Senior Manager of GxP Learning and Development

About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

About the role:

Allogene is seeking a Senior Manager of GxP Learning and Development to design, implement and provide oversight of the training program to drive training compliance, align training with regulatory expectations and business goals while also supporting individual’s career growth and opportunities. The Learning and Development Manager will be responsible for the development of technical and business-related training materials and programs. This position will require active engagement with organizations across the company to provide expertise and guidance in training strategies and be responsible for the day-to-day administration of our Learning Management System and associated applications. This position will report to the Head of Quality Systems and require on-site presence at both our South San Francisco and Newark Ca. locations.

Responsibilities include, but are not limited to:

• Support driving the learning and talent development strategy across the organization for new hires, employees, managers to enable their continued growth, development, and engagement
• Apply instructional design theories/principles to analyze and create training materials which may include Instructor Led, On the Job and eLearning training solutions delivered across multiple training platforms.
• Collaborate with functional managers and business owners to determine and develop GxP, compliance and technical training needs, training assignments and curricula. Approve training material content and design.
• Serve as Business Owner and administrator for the Learning Management System (LMS) to ensure system data is accurate and up to date, including, but not limited to running day-to-day operations of the LMS and resolving system related issues.
• Partners with stake holders to conduct qualified train-the-trainer sessions when required, including coaching and mentoring.
• Identify, escalate, and make recommendations to resolve training compliance gaps.
• Generate system reports and metrics for stakeholders on training activities, end-user compliance and internal and external audit inspections.
• Ensure training activities align with the company’s goals, policies and best practices.
• Lead and participate in special projects and assignments as required.

Position Requirements & Experience:

• Bachelor of Science Degree in Biological Sciences, Chemistry, Engineering preferred.
• Minimum of 8 years in Pharma/Biotech industry including 2-3 years working with a Learning Management System (LMS)
• Strong knowledge of GxP, training processes/systems, regulatory requirements for pharmaceutical and biotech commercial manufacturing and supporting activities.
• Excellent interpersonal, communication, presentation skills, and classroom facilitation skills.
• Collaborative style and customer focus.
• Ability to work independently and within a team environment. Excellent time management and planning skills.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $150,000 to $175,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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