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Technical Operations Director

Location: Unknown
Contact Name: Director of The RFT Group
Contact Email: gerry@rftgroup.ie

Job Description

Technical Operations, Director

Our client is a highly successful global pharmaceutical manufacturer.

Responsible for the effective day to day management for the Technical Operations team in their interactions across the company supply network to ensure robust supply of quality product to our patients. The role will work closely with company’ CMC teams, Process Development, Manufacturing, Engineering and Supply Chain operations to ensure successful product launches at commercial scale.

Job Spec

• Review and maintain company 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 all 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.
• Participate in late stage Drug Product development (OSD and Biologics) and technology transfer into commercial production and ensure the network capabilities and competencies are available to Tech Transfer to CMO’s should the network require alternative sources of supply.
• Oversee all activities related to Packaging across the 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.
• Work closely with the Process Development providing that link between Development and Commercial manufacturing/packaging. Would be required to provide input and guidance to the manufacturing/packaging decision making processes prior to filing and validation.
• Support Company CMOs in regulatory and external auditor inspections and respond to observations as needed.
• 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 Company facilities.

Business Partnership

• Provide management with accurate and timely information necessary to make strategic, investment and operating decisions.
• Preparation of project cost analyses and 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.

People Management

• Oversee the management and leadership of Tech Op’s employees – hiring & training of employees, planning assigning &
directing work, appraising performances, rewarding and disciplining employees, addressing grievances and resolving
problems.
• To lead, develop, mentor and guide managers on key policies, processes and practices and good decision making/judgments.
• Develop, set and communicate sustainable targets and goals for direct reports/teams.
• Ensure adequate staffing and continued employee training and development.
• Foster a positive Employee Relations environment and a culture of continuous improvement and teamwork through the use of
good and consistent management principles.
• Create a supportive work climate that enable staff members to develop professionally, values diversity and open
communication, promotes teamwork and collaboration, and stresses quality, safety, customer satisfaction and profitability/cost
effectiveness.
• Delegates duties and ensures that employees understand job duties and responsibilities.
• Play appropriate role in the development, operation and evaluation of training/re-training programmes. In relation to area of
responsibility, ensure that training carried out is in accordance with the training plan/specific training needs, documented,
tracked, evaluated to effectively manage attendance, absence levels and associated costs across group’s in accordance with
guidelines.

Person Spec
  • Educated to degree level in relevant technical/engineering/scientific discipline, preferably multi-disciplinary with a strong technical/scientific orientation. Masters/Phd/BPharm advantageous.
  • Lean/Six Sigma qualification at Green Belt or above obtained and certified by an Internationally Recognized body in a pharmaceutical / medical device setting an advantage
  • Strong understanding of technical/scientific challenges as those apply to the production processes used in the manufacture of API, OSD, Biologics and the subsequent packaging of those products.
  • 10-15 years’ experience in high volume/manufacturing/relevant environmental likely to include:
  • Pharmaceutical with a minimum of 5 years at senior manager / associate director level.
  • Preferable to include some and preferably experience in all of the following areas, API, Solid Oral Dose, Biologics and Packaging
  • Established track record with evidence of excellent people management experience, project management, problem solving, collaborative, leadership and communication skills.
  • Ability to foster and promote internal collaboration.
  • Logical and problem solving skills.
  • High level of customer orientation/understanding.
  • Excellent interpersonal and communication skills.
  • Strong influencing skills,
  • Responds well to questions; Demonstrates group presentation skills;
  • Balances team and individual responsibilities.
Cv to gerry@rftgroup.ie