| Employment Type: Permanent Staff (EHRA NF) Vacancy ID: NF0004644 Salary Range: Dependent on Qualifications and Experience Position Summary/Description: The Advanced Cellular Therapeutics (ACT) Facility 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. This position will serve as a chemistry, manufacturing and control (CMC) medical writer for products produced within the ACT Facility. This individual will author the CMC sections of initial investigational new drug (IND) applications, amend the CMC sections of IND applications and prepare annual report updates for the CMC sections. This position will track required information that needs to be relayed to the FDA and will work with the ACT staff to ensure that required updates are reflected in the CMC section and submitted to the FDA in a timely manner. This individual will work across the ACT Facility IND portfolio to identify required differences in production and to standardize procedures when applicable. This position will author technical standard operating procedures (SOPs) and assist in performing quality assurance of SOPs, when written by others, to ensure that consistency with the current CMC sections of applicable INDs. This position 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. This individual will aid in preparation for FDA meetings, inspections and audits including drafting sections of briefing documents. This individual will led trainings for ACT personnel and other investigators on FDA requirements for GMP work. Education and Experience: Experience in GMP research required, including 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. Previously experience writing documents for gene therapy or cellular products, highly preferred. Previous experience writing and/or reviewing GMP policies and standard operating procedures (SOPs) highly preferred. Familiarity with GMP standards and the Code of Federal Regulations required. Familiarity with the Foundation for the Accreditation of Cellular Therapy (FACT) Hematopoietic Cellular Therapy or Common standards preferred. AA/EEO Statement: 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. |
