Associate Expert Science & Technology, Stability & Microbiology

Novartis • East Hanover, NJ

1d • $55,000 - $102,200 • Onsite

About The Position

At Novartis, we are on a transformative journey in cell and gene therapy, pushing the boundaries of medical innovation. As an Associate Expert Science & Technology, under general direction, this person will perform stability and EM testing and other activities in functions supporting the Quality Control department. This position will be located at the East Hanover site and will not have the ability to be located remotely. Please note that this role would not provide relocation and only local candidates will be considered. #LI-onsite

Requirements

• A minimum of a BA/BS degree in microbiology, biology, biochemistry, or other related science.
• A minimum of 1 year of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, medical device industry or related field
• Knowledge of cGMP and an understanding of the concepts of GDP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.).
• Knowledge of stability program and sample management.
• Environmental Monitoring knowledge to facilitate investigations.
• Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Strong interpersonal skills which include a professional demeanor when interacting with Novartis personnel.
• Strong written and verbal communication skills are essential.

Nice To Haves

• A Master’s degree in microbiology, biology, biochemistry, or other related science is preferred.
• Knowledge of LIMS systems

Responsibilities

• Support stability program for Cell and gene therapy including protocol, report authoring and stability sample management and testing.
• Perform EM testing in support of clinical release strategies, perform all testing and activities compliantly following appropriate SOPs and procedures.
• Support raw material inspection and sample management, executes and follows SOPs, WPs, and quality policies.
• Peer review and archive analytical data in lab documentation systems and support monthly/quarterly laboratory cleaning.
• Appropriate use of laboratory logbooks, ensures cleanliness of laboratory working areas, monthly laboratory cleaning.
• Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibilities, support and author OOS/OOE/OOT and deviation investigations.
• Participate in CAPA implementation in a timely manner, follows GxP quality policies and procedures, support 5S and Lean projects.
• Identify process improvements and interface with regulatory agencies during audits as required.
• Knowledge of LabWare, LIMS and/or other QC data systems, knowledge of appropriate GMP/GLP quality systems (e.g., ESOPs, Trackwise, 1QEM, BMRAM, etc.).
• Collects and generates data for stability trend reporting.
• Contributes to the gowning qualification program by taking samples and analyzes and generates data.
• In addition to these primary duties, provide coverage for all appropriate areas.
• Contributes to assigned projects by following predefined tasks and executing as instructed.
• Perform other job duties as assigned.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level