What are the responsibilities and job description for the Senior Manager/Manager, Cell Culture Process Development position at Viridian Therapeutics, Inc?
At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.
The ideal candidate will be innovative and highly motivated with a strong background in program management and drug development with recent product launch experience. The candidate has a proven ability to manage a cross-functional launch and program team, driving results, to ensure launch priorities are set and milestones are achieved. The candidate will be a team player with well-developed skills for gaining the cooperation of others and ensuring effective communication among team members.
Reporting to the Director, Process Development, the Manager/Sr Manager of Cell Culture Process Development is responsible for leading a molecule for cell culture and cell line process development to advance drug substance from development to commercialization. The incumbent will work in a hybrid model and collaboratively with internal stakeholders and be responsible for the process development, tech transfer, and oversight of engineering/clinical batches at contract manufacturing sites.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
- Lead cell culture and cell line process development for an antibody or fusion protein process
- Manage and support cell culture and cell line process development activities at CDMOs i.e. design and review studies and technical reports
- Focus on speed to clinic, technology transfer and scale up
- Based on an outsourced model, oversight of non-GMP and GMP upstream drug substance manufacture at CMOs, from phase I to PPQ/PV
- Author and review internal and external documentation, technical memos and manufacturing investigations (change controls, deviations, CAPA, etc.)
- Review and approve batch master batch records, bills of materials, executed batch records, etc.
- Manage, evaluate, and maintain critical data and records of all process development / MS&T operations in support of regulatory requirements for multiple projects
- Partner with Quality, to support cGMP manufacturing using Quality Systems tools
- Work collaboratively with SMEs in CMC such as formulation, analytical, and device and team members
- Data mine and support preparation of IND/IMPD
- Act as an SME on behalf of process development for internal team meetings, updating dashboards and presenting to the group where appropriate
