Sr. Director, Project Management/Product Development

South San Francisco, CA

 

Trucode Gene Repair Inc. is a stealth-mode therapeutics development company pioneering a novel synthetic gene editing technology to treat and cure patients with devastating rare diseases. We seek a highly skilled, motivated and creative Project Manager with a background in CMC/Product Development, ready to function in a fast-paced and collaborative environment. Candidates should have industry experience with Project Management and CMC/Product Development in preclinical therapeutics development through IND. Reports to the CEO. The successful candidate will be part of a dynamic and rewarding work environment where the abilities to effectively communicate and function in a team environment will be essential for success.​

Responsibilities:

  • Primary responsibility is to manage, maintain and communicate Corporate and R&D Gantt chart timelines, ensuring critical path items are identified and contingencies and risk mitigation strategies are considered

  • Collaborate with the Finance Team to manage and revise Gantt-aligned budgets

  • Draft target product profiles, program objectives and go/no go criteria, and development plans, tracking planned and actual project timelines to proactively identify potential issues and manage resolution, and draft agendas and minutes for cross-functional project teams

  • Selection and management of vendors

  • CMC project management, including defining requirements for manufacture and testing of novel gene therapies consistent with program development needs and regulatory expectations and ensure these needs are met, such as:

    • Selection and management of Contract Development Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of development programs

    • Stage-appropriate process development, scaleup, and analytical methods are developed

    • Project API and DP needs for preclinical and clinical programs and ensure sufficient material is manufactured on-time to supply these activities

    • With team, draft project documentation such as Critical Quality Attributes and phase-appropriate specifications

    • Establish a distribution chain for clinical trial materials

Essential Qualifications:

  • Thorough knowledge of cGMP, GLP, FDA and international regulatory requirements, particularly those related to CMC.  Prior hands-on experience in drafting regulatory submissions.

  • Excellent interpersonal, communication, and leadership skills with the ability to maintain positive relationships with management, peers, subordinates, and external contract organizations

  • Strong analytical and problem-solving skills with a proactive approach to identifying and mitigating roadblocks

  • Team player, clear communicator, ability to adapt to change

Trucode is proud to be an equal opportunity employer. We do not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.

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