Senior Expert - Good Manufacturing Practices

4+ years

$118,000–$177,600 Annually

Remote, USA

10 Dec. 5, 2024

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

Here’s a concise and organized summary of the job description:

Analytical Operations Specialist – Gene Therapy (GMP)

Location: East Hanover, New Jersey, USA

About Novartis:
Join a passionate community striving for breakthroughs in healthcare. Novartis combines innovative science and collaboration to improve lives and advance quality care.

Role Overview:
The Analytical Operations Specialist supports GMP activities to enable gene therapy delivery, including analytical testing, method development, and process monitoring. This role emphasizes teamwork, innovation, and continuous improvement, with a focus on serving patients and advancing gene therapy development.

Key Responsibilities:

Shift Schedule: Flexible shift work (4 days/week, 10 hours/day).
Technical Expertise: Acts as SME for GMP assays such as AUC, cell-based potency, ELISA, PCR, flow cytometry, next-generation sequencing, and separations-based assays.
Lab Operations:
- Routine sample testing (in-process, release, and stability) under GMP or non-GMP modes.
- Participation in method qualification, validation, transfer, and improvement.
- Lab equipment procurement, maintenance, and system management.
Documentation:
- Drafts/revises SOPs, validation/transfer protocols, and technical reports.
- Reviews and trends test results.
Problem Solving: Leads investigations of deviations and implements corrective/preventative actions.
Innovation: Introduces technologies to enhance GMP operations’ efficiency and compliance.
Collaboration: Represents GMP in cross-functional teams (e.g., Quality Assurance, Analytical Development).
Compliance: Ensures adherence to GMP/GLP regulations, FDA/EMEA requirements, and Novartis guidelines.

Essential Requirements:

Education: Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Immunology, or a related field.
Experience:
- 4+ years in GMP laboratory operations, with expertise in assays such as AUC, ELISA, PCR, and flow cytometry.
- Proficient in GMP testing, problem-solving, and managing lab investigations.
Skills: Strong collaboration, technical adaptability, and effective communication in fast-paced environments.

Compensation and Benefits:

Salary Range: $118,000–$177,600/year (subject to market and performance factors).
Total Compensation Package: Includes potential sign-on bonuses, stock units, medical benefits, 401(k), and paid time off.
Growth Opportunities: Comprehensive training and retraining programs to support professional development.

Why Novartis:

Novartis believes in creating a brighter future through collaboration and passion for innovation. Be part of a diverse, inclusive workplace that values individuality and fosters bold innovation.

Diversity & Inclusion Commitment:

Novartis is an Equal Opportunity Employer, dedicated to fostering an inclusive environment that reflects the world around us.

Accessibility & Accommodations:

Novartis provides reasonable accommodations for individuals with disabilities. For assistance, contact us.reasonableaccommodations@novartis.com or call +1(877)395-2339.

Division: Development
Business Unit: Innovative Medicines
Functional Area: Quality
Job Type: Full-Time, Regular

For more information about Novartis benefits and opportunities, visit:

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