2018-05-02

Manufacturing Associate
Job Opportunity at Clinical Dynamix, Inc.

Posted on May 2

http://www.clinicaldynamix.com    888-558-2546

Location: Norwood, MA
Job Type: Contract
Job ID: W4158799

Manufacturing Associate (five needs)
1st and 2nd Shifts available
6 month contract, and renewable up to 4 years

 
Company is seeking a cGMP Manufacturing Associate for mRNA Manufacturing of Personalized Cancer Vaccines. This position will eventually transition from Cambridge, MA to our new GMP Manufacturing site in Norwood, MA.
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)
  • Help 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 Company’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:
  • 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
 
Here’s What We’ll Bring to the Table:
  • Daily on-site catered lunches.
  • Company-provided iPhone.
  • Free parking, monthly subway pass or a subsidized commuter rail pass.
  • Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
  • Flexible Spending Accounts for medical expenses and dependent care expenses.
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
  • A suite of Company paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
  • Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
 
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured – at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry’s leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage. 
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