Senior Manager, Process Science - Operations

Location
San Diego, CA, US
Posted
Jul 01, 2021
Ref
6157
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Senior Manager, Process Science - Operations, manages business critical projects across the Process Science Department. The primary responsibility of this role is to support the Process Science groups in planning, implementation, communication and execution of pipeline and process development projects.

Responsibilities
  • Communicates with internal and external project team members and stakeholders as needed to identify and drive the completion of all project tasks and work streams.
  • Maintains the Master Project Plan, pre-clinical manufacturing schedule, and manage project documentation according to the Product Development Process (PDP); driving closure/completion of action items and deliverables through follow up with stakeholders and contributors.
  • Manages projects to desired timeline; anticipating project risks and actively drive towards resolution
  • Definition of project scope and goals.
  • Presents project status to management and stakeholders, and maintain visibility into milestones and deliverables.
  • Generates monthly updates including tracking relevant metrics for PS department.
  • Acts as liaison with internal groups (Research, Analytical Development, Finance, Tech Ops, QC/QA...etc) and external groups (partner, collaboration efforts) for planning, securing resources and execution; tracking budget data to ensure accurate forecasting; and managing the project SharePoint sites.
  • Manages pre-clinical manufacturing and early process development schedules, and coordinate activities between sub teams and stakeholders.
  • Motivates people involved in the project to complete tasks on time
  • Identifies and reports on lessons learned after the project close-out.
  • Drive operational excellence and continuous improvement.
  • Other related job duties as assigned.

Qualifications
  • B.S. degree in biochemistry, molecular biology, chemical engineering, bioengineering, or related technical field with 10 years relevant experience; Master's degree or PhD preferred with 8 years relevant experience.
  • 8 years of Project Management experience in biologics or gene therapy industry experience in technical development.
  • PMP® certification is preferred.
  • Technical understanding of biological systems including Process Development, Manufacturing, and Analytical testing.
  • Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
  • Previous experience with viral vector manufacturing is a plus.
  • Adept at both navigating the complexities of a large organization and within a start-up environment.
  • Effective communication across multi-disciplinary groups.
  • Demonstrated leadership skills and experience.
  • Proven understanding of project management software and platforms and willingness to expand knowledge in this area.
  • Experience with a stage gate process.
  • Demonstrated ability to manage stakeholders and influence contributors across a variety of levels.
  • Agility, flexibility, adaptability due to shifting landscape of priorities.
  • Excellent verbal and written communication skills with a high level of attention to detail.
  • Excellent interpersonal skills with a demonstrated ability to perform in a virtual environment and to interact effectively with staff at all levels of the organization in face-to-face and remote settings.
  • Demonstrated decision-making skills as well as strong business acumen.
  • Attention to detail and accuracy with respect to internal and external reporting.


The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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