CMC Associate II 2065429

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™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.