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Reports To: Associate Director, Quality Control
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.
The Quality Control (QC) Stability Manager coordinates and schedules resources required to support GMP product stability testing for both Tocagen’s Toca 511 viral vector investigational product, as well as its Toca FC solid dosage form. The QC Stability Manager has had previous Quality Control product stability management experience relating to investigational or commercial products in a GMP setting, and has a sound scientific understanding of stability-indicating assays pertinent to each of the two Tocagen product types. The QC Stability Manager is responsible for implementing and maintaining stability studies to support commercial launch of Tocagen’s Toca 511/Toca FC cancer immunotherapeutic. The QC Stability Manager has demonstrated previous expertise in designing stability studies that are in compliance with FDA, ICH, and WHO expectations for formal product stability, and has demonstrated a level of organization sufficient to coordinate both internal and external resources as required to execute stability studies in support of commercial product launch. This position works with the QC department head, Quality Assurance, Process Development, Manufacturing, Regulatory Affairs, as well as external laboratory and project management staff to achieve agreed-upon timeline projections and goals. The QC Stability Manager is responsible for performing independently at reasonably high scientific level and can confidently lead lab investigations or assay optimization studies under a QC or development setting. Communicates scientific concepts, approaches and final results to others inside and outside the organization; can provide strategic scientific and operational advice to senior organization executives and aids the department head in establishing group goal objectives and budgets.
Duties and Responsibilities Include But Are Not Limited To:
- Performs a critical assessment of existing stability programs; assesses gaps and works to continuously improve and harmonize systems across Toca FC and Toca 511 products
- Works with QC management, Quality Assurance, Manufacturing, and Regulatory Affairs to generate new SOPs and policy documents as required to effectively administer stability programs
- Designs and implements new product stability studies to support shelf life, temperature excursions, in-use characteristics, BLA filing, and marketed product
- Ensures that stability studies performed are in compliance with relevant existing and emerging US and foreign regulatory requirements
- Works closely with contract testing laboratories to draft and approve required testing protocols, maintain appropriate storage conditions, and review and approve completed testing Certificates of Analysis and reports
- Tracks and trends stability data in real-time to alert management to potential stability concerns
- Works effectively with external stability and statistical consultants as needed to leverage industry trends and analyze data
- Prepares final stability reports for individual studies
- Contributes to CMC sections of Annual Reports and other regulatory documents; assists Regulatory Affairs in preparing stability data for foreign filings
- May assist with other QC and Quality Systems responsibilities as needed based on additional areas of expertise, such as raw materials, and assay development, qualification, and validation
- May supervise supporting staff
- Performs other duties as required.
Desired Knowledge and Abilities:
- Intact active scientific curiosity and excellent expertise in area of responsibility
- Prefer experience working with both ambient storage oral solid dosage forms and ultra-cold storage viral vectors
- Understanding of QC lab operations and familiarity with industry standards and GMP requirements
- Excellent organizational, interpersonal and managerial skills.
- Well-developed scientific writing and communication skills.
Education & Experience:
- BS plus 4 years or MS degree plus 2 years of relevant QC industry experience with formal training in virology, immunology, cell biology and/or biochemistry or related scientific discipline.
- Excellent understanding of requirements for pharmaceutical and biopharmaceutical stability studies required to support clinical trials, product launch, and marketed product as demonstrated by successful prior performance managing stability studies