Technical Writer

Technical Writer

Position Summary:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Catalent's facility in Bloomington, Indiana, provides a fully integrated and unique model for process development, clinical and commercial mammalian cell culture manufacturing, formulation, parenteral drug manufacturing and packaging under one roof. The award-winning facility provides clinical and commercial bulk drug substance and drug product manufacturing, including liquid and lyophilized vials, and prefilled syringes, along with an array of support services.

The Manufacturing Sciences and Technology (MS&T) department's primary function is to serve as an agile technical services team to support process & technology transfer (e.g., mAbs, fusion proteins, mRNA, new modalities, etc.), equipment, consumables, technical writing, and drug substance lifecycle management. The MS&T organization supports the Bloomington facility as well as Catalent Biologic's network through client-facing support, on-the-floor or on-call technical coverage, and continuous improvement.

The Technical Writer position requires the coordination and writing of cGMP manufacturing batch records or batch summary reports for platform processes. The position responsibilities will include addressing revisions to the documents, supported by subject matter experts. The position is expected to possess a scientific or writing background, strong organizational skills, and a high attention to detail.

This is a fulltime role working days; Monday - Friday

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

• Responds to internal comments and works with SMEs to ensure comments are incorporated.
• Executes procedures of moderate complexity with high quality with a minimum degree of guidance.
• Support other activities within the Technical Writing Group as assigned.
• Authors non-process batch production records (solution, column, bulk fill) to support cGMP manufacturing with minimal technical understanding.
• Generates batch production records in accordance with applicable regulator guidance and site SOPs.
• Authors platform documents from execution batch production records with minimal technical understanding.
• Copy-edits documents in accordance with applicable regulator guidance and site SOPs.

The Candidate:

• Associate's degree required
• 2+ years of experience writing with peer review or other editorial oversight
• GMP experience, preferred
• Must be able to read and understand English-written job instructions and safety requirements

Why You Should Join Catalent

• Competitive medical benefits and 401K
• 152 hours of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.