Salary Range: Dependent on Qualifications and Experience
The Advanced Cellular Therapeutics (ACT) Facility is looking for an experienced medical writer to join our growing team as a CMC Development and Strategy Associate. The ACT is a Good Manufacturing Practices (GMP) facility focused on expansion and manipulation of human cells for clinical applications, including the manufacturing of chimeric antigen receptor (CAR) T cells, therapeutic vaccines and other cellular products.
As the CMC Development and Strategy Associate, you will provide strategic and tactical leadership to UNC investigators in support of their interdisciplinary biologic development and regulatory submissions. The individual will serve as a chemistry, manufacturing and control (CMC) medical writer for products produced within the ACT Facility, and will author and review CMC regulatory documents for IND applications, perform CMC gap analysis and perform strategic CMC planning/execution. Additionally, they will author technical standard operating procedures (SOPs) and serve as a CMC regulatory expert.
The CMC Development and Strategy Associate will perform regulatory strategic planning by working with investigators and ACT leadership to identify key validation elements, processes, policies, and SOPs to ensure successful FDA review and identify shortcomings in current proposals. The individual will aid in preparation for FDA meetings, inspections and audits including drafting sections of briefing documents, and will lead trainings for ACT personnel and other investigators on FDA requirements for GMP work.
Education and Experience:
Experience in GMP research required, including GMP standards and the Code of Federal Regulations required. Additionally, previous experience writing part or the entirety of the chemistry, manufacturing and control (CMC) section of either academic traditional style (Section 7.0) or common technical document (CTD) (Modules 3 and Section 2.3) Investigational New Drug (IND) applications is required.
Previous experience writing documents for gene therapy or cellular products and writing and/or reviewing GMP policies and standard operating procedures (SOPs) highly preferred. Familiarity with the Foundation for the Accreditation of Cellular Therapy (FACT) Hematopoietic Cellular Therapy or Common standards preferred.
An advanced proficiency with Microsoft Office Suite and significant computer knowledge is required.
Regulatory Affairs Certification (RAC) preferred.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.
Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.