Biopharmaceutical Manufacturing Director

4 days ago


San Diego, California, United States Mapp Biopharmaceutical Full time

Overview

Mapp Biopharmaceutical, Inc. is a leading biopharmaceutical company focused on developing life-saving monoclonal antibody treatment options for various neglected and tropical infectious diseases.

The company's Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) are responsible for executing high-quality research and development activities to achieve a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities.

Salary and Benefits

The anticipated pay scale for this position is $130,000 to $250,000 per year, plus applicable bonuses.

Eligible employees and their families receive medical, dental, and vision insurance benefits, basic life insurance, short and long-term disability, and a 401K plan with Company contributions.

Full-time employees enjoy 7 days of sick time, 14 paid holidays, and accrue 18 days of vacation throughout the calendar year.

Job Description

This exciting opportunity is for a Director, Drug Product Manufacturing SME who will lead the planning, design, and execution of large molecule Drug Product manufacturing for all stages of development, including validation strategies and qualifying manufacturing unit operations at site(s).

The successful candidate will serve as a key process owner in leading CDMOs on manufacturing process improvements and providing technical leadership through all aspects of DP development, characterization, manufacturing, and release.

Required Skills and Qualifications

  • PhD or equivalent with 10+ years of experience in biologics process development, process scale-up, technology transfer, process validation, cGMP manufacturing support, and regulatory submissions for protein therapeutics/monoclonal antibodies.
  • Possesses a deep understanding of biologics DP production, liquid fill and lyophilization development, process characterization, and regulatory submission support.
  • Demonstrated hands-on experience with DP manufacturing/large molecule parenteral activities.
  • Experience in a management-level leadership role, regulatory (FDA etc.) experience, and ability to work cross-functionally to achieve objectives.
  • Excellent collaboration skills and ability to work with internal and external partners, vendors, and stakeholders.

Other Requirements

This position requires willingness to travel domestically up to 4-6 times per year.

Please submit your application through the Mapp Biopharmaceutical, Inc. Job Openings website page.



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