What are the responsibilities and job description for the CMC Associate II 2065429 position at Stratacuity: Proven Scientific Placement?
Location: Cambridge, MA (Onsite)
Focus: Microbiome
Job Overview: This position involves supporting the manufacturing process for the production of innovative biotherapeutics.
Primary Job Responsibilities:
- Adhere to and enhance safety protocols, actively identifying and rectifying hazards.
- Prepare media and buffers, operate autoclaves, and ensure the facility is audit-ready.
- Perform Environmental Monitoring, Utilities (EM/UM), and Bioburden testing to maintain product quality.
- Address OOS results, deviations, and CAPAs, promoting continuous improvement.
Primary Job Requirements:
- Possess a BA/BS in Microbiology or related, with 1-2 years of cleanroom and aseptic technique experience plus GMP knowledge.
- Proficient in using lab equipment like pH and conductivity meters, balances, and particle counters.
- Knowledgeable in cGMP, ICH, FDA, and EU regulations, with a commitment to quality and regulatory compliance.
- Strong communicator capable of fostering teamwork and building effective stakeholder relationships.
- Detail-oriented with excellent organizational skills, able to work independently or under supervision with a positive outlook.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
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