What are the responsibilities and job description for the Associate I, CMC Manufacturing (100% ONSITE) position at Seres Therapeutics?
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.
Position Summary
Seres Therapeutics is seeking an Associate I, 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.
What You'll Do
- Operation of bioprocess equipment for microbial cultures, recovery and purification
- Execution of Batch Records and Author Standard Operating Procedures
- Troubleshooting of manufacturing and process challenges
- Management of raw materials and consumables required for manufacturing
- Proactive identification and mitigation of risks
- Identification of process changes and improvements
- Initiation and support of deviation/quality event investigations and close-out
What You'll Bring
- Bachelor's degree in Life Sciences or Biotechnology Certificate with 0-1 years 'experience in Biotech manufacturing
- Experienced with aseptic techniques
- Exposure to cGMP standards for clinical and/or commercial manufacturing
- Knowledge of biotech manufacturing process and equipment in some aspects of fermentation, filtration, purification, and formulation processes
- Flexible with schedule and willingness to work long shifts if necessary
- Ability to work in a fast-paced and constantly changing environment to meet current challenges
- Works well independently and in group settings
Candidates should be aware that Seres Therapeutics currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date.
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.
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