Associate Department Manager, MSAT - Cell Therapy

Singapore, Tuas Singapore

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The growth of the Cell Therapy MSAT team in Singapore is integral to the multi-customer, multi-process, late phase and commercial manufacturing site strategy.  The successful candidate must demonstrate the depth of understanding, drive, resilience and strategic thinking required to make this happen.

Key responsibilities:

Management

Working closely with the Cell Therapy Manufacturing management team:

  • Manages a high performing team of staff, aligning resources with daily tasks to ensure smooth execution of the MSAT activities.  Responsible for recruitment and co-ordination of training to maintain budgeted headcount.  Sets individual personal development goals and provides appropriate performance feedback.  Champions a culture of high importance, focus and low error rate, driving improvements to Cell Therapy processes, quality and right first time.
  • Ensures department functions and personnel comply in accordance with site EHS standards (policies, rules and regulations).
  • Ensures high level cGMP compliance and integrity.  Reviewer/approver of manufacturing documentation ensuring ease of completion and compliance to site standards.  Technical review of production deviations and CAPAs.
  • Participates in Customer/Site Quality/Global Quality audits and regulatory inspections.
  • Provides leadership and guidance to complex technical problems, compliance failures and continuous improvement initiatives. 

Technology Transfer

  • Lead and/or support the timely and successful transfer of the customer’s manufacturing processes into the Lonza Cell Therapy Singapore production facility
  • Close collaboration within Walkersville and Site MSAT teams and across various functional groups i.e. Manufacturing, Supply Chain, Project Management, QA, QC, project management, Process Development and Supply Chain etc).
  • Analysis of process fit, facility fit, process-scale up, determination of material requirements in collaboration with vendors, customer technical experts or Lonza’s Process Development and MSAT Departments.
  • Actively engage Lonza’s customers to progress technology transfer and process support activities.
  • Author of process-related documents i.e. batch records, APS protocols, development/investigative protocols and reports.
  • Develop and define training programs and requirements to facilitate integration of new manufacturing processes into Manufacturing
  • Perform/support experiments in the MSAT lab to support technology transfer in accordance with Lonza’s lab safety policies.
  • Deliver pre-campaign classroom trainings and hands on process-related trainings.

Process Support

  • Performs technical review and approval of batch records, process SOPs, deviations, change controls, training documents, protocols, development/investigative reports, CAPAs.
  • Support investigations into process issues/deviations and if required, coordination of the associated troubleshooting activities.
  • Manage change implementation for process changes which includes generation of planned deviations/change controls that are driven by process changes/improvements and coordination of non-GMP and/or non-clinical runs.
  • Oversight on the production floor to provide support and review of operations. Escalate issues to management appropriately and interface with customer on issue resolution.
  • Oversight of on-going trainings to ensure alignment between training and process requirements
  • Monitor manufacturing run process data and monitor for run to run consistency
  • Support inspections and audits by customer and regulatory authorities as required.

Key requirements:

  • Bachelor’s Degree or PhD in Life Sciences or related discipline plus significant years of related cGMP clinical development/steriles experience in the biotech/pharma manufacturing sector.  Note: appropriate experience may substitute for education.
  • Previous supervisory/people management experience including recruitment, training, development and mentoring/coaching of technical staff.
  • Knowledge of cell culture and the principles of aseptic processing within a classified environment.
  • Time management, planning, prioritization and delegation skills.
  • Communication skills – regular, clear and concise communication to the MSAT team, customer representatives, customer auditors and regulatory inspectors (both written and oral).
  • Ability to manage change and communicate it effectively.
  • Reliable and trustworthy with confidential information.
  • Influencing skills, assertiveness and an ability to challenge views and beliefs.
  • Strong independent work ethic.
  • Preferably with significant years of working experience in process development, process support or research. Pharmaceutical or biomedical industry experience is an added advantage.
  • Prior hands-on technical experience in adherent cell culture work and/or manufacturing environment.
  • Strong sense of urgency and problem solving skills
  • Meticulous, self-motivated and capable of working independently and as part of closely knitted teams in a dynamic environment
  • Proficient in Microsoft Office, SAP, TrackWise Knowledge of statistical data analysis tools is advantageous.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R41134
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