MSAT Process Specialist

US-IL-Libertyville
1 month ago
Job ID
2017-1044
# of Openings
1
Category
Engineering/Validations/BioProcess

Overview

Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases?  AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101.  We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

 

The successful candidate will be an internal consultant to the manufacturing organization and have responsibility for documentation of investigations, deviations,  CAPAs, continuous improvement plans and initiation, investigation and completion of non-conformances aimed at identification of root cause as well as implementation of corrective actions and preventive actions.  The successful candidate will work in a cGMP environment and must have working knowledge of biopharmaceutical manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations and driving to root cause. The Process Investigations and Continuous Improvement Specialist must have the ability to understand and problem solve in an environment that is focused heavily on Chemical and Biological issues. The successful candidate will understand the concepts incorporated in Quality Assurance in a GMP environment.  Skills in statistics are required to effectively analyze trends.

Responsibilities

  • Authoring of notice of events and investigations related to cell culture, purification, formulation, filling, inspection, packaging, facilities and engineering
  • Technical writing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records 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 tool (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
  • Act as liaison with the Technical Quality of Operations Department for the acceptability and timeliness of reports
  • 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
  • Ability to 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 and CAPAs
  • Track, trend and facilitate all manufacturing related Notice of Events, deviations, investigations 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 minimum 5+ years’ relevant experience
  • Manufacturing, specifically upstream and downstream processing in a GMP environment is preferred
  • Prior experience in quality investigations and deviation writing in a manufacturing environment required
  • 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
  • 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
  • Must have strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills

AveXis 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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