Description
This position is with a large, well established Pharamceutical company looking to grow the Stability and Controls group with an experienced manager level employee. This exciting, newly created position is urgent and candidates are urged to apply quickly to ensure interview potential. We are looking for local candidates who can go onsite relatively quickly to initially meet the team.Job Function:
- Manage the design, execution, and technical oversight of commercial stability programs for several protein pharmaceutical products
- Establish new and improve existing standards and controls programs ensuring alignment with laboratory Subject Matter Expert (SME), and written SOPs
- Implement processes for tracking the life cycle management of these standards and controls.
- Prepare Stability sections for regulatory submissions.
- Provide strategic technical guidance and management support for all stability operations and related discrepancies, as well as take corrective and preventative actions.
- Summarize and evaluate stability data. Control trending using statistical analyses software like JMP etc. Author Quality Control technical reports.
- Interact directly with internal and external auditors/inspectors from governmental regulatory agencies and partners/suppliers.
- Actively manage laboratory operations' associated costs and ensure compliance with cost center goals. Identify opportunities to reduce costs and operate more efficiently; make recommendations to management.
- Ensure that all stability standards and controls group personnel are properly trained and adhere to their training plans; ensure compliance with programs and adherence to Good Manufacturing Practices and health, safety, and protection of environment.
- Provide effective leadership including individual goal setting/performance reviews; manage the development of employees, recognizing and appreciating employee contributions; mitigate conflict and communication problems; support workforce diversity and quality; plan and facilitate team activities; select personnel and motivate members of the functional area.
Qualification Requirements:
- Bachelor's Degree in a Science or technical field; M.S. preferred
- 8 years of experience in Pharmaceuticals or a related industry with 3+ years in management positions or an equivalent combination of education and experience
- Working knowledge of current GMP and regulatory compliance (US and other international agencies)
- Experience with statistical data analysis and trending software such as JMP is required
- Experience with Stability Program management and data evaluation per ICH Guidance is required
- Experience with stability indicating analytical methods such as Chromatography, potency assays, Gel Electrophoresis, binding assays is required
- Demonstrate a passion for people through strong leadership, interpersonal communication, and team-building skills
- Ability to multi-task and good adaptability to changing trends and business requirements in a corporate environment
- Experience with Laboratory Information Management Systems (LIMS)
If you feel you meet these requirements and are interested in finding out more details and possibly interviewing, please respond to b.ross(@)realstaffing.com
Thank you for your time
To find out more about Real please visit www.realstaffing.com