Production Support Specialist I

Location
Libertyville, IL, US
Posted
Nov 21, 2020
Ref
5614
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 I, is responsible for the investigation and completion of non-conformances aimed at identification of root cause, assessing potential impact as well as implementation of corrective actions and preventive actions.

Responsibilities
  • Authoring of investigation reports related to cell culture, purification, formulation, filling, inspection, packaging, facilities and engineering.
  • Initiate, own, and drive change controls related to manufacturing operations.
  • Technical writing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOPs), batch records, change controls and white papers.
  • Review of product support documentation (e.g., batch records, process validation, work orders, production of log books).
  • Perform appropriate root-cause analysis for events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams).
  • Assign proper corrective action and preventive action (CAPA) to resolve, and prevent recurrence of events.
  • Utilize appropriate risk management tools for recommendation on disposition of materials.
  • Present completed investigations for final approval.
  • Perform risk assessments.
  • Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
  • Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of exception events.
  • Management of multiple projects and timelines concurrently.
  • Adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
  • Work on the manufacturing floor for data gathering, observing of processes for investigations, and interviewing employees.
  • Conduct personnel interviews and system reviews; act as an unbiased investigator with questions surrounding the specific issue.
  • Remain current in regulatory expectations and industry practices regarding investigations, change controls and CAPA
  • Track, trend and facilitate all manufacturing related deviations, investigations, change controls and CAPAs.
  • Support manufacturing and Quality to assist in the data collection from manufacturing and preparation of necessary documentation to support Annual Product Reviews.
  • Other duties as assigned.

Qualifications
  • Bachelor of Arts/Science or equivalent combination of education and work experience and 3 years of relevant experience.
  • Working knowledge of bio pharmaceutical manufacturing processes.
  • Ability to manage multiple ongoing projects concurrently.
  • Strong meeting facilitation and conflict resolution skills, a strong technical writing capability.
  • Action oriented and compliant minded while performing investigations.
  • Ability to understand and problem solve in an environment that is focused heavily on Chemical and Biological issues.
  • Understanding of the concepts incorporated in Quality Assurance in a GMP environment.
  • Skills in statistics are preferred to effectively analyze trends.
  • Experience in quality investigations and deviation writing in a manufacturing environment preferred.
  • Manufacturing experience, specifically upstream and downstream processing, in a GMP environment is preferred.
  • Ability to work in a fast paced, high workload environment and 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 adaptable to 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 the manufacturing schedule as required.
  • Strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.


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.