Our client is a highly successful global pharmaceutical manufacturer. API process expert responsible for being the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations’ (CMO’s). Required to support new product introductions, technology transfers, continually monitor and improve API operations conducted at CMO’s.
- Review and maintain practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements – ensuring that appropriate policies, rules, regulations and agreements are followed
- Oversee activities related to API production across the commercial supply network including routine production and associated monitoring/control plans as well as investigations and CAPA’s. In conjunction with Commercial Supply Chain oversee network optimization to include vendor selection and technology transfers/validations as required.
- Lead and oversee validation planning and execution of APIs as needed as part of cross functional teams involving Supply Chain, Quality and Validation
- Work closely with the Process Development providing that link between Development and Commercial manufacturing. Would be required to provide input and guidance to the manufacturing decision making processes prior to filing and validation.
- Support CMOs in regulatory and external auditor inspections and respond to observations as needed.
- Identify, develop and execute continuous process improvements to support safety, efficiency or compliance.
- Support the Operations leadership with the implementation of key technical projects which are identified as part of the company’s objectives in both CMOs and facilities.
- Establish strong working relationships to build partnerships based on trust with CMOs
- Develop recommendations for strategic/business decisions. Provide management with accurate and timely information necessary to make strategic, investment and operating decisions.
- Preparation of CMO competency assessment to ensure robust decision-making processes when it comes to vendor selection and vendor optimization discussions with senior management.
- Facilitate the transfer of new products and development projects to site’s through the development of effective business cases and management support.
- Preparation of credible and reliable business plans, budgets, and forecasts.
- Foster and promote internal collaboration.
- Ensure support and integration of Tech Op’s with relevant functions in order to achieve customer service objectives.
Bachelor’s degree in relevant technical/engineering/scientific discipline, preferably multi-disciplinary with a strong technical/scientific orientation.
8-12 years’ experience in high volume/manufacturing/relevant environmental likely to include:
Pharmaceutical with a minimum of 2 years at senior engineer level.
Established track record with evidence of excellent project management, problem solving, collaborative, leadership and communication skills.
Lean/Six Sigma qualification at Green Belt or above obtained and certified by an Internationally Recognized body in a pharmaceutical / medical device setting.
Strong understanding of technical/scientific challenges as those apply to the production processes used in the manufacture of API products.
Ability to foster and promote internal collaboration.
Logical and problem- solving skills.
High level of customer orientation/understanding.
Excellent interpersonal and communication skills.
Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification.
Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Balances team and individual responsibilities.
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