Senior Technical Development Leader

Employer
Genentech
Location
94080, South San Francisco
Salary
Compensation commensurate with experience
Posted
Dec 19, 2018
Closes
Jan 18, 2019
Field of specialization
Pharmaceutical
Job Type
Full time

Join a Team that Lives to Improve Lives

People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen. 

The following opportunity exists in our South San Francisco, CA headquarters:

[SENIOR TECHNICAL DEVELOPMENT LEADER]

 

Description

The Technical Development Leader (TDL) leads technical development team(s) in developing and implementing CMC strategies and activities associated with large or small molecule clinical candidates, from pre-entry into humans until launch.  He/she is the primary advocate for development programs on CMC strategies, activities and issues and is accountable for ensuring that Technical Development Teams are successful in achieving their goals.  He/she represents CMC functions with stakeholders, on Project Teams and when interacting with external partners.  The TDL also ensures adequate 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.  He/she is also accountable for all project planning, scheduling, resourcing and reporting for the team.


Major Responsibilities

  • Leads technical development teams in developing and implementing CMC strategies and activities associated with large and small molecule programs from pre-EIH, during preparation of major regulatory filings and approval in major countries.
  • Represents the technical development functions on the Project Team; collaborates closely with other Project Team members to define and deliver the project strategy, objectives and plans; ensures that the TDT strategy is aligned with the Project Team objectives and corporate goals.
  • Interacts closely with the small or large molecule technical functions and key stakeholders within the Research, Development and Technical Operations organizations globally.
  • Provides regular updates to the Project Team and the relevant governance committees; communicates the CMC strategy and activities to external partners as needed.
  • Ensures the scientific integrity of the technical development process, CMC strategy, and TDT deliverables
  • Ensures the TDT is successful in making progress toward its goals and adheres to timelines, milestones, and resource forecasts as previously defined in Technical Development Agreements and in agreement with license partners (if any).
  • Supervises technical development team members in a matrix environment.
  • Establishes effective decision-making and risk management processes.
  • Monitors, tracks and reports progress against team goals and approved plans.
  • Leads TDT meetings and manages the team
  • Anticipates and identifies issues, develops 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.


Who You Are

  • B.S./M.S/Ph.D. degree in chemistry, pharmaceutics, chemical engineering or related field
  • 12 or more 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 a sound knowledge of the drug development process.
  • Proven track record of technical accomplishments.
  • Demonstrated ability to build and lead cross-functional teams
  • Excellent verbal and written communication skills with success in influencing others in cross-functional areas
  • Proven ability to work with cross-functional teams and senior management
  • Strong collaborative and relationship-building skills
  • Proven ability to work proactively and think strategically
  • Experience working with third parties
  • Strong decision-making skills and strategic thinking ability


A Job with Benefits Beyond the Benefits

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.

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