Associate Expert Science & Technology, Stability & Microbiology

Key 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.

Essential Requirements:

• A minimum of a BA/BS degree in microbiology, biology, biochemistry, or other related science. A Master’s degree in microbiology, biology, biochemistry, or other related science is preferred.

• 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.

Desirable Requirements:

• Knowledge of LIMS systems

The salary for this position is expected to range between $55,000 and $102,200 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

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.

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