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Principal Associate, Compliance Manufacturing

Company: SERES THERAPEUTICS, INC.
Location: Cambridge
Posted on: February 17, 2021

Job Description:

Career Opportunities with Seres Therapeutics, Inc. A great place to work. Careers At Seres Therapeutics, Inc. Share with friends or Subscribe! Even if you don't see a job that's a fit, but you're excited by what Seres is doing and want to be a part of it, we'd appreciate hearing from you and will keep you in mind for a future opportunity.--Click here --to submit your resume.-- Principal Associate, Compliance Manufacturing Principal Associate, Compliance Manufacturing Why Seres Therapeutics Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres Therapeutics is a member of the Flagship Pioneering family of companies. Job Summary Seres Therapeutics is seeking a Principal--Associate, Compliance Manufacturing to join our team who will be responsible for supporting manufacturing operations and clinical supplies across several phases of clinical trials. This individual serves as a liaison between Manufacturing Operations and Quality Assurance team to ensure products are consistently produced and controlled in accordance with quality standards set forth by regulatory agencies. The candidate promotes data and product integrity to ensure patients and clinical trial subjects receive safe and effective therapies. 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. What You'll Do

  • Author Standard Operating Procedures, Work Instructions and Batch Records
  • Manage compliance by owing and authoring deviations, impact assessments and--change controls
  • Participate in investigations and quality events cross functionally
  • Perform root cause analysis and identify contributing factors
  • Implement corrective and preventative actions
  • Support internal and external audits
  • Support post audit activities partnering with Quality Assurance
  • Maintain and facilitate timely closure of quality events as required
  • Maintain compliance tracker and provide update to manufacturing and cross functional teams
  • Facilitate overall compliance by building cross functional relationships
  • Utilize manufacturing process knowledge to improve procedure, policies and regulations
  • Review executed records and resolve quality related comments
  • Ensure availability 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-- Model Manufacturing Core Behaviors
  • Collaborate with affected group or individuals to resolve or mitigate effects of an error or abnormality
  • Thoroughly understand the process critical path
  • Understand how to spread the knowledge/experience and utilize talent of the team members to maintain SME's across process steps What You'll Bring
    • Bachelor's degree in Science, Engineering or a related field with 5-8 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 Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

Keywords: SERES THERAPEUTICS, INC., Cambridge , Principal Associate, Compliance Manufacturing, Other , Cambridge, Massachusetts

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