Supervisor Analytical Services

Lannett Company; Seymour (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Lannett Company in Seymour, IN is seeking a Supervisor to oversee a team of analysts performing raw material, in-process, release and stability testing for pre-commercial drug products, plus method transfers and validations.

The ideal candidate will hold a BS in Chemistry, have at least 5 years of pharmaceutical product analysis in a cGMP environment, and demonstrate leadership, data review, and coordination of projects and regulatory documentation for IND/ANDA/NDA submissions.

Qualifications

• BS Degree in Chemistry or related field.
• Minimum of 5 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment.

Responsibilities

• Develop strategies to delegate responsibilities and organize workflows while monitoring task completion.
• Ensure testing is completed by due dates and communicate delays to internal customers.
• Critically review raw data, chromatography, data sheets/LIMS, and reports for accuracy and completeness.
• Provide technical support for evaluation of development, release, and stability data; review method validation protocols and reports.
• Lead a team of analysts; write performance reviews and support team development.

Skills

Leadership

Project management

Laboratory testing

Education

BS in Chemistry

Tools

LIMS

Job description

Description

Summary

This position is primarily responsible for the supervision of the daily operations of a team of analysts whose activities consist of laboratory testing of raw materials, packaging materials, in-process, release and stability samples for pre-commercial drug products and method transfers/validations, as well as conducting lab investigations.

Scope of Job

Supervisor 3 or more analysts consisting of a Team Leader, Chemists, and Lab Technicians that are responsible for testing of various samples for pre-commercial drug products as well as method transfers/validations. No purchase approval or budget responsibilities.

Requirements

Responsibilities

Project Management

• Develops strategies to ensure effective achievement of objectives by delegating responsibilities and organizing work flows while monitoring and evaluating the completion of tasks and projects

Testing

• Ensure testing is completed on or before assigned due date
• Communicate material issues or testing delays to the appropriate internal customer(s) (i.e. Manager)
• Critically review raw data, chromatography, data sheets/LIMS, and protocols/reports for accuracy and completeness

Technical Review

• Provides technical support for the evaluation of development, release, and stability data
• Review method validation protocols and reports
• Review analytical procedures
• Review and approve all necessary documentations for IND/ANDA/NDA submissions
• Prepare and/or review responses to FDA deficiency letters

Leadership

• Demonstrates ability to lead a team of analysts and several projects independently while having a positive impact on personnel and colleagues
• At all times strive to maintain the self-esteem of individual team members and the professionalism of the group as a whole

Team Development

• Participates in the selection, development/training and evaluation of direct reports by providing ongoing guidance and support, and write performance reviews and/or evaluations

Experience

• BS Degree in Chemistry or related field

Minimum of 5 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment