Associate Scientist, QCA - PM Shift

Location: This position is on-site in Morris Plains, NJ

#LI-Onsite

PM Shift: 12-hour 4/3 shift (alternates every other week) Please only apply if you are able to work these exact hours.

• Week 1: Wednesday–Saturday, 3:30 PM–3:30 AM
• Week 2: Thursday–Saturday, 3:30 PM–3:30 AM

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Major Accountabilities:

• Perform Bio-Analytical testing such as qPCR, Flow Cytometry, ELISA, cell count, cell viability, sterility testing, endotoxin, and mycoplasma.
• Maintain controls and reference standards to support testing.
• Follows quality policies.
• Plan and schedule assigned activities.
• Review/approve data generated by other team members.
• Perform method qualification/optimization of methods as per appropriate protocols.
• Contribute to OOS/OOE investigations and deviation investigations.
• Support 5S and Lean projects.
• Identify potential improvements in project work.
• Interface with regulatory agencies during audits.
• Contribute to assigned projects.
• Knowledge of LabWare LIMS and/or other QC data systems. Maintain GMP/GLP quality systems.
• In addition to these primary duties, provide coverage for all appropriate areas and testing.
• Performs other job duties as assigned.

Key Performance Indicators:

• ·Deliver quality products and services on time to all customers, internal and external.

Ideal Background:

Education: BA or MS in chemistry, biochemistry, microbiology or other related science.

Languages: Fluent in English.

Experience:

• 0 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
• Knowledge of cGMP and an understanding of the concepts of GLP, 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 bioassay test methods, as appropriate.
• Knowledge of LIMS systems.
• 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.
• Sound, practical and appropriate regulations with regards to Novartis § Strong written and verbal communication skills are essential.

Internal orientation:

• Thorough understanding of cGMP requirements
• Good communication and organizational skills
• Ensure customer satisfaction and react to customer requests
• Is seen as a competent team player

Others:

• Strong ability to work independently, compliantly and results driven
• Strong analysis and decision-making skills surrounding documentation
• Attention to detail
• Able to proof work and identify non-standard format or wording, and errors within documents

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $66,780 and $124,020/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.