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Head of Biologics Development and Technology

LocationNew York, NY 10001 - United States
Work TypeFull time
Positions1 Position
Published At:8 months ago
Job no: 44824
Category: Production/Manufacturing

Job Description

A leading company in the pharmaceutical industry is currently seeking a Head of Biologics Development and Technology to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:

1) Be accountable as a technical subject matter expert for all drug substance process development and manufacturing information supportive of the Biologics Licensing Application

2) Provide input to the selection of drug substance Contract Development and Manufacturing Organizations to the company Executive team

3) Manage and oversee the delivery of process development and characterization activities to ensure a robust, efficient process is developed and approved by US FDA

4) Act as accountable person for all drug substance-related sections of the CMC dossier for IND and BLA filings with health authorities

5) Ensure robustness and quality of drug substance

6) Work with the DP Development Team to ensure drug substance input material meets requirements.

7) Act as an individual contributor working through CDMOs at first but may build/manage a small team of scientists and engineers to enable program delivery

8) Work with CDMO project management and company program management to build tech transfer and startup schedules, and carefully manage schedule adherence

9) Work directly with general management and staff to recommend and implement operational improvements

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the pharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in manufacturing management

If you are qualified and looking to work with a well-established company – one of the top names in the industry – you should not let this opportunity pass by. However, for this Head of Biologics Development and Technology role, you must be someone who is experienced and passionate about manufacturing management

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

  • Published on 19 Nov 2023, 9:50 AM