Process Technical Writer - Cell Therapy

United States, Portsmouth (New Hampshire)

Lonza is searching for a Process Technical Writer for our Cell Therapy Department at our Portsmouth, NH facility. This is an excellent opportunity to showcase your technical writing skills.

Our Technical Writers hone their inter-departmental management skills, collaborating with various department colleagues to address comments from internal and external customer reviews and to drive schedule adherence. Stemming from a developing understanding of documentation and manufacturing processes, Technical Writers produce quality batch records to support operational execution, as well as patient safety, drug quality, and business reputation.

Responsibilities included, but not limited to:

  • Edit documents: Review and template documents with accurate, clear, and explicit description and justifications.

  • Manage document revision: Perform initial review for scope, attain sign-offs and justifications, set up review meetings, etc.

  • Manage document comments: Answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the aid of document owners.

  • Maintain and review schedules/campaigns: Manage document timelines to support the manufacturing schedule; communicate and escalate appropriately to maintain document timelines.


The successful candidate will need to have the following requirements in order to be a top contender for this role:

  • High School Diploma, Bachelor Degree in Science related discipline preferred.

  • Some experience of pharma/biotech (or equivalent) preferred.

  • Project management skills required.

  • Strong MS Word experience.

Reference: R39205