Senior Specialist, Manufacturing Support

Location
Durham, NC, US
Posted
Jul 09, 2021
Ref
6096
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

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 Senior Specialist, Manufacturing Support, is responsible for the complete ownership of high-impact and high-visibility investigations aimed at identification of root cause, assessing potential impact and implementation of corrective and preventive actions. This role's focus is on the fill finish of drug product and the sterility assurance requirements associated with filling.

Responsibilities
  • Creation and leadership of a contamination control program which includes visual inspection, particulates identification, product and media simulations, and other aspects of the filling operation as well as contamination control as a whole.
  • Authors/owns contamination control program including isolator and autoclave sterilization cycles, operator qualification program for aseptic processing, visual inspection, particulates identification, product and media simulations, and other aspects of the filling operation as well as contamination control from input materials through drug product.
  • Authoring, ownership, and management of Major and Critical deviations; including those impacting multiple sites, or with product quality, data integrity, and regulatory implications.
  • Supports audit and inspections for both internal and agency inspections at the global and site level.
  • Collaborates on responses to any regulatory findings
  • Collaborates with Quality site leadership to strategize Investigational Excellence implementation, execution, and continuous improvement.
  • Conducts personnel interviews; 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.
  • Management of multiple projects and timelines concurrently.
  • Adheres to standard timeline and escalates actions appropriately for resolution in a timely manner.
  • Other relates duties as assigned.

Qualifications
  • B.S. degree in Engineering or relevant life sciences with 10 years of work experience in biopharmaceutical based GMP manufacturing operations or Masters in Engineering or the life sciences with 7 years' experience in biopharmaceutical based GMP manufacturing operations.
  • Strong experience in sterility assurance, investigations, project management, communication and presentation skills.
  • Ability to synthesize detailed information and provide clear communication and messaging across quality, manufacturing and supply chain.
  • Expert knowledge and understanding of cGXPs.
  • 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.
  • Proactive, action oriented, and have the ability to adapt to a change.
  • 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.
  • Strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.


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.

#LI-JB1