At Neurogene, we are working to provide medicines to improve the lives of neurologically impaired children and their families. We envision a world in which all families have access to genetic medicines, even if the disorder is exceedingly rare. For children, our goal is to enable them to have a healthier future. For families, we want to make their lives better by easing the challenges of caring for someone with a devastating neurological disorder. As an employee of Neurogene, you will be part of a culture helping to make this dream a reality, collaborating with people in a start-up environment, whose mission is to improve the lives of the patients we serve and make the world a better place.
The applicant will be a team player in a small company environment in this highly cross-functional role. Reporting to the Head of Quality Assurance, this person will assist in ensuring GxP compliance and quality oversight for Neurogene’s manufacturing operations. This role will collaborate across the company and support the filing of multiple investigational new drug applications and be part of the transformative shift the company is making as we move from the pre-clinical stage to IND enabling studies and to accelerating clinical development.
Accountabilities and Responsibilities
- Manages the Quality Assurance team and related GMP quality systems; Hires, trains, coaches and develops staff within the QA team.
- Oversees development and approval of the Quality System and cGMP documents including, but not limited to, SOPs, Batch records, protocols and specifications.
- Acts as Quality and Compliance SME for manufacturing operations and may be asked to support other functional areas of the company as well. Participates or ensure QA participation in project teams, as required.
- Ensures internal audits are conducted of manufacturing operations on a timely basis; ensures follow-up of audit CAPAs
- Ensures a risk-based supplier quality program is in place and maintained, appropriate for stage of clinical development
- Ensures all non-conformances, OOS, deviations, complaints and related items are thoroughly investigated and resolved
- Ensures QA review of all manufacturing and QC related records, resolution of all related issues and QA disposition of product batches
- Ensures QA review and disposition of raw materials, buffers and other components
- Ensures GMP training program is in place for all staff engaged in cGMP activities at the manufacturing site
- Ensures all initial qualifications, validations and re-validations are in place for facilities, equipment and processes related to manufacturing. Ensures facilities are suitable for products manufactured.
- Manages Quality Council, monitoring of Quality Systems, including tracking of KPIs, and Quality Risk Management program. Ensures escalation of quality issues to Head of Quality Assurance and Executive Team, as appropriate.
- Manage relationships and provide oversight of GMP activities conducted by third parties
- Ensure quality and rigor across nonclinical development programs both internally and at third parties
- Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner
- Work Schedule – Full-time; days. The role will mostly involve standard working hours, but flexibility is required to attend meetings and calls.
- Travel – The role may include travel to meet vendors and attend conferences and meetings
- Quality Responsibility
- Development and maintenance of quality systems and GxP compliance for the business by ensuring that all QA team members comply with processes, procedures and instructions for all activities in which the team participates.
- Works on complex problems where analysis of multiple factors and consideration of data must be interpreted for decisions to be made. Must be able to utilize past experience and established industry practices to temper decisions under consideration. Exercises judgment within a broad spectrum of situations which affect product, policy and procedures. This is a supportive role within the company and will provide responsibility for Quality Assurance. The role will involve working closely with the Head of Quality Assurance as well as operational teams across the company.
- Leadership Responsibility
- The role is to provide support in development and maintenance of quality systems and GxP compliance. The role will involve working closely with the Head of Quality Assurance as well as operational teams across the company.
- Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field
- 8+ years of relevant experience in the biotech/pharmaceutical industry with proven management experience.
- Working knowledge of cGMP requirements for biologics manufacturing.
- Working knowledge of requirements for aseptic manufacturing.
- Basic knowledge of cell biology, cell culture.
- Ability to effectively develop and lead teams and work collaboratively in matrix organizations and team.
- Ability to interpret cGMP requirements.
- Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
- Excellent communication (verbal and written) skills required.
- Problem solving skill and ability to make quality decisions based on technical facts and sound risk assessments is required.