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Title: cGMP Manufacturing Associates
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: cGMP Manufacturing Associates – All Shifts
- Ideally seeking candidates with 2-3 years of chromatography, GMP or any single system experience
Compensation, Benefits, and Employment Type
- Duration – Contract to Permanent
- Pay rate: 30-35/hr. Plus 15% shift differential
- Job Location: Dedham, MA
- Job# bh11619
- Date Posted: 8/20/2020
The individual in this role will be part of a cohesive team responsible for supporting GMP mRNA-based medicines for evaluation in human clinical trials focusing primarily in Buffer Preparation and Central Services activities. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently. They will be able to operate pilot-scale bioprocessing equipment and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts.
Here’s What You’ll Do:
- Closely partner with QA peers for rapid disposition of mRNA therapeutics
- Demonstrate general knowledge of standard manufacturing practices and equipment.
- Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
- Monitor process operations to ensure compliance with specifications.
- Assist in the investigation of procedural deviations.
- Practice safe work habits and adhere to our safety procedures and guidelines.
- Utilize knowledge to improve operational efficiency.
- Adhere to gowning procedures and maintain a clean general operating area.
- Adhere to documented waste handling procedures to respect environmental regulations.
Here’s What You’ll Bring to the Table:
- Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field, Associates with 2+ years related experience or 4+ years of related GMP experience
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
- Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
- Exceptional written, oral communication, and organizational skills required
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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