WHAT WE ARE LOOKING FOR:
We are seeking a Quality Control / Attribute Sciences Sr. Manager / Director to support the oncolytic virus program at Sorrento. The selected candidate would be responsible for analytical testing strategies to support process development and cGMP manufacturing activities for oncolytic virus. Responsibilities include overseeing Quality Control functions in support of in-process and release testing for drug substance and drug product.
- BSc in Biochemistry, Chemistry, Cell Biology, Microbiology, or Molecular Biology.
- Preferred qualifications: PhD in Biochemistry, Chemistry, Cell Biology, Microbiology, or Molecular Biology.
- 5+ years of biotechnology / pharmaceutical experience.
- Experience with assay development and / or quality control for viral products / biopharmaceuticals.
- A strong understanding of and the ability to apply quality requirements, regulatory requirements and risk management to viral / biopharmaceutical products
- Qualification and validation of analytical methods experience.
- Strong written and verbal communication skills.
- Demonstrable ability to lead a multi-disciplinary team.
- Demonstrable ability to work independently and in teams.
YOUR DAY-TO-DAY WORK INCLUDES:
- Define clinical product critical quality attributes through risk assessment and define the product quality target product profile for various oncolytic viruses based on HSV1 platform.
- Author drug product specification technical report and certificate on analysis.
- Hands-on development and qualification of analytical methods.
- Author technical protocols, reports and Standard Operating Procedures (SOPs) for analytical methods.
- Serve as analytical subject matter expert to supportinvestigations and studies carried out by other functional areas.
- Oversee the development and characterization of all methods used to test the product.
- Answer analytical and product quality questions from health authorities.
- Responsible for reference standard qualification.
- Define analytical testing strategy with respect to in-house testing vs. the use of contract testing organizations.
- Deliver GMP compliant data and reports to support release of reference standards, raw materials, cell banks, virus banks, starting materials, drug substance and drug product.
- Ensure change control records, quality deviations and out of trend/specification results within the quality control area are appropriately addressed.
- Author or review analytical data for regulatory submissions as required.
- Lead team to perform assays in support of process development and cGMP manufacturing for the oncolytic virus group.
- Support scientists who are on the leading edge of immunotherapies for the treatment of cancer.
- Earn a competitive salary that allows you to focus your attention on your passion.
- A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and three-weeks’ PTO, plus stock options.