Associate Expert Drug Supply (Car-T Cell Processing Specialist)

1-2 years

Not Disclosed

United States

10 April 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Expert Drug Supply (CAR-T Cell Processing Specialist)

Job ID: REQ-10048005
Date: April 14, 2025
Location: East Hanover, New Jersey, USA
Work Type: Onsite (no remote work option)
Travel Requirements: Minimal as defined by the business

Summary:
The Associate Expert Drug Supply is responsible for the production of patient-derived clinical cellular immunotherapy products, functioning as both operator and verifier. This role also includes the formulation and verification of all media. Due to the critical nature of the starting material (patient cells), a high level of proficiency and process ownership is required.

Key Responsibilities:

Own the processing of assigned clinical batches in the cleanroom environment through cryopreservation.
Ability to gown aseptically and work in cleanroom environments (Grades A-C) for extended periods.
Execute production batch records using both manual and automated equipment with high integrity.
Verify manufacturing processes, including operation of automated cell production equipment and in-process environmental monitoring.
Maintain and prepare equipment/environment for operational readiness.
Proficient usage of production-related IT systems such as SAP, LIMS, and MES.
Document all steps in batch records adhering to cGMP requirements, following ALCOA+ principles.
Independently manage and assist in deviation investigations and regulatory inspections.
Drive and/or support the assessment, implementation, and closure of change requests.
Revise, author, review, and approve production-related documentation as needed.
Actively participate in team meetings, fostering a proactive and curious mindset.

Qualifications:

Bachelor’s degree in a relevant scientific discipline with a minimum of 1 year of experience in a cGMP, academic, or laboratory setting with aseptic or cell culture experience.
In lieu of a degree, minimum of 2 years of experience in a cGMP setting with aseptic or cell culture experience.
Experience in cell therapy manufacturing is preferred.
Ability to adapt and learn new systems and perform manual calculations.
Capability to collaborate effectively across teams and departments.
Strong discipline, self-motivation, and a "Speak Up" mentality.
Ability to maintain composure during high-pressure situations.

Compensation and Benefits:

Expected pay range: $57,800 to $107,300 annually (effective 1/1/25 – 12/31/25).
Final pay determinations based on location, experience, knowledge, skills, and abilities.
Total compensation may include sign-on bonus, restricted stock units, discretionary awards, and a full range of benefits including 401(k) eligibility, vacation, sick leave, and parental leave.
Detailed benefits information available upon offer of employment.
Employment is "at-will"; salary and benefits may be modified based on performance, company needs, or market conditions.

Why Novartis:
At Novartis, we believe breakthrough innovations require a strong, supportive, and collaborative community. Together, we work to transform the lives of patients and families worldwide. Learn more about our people and culture: Novartis People and Culture

Join Our Novartis Network:
Stay connected for future career opportunities: Novartis Talent Network

Benefits and Rewards:
Discover how Novartis supports your growth personally and professionally: Novartis Benefits and Rewards

EEO Statement:
Novartis is an Equal Opportunity Employer. We do not discriminate based on 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:
Novartis is committed to providing reasonable accommodations to individuals with disabilities. For assistance during the application process or to perform the essential functions of a position, please email: us.reasonableaccommodations@novartis.com or call +1 (877) 395-2339. Include the job requisition number in your message.

Division: Development
Business Unit: Innovative Medicines
Company: Novartis Pharmaceuticals Corporation
Functional Area: Technical Operations
Job Type: Full-Time
Employment Type: Regular
Shift Work: No

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Associate Expert Drug Supply (Car-T Cell Processing Specialist)

Job Description

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