Supervisor, Production Support - Change Control

Location
Libertyville, IL, US
Posted
Oct 03, 2020
Ref
5644
Hotbed
BioMidwest
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 Supervisor, Production Support - Change Control, is part of the manufacturing organization and is responsible for initiating, owning, driving, and managing change controls.

Responsibilities
  • Provides work direction, performance management and professional development to specialists.
  • Manages the assignment of change control records to specialists based on event and resource workload.
  • Manages and tracks the progress and closure of change control records in accordance with established target timelines.
  • May have change control ownership extends to several supporting groups outside of direct manufacturing, and may include tech transfer and new production introduction.
  • Reports out status of the change control records to cross-functional teams, management, review board, and Quality Management Review.
  • Tracks, trends and facilitates manufacturing and/or processing related deviations, investigations, change controls and may be involved with CAPAs.
  • Initiates, owns, drives, and manages change controls related to including but not limited to manufacturing (cell culture and purification) operations, formulation, filling, inspection, packaging, MSAT, Supply Chain, Facilities and Engineering -including multi-site and phased implementations.
  • Leads and/or acts as an empowered member of the Change Control Review Board (CCRB) both locally as well as at the network level.
  • Reviews change control records and provide feedback and direction to specialists.
  • Facilitate and participate in meetings, aligning internal review team and area subject matter experts on a change control path forward.
  • Solves conflict/problem solving in a cross functional setting, and meets timelines for implementation of changes.
  • Remains current in regulatory expectations and industry practices regarding investigations, change controls and CAPAs.
  • Management of multiple projects, change controls, and timelines concurrently.
  • Utilizes appropriate risk management tools for recommendation on disposition of materials and product impact due to changes; May construct, conduct, and participate in risk assessments.
  • Develops and communicates progress updates and presentations to all levels of the site organization.
  • Adheres to standard timeline and escalate actions appropriately for resolution in a timely manner.
  • Supports Manufacturing and Quality to assist in the data collection from manufacturing and preparation of necessary documentation to support Annual Product Reviews.
  • Facilitates and participates in cross-functional and global meetings, aligning internal review team and area subject matter experts on an agreed to change control path forward.
  • May be responsible for technical writing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records, change controls, training documentations, protocols and white papers.
  • Other related duties as assigned.

Qualifications
  • Bachelor's degree (preferred) in a Life Science (or relevant Liberal Arts degree) and 6 years of relevant experience in manufacturing/ production support preferably in biopharmaceutical cGMP manufacturing environment or 10 years equivalent combination of education and work experience,
  • Prior experience in managing change control records and understanding change management methods and standard practices.
  • Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.
  • Must have ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
  • Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting.
  • Must be proactive, action oriented, and have the ability to adapt to a change.
  • Must be able to identify and flag risks in a timely manner to keep deliverables on track.
  • Must have strong communication skills both verbally and written.
  • Must have proven logic and decision-making abilities, critical thinking skills.
  • Possess highly-developed technical writing skills - and the ability to communicate in a clear and succinct manner.
  • Must be able to accommodate manufacturing schedule as required.
  • Must have strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.
  • Preferred - GMP Manufacturing experience, specifically upstream and downstream processing
  • Preferred - Prior supervisory experience.


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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