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Production & Process Design Manager

1 month ago

Malvern, United States Clinigen Full time

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.


We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.


We are currently seeking a people orientated, driven and process focused Production & Process Design Manager who will play a pivotal role in ensuring the IMP Production and Process Design Department unit always meets the defined specifications in terms of quality, regulatory requirements, deadlines, and other indicators. You will be an expert in the field of activity and propose technical solutions and improvements.


Key Responsibilities:

  • You will build and manage a high-performing and collaborative production and process design team that works in line with the Group’s values at all times
  • Ensure the appropriate level of resource and expertise is in place and that this is structured in the most effective way to deliver the strategy
  • Ensure proper generation and review of the batch records
  • Improve and challenge the processes used in the department
  • Establish qualification/calibration/maintenance programs for the equipment and ensure their follow-up
  • Ensure the team is adequately trained and adhere to the respective procedures
  • Ensure that the operations team is trained on the WI before the start of a study
  • Develop the capacity and resources of the department
  • Ensure good communication within the team
  • Work closely with the production team lead and process design team lead in order to be updated on the daily activities
  • Maintain up-to-date know-how and expertise in the IMP Production and Process Design field
  • Attend regular meetings with the Director of Operations
  • Work closely with the project management department for each new project as needed
  • Organize regular meetings with the project managers in charge of IMP projects
  • Collect from the PM information concerning the studies in order to write out appropriate WI
  • Contribute to discussions and give advice and reviews about the production activities to the sales team, to the project managers and to the QA/QC team
  • To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures
  • Perform other related job duties or responsibilities as assigned


Function-Specific Responsibilities:

  • Understand the specifications of each study and accordingly inform/train the operators about it
  • Optimize the planning of activities according to the availability of human and material resources
  • Maintain tools and equipment and ensure their efficient use
  • Ensure and maintain proficiency and social skills of the collaborators of the IMP Production department
  • Control that everything goes smoothly and report directly all deviations to the respective people in the company (line manager, project management, QA) within the timelines given by the respective QTAs


Key Requirements:

  • High School Diploma or GED
  • Minimum 7 years of supervisory experience
  • Minimum 5 years of experience in pharmaceutical manufacturing/packaging operations or principles and practices involved in clinical trials
  • Experience with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), or Good Documentation Practices (GDP) required
  • Detail oriented with ability to take initiative when working independently and with the team
  • Excellent oral, written and interpersonal communication skills to work effectively across the organization, with active listening ability
  • Self-motivated with exceptional time management skills to prioritize work and efficiently react to change in a fast-paced environment
  • Maintain a high regard for confidentiality while dealing with all clients, proprietary and pharmaceutical related information


Interested? We would love to hear from you, please apply today for consideration.