Process Development Manager

2 months ago


Sandwich, Kent, United Kingdom Asymchem Group Full time
About Asymchem Group

Asymchem Group is a leading Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing services to pharmaceutical and biotech companies. Our mission is to drive smarter, greener, and more cost-effective manufacturing to support clinical research and commercialization.

Job Overview

We are seeking a highly skilled Process Development Manager to contribute to all aspects of the transfer of processes from CRD laboratories to produce API for our customers and to aid the development of commercial manufacturing processes for transfer to Production Good System.

Key Responsibilities
  • Process Development: Develop chemical processes including an evaluation of the operability and safety of a process, the evaluation of the process safety information and responsibility for the safe operation of the process in the facilities.
  • Batch Planning and Management: Plan and manage batches in conjunction with the Planner Scheduler, including availability and status of raw materials, preparation and checking of batch documentation and liaison with CRD support functions.
  • Closure of Documentation: Close the documentation for each batch and process for which they are responsible, including batch records, excursions and deviations, disposition and transfer documentation.
  • Process Improvement: Provide input into the development and scale up of safe, sustainable and appropriately robust chemical processes, and provide feedback on processes and suggest potential areas for improvement.
  • Campaign Feedback and Review: Issue campaign feedback reports, and lead comprehensive post-action reviews for API-sub team participants.
  • Team Collaboration: Collaborate with CRD personnel and partnering departments, CRD project teams, and the local Scheduler to both schedule and execute the campaign plan.
  • Implementation of New Technologies: Proactively implement new or under-utilized manufacturing technologies and techniques for efficiency and versatility improvement in the API facilities.
  • Procedure Development and Training: Assist in the development and delivery of procedures and associated training.
  • Predictive Tools and Process Metrics: Participate in the development and application of predictive tools in the lab environment and support the capture and analysis of process and plant metrics.
  • Continuous Improvement: Actively support activities in the CRD Labs and API Manufacturing, including initiatives, continuous improvement, EHS compliance, training, scheduling, planning and GMP compliance.
  • External Representation: Influence the external environment by attending and participating in conferences and presenting to internal and external groups.
Requirements
  • Education: B.Sc. level in an appropriate discipline (engineering or chemistry) with relevant experience in pharmaceutical manufacturing.
  • Experience: Relevant experience in an API manufacturing or API technical (process chemistry, process engineering) environment.
  • Desirable Skills: New product introduction experience at clinical or commercial scale manufacturing, excellent technical, problem-solving and communication skills, performance at a consistent level of excellence in a dynamic operating environment, and ability to deal with the challenges that a facility start-up may present.
What We Offer
  • Competitive Benefits: Performance-related bonus, pension, life insurance, private medical insurance, income protection, and other insurance benefits.
  • Generous Time Off: 25.5 days holidays plus Bank Holidays, sick leave, volunteer time off, and buy & sell holidays.
  • Professional Development: Opportunities for professional growth and development in a dynamic and collaborative environment.


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