Halo Pharmaceuticals

Manager, Analytical Development

US-NJ-Whippany
Type
Regular Full-Time

Overview

Oversee and lead a group of 12-14 scientists in the Analytical Development laboratory

Responsibilities

  • Plans and directs all activities in analytical development laboratory and execute those activities smoothly.
  • Assists the director to track and monitor the department budget (operational expenses, capital expenses and head counts) according to the agreed budget.
  • Ensures Analytical Development department is in compliance with cGLP and cGMP.
  • Leads analytical discussions with clients for all clients' analytical projects.
  • Provides internal and external technical support for methods development, transfer and validation, etc activities.
  • Responsible for scientific proposals, procedures, specifications and reports.
  • Works closely with other functional areas such as Formulation, Project Management, Quality Control, Quality Assurance and Commercial Manufacturing as well as with clients to meet the timelines and requirements.
  • Participates in research and development activities and is accountable for preparation of all technical documents to support our clients' submissions for INDs, NDAs, and ANDAs, etc.
  • Provide technical support for regulatory agencies and clients’ inspections/audits.
  • Analytical Skills and knowledge of scientific protocols and complex scientific principles necessary to provide inputs on complex experiments and research on chemicals and medicines.
  • Author, Review and/ or  Approve the technical documents such as protocols, reports, change controls, calibration records, CAPAs, Manufacturing protocols/ reports etc.
  • Problem Solving - Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions.
  • Ability to design/ conduct and write a systematic, objective, and critical investigation.
  • Advanced computer skills and be able to develop conclusions based on information from multiple sources.
  • Any assigned task by laboratory managements

Qualifications

 

  • Must have experience with FDA, EMA and other regulatory inspections etc.

EDUCATION:     

  • A Bachelors of Science in analytical or pharmaceutical related field.

EXPERIENCE:

  • 7+ years of experience in the area of analytical development, pharmaceutical and contract services laboratory with 3+ years of supervisory role/analytical project management role

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