Critical Reagent Manager

4-5 years

Not Disclosed

Hyderabad India

10 Feb. 10, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Critical Reagent Manager

Location: Hyderabad, India
Job ID: REQ-10037567
Date Posted: Feb 03, 2025
Division: Biomedical Research
Business Unit: Pharma Research
Functional Area: Research & Development
Employment Type: Full-time, Regular

Job Summary:

Novartis Biomedical Research is looking for a Critical Reagent Manager to join the Translational Medicine PK Sciences Regulatory & Registration Readiness group. The position focuses on the production, inventory management, and delivery of critical reagents and biological reference standards used in internal and external bioanalytical laboratories. This role offers an opportunity to impact the development and qualification of assays supporting pharmacokinetic, pharmacodynamic, and immunogenicity studies across all phases of the drug discovery and development pipeline.

Key Responsibilities:

Production & Project Management:
- Lead and coordinate outsourced production of customized critical reagents, including those from Novartis Biologics and in-licensing programs.
- Contribute to production strategy, reviewing production protocols, requesting quotes, interacting with vendors, securing funds, troubleshooting technical issues, and reviewing results.
- Ensure timely communication with stakeholders about production outcomes and timelines.
Collaboration & Process Improvement:
- Work closely with cross-functional teams and external service providers to identify ways to improve processes, focusing on optimizing KPIs, quality, costs, and timelines.
- Actively engage in process improvements, collaborating to optimize workflows and reduce costs without compromising quality.
Documentation & Data Management:
- Maintain a centralized critical reagent database and team SharePoint. Ensure efficient inventory management and seamless integration of new reagents from in-licensing programs.
- Oversee the review of technical documentation, including knowledge transfer and integration logistics for reagents.
- Provide up-to-date documentation, prepare presentations, and technical reports as required.
Training & Team Growth:
- Provide technical training to other scientific staff, contributing to team development and knowledge-sharing.

What You Bring to the Role:

Educational Qualifications:
- MSc, PhD, or Pharm.D. in a relevant scientific field.
Experience:
- 4+ years in the pharmaceutical industry, with experience in drug discovery, development, or a CRO, pharma, or biotech environment.
- Experience in coordinating the outsourced production of reagents, including monoclonal antibodies, recombinant proteins, and Stable Isotope Labelled (SIL) proteins in various hosts (e.g., E. coli, yeast, insect, mammalian cells).
- Experience with bioanalytical assays and knowledge of GLP/GMP requirements and health authority expectations.
- Strong project management, problem-solving, and collaboration skills.
Technical Skills:
- Experience in SharePoint site creation, maintenance, and reagent database management.
- Proficiency with tools like KNIME and Spotfire. Coding skills are a plus.
- Experience with import/export logistics for reagents and managing external vendors.
Leadership & Communication:
- Previous experience leading small teams will be an advantage.
- Strong communication skills (both oral and written) for coordinating with internal teams and external vendors.

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Critical Reagent Manager

Job Description

Job Title: Critical Reagent Manager

Job Summary:

Key Responsibilities:

What You Bring to the Role:

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