Supervisor, Quality Control (Microbiology-Night Shift)

Location
Libertyville, IL, US
Posted
Jun 10, 2021
Ref
5959
Hotbed
BioMidwest
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 Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

We are seeking a highly motivated individual to join us as a Supervisor, QC Microbiology in our gene therapy production center located in Libertyville, IL. You will work with the Quality Control team in supporting our efforts in the area of gene therapy. In this role you will be responsible for the day to day oversight of the QC Microbiology team. You will also be responsible for the environmental and utilities monitoring, raw material testing, and final product testing.

Responsibilities
  • Supervision of all QC Micro laboratory testing.
  • Sustain environmental monitoring program for GTx.
  • Management and optimization of the Aseptic gowning training and qualification program.
  • Management of QC Microbiology training program.
  • Work with QC raw materials team to establish specifications and testing process of raw materials.
  • SME on investigations of sterility failures and environmental excursions.
  • Monitor and trend data.
  • Assemble reports on findings from environmental monitoring of GTx's cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary.
  • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
  • Develop, revise and review SOPs, qualification/validation protocols and reports.
  • Conduct investigations regarding out of specifications (OOS) results and address and manage non-conformances related to micro procedures.
  • Provide updates at daily and weekly meetings.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Other duties as assigned.
  • NOTE: Shift may include weekends and second shift hours.

Qualifications
  • Bachelor's degree or advanced degree in Microbiology or related discipline.
  • Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
  • A minimum of 5 years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required. A minimum of 1 year experience supervising/managing/leading microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry.
  • The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell/gene therapy product.
  • Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes.
  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift up to 25 lbs.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, cGMPs, microbiological method development and validation.
  • Strong data integrity knowledge and practices.
  • Identifying, writing, evaluating and closing OOS investigations.
  • Strong knowledge of aseptic manufacturing and EM processes.
  • Equipment and utility IQ/OQ/PQ/PV.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

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.

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