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AAIPharma Services is a leading provider of drug development and manufacturing
services to pharmaceutical, biotech and medical device companies around the world.
With over thirty years of drug development expertise, we offer exciting and challenging
career opportunities in a dynamic and growth oriented business.

Headquartered in coastal Wilmington, NC and just minutes from beautiful Wrightsville
Beach, Wilmington is a vibrant city that boasts a variety of cultural resources, a strong
business climate, and a family oriented environment. Wilmington is home to the
University of North Carolina Wilmington, one of the top-ranked southern public
universities. Wilmington has been recognized as one of the The Best Places to Live
(Money Magazine) and ranked #13 as Best Places for Business and Careers (Forbes
Magazine). We are currently seeking highly qualified candidates for the following
leadership position:

                       Sr. Director, Formulations Development

Position Summary:

Reporting to the Executive Vice President, Laboratory Operations, the Sr. Director of
Formulations Development will have overall operational, regulatory, and client-service
responsibility for the Formulations Development Services group. This group is part of
our Product Development Services that provides support through the development and
scale-up of clinical and commercial formulations in a Quality by Design (QbD)
environment. The Formulations team, through the design and execution of experimental
programs to optimize and scale-up clinical formulations, achieves its objective of
supporting the manufacture of clinical trial materials to support first in man through to
pivotal clinical trials.


Key Job Responsibilities:

       Provides leadership in developing the business, fostering scientific excellence and
       positioning the group at the forefront of industry, scientific, regulatory and
       business trends.

       Manages key performance metrics and ensures that deliverables are met or
       expectations are proactively managed towards alternative solutions.
   Oversees the design and executes, analyzes, and presents experiments/results
       toward developing formulations for early phase clinical and future commercial
       products.

      Develops prototype dosage forms and final market images for peptide, protein,
       monoclonal antibody therapeutics.

      Leads internal development of new formulation technologies as required.

      Oversees the scale-up and technology transfer to AAIPharma manufacturing
       centers.

      Maintains a high level of professional expertise and assumes a leadership role in
       client interaction, regulatory and/or client audits.

      Coordinates with other AAIPharma groups including Analytical Development,
       Preformulation, Manufacturing centers, and Quality Assurance to ensure that
       Clinical Trial Materials are delivered in a timely manner.

       Works with business development group and leads client services activities.

       Ensures a safe working environment and compliance with local and national
       safety regulations and ensures adherence to all SOPs and other regulatory
       requirements.

Qualifications:

       Ph.D. in Pharmaceutics or related life science degree with 10+ years of experience
       in the development of biopharmaceutical products as liquid and lyophilized
       products. Candidates with MS, BS and relevant experience are encouraged to
       apply.
       Proven experience managing the scale-up and successful technology transfer
       demonstrated by manufacturing of solid oral dosage forms.
       A history of success managing scientific groups in environments defined by
       innovation and initiative.
       Excellent project management skills, a strategic and results-oriented approach to
       operational excellence, proven ability to develop productive professional
       relationships, sound operational judgment, and a strong customer-focus.
       Excellent leadership, teamwork, organizational skills and a can do attitude.
       Excellent verbal and written communication skills.

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Aai Pharma Sr Director Formulations

  • 1. AAIPharma Services is a leading provider of drug development and manufacturing services to pharmaceutical, biotech and medical device companies around the world. With over thirty years of drug development expertise, we offer exciting and challenging career opportunities in a dynamic and growth oriented business. Headquartered in coastal Wilmington, NC and just minutes from beautiful Wrightsville Beach, Wilmington is a vibrant city that boasts a variety of cultural resources, a strong business climate, and a family oriented environment. Wilmington is home to the University of North Carolina Wilmington, one of the top-ranked southern public universities. Wilmington has been recognized as one of the The Best Places to Live (Money Magazine) and ranked #13 as Best Places for Business and Careers (Forbes Magazine). We are currently seeking highly qualified candidates for the following leadership position: Sr. Director, Formulations Development Position Summary: Reporting to the Executive Vice President, Laboratory Operations, the Sr. Director of Formulations Development will have overall operational, regulatory, and client-service responsibility for the Formulations Development Services group. This group is part of our Product Development Services that provides support through the development and scale-up of clinical and commercial formulations in a Quality by Design (QbD) environment. The Formulations team, through the design and execution of experimental programs to optimize and scale-up clinical formulations, achieves its objective of supporting the manufacture of clinical trial materials to support first in man through to pivotal clinical trials. Key Job Responsibilities: Provides leadership in developing the business, fostering scientific excellence and positioning the group at the forefront of industry, scientific, regulatory and business trends. Manages key performance metrics and ensures that deliverables are met or expectations are proactively managed towards alternative solutions.
  • 2. Oversees the design and executes, analyzes, and presents experiments/results toward developing formulations for early phase clinical and future commercial products. Develops prototype dosage forms and final market images for peptide, protein, monoclonal antibody therapeutics. Leads internal development of new formulation technologies as required. Oversees the scale-up and technology transfer to AAIPharma manufacturing centers. Maintains a high level of professional expertise and assumes a leadership role in client interaction, regulatory and/or client audits. Coordinates with other AAIPharma groups including Analytical Development, Preformulation, Manufacturing centers, and Quality Assurance to ensure that Clinical Trial Materials are delivered in a timely manner. Works with business development group and leads client services activities. Ensures a safe working environment and compliance with local and national safety regulations and ensures adherence to all SOPs and other regulatory requirements. Qualifications: Ph.D. in Pharmaceutics or related life science degree with 10+ years of experience in the development of biopharmaceutical products as liquid and lyophilized products. Candidates with MS, BS and relevant experience are encouraged to apply. Proven experience managing the scale-up and successful technology transfer demonstrated by manufacturing of solid oral dosage forms. A history of success managing scientific groups in environments defined by innovation and initiative. Excellent project management skills, a strategic and results-oriented approach to operational excellence, proven ability to develop productive professional relationships, sound operational judgment, and a strong customer-focus. Excellent leadership, teamwork, organizational skills and a can do attitude. Excellent verbal and written communication skills.