Senior Manager, Process Science - Operations

Location
San Diego, CA, US
Posted
Nov 03, 2020
Ref
5767
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

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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