Seres Therapeutics

Job Title: Senior Associate, CMC Manufacturing

Job Number: 23300

Location: Cambridge, MA

Job Description

Seres Therapeutics is seeking a Senior Associate, CMC Manufacturing to join our team who will be responsible for supporting manufacturing operations and clinical supplies across several phases of clinical trials. This individual will be involved in the execution and documentation of cGMP manufacturing processes, and operations pertaining to drug substance and drug product manufacturing. S/he will also ensure proper safety and aseptic protocols for floor operations. This individual will collaborate with multiple support groups such as Quality Control, Quality Assurance, Bioprocess and Facilities to support the transfer of process changes to manufacturing operations.

Responsibilities

  • Prepare raw materials, media culture, solutions and consumables according to Standard of Protocols and safety regulations for manufacturing operations
  • Authorize Standard of Protocols, batch records, Corrective and Preventative Actions and deviations
  • Ensure availability, validation and maintenance of required materials and equipment for manufacturing operations
  • Follow and complete daily standard operation procedures by completing reports, performing batch records, logging equipment, maintaining safety procedures and reviewing manufacturing documentation to ensure compliance
  • Maintain cleanliness and orderliness of manufacturing facilities
  • Provide training to and review safety procedures with junior employees
  • Plan production activities within assigned area
  • Perform as Subject Matter Expert or system owner for specific pieces of equipment

Required Skills

Required Skills

  • Bachelor's degree in Science, Engineering or a related field with 3-5 years of experience in biopharma clinical manufacturing or relevant industry
  • Previous experience in a cGMP or clinically regulated environment
  • Strong organizational skills and attention to detail
  • Excellent communication skills and strong team player
  • Flexible and adaptable work schedule

Preferred Skills 

  • Project Management
  • Tangential Flow Filtration
  • Fermentation
  • Lyophilization

 

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