Director, Technical Development

Location
Longmont, CO, US
Posted
Nov 19, 2020
Ref
5801
Required Education
Doctorate/PHD/MD
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 Director, Technical Development, is responsible to ensure the execution and management of time-sensitive, studies, and validation at Novartis Gene Therapies and external partners while capturing related data and knowledge, to advance the development of products and processes from Research to Development, and on to GMP manufacturing.

Responsibilities

 

  • Defines and direct the activity of staff, as well as internal and external organizations, to plan, execute, and document experiments, studies, and manufacturing that qualify key equipment, raw materials, and processes for clinical and commercial production.
  • Provide ownership and management for process, analytical, and characterization knowledge related to the production of gene therapy products, and the raw materials need to make them.
  • Builds and maintains a high performing staff of engineers and scientist to support ongoing process and pipeline development, production as well as process transfers into the site.
  • Serves as a key scientific and technical representative for process at internal sites, as well as with external partners.
  • Partners with Manufacturing Science and Technology to meet the production schedule, ensure commercial supply and uphold quality standards.
  • Partners with Regulatory to support submissions and approval of product applications.
  • Manages team that evaluates and monitors relevant process parameters and quality attributes through process lifecycle to ensure appropriate process development and assure comparability.
  • Identifies, recommends and implements potential process improvements in conjunction with MSAT.
  • Participates in start-up efforts of new equipment, software or processes in manufacturing.
  • Assists in documenting changes/updates to manufacturing processes and working with MSAT to implement those changes.
  • Reviews and provides feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
  • Provides assistance in manufacturing investigations to determine root cause for variation, implement solutions, and ensure corrections are effective.
  • Owns the process, planning to avoid delays, and leading the activity to deliver a robust and effective product and manufacturing process.
  • Participates with other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures operations effective achievement of objectives.
  • Ensures budgets and schedules meet corporate requirements.
  • May have overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods.
  • Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
  • Other related job duties as assigned.


Qualifications

 

 

  • Bachelors' degree in biochemistry, chemical engineering, bioengineering, or related technical field with 12 years' experience in biopharmaceutical development including direct experience in cell culture, recovery, purification, analytics, and/or aseptic fill/finish preferred processes, process development, and tech transfer or Master's degree with 10 years of relevant experience or PhD with 8 years relevant experience.
  • 11 years leadership experience.
  • Excellent oral and written communication skills; attention to detail.
  • Familiar with global regulations, regulatory filings, and on devices, drugs, validation/qualification requirements.
  • Excellent communication skills and attention to details.
  • Strong organizational skills and ability to multitask across projects and activities.
  • Proven ability to effectively lead and participate on teams.
  • Ability to works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
  • Up to 20% travel.

 


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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