Company Overview: Founded in 1999, Asymchem is a global integrated Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing for leading pharmaceutical and biotech companies.
Our mission is to drive smarter, greener, and more cost-effective manufacturing to support clinical research and commercialization.
Asymchem was thrilled to recently announce the acquisition of R&D laboratories and small molecule API pilot plant at Discovery Park, Sandwich, UK, establishing our first manufacturing facility in Europe and expanding our capabilities to meet the needs of global clients.
It is envisaged that the Sandwich facility will continue to flourish and act as the flagship site for European R&D capabilities.
We are looking to recruit into key roles and see this as a fantastic opportunity to join a collaborative dynamic team and help improving the health and lives of people around world.
Job Overview: Contributes 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.
Reports directly to the API Process Supervisor Lead.
Collaborates with CRD personnel and partnering departments, CRD project teams, and the local Scheduler to both schedule and execute the campaign plan.
Duties & Responsibilities: Training and self-development, developing others, proactive involvement in keeping up with appropriate equipment and GMP training.
Development of 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, e.g., process hazard and COSHH assessment execution and implementation.
Batch planning and management in conjunction with the Planner Scheduler including availability and status of raw materials, preparation and checking of batch documentation and liaising with CRD support functions.
Closure of the documentation for each batch and process for which they are responsible, including batch records, excursions and deviations, disposition and transfer documentation.
Provide input into the development and scale up of safe, sustainable and appropriately robust chemical processes.
Provide feedback on processes and suggest potential areas for improvement to ultimately produce a commercial process.
Issue campaign feedback reports, and for development projects, lead comprehensive post action reviews for API-sub team participants.
Proactive member of the API-sub team including support for co-design of commercial route and processes and RFT initiatives to improve robustness and transfer of commercial processes.
Be proactively involved in, or lead, the implementation of new or under-utilised manufacturing technologies and techniques for efficiency and versatility improvement in the API facilities.
Assist in the development and delivery of procedures and associated training.
Participate in the development and application of predictive tools in the lab environment and support the capture and analysis of process and plant metrics.
Maintain, develop and utilise chemical and process engineering knowledge and experience in the development of the portfolio, e.g., better process understanding and science of scale initiatives within CRD.
Actively support activities in the CRD Labs and API Manufacturing including initiatives, continuous improvement, EHS compliance, training, scheduling, planning and GMP compliance.
Influence the external environment by attending and participating in conferences and presenting to internal and external groups.
All other duties as assigned.
Experience Requirements - Knowledge, Skills, & Abilities (KSAs): It is expected that the successful candidate be qualified to B.Sc.
level in an appropriate discipline (engineering or chemistry) with relevant experience in pharmaceutical manufacturing.
Relevant experience in an API manufacturing or API technical (process chemistry, process engineering) environment It is also desirable that the successful candidate has 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, where the focus will be on flawless execution and demonstrated flexibility to get the job done.
Comfortable as part of a highly competent and self-motivated team, and will have the ability to deal with the challenges that a facility start-up may present.
Demonstrated evidence of high performance in a continuous improvement-oriented work environment.
Excellent interpersonal skills, team orientation and attention to detail.
Facilitation of an environment of open and team-based communication where all members of the Process Team work together to ensure that business targets are met.
Strong ability to lead, challenge and positively influence in an interactive team environment.
Demonstrated ability to work on own initiative and proactively respond to business needs.
We offer competitive benefit offerings including: Performance related bonus Pension, Life insurance, Private medical insurance(PMI),Income protection and other Insurance Benefits like Dental Insurance/ Critical Illness which are enjoyed through salary sacrifice or other ways 25.5 days holidays plus Bank Holidays, Sick Leave, Volunteer time off, Buy & sell holidays Car allowances, Shift allowances, Cycle to Work, Gym Memberships, etc.