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United Kingdom - Paisley
Job Description

Director, Operations - Inchinnan

Experienced operations and business leader needed to drive a global manufacturing site for GMP production of cell culture products including cell culture media and process liquids for use in biopharmaceutical manufacturing and research. This position will report directly to the Vice President of Operations within the BioProduction Division. Responsibilities include an intense focus on meeting customer needs in a demanding cGMP environment, leading and ensuring all functions at the site are functioning at peak efficiency with proper internal communication and interfaces, developing the operations and manufacturing teams while ensuring delivery of high quality products which are in compliance with all applicable cGMP manufacturing regulations.

Key Objectives of the role:

  • Develop and establish strong operating mechanisms to ensure business objectives are met
  • Develop and cascade Op’s strategies, goals and objectives as well as strong execution mind-set well aligned with the business and global Ops team
  • Coordinate the hiring, training, coaching and annual performance reviews of team. Facilitate and mentor the development of team members and front line leaders to be exceptional players.
  • Effectively use prioritization mechanisms to utilize resources across teams to complete required workload.
  • Drive compliance to applicable Quality System Regulations.
  • Establish key performance indicators that drive change and visibility to the team and leadership. Track, trend, and monitor routinely with active data analysis to target and drive results.
  • Monitor and manage progress on projects, ensuring key requirements and milestones are met.
  • Coordinate the development of action plans when corrective steps (CAPA) are required and implement these in a timely manner.
  • Manage budgets, schedules and key operating metrics.
  • Define and establish clear objectives and expectations, provide direct feedback routinely for performance management.
  • Identify projects and recommend appropriate course of action (e.g., discontinuation, outsource, process improvement) to maximize profitability and supply.
  • Execute robust Risk Management practices to maintain high probability of project success, ie, satisfaction of scope, schedule and budget.
  • Responsible for assessing resource needs across multiple projects and working with appropriate managers to assign resources per established priorities.
  • Ensure effective transfers of new products into production that meet all the Quality requirements for the classification.
  • Ensure site wide training is effective and that the team operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective

Minimum Qualifications:

  • Bachelor's degree in related discipline and/or equivalent experience. Master’s Degree preferred.
  • Minimum of 5-7 years of management experience in a complex manufacturing environment.
  • Excellent communication and interpersonal skills both written and verbal and the ability to facilitate team interactions.
  • Strong leadership ability with the capability to leverage diverse resources, respond quickly, understand the impact of changes and decisions, facilitate agreement, build collaborative relationships and focus on customer needs.
  • Ability to work with individuals at all levels and within all functions to motivate strong results.
  • Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
  • Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
  • Experience in leading an organization in a cGMP environment with a focus on Make to Order (MTO)/Custom products is desirable.
  • Audit experience within a cGMP environment with successful outcomes is valuable.
  • Ability to partner with and influence key stakeholders including Finance, R&D, Product Management and the Commercial team.
  • Must be able to independently manage multiple complex projects concurrently while meeting target dates.
  • Demonstrated experience as a change agent with ability to influence and communicate at all levels in the organization.

Preferred Qualifications:

  • Larger site leadership
  • Experience in leading an organization in a cGMP environment with a focus on Make to Order (MTO)/Custom products is desirable
  • Audit experience within a cGMP environment with successful outcomes is valuable.

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