Senior Analyst, Quality Control (Microbiology-Day Shift)

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 Senior Analyst, Quality Control Microbiology performs Environmental Monitoring and Microbiological testing in support of manufacturing at the Novartis Gene Therapies GMP Manufacturing facility. The Senior Analyst, Quality Control Microbiology responsibilities include, but are not limited to, routine product and raw material testing, environmental monitoring of the manufacturing cleanrooms and processes, participate in method and instrument qualifications, and support investigative testing. A potential candidate will possess working knowledge of QC Microbiological/Cell Culture/Environmental Monitoring testing techniques. The Senior Analyst, Quality Control Microbiology should be able to work effectively within the group, within Quality, and cross functionally.

Responsibilities

• Perform environmental and utilities monitoring in clean rooms.
• Perform bioburden, endotoxin and cell culture assays.
• Perform data entry.
• Assist in drafting and revising SOPs and reports.
• Trend EM data and publish quarterly and annual trend reports.
• Assist with investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Establish and maintain library of environmental isolates.
• Assist in assay troubleshooting, qualification and validation.
• Manage the use and maintenance of scientific equipment and instrumentation and computer systems.
• Perform other duties as assigned.

Qualifications

• Minimum B.A. or B.S. Microbiology or in scientific related field.
• Minimum of 2 years in a GMP Quality Control Microbiology/ Environmental Monitoring laboratories, preferably in a biologics aseptic processing facility.
• Working knowledge of Environmental Monitoring and Microbiological Assays (e.g. Bioburden, Endotoxin, Gram Stain, and Sterility).
• Good understanding and demonstration of aseptic techniques.
• Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP, JP).
• Proficient in MS Word, Excel, Power Point and other applications.
• Ability to communicate and work in a team environment.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Ability to think critically and demonstrate troubleshooting, and problem-solving skills
• Excellent interpersonal, verbal, and written communication skills.

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

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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