Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need. 

Working at Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning. 

  Our benefits include:

• 401K matching
• PTO
• Employee discount programs
• Medical, dental and vision insurance
• and much more

The Manufacturing Technical Writer is responsible for providing documentation support in manufacture of Master and Working Cell Banks Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). 

• Perform job specific tasks in compliance with applicable Regulations, International Standards, and Internal Policies and Standard Operating Procedures.
• Uses all support systems (e.g. LIMS, BMRAM) with demonstrated proficiency
• Trains others on the use of support systems
• Authors, revises, and assists others on technical documents
• Owns and supports basic change controls and action items
• Revises, authors, standardizes and aligns simple and complex SOPs and BRs
• Reviews executed BR as applicable
• Identifies, communicates, addresses and improves simple cGxP compliance and regulatory gaps and issues across site
• Gather data to support and author investigations as applicable
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Performs basic collection, analysis, interpretation, draws conclusions and identifies trends of scientific and process data per good document practices
• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
• Understand the processes that go into GMP manufacturing services for advanced gene and cellular therapeutics, to ensure documents are accurate and consistent in approach and format.
• Ensure consistency, quality, completeness and timeliness of all submissions to clients, both internal and external.
• Understanding of client information on different technologies, unique cell processes, upstream / growth as well as downstream / purification for viral vectors, as well as autologous and allogenic cell therapies.
• Performs well under minimal supervision and ability to work independently on assignments
• Identifies, suggests, participates and implements continuous improvement ideas
• Interacts and coordinates with other support groups in the creation and revision of technical documents,
• May be required to enter manufacturing areas in support of documentation and procedural creation and revisions.
• Possess basic computer skills and able to efficiently use Microsoft applications.
• May be required to work outside normal business hours, overtime, holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals
• Thorough understanding of Good Manufacturing Practices and Good Documentation Practices
• Other duties as assigned

Experience / Education:

• Bachelor’s Degree in related discipline and 2 years of experience within Manufacturing or High School Diploma with greater than 5 years of experience within Manufacturing with preference for cell and gene therapy programs.

Knowledge / Skills / Abilities:

• Prior experience with either research or development at a pharmaceutical company, contract service organizations, or a university.
• Versatility with scientific, process and analytical terminology.
• Strong oral and written communication skills with the ability to convey complex information in a way that others can readily follow.
• Strong organizational skills, ability to multi-task, and the ability to meet strict timelines.
• Experience using MS Office products.
• Possess the skills to work both independently and as part of a team in a fast-paced, deadline-driven environment.
• Attention to detail and ability to self-prioritize work on an ongoing basis.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.

Advanced Therapies:   provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.”