Production Support Specialist II, Change Control

Location
Libertyville, IL, US
Posted
Oct 31, 2020
Ref
5636
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 Production Support Specialist II - Change Control is responsible for initiating, owning, driving and managing change controls.

Responsibilities
  • Initiates, owns, drives, and manages complex change controls related to including but not limited to manufacturing (cell culture and purification) operations, formulation, filling, inspection, packaging, facilities and engineering -including multi-site and phased implementations.
  • Effectively communicate, collaborate, and partner with a wide variety of stakeholders; Manufacturing staff, Manufacturing, Science, and Technology (MSAT), engineering disciplines, Quality Assurance, Facilities, Utilities, Maintenance, and Management.
  • Act as an empowered member of the Change Control Review Board (CCRB) both locally as well as at the network level.
  • 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.
  • Maintains a presence on the manufacturing floor for data gathering, observing of processes for insight related to pending changes, investigations, and interviewing employees, as required.
  • Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of critical records.
  • Remain current in regulatory expectations and industry best practices regarding change control and change management, investigations, and CAPAs.
  • Tracks metrics tied to change management and provide updates to management on routine basis.
  • Management of multiple projects, change controls, and timelines concurrently.
  • Performs and conduct risk assessments.
  • Develops and communicate 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.
  • 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 5 years of experience in manufacturing/ production support or 9 years equivalent combination of education and work experience,
  • Prior experience in managing change control records and understanding change management methods and standard practices.
  • Possess highly-developed technical writing skills - and the ability to communicate in a clear and succinct manner.
  • Manufacturing experience, specifically upstream and downstream processing, in a GMP environment is preferred.
  • 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 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.
  • Proven ability to identify and flag risks in a timely manner to keep deliverables on track.
  • Strong communication skills both verbally and written.
  • Proven logic and decision-making abilities, critical thinking skills.
  • Ability to accommodate manufacturing schedule.
  • Strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.
  • Experience in conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of critical records.
  • Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.


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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