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Jobs or company...
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Senior Manufacturing Specialist (Pharma/Biotech)

$ 5,500 - $ 8,000 / month
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Responsibilities:

  • Monitor, optimize, and troubleshoot issues related to either fermentation/cell culture or protein purification processes and unit operations.
  • Supervise the product quality impact assessments and support root cause assessments for process discrepancies and Quality investigations.
  • Identify and implement corrective actions, preventative actions and continuous improvements for process and equipment.
  • Create, review and revise cGMP documents such as batch records, SOPs, change records, etc.
  • Perform gap and technical assessments for global standards and procedures (GSPs and SOPs).
  • Serve as risk lead or subject matter expert in support of risk assessments and hazards analysis e.g. microbial control risk assessments.
  • Develop technical training material and conduct technical training for production staff.
  • Support the technology transfer of new products/processes e.g. perform field testing.
  • Create, review, revise and approve technical reports and engineering documents such as URS, FS, SDS, P&IDs, etc.
  • Design, procure, commission, and qualify new equipment.
  • Ensuring successful and efficient processes for the production of recombinant proteins.
  • Serve as subject matter expert for regulatory inspections as well as internal audits and support inspection response.
  • Collaborate with multidisciplinary teams to achieve project objectives.

About You:

  • Has 1 to 2 years supervisory experience in the Biologics (Upstream/Downstream/Central Services).
  • Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry).
  • Strong attention to detail, organizational skills, and the ability to work independently or in a team.
  • Excellent communication skills, both written and verbal, in English.
  • Adherence to safety protocols and regulatory compliance.

Job Type: Contract
Contract length: 12 months

Pay: $5,500.00 - $8,000.00 per month

Experience:

  • Biologics (Upstream/Downstream/Central Services).: 4 years (Preferred)
  • Quality investigations: 2 years (Preferred)
  • CAPA, change control: 2 years (Preferred)