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 be responsible for all activities for the validation department, including the scheduling and execution of qualifications and validations of manufacturing facilities, utilities, equipment, and processes and overseeing the site Master Validation Plan. 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
- Oversees the site Master Validation Plan, using input from internal and external resources for continuous improvement. Creates, coordinates and enforces Neurogene’s Validation systems, policies and procedures.
- Manages validation department personnel; Hires, trains, coaches and develops staff within the Validation team. Maintain adequate staffing levels for the department and workload. Monitors the performance of the validation department by tracking appropriate metrics and reporting the results to management.
- Responsible for the day-to-day activities conducted by the Validation Department. Establishes priorities to ensure that deadlines are met and budgets are not exceeded.
- Liaise with outside vendors as a representative of validation and supervises the activities of external validation contractors.
- Oversees development and approval of Validation SOPs and validation-specific documents.
- Supports commissioning activities, projects and validation functions by performing, preparing and reviewing/approving validation protocols and other documentation. Generates validation final reports as needed.
- Acts as Validation SME for manufacturing operations. Assess change controls with an accurate understanding of the bigger picture implications of changes.
- Communicates validation activities and schedules to other departments as required.
- Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner.
- Performs other duties as required.
- Work Schedule – Full-time; days. The role will mostly involve standard working hours, but flexibility is required per production schedule or to attend meetings/calls
- Travel – The role may include travel to meet vendors and/or attend conferences and meetings
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations
- Ensure that all team members comply with safety rules and regulations
- Quality Responsibility
- Development and maintenance of quality systems and GxP compliance for the business by ensuring that all validation 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 preclinical development. The role will involve working closely with the Executive Director of Preclinical Development as well as operational teams across the company.
- Leadership Responsibility
- The role is to provide support in development and maintenance of validation system, policies and procedures. The role will involve working closely with the Head of Quality Assurance as well as operational teams across the company.
- Education – BS/MS degree or equivalent in technical area
- 8+ years of relevant experience in validation in the biotech/pharmaceutical industry with management experience
- Licenses or Certifications
- Not applicable
- Working knowledge of validation and GxP requirements for biologics manufacturing. Working knowledge of requirements for aseptic manufacturing.
- Ability to operate Kaye (or other) validation equipment and interpret resulting data and discussing validation policies and philosophies during audits/inspections by internal and external entities.
- Ability to effectively develop and lead teams and work collaboratively in matrix organizations.
- Ability to interpret cGMP requirements.
- Ability to forecast and manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
- Must have strong organizational skills and excellent communication (verbal and written) skills.
- Problem-solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required.
- Working Conditions
- Fifty percent of the work is done in an office environment. The other fifty percent of the work is performed on the shop floor (i.e. protocol execution, etc.). Some of this work requires entry into a laboratory setting, cleanroom or utility space. While working in these areas, a lab coat or clean room attire is required along with appropriate safety equipment as denoted for the designated area (i.e., safety shoes, hair cover, gloves, shoe covers, safety glasses).