API Process Coordinator

3 months ago

Sandwich, Kent, United Kingdom Asymchem Group Full time

Company Overview:

Established in 1999, Asymchem is a worldwide integrated Contract Development and Manufacturing Organization (CDMO) that specializes in drug research and manufacturing for prominent pharmaceutical and biotech firms. Our goal is to promote smarter, more sustainable, and cost-efficient manufacturing practices to support clinical research and commercialization. Asymchem is excited to announce the recent acquisition of R&D laboratories and a small molecule API pilot plant, enhancing our capabilities to serve global clients.

Job Overview:

This role plays a vital part in the transition of processes from the CRD laboratories to produce Active Pharmaceutical Ingredients (API) for our clients and assists in the development of commercial manufacturing processes for transfer to Production Good System. The position reports directly to the API Process Supervisor Lead and involves collaboration with CRD personnel, project teams, and local scheduling to effectively plan and execute production campaigns.

Key Responsibilities:

  • Engage in training and self-improvement, while fostering the development of others and maintaining up-to-date knowledge of relevant equipment and GMP training.
  • Develop chemical processes, ensuring the operability and safety of each process, and evaluate process safety information to uphold safe operations within the facilities.
  • Manage batch planning in coordination with the Planner Scheduler, ensuring the availability of raw materials and the accuracy of batch documentation.
  • Oversee the closure of documentation for each batch and process, including batch records, excursions, deviations, and transfer documentation.
  • Contribute to the development and scaling of safe, sustainable, and robust chemical processes, providing feedback and identifying areas for improvement.
  • Issue feedback reports on campaigns and lead comprehensive post-action reviews for API-sub team participants involved in development projects.
  • Actively participate in the API-sub team, supporting the co-design of commercial routes and processes, as well as initiatives aimed at improving process robustness.
  • Lead or participate in the implementation of innovative manufacturing technologies and techniques to enhance efficiency in API facilities.
  • Assist in creating and delivering procedures and associated training programs.
  • Engage in the development and application of predictive tools in the laboratory and support the collection and analysis of process metrics.
  • Maintain and enhance chemical and process engineering knowledge to support the development of the portfolio.
  • Support activities in the CRD Labs and API Manufacturing, focusing on continuous improvement, EHS compliance, training, and GMP adherence.
  • Represent the company at conferences and internal/external presentations to influence the external environment.
  • Perform other duties as assigned.

Experience Requirements - Knowledge, Skills, & Abilities (KSAs):

  • A B.Sc. degree in a relevant discipline (engineering or chemistry) is expected, along with pertinent experience in pharmaceutical manufacturing.
  • Experience in an API manufacturing or technical environment is essential.
  • New product introduction experience at clinical or commercial scale is desirable.
  • Strong technical, problem-solving, and communication skills are required.
  • Demonstrated performance in a dynamic operating environment with a focus on excellence and flexibility.
  • A collaborative team player who can navigate the challenges of a facility start-up.
  • Evidence of high performance in a continuous improvement-focused work environment, with strong interpersonal skills and attention to detail.
  • Ability to foster open communication within the Process Team to achieve business objectives.
  • Proven leadership skills to positively influence team dynamics.
  • Ability to work independently and proactively address business needs.

We offer a competitive benefits package that includes:

  • Performance-related bonuses
  • Pension, life insurance, private medical insurance (PMI), income protection, and other insurance benefits
  • 25.5 days of holiday plus bank holidays, sick leave, and volunteer time off
  • Car allowances, shift allowances, cycle to work schemes, and gym memberships

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