Specialist I, Production Support - Investigator

Durham, NC, US
Jun 10, 2021
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Specialist I, Production Support - Investigator, 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.

  • Authoring of minor and major investigation reports related to cell culture, purification, formulation, filling, inspection, packaging, facilities and engineering.
  • Works on the manufacturing floor for data gathering, observing of processes for investigations, and interviewing employees.
  • Conducts personnel interviews and system reviews; act as an unbiased investigator with questions surrounding the specific issue.
  • Performs appropriate root-cause analysis for events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams).
  • Assigns and implements proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.
  • Facilitates and participates 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.
  • Remains current in regulatory expectations and industry practices regarding investigations, change controls and CAPAs.
  • Management of multiple projects and timelines concurrently.
  • Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
  • Utilize appropriate risk management tools for recommendation on disposition of materials.
  • 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.
  • Review of product support documentation (e.g., batch records, process validation, work orders, production of log books).
  • Other related duties as assigned.

  • Bachelor of Arts/Science or equivalent combination of education and work experience and 2 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.
  • 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.
  • Preferred: Experience in quality investigations and deviation writing in a manufacturing environment
  • Preferred - GMP Manufacturing experience, specifically upstream and downstream processing.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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.