Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How will you make an impact?

• We are searching for a Technical Writer I with a good background in scientific writing. This member of our team is responsible for crafting and updating cGMP (Current Good Manufacturing Practices) documentation that supports the manufacture of life-saving clinical and commercial drug products. The technical writer I will use standard batch record templates and collaborate with subject matter experts to deliver high quality documents that enable Right-First-Time manufacturing. Additional responsibilities include correcting gaps or misalignment between batch records and Standard Operating Procedure (SOP), analyzing manufacturing deviations to identify ways to improve reference documentation (i.e., batch records, SOPs, job aids), and optimizing the lay-out, organization, and content of documents. This role is encouraged to possess a scientific background, preferably in biologics, proven organizational skills, and attention to detail.

• We will draft documentation, with supervision, translating process knowledge from the Manufacturing Science and Technology (MSAT) engineers and Process Development groups into production records, validation protocols and technical documents for cGMP manufacturing and process validation.

• Limited knowledge of processing equipment and operations

• We will review documentation generated by MSAT for grammatical errors, technical style, and general readability.

• We will respond to internal and client comments and proactively work with SMEs to deliver accurate documents that enable successful execution and data summary.

• We will partner with other areas to ensure high quality and cGMP practices are retained when revising documents for process changes.

• We will identify errors and participate in error proofing activities.

• Ability to stand for long periods of time and gown into manufacturing areas to observe manufacturing process.

• Bachelor's degree in STEM field preferred

• Equivalent combinations of education, training, and relevant work experience may be considered.

• Minimum 4 year related experience, if no degree, in GMP regulated Biologics / Pharma Industry, or equivalent experience

• Experience writing SOP and/or pharmaceutical batch record or validation documents is preferred

• Demonstrates a foundation in general scientific practices, principles and concepts

• Shown success working in cross functional teams, ability to work collaboratively, and provide pro-active communication

• Knowledge of Good Manufacturing Practices and US/EU regulations

• Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment

• Organized, efficient, and results oriented with ability to work under pressure and meet tight deadlines

• Expert in oral and written communication (verbal and written in English), as well as interpersonal skills

• Proficient in Microsoft Office applications