This is a unique opportunity to join an early stage Gene/Cell therapy company focused on developing life transforming therapeutics for patients with diseases.
This position is responsible for Quality Control oversight of the products analytical testing including raw materials, in-process, bulk and final product release and stability testing. Accountable for Assuring GMP compliance of analytical and microbiological testing activities at contract testing lab or CMOs through testing documentation review and feedback to the suppliers to meet the regulation requirements and ASC requirements.
The position will report to the Quality Head and may manage others.
- Set up a QC lab and manage internal QC lab as needed to support method qualification, transfer and products testing.
- Develop QC System to compliance regulations and company policies and SOPs.
- Ensure the QC GMP operation by managing the sample life cycle, equipment life cycle and critical reagents life cycle.
- Collaborate with CMC core team or Analytical Development to develop materials and products specifications.
- Author or review and approve the analytical method qualification/validation for use in release testing and stability of materials, drug substances and drug products.
- Manage project associated timelines.
- Review and approval of analytical test data generated by internal and external lab.
- Perform or review the deviation/OOS investigations and CAPA implementation of issues involving testing conducted by external and internal QC.
- Design and implement appropriate corrective actions as needed in a timely manner
- Manage review and approve changes to methods, processes and specifications for all ASC programs.
- Review and approve stability protocol, reports.
- Analyze and trend stability data for management review and prepare reports in support of IND/BLA submissions.
- Assist during inspections/audits (regulatory or internal) and audit observation responses
- The individual will be expected to lead and participate in continuous improvement activities for the quality control operations.
- Other duties as assigned.
QUALIFICATION AND REQUIREMENTS:
- Bachelor’s degree in Chemistry, Biology, or a related field required; graduate degree is highly desirable.
- Minimum of 8 years in a GMP environment (Pharmaceutical industries) is required.
- Extensive experience in protein characterization, analytical method development and validation, such as the methods of Immuno-Assay and potency methods will be considered a plus.
- Experience with technology transfer to third parties is desired.
- Knowledgeable in global regulatory CMC documents and familiar with GMP’s and ICH Guidelines.
- Excellent communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrix environment.
- Proficiency in MS Word and Excel – Proficiency in other statistical analysis software desired
- High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
- Management/communications with Contract Testing Laboratories.