Manufacturing Associate

SGS_JOB_1331

Admin/Clerical
 Massachusetts
Manufacturing
GMP
SOP.

Contract - 12 Months

You will be part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Biotherapeutics portfolio. Your initial focus will be as part of the manufacturing team focused on mammalian bio-processing. This includes and not limited to supporting the manufacturing operations team, reviewing Standard Operating Procedures, reviewing batch records, and standard work. As part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team’s success by sharing of previously acquired knowledge. It is your hard work and focus that will help in making ready to achieve new milestones and help patients across the globe.

Job Responsibilities:

  • Manage own time and professional development, be accountable for own results and begin to prioritize own workflow.
  • Cross-functional communication with tech transfer team, quality and engineering as necessary.
  • Implement {Current} Good Manufacturing Practices {part of GxP} procedures and safe handling techniques for solid dosage processing within the continuous manufacture /PCMM work stream.
  • Ability to follow Standard Operating Procedures and work under minimal supervision.
  • Identify and support continuous improvement initiatives and root cause analysis tools.
  • Generate, assist and execute documentation associated with solid dosage manufacture, such as, working batch record documentation, in-process run sheets.
  • Complete activities identified as Operator care tasks associated with the maintenance and operation of complex pharmaceutical manufacturing equipment.
  • Actively participate in shift exchange activities and communication channels.
  • Complete training to take part in safety inspections within the facility.
  • Manage solution preparation and laboratory consumables.
  • Understand and comply with the policies, procedures and working practices of Environment, Health & Safety and where necessary contribute to the review and implementation of the practices in the plant.
  • Help to coordinate shipments of solutions and medias to other sites.

Skills:

  • Demonstrated experience in a biotechnology manufacturing or laboratory environment
  • Operational knowledge of computerized systems, Familiarity with Production Control Systems, Enterprise Resource Planning Systems and other business systems
  • Maintains a safe work environment
  • Demonstrated capability to work as a team member in a matrix development team
  • Excellent oral and written communication skills
  • Strong computer skills in Microsoft Office required, especially MS Word, MS Excel

Education/Experience:

  • High School

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