Under the supervision of the Head of Development, the Director Quality Control supports the success of our AAV and LVV gene therapy programs by actively managing and coordinating with key internal and external stakeholders. The ideal candidate for this position will have at least 4 years’ experience working with Quality Control in support of viral vector gene therapy development programs, preferably in the biotechnology industry. Initially, this role is to ensure that CMOs are aligned with Rocket and regulatory GMP compliance expectations: this role will oversee on-going quality control testing programs and processes in support of GMP manufacturing for Rocket.
- Responsible for release of raw materials, drug substance and drug product lots including approval of completed manufacturing batch records/QC data, review of related nonconformance’s and ensuring adequate investigation activities are performed and appropriate actions are identified.
- Liaison with Rocket contracted laboratories and manufacturing facilities regarding GMP QC material testing. Assures that all contractor QC data/reports are properly documented in cGMP compliant manner.
- Establish SOPs, Investigations, Deviations and CAPA implementation for GMP facilities, method transfer of laboratory procedures, method design and method validations.
- Partner and align the with Process Development, Preclinical, Technology Development, Regulatory, Quality Assurance, and Program Management to implement development strategies and drive organizational success.
- Collaborate with regulatory to support the review and approval of controlled documents as required, including methods, SOPs, protocols, reports, document changes, etc.
- Ensure QC decisions align with Quality System, GMP and regulatory requirements
- Build, train, mentor, and manage a QC group
- Support GXP functions as required.
- Extensive experience in the biotechnology or biopharma manufacturing industry with prior experience in QC focused on gene therapy
- Experience in retrovirology, vector design/production (lentiviral and AAV), cell line production, designing analyzing research data, writing SOPs, and validation protocols
- Working knowledge of US and EU CGMPs
- Experience managing CMO/CRO relationships and projects
- Thrive in a fast‐paced environment combining strategic and tactical capabilities
- Excellent written and verbal communication skills, analytic and problem-solving
- BA/BS/University degree in Life/Health Sciences required; advanced degree preferred.
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs.
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to email@example.com