(Contract) Technical Writer, Manufacturing

March 08 2018
Organization Type
(Contract) Technical Writer, Manufacturing

The Role:

This role is an exciting opportunity to be a critical part of a high growth organization that is radically changing the biotech industry. Currently, Moderna is building a state-of-the-art, LEED certified, cGMP manufacturing facility in Norwood, MA. This 200k sq. foot campus is critical as we continue to move more of our therapies into the clinic and require in-house manufacturing.

Moderna is seeking a cGMP Manufacturing Support team member focusing on technical writing for our new site in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials.  The Manufacturing Support Technical Writing team member uses knowledge of cGMP regulations and biopharmaceutical production processes to create and revise standard operating procedures, batch records, specifications, forms and other critical documentation. They will work directly with subject matter experts to ensure content accuracy, improve efficiency and documentation practices.

Here's What You'll Do:

  • Practices and promotes safe work habits and adheres to safety procedures and guidelines
  • Conducts document revisions and/or document management
  • Utilizes manufacturing process knowledge and documentation skills to identify areas of improvement or gaps within documentation and resolve issues and drive continuous improvement
  • Participates in cross functional teams to drive completion of document revisions or creation with a focus on prioritization and timelines for completion
  • Participates in cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
  • Works independently with minimal supervision and direction
  • Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
  • Creates and presents trending and metrics reports

Here's What You'll Bring to the Table:

  • High school diploma/GED or Biotech Certification with 2-4 years of experience, or Bachelor's Degree with 1-2 years of experience in biopharmaceutical operations
  • Understanding of biologics drug substance operations or a similar complex specialized environment
  • An understanding of regulatory requirements and their applications in a cGMP environment
  • Experience with electronic documentation systems for controlled documents in a cGMP environment
  • Excellent written and oral English language skills
  • Strong skills in the use of Microsoft Word including formatting
  • Bachelor's degree in Engineering or Life Sciences is preferred
  • Demonstrated ability to lead cross functional teams and deliver results with minimal supervision
  • Ability to manage multiple competing priorities in a fast-paced environment
  • Understanding of lean manufacturing methodologies and operational excellence

Why join Moderna Therapeutics

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. 

We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world. 

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

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.

Similar jobs

Similar jobs