Senior or Principal Scientific Manager (Product Quality and Occupational Toxicology)

Research Biology             ·            South San Francisco, California, United States of America          ·         Full time

Senior Or Principal Scientific Manager (Product Quality And Occupational Toxicology)

• Location South San Francisco, California, United States of America 
• Full time

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The Position

Senior or Principal Scientific Manager (Product Quality and Occupational Toxicology)

Job Description:

Genentech’s Product Quality and Occupational Toxicology (PQOT) group is responsible for providing robust, scientifically-sound hazard and risk assessments to support product quality activities, primarily associated with manufacturing, and health and safety of the workplace for employees handling proprietary and non-proprietary chemicals used in the production of Genentech products.   Execution against these responsibilities requires solid scientific practices to support business-sensible solutions for which the position provides tactical and strategic leadership and management in compliance with corporate policies and standards and global regulatory requirements.  

This is a highly interactive position within a cross-functional, matrixed environment.  This position requires a solid track record of experience and strong leadership in strategic planning and execution in the areas of hazard/risk assessment, hazard communication, toxicology testing, and regulatory compliance.  The team member is expected to manage independently and demonstrate appropriate decision-making capabilities that take into account the cross functional aspects of the role and to understand the consequences of such decisions. The ability to socialize complex science-based messages and processes at all levels of the internal and organizations is critical to success.  An eye toward benchmarking, continuous improvement, inter- and intra-departmental teamwork and collaboration, and high-energy, positive attitude will facilitate success.  Coaching and development of internal staff or peers, as appropriate, is expected.  Excellent verbal and written communication skills are essential.  

Responsibilities:

• Development, documentation, implementation, and oversight/management of business processes and strategies for PQOT deliverables including, but not limited to, tracking and managing requests, delivery of high quality documented hazard assessments and risk assessments, hazard communication to support regulatory compliance, occupational toxicology testing; budget management/oversight of assigned projects/programs
• Preparation of health-based assessments and criteria documents such as Acceptable Daily Exposures (ADEs) to support product quality activities (e.g. cleaning validation) and worker health and safety (e.g. health hazard categorization, occupational exposure limits, etc.), impurity assessments (e.g. genotoxic and non-genotoxic) 
• Assessment of product quality excursions encountered in large- and small-molecule pharmaceutical manufacturing and performing risk assessments associated with those excursions
• Performance of toxicology-based assessments for non-proprietary chemicals (e.g. materials of construction, extractables and leachables) 
• Preparation and communication of expert guidance and provision of operational assistance for product quality and occupational health/safety issues in compliance with multiple, global jurisdictional requirements to internal and external stakeholders at all levels in the organization such as project teams, senior management, operational staff, and health authorities 
• Execution of job responsibilities within agreed upon timelines and proactive communication with internal stakeholders. 
• Execution of above responsibilities through informed interpretation and compliance with evolving global and Company regulations and guidances, including outreach, education and alignment of practices with internal stakeholders.
• Oversight of staff/contractors and support of other group deliverables, including budget activities, may be required

Qualifications & Experience: 

The job title is commensurate with the level of education, years of experience, and demonstration of the job responsibilities.  The ideal candidate will satisfy many of the following requirements: 

• A PhD in toxicology or an equivalent field.
• A minimum of 5 years of experience in the field of occupational toxicology and product quality in the biotech or pharmaceutical industry. 
• Demonstrated strong technical writing and presentation development / delivery skills. 
• The ability to lead as well as work with others in a positive, proactive, and constructive manner.
• Knowledge of best practices in the field of occupational toxicology and product quality in the pharmaceutical industry.
• Demonstrated public speaking skills, outgoing efforts to advance company priorities, and a drive to enable and support innovative practices and policies.
• Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders; ability to work effectively on multiple projects simultaneously.
• Demonstrated active and engaged collaborator and contributor on project teams and/or committees (whether internal or external).
• A high degree of flexibility, adapting to the organization’s priorities in a fast-paced environment, and in understanding and complying with company practices.
• Well organized and efficient; results and detail-oriented; self-motivated and self-driven
• Demonstrated people and project management skills
• Board certification in Toxicology a plus

The expected salary range for this position based on the primary location of California is $117,600- $218,400.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Job Facts

• Job Sub Category: Research Biology

• Schedule: Full time

• Job Type: Regular

• Posted Date: Dec 11th 2023
• Job ID: 202312-127638

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