Associate Scientist, Raw Materials

Novartis Group Companies; Morris Plains (NJ); On-site; USD 63,000 - 119,000; Full time

Job summary

Join a leading company in gene and cell therapy as an Associate Scientist, Raw Material. You will engage in critical QC testing, ensure compliance with industry regulations, and collaborate across teams. Ideal candidates hold a degree in a related science and have relevant experience, contributing to life-saving therapies.

Benefits

Full range of medical and financial benefits

401(k) eligibility

Paid time off benefits

Potential for sign-on bonus

Qualifications

• Minimum 1 year relevant experience in pharmaceuticals or biologics.
• Thorough knowledge of raw material test methods.
• Fluent in English.

Responsibilities

• Perform raw material testing per USP, EP and in-house methods.
• Review QC documents for accuracy and completeness.
• Assist with investigations to understand root causes.

Skills

Quality Control (Qc) Testing

Decision Making Skills

Technological Expertise

Laboratory Equipment

Education

Bachelor's degree in Biology, Chemistry, Biochemistry or related science

MS or advanced degree preferred

Tools

LabWare LIMS

Job description

Job Description Summary

365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
Under general direction; the Associate Scientist, Raw Material will direct and assist in functions supporting QC raw materials.

Job Description

Your responsibilities include, but are not limited to:
* Perform raw material testing following United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and in-house methods
* Perform testing on raw materials per using pH, Osmometer, Flow Cytometry, qPCR, UV, FTIR, NIR, wet chemistry and other techniques.

* Perform visual inspection of raw materials, consumables and packing materials using AQL/specification requirements.
* Perform all testing and activities compliantly following appropriate SOPs and procedures.

* Review data generated by other team members.
* Review QC documents to ensure completeness, accuracy, consistency and clarity.
* Perform quality impacting assessments and make decisions.
* Participate special projects and facilitate any issues that arise.
* Assist with initiating change controls.
* Assist with authoring validation documentation.
* Assists with investigations of complexity
* Assist with investigations to understand root cause.
* Participate in OOS/OOE investigation
* Participate in deviation investigation/CAPA implementation in a timely manner
* Evaluate compendial updates against internal methods
* Serve as Quality Control representative on cross-functional teams.
* Knowledge of LabWare LIMS and/or other QC data systems.
* Knowledge of appropriate GMP/GLP quality systems (eSOPs, TEDI, etc.).
* Assist with planning and scheduling activities.
* In addition to these primary duties, provide coverage for all appropriate areas.

* Perform other job duties as assigned.
* Ability to lift 35 pounds

Role Requirements:

* Bachelor's degree in Biology, Chemistry, Biochemistry, Microbiology or other related science. MS or advanced degree in preferred
* Fluent in English
* A minimum of 1 year of relevant experience in the pharmaceutical, biologics, or medical device industry
* Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and ICH guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e. ANSI, ISO, etc.)
* Thorough knowledge of raw material test methods
Desirables:
* Analytical chemistry knowledge to facilitate investigation is desired
* Knowledge of LIMS systems is desired
* Change controls or CAPA experience is desired
* 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

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $63,600 and $118,200 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

You'll Receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$63,600.00 - $118,200.00

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management