(Contract) Manufacturing Associate II, 2nd Shift

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
September 05 2019
Ref
R1729
Discipline
Life Sciences, Biology
Organization Type
Biotech
The Role:

Moderna is seeking a cGMP Manufacturing Associate for mRNA Manufacturing of Personalized Cancer Vaccines. This position will be based in our new GMP Manufacturing site in Norwood, MA. The duration of this assignment is expected to be 6 months.

The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based personalized cancer vaccines for evaluation in human clinical trials. 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:
  • Produce mRNA Personalized Cancer Vaccines
  • Execute manufacturing operations using disposable technologies, automation and Manufacturing Execution Systems (MES)
  • Develop batch records, SOPs and training materials for startup of the Norwood Facility
  • Closely partner with QA peers for rapid disposition of personalized cancer vaccines
  • 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 Moderna's 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:
  • 2-4+ years of experience in a GMP manufacturing environment.
  • Bachelor's Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field, Associates with 4+ years related experience or 5+ 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


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna 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. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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