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 continually function as a subject matter expert support and provide input pertaining to the Manufacturing client proposal process to the Manufacturing Management Team, the Manufacturing department, & other departments as needed.

• Provide inputs on behalf of Manufacturing to support the business’s manufacturing client intake process.
• Provide labor estimates and models to support the manufacturing client proposal process
• Complete capacity planning estimates and models to support the manufacturing client proposal process
• May act as manufacturing subject matter expert on technical calls in support of manufacturing client proposal process
• Complete and prepare capacity planning information for new clients as an input to support the S&OP process
• Understand the processes that go into  Advanced Therapies GMP manufacturing services for advanced gene and cellular therapeutics, to ensure proposals and other documents are accurate and consistent in approach and format.
• Collaborate with Business development, finance and other departments, as needed in support of the proposal process.
• Assist in preparing responses to Requests for Proposal or Information (RFP or RFIs) from external clients.
• 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 is important.
• Work with manufacturing and testing operations for portions of technical documents as needed to support the proposal process.
• Collaborate with Process Development, Analytical Development, CMC and Manufacturing leadership and team members prepare consistent, high quality client proposals and other documents detailing the service offerings of Advanced Therapies within a timely manner.

• 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.
• Prior experience in drafting and or reviewing manufacturing client proposals
• Prior experience in capacity planning and labor modeling related to Manufacturing operations.
• Versatility with scientific, process and analytical terminology.
• Cell and gene therapies experience is a plus.
• 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.

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.