Brammer Bio is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
The primary responsibility is to support the technology transfer teams for the late stage, PPQ and commercial manufacturing of viral vectors. This position requires close interaction with the MS&T colleagues, Manufacturing, Process Development, and other departments. This role will focus on aspects of ensuring a robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.
MST Associate will work closely with the MST teams to support client projects and with Brammer’s Florida site, PD, Quality, EHS, and Manufacturing to ensure compliance and technology transfer. Additionally, based on project assignment the role executes process characterization projects for Brammer Bio.
- Supports cross functional technology transfer teams for cGMP DS manufacturing of viral vectors. Collaborate with another site or clients to ensure success of scale up/ process transfer. Includes authoring of upstream or downstream plan documentation and associated detail process descriptions (DPDs).
- Partner with Brammer’s Alachua/Cambridge Process Development as well as Cambridge Manufacturing and Quality organizations in tech transfer activities to facilitate project success.
- Identify, own and resolve technical process issues arising from deviations, investigations and client programs in a timely manner
- Generate documents (technical memos and reports, protocols, etc.,) related to tech transfer of new processes. Accurately forecast and drive schedule/project plan of assigned MST deliverables.
- Support the MST PPQ programs to operate efficiently. This may include data management from executed runs, operational support for engineering and GMP runs, and standardization of programs to limit bespoke elements
- Assist investigation root causes of deviations for cGMP manufacturing, and implement CAPA
- Identifying opportunities to improve systems and practices, and drive harmonization across manufacturing platforms
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.