South San Francisco, California
Please note: This role may be filled at the TDL or Sr. TDL level. The position description is written at the Sr. TDL level.
The Technical Development Leader / Senior Technical Development Leader (TDL) leads Technical Development Team(s) in developing and implementing Chemistry, Manufacturing and Control (CMC) strategies and activities associated with clinical drug candidates, from pre-entry into humans through product launch. He/she is accountable for design and execution of CMC development strategies that include cell culture, purification, formulation, drug product configuration, process engineering, quality controls, and regulatory submissions. The TDL is accountable for ensuring that Technical Development Teams are successful in achieving their goals and executes effective risk mitigation strategies. The incumbent represents the TDT and CMC functions on Project Teams, with stakeholders across company and when interacting with external business partners. The TDL also ensures excellent information flow between team members, to functional management, and to governance committees to ensure transparency, informed decision making, and optimal alignment of all technical deliverables with the Project Team strategy and Clinical Development plan. The TDL is also accountable for all project planning, scheduling, resourcing and reporting for the team. This position requires excellent communication, collaboration, strategic thinking, decision making skills, negotiating skills, influencing skills, ability to solve complex problems, and manage complex projects.
MAJOR DUTIES AND RESPONSIBILITIES
Develop and execute multifaceted technology strategies that are essential for product success
Leads cross-functional Technical Development Teams including 10-12 core team members and ~40 extended team members
Lead scientific and technical teams in the development and implementation of manufacturing processes, formulations, drug product configurations, supply chains, control strategies/systems and regulatory submissions for new molecular entities throughout the development and product lifecycle, which includes preclinical development, human clinical studies, product licensure (BLA submission) and launch, product versions and line extensions. Encourages minimum viable product development strategies, as appropriate.
Provide enterprise-wide perspective strategic insights and context to project teams and assure customer focus of project deliverables.
Ensures the scientific integrity of the technical development process, CMC strategy, and team deliverables (manufacturing processes, control systems, drug product formulations & configurations, risk management plans, and regulatory submissions)
Design and execute novel technical development strategies that enable successful licensure of new/novel modalities (e.g., gene and cell therapies, novel/advanced drug delivery systems), more rapid and efficient development for standard therapeutics, and that build new capabilities for the company (e.g,. establishment of new technologies, process development and/or manufacturing facilities)
Represents all Pharma Technical functions on the Product Development Teams (i.e., Core and Lifecycle Teams)
Partners with Project/Lifecycle Team Leaders and associated team members to develop and deliver the overall product development strategy
Ensure alignment of CMC strategy with clinical, toxicology, pharmacology, regulatory, marketing/commercial strategies, timelines and corporate goals.
Serves as the primary point of contact for project related business for Pharma Technical Development with other company divisions, e.g., g/pRED, Pharma Development, Pharma Technical Regulatory/Quality/Galenical/Manufacturing/Supply Chain.
Represents projects to Senior Management (e.g., division heads, Sr. VPs) and company-wide governance committees and contributes to key business justifications requiring corporate approvals
Plans and drives manufacturing and delivery of clinical and primary product launch supplies is responsible for managing CMC development costs
Provides regular updates to the Project Team, senior management and the relevant governance committees; communicates the CMC strategy and activities to external partners as needed.
Ensures the TDT is successful in making achieving goals and adheres to timelines, milestones, and resource forecasts as previously defined in Technical Development Agreements and in agreement with license partners.
Leads TDT meetings and manages the team: supervises technical development team members in a matrix environment and facilitates the removal of barriers for TDT members.
Primary decision-maker regarding CMC development, investments and risk management for molecules in development
Establishes and employs effective decision-making processes, enabling decision-making at the lowest appropriate level on the team.
Anticipates and identifies issues, develops effective contingency and risk mitigation plans, and communicates the potential impact to the relevant governance committees.
Partners with functional area management and seeks input from functional area forums and committees to ensure that technical expertise is provided as necessary.
Contributes to the development of department business initiatives and facilitates their implementation.
Recognizes individual/team accomplishments and provides performance feedback for CMC team members.
Identifies and leads continuous improvement activities, including implementation of new technologies into CMC projects.
Coaches and mentors future Technical Development Leaders.
Provides conflict management and durable resolution for the CMC team
B.S./M.S/Ph.D. degree in chemistry, pharmaceutics, chemical engineering or related field
10+ years experience in the pharmaceutical industry with prior experience as a CMC team leader, combined with a strong technical knowledge of small and/or large molecule process development and an advanced knowledge of the drug development process.
Proven track record of successful innovation and recognition as a thought leader in CMC and/or product development.
Proven track record of managing complex, cross-functional programs and for creating new ideas and innovative approaches.
Proven track record of effective collaboration with team members and senior management in PTD
Excellent verbal and written communication skills with success in influencing others in cross-functional areas
Proven ability to work proactively and think strategically
Proven track record of successfully working with third parties
Strong negotiation skills
Strong decision-making skills
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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