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Inhalation Senior Scientist

5+ years
$85,000 - $130,000
10 Feb. 7, 2025
Job Description
Job Type: Full Time Education: PhD/M.Sc./M.Pharm 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

Inhalation Senior Scientist

Posting Date: February 3, 2025
Req ID: 84805
Country: United States
State: New York
Location: Central Islip
Employment Type: Permanent


Job Description

The Inhalation Senior Scientist is an individual contributor role within the R&D Inhalation team at InvaGen/Cipla New York. Reporting to an R&D Manager, this role involves hands-on work in analytical method development for inhalation products like metered dose inhalers (MDI) and dry powder inhalers (DPI).

The selected candidate will act as a subject matter expert (SME) for analytical methods related to inhalation products, supporting product development, site transfers, and commercialized products.


Key Responsibilities

1. Analytical Method Development & Compliance

  • Develop, assess, verify, and validate analytical test methods for APIs, excipients, packaging components, devices, and drug products.
  • Ensure compliance with QbD principles, US FDA & EU regulations, USP, and ICH guidelines.
  • Conduct preformulation studies following regulatory guidelines and best practices.
  • Perform analytical techniques including:
    • Cascade Impactor (ACI/NGI), DUSA, Spray Pattern, Plume Geometry
    • HPLC, UPLC, UV, GC, LC-MS, XRPD, DVS, Particle Size Analysis
    • Viscometer, Karl-Fisher, IR, Dynamic Vapor Sorption (DVS)

2. Product & Material Evaluation

  • Assess new vendor materials for suitability based on physicochemical properties.
  • Perform characterization studies for inhalation drug products.
  • Draft product specifications and analytical procedures.

3. Regulatory & Documentation Support

  • Draft and review high-quality technical documents (protocols, reports, memos).
  • Lead responses to US FDA deficiency letters & information requests.
  • Prepare Quality Overall Summary (QOS) for US FDA submissions.
  • Support 505(b)(1), 505(b)(2), and 505(j) submissions.

4. Quality Investigations & Process Optimization

  • Lead investigations for quality deviations and implement corrective actions (CAPA).
  • Implement new analytical techniques to enhance capabilities.
  • Conduct trend analysis, kinetic modeling, and statistical assessments.

5. Cross-functional Collaboration

  • Act as technical liaison for CROs & CDMOs, ensuring successful project execution.
  • Work closely with regulatory, quality, and development teams to meet project timelines.
  • Provide training and mentorship to junior scientists.

Education & Experience

Qualifications:

  • Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry, or Medicinal Chemistry
  • Master’s Degree in the same fields with 5+ years of industry experience in inhalation product development

Required Skills & Expertise:

Deep understanding of inhalation analytical methods & regulatory guidelines
Strong expertise in UV-Vis, HPLC, UPLC, GC, LC-MS, and spectroscopy techniques
Proficiency in statistical analysis and process analytical technologies (PAT)
Excellent documentation & technical writing skills
Ability to lead investigations & troubleshoot analytical issues


Additional Information

💰 Salary Range: $85,000 – $130,000
📍 Relocation Support: Negotiable
🌍 Employment Sponsorship: Negotiable
🚫 Remote Work: Not available
📆 Weekend Work: May be required based on business needs