Reports To: Vice President, Product Development and Manufacturing
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.
This position is focused on setting up and implementing CMC and related activities for successful and effective submission of a BLA and commercialization of Tocagen’s lead products. This position will work with our existing and new contract manufacturing organizations, and Tocagen’s Process Development Department, to ensure adequate documentation of manufacturing process to support a BLA filing, and assist finalization of commercial product labelling, packaging and distribution channels that meet regulatory requirements for both US and ex-US markets. This position will support systems and processes that ensure peak performance, drug supply forecasting and ensure reliability throughout the supply chain for commercial product supplies. This includes support of risk assessment evaluations, process validations, incorporation of serialization, secondary suppliers and global regulatory filings. This role will liaise with many of the company functional departments such as Process Development, Regulatory, Quality Assurance, Quality Control Testing, Marketing, Clinical Supplies and Clinical Operations. In addition, this position will assist in negotiating clinical and commercial master service agreements, as well as contracts and task orders for Tocagen’s contract manufacturers and supply chain partners to support global market launches. This role will also maintain effective cross-functional, collaborative interactions across Technical, Quality and Regulatory groups to solve problems and write effective INDs/CTAs, license applications, and amendment documents to support regulatory filings for global marketing applications.
Duties and Responsibilities Include But Are Not Limited To:
- Supports program and project management needs of the VP of Product Development and Manufacturing.
- Supports global regulatory filings of Tocagen’s breakthrough therapy and PRIME-designated products by compiling, writing, reviewing, and editing CMC information for US Marketing Applications and European filings.
- Helps formulate, understand, and implement long and short-term goals of the Company and Department.
- Implements effective contract lifecycle management and effective benchmarking methods to manage external contract services.
- Implements and ensures industry and regulatory accepted product development processes within Tocagen’s CMC operations.
- With other subject matter experts, supports selection of methods, techniques and evaluation criteria, to ensure data driven scientific investigations, when needed.
- Meets process validation needs, manages key documents, and produces trending analyses to set data-driven product specifications to support GMP certifications in partnership with contract manufacturers.
- Triage, assess and define global CMC requirements with contractors, consultants and collaborators.
- Actively participates in internal process development activities to learn process and gain expertise in Tocagen’s viral gene therapy and/or small molecule platforms, to be able to support CMC and process commercialization effort.
- Performs other duties as required.
Desired Knowledge and Abilities:
- Strong technical writing and interpersonal skills, with the ability to deal effectively with a variety of business areas including R&D, quality, compliance, technical development, process chemistry, manufacturing, contract negotiations and external partners/collaborators.
- Strong organizational, prioritization, and execution skills
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals and key project milestones.
- Ability to represent the department in project teams.
- Ability to assess and provide strategic guidance and impact organizational effectiveness across functional teams.
Education & Experience:
- Ph.D. or a Masters (or equivalents) in a biological, small molecule pharmaceutical chemistry, analytical or process engineering discipline.
- Minimum 8-10 years industrial CMC experience with previous commercial filing experience preferred.
- Experience and knowledge in the preparation of major CMC global regulatory submissions including INDs/CTAs, license applications, supplements/variations, and amendments.
- Experience with both biologics and small molecule CMC is much preferred, viral vector CMC experience a plus but not required.