of organic chemistry and small molecule batch manufacturing technology
- Industrial experience in technology development, scale-up & manufacture of pharmaceutical & speciality chemicals in a contract environment
- Experience in management of complex programs involving multi-disciplinary groups in contract environment
- Experience in management of site, facilities and capital project
Skills and Requirements
- Experience in management of the people who operate the technology development, scale-up & manufacturing of chemical-based products/API's
- Plant-wide project management experience in a contract organization (CRO)
- Familiarity with business and financial principles & practices of managing throughput to maximize revenue
- Highly motivated team player with excellent written and oral communication skills
- Creative problem solving capabilities
- Experienced in managing/collaborating in interdisciplinary/matrix organization
- Experienced in manufacturing under FDA/ICH cGMP guidelines for APIs
- Knowledgeable in lab-, kilo-, & plant-scale process equipment
- Demonstrated success in in prior positions(s)
- Experience in operations management, financial management, organizational effectiveness, process justification, process validation, and equipment qualification is a plus
