The Sr. Group Leader will be responsible for leading and developing a cross functional team of up to 8 direct reports. The role directs the design, development and implementation of primary drug containers and new device delivery technologies to support project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech.
The position has leadership responsibility in assessment, selection and implementation of new combination product configurations and provides guidance and input to support engineering and scientific activities within Genentech’s device development programs, including interaction with cross-functional senior stakeholders. The role will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, develop innovative and implementable solutions to complex process design problems, takes initiative to expand on assignments and pursue new ideas, and focuses on the continuous improvement of our work in her/his team. The incumbent will work independently and will provide guidance, coaching and training to direct reports and manage work activities of staff members. The work is reviewed with a focus on long-term perspectives, as the candidate exercises considerable latitude in determining objectives and approaches to assignments.
The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:
Manage and administer all aspects of personnel performance and staff development for the group.
Select, hire, and train staff on company and department policies, systems, and processes.
Coach and develop staff by providing an environment that encourages ongoing personal and professional development.
Manage and ensure the setting of goals for the team and the staff, and provide regularly scheduled feedback throughout the year, including workload prioritization and balancing.
Component selection, assessment of container-device compatibility and container-drug compatibility, development of testing methods to assess container and deliver system quality and functionality for existing and new technologies.
Regularly interface with staff and leaders in Contract Manufacturing, Project Core Teams, Development, Early and Late Stage Pharmaceutical Development, Quality and Regulatory Affairs.
Regularly interact with external development partners and component suppliers.
Drive problem solving using state of the art tools such as DMAIC, DFFS, DOE, Modelization, Monte Carlo Simulation and Probabilistic Design.
Quality Systems Compliance:
Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
Use (and create and implement, if necessary) local Device Development procedures and templates ensuring alignment with current versions of PQS documents and best practices.
Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
Ensure compliance of training to PQS and job-related requirements.
Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
Participate in hazards analyses and design assessments and reviews.
Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
The right candidate will possess the following skills and experience:
BS, MS, PhD or advanced degree in Engineering. Preference for Mechanical Engineering or the equivalent.
At least 12 years of experience in the industry and/or academia (including advanced studies) post bachelor’s degree.
Direct supervisory experience with the demonstrated ability to build and lead strong technical teams and develop technical staff.
Experience in DOE, problem solving and modelling using physical rules.
Expertise in 6-sigma as a green or black belt and excellent understanding of statistics.
Expertise in development of elector-mechanical medical devices is preferred.
Working knowledge of manufacturing, quality control, preclinical and clinical development and regulatory issues pertaining to combination products is preferred.
Extensive application of relevant modeling, design controls and/or statistical analysis. For example:
Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis, Probabilistic Design.
Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
Six Sigma (Green/Black Belt): DMAIC and DFSS
Proven track record of working effectively in a matrix organization with cross-functional teams (e.g., device development, regulatory, clinical, quality, and program management) and experience working in a highly collaborative environment.
Excellent communication skills.
Experience working with external partners is highly desirable.
Highly organized and detail oriented.
Excellent leadership skills.
Who We Are
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.
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