Shire Mfg Science Specialist II in Lessines (Baxalta), Belgium

Technical services at Shire is a group that develops process improvements and provides scientific & technical expertise to the facility manufacturing operations. Focus areas are achieving higher process yields, improving the process robustness, performing quality assessments and leading complex investigations. The Technical Services group also works closely with Process Science group for the implementation and transfer of new technologies into the regular manufacturing. In the Process Laboratory the manufacturing operations are simulated in smaller scales to study and optimize the process parameters (ie. upscaling & downscaling).

Summary

The Manufacturing Science Specialist II handles large and complex investigations related to manufacturing processes and ensures that adequate corrective actions are implemented in a timely manner.

He defends such investigations in front of regulators. He also works on process improvements and process robustness initiatives and leads such projects from start to implementation, including the submission preparation. He leads risk analyses for existing manufacturing processes as well as for new/upgraded processes. He leads cross-functional groups (also with other facilities), evaluates possible actions to mitigate/reduce the effect of the identified risks, and ensures the follow-up of the implementation of the actions.

Responsibilities:

Handles complex CAPA investigations related to manufacturing operations. In view of this:

  • Uses Six Sigma and DMAIC methods where appropriate.

  • Defines tasks/experiments to be performed, provides required documentation and ensures also that adequate corrective actions are implemented to address the identified root-cause(s).

  • Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by Baxalta Procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities.

  • Ensures and defends the Compliance to cGMP’s, GDP’s, Licenses and Baxalta Procedures by defining, implementing and maintaining appropriate SOP’s and training.

  • Favors communication, critical thinking, problem solving and team work across all manufacturing facilities.

  • Defends investigations in front of regulators during audits.

Develops and leads projects that will improve yields, throughput & process efficiency, production process control and/or will reduce process variations. In view of this:

  • Uses QbD, DIDOV, Lean and implements new technologies (including PAT) where appropriate.

  • Conducts risk analyses for existing bulk manufacturing processes as well as for new/upgraded processes (Capacity increase, Change Request, …), evaluate and implement actions to mitigate/reduce the identified risks.

  • Defines tasks/experiments to be performed, provides required documentation and leads the project from start to the implementation, including the submission preparation.

  • Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by Baxalta Procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities.

  • Ensures and defends the Compliance to cGMP’s, GDP’s, Licenses and Baxalta Procedures by defining, implementing and maintaining appropriate SOP’s and training.

  • Favors communication, critical thinking, problem solving and team work across all manufacturing facilities.

  • Defends submissions in the role of recognized process expert.

As a recognized process expert:

  • Is involved in technology transfers, CMO related activities

  • Ensures training of personnel on Scientific & Technical topics

Profile

  • Master or PhD degree in Pharmaceutical Sciences, Bio-Engineering or BioChemistry or equivalent by experience

  • 3 to 5 years in Pharmaceuticals & Bio-therapeutics manufacturing

  • Honest and responsible, flexible, customer focused, team player, open minded

  • Critical thinking and Problem Solving

  • GMP and bioprocessing knowledge and experience

  • Experience with Technical writing (in English) in preparation of regulatory submission files and defending topics during an FDA or cGMP audit

  • QbD, DIDOV, Lean, Six Sigma and DMAIC methods as appropriate

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.