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Novartis Gene Therapies Associate Director, Technical Research & Development - Labs in Longmont, Colorado

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 Associate Director, Tech R&D Labs, is responsible to ensure the execution and management of time-sensitive analytical studies at Novartis Gene Therapies and external partners while capturing related data and knowledge, to advance the development of Novartis Gene Therapies products and processes from Research to Development, and on to GMP manufacturing.

Responsibilities

  • Partners with Regulatory to support submissions and approval of product applications.

  • Manages team that provides process development analytical testing to ensure that process parameters and quality attributes appropriately reflect process performance, product comparability and product stability.

  • Identifies and implements potential analytical improvements in conjunction with process development and process characterization laboratories. Participating in start-up efforts of new equipment, software or processes in the process development laboratories.

  • Assisting in documenting changes/updates to manufacturing processes and working with MSAT to implement those changes.

  • Reviews/provides feedback and technical/scientific support on project deliverables, (e.g. remediation initiatives, plan reports).

  • Build and maintain a high performing staff of analytical and process scientists to support rapid and robust process and platform development in addition to supporting process tech transfers between development sites.

  • Provides assistance in manufacturing by conducting Investigations to determine root cause for variation, implement solutions, and ensure corrections are effective.

  • Completes requisite training on all applicable policies and procedures related to the job function.

  • Establishes operational objectives and work plans and delegates assignments to subordinates. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect.

  • Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.

  • Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.

  • Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.

  • Manages activities of the Tech R&D Laboratories Analytical Sciences department. Exercises supervision in terms of costs, methods, and staffing. In some instances this manager may have subordinate supervisors.

  • Other related duties as assigned.

Qualifications

  • Bachelors' degree in biochemistry, chemical engineering, bioengineering, or related technical field with 11 years’ experience in biopharmaceutical development; Master’s degree with 9 years or PhD with 7 years.

  • Excellent oral and written communication skills; attention to detail.

  • 11 years direct experience in cell culture, recovery, purification, analytics, and/or aseptic fill/finish processes, process development, and tech transfer.

  • Familiar with global regulations, regulatory filings, and validation/qualification requirements.

  • Strong organizational skills and ability to multitask across projects and activities.

  • Proven ability to effectively lead and participate on teams.

  • 7 years leadership experience.

  • 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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Job Locations US-CO-Longmont

Posted Date 6 days ago (9/16/2020 7:21 PM)

Job ID 2020-5577

# of Openings 1

Category Engineering/Validations/BioProcess

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