Associate Director, Analytical Research and Development
Associate Director, Analytical Research and Development
Experienced
Undisclosed
Full Time
4 Year Degree
Undisclosed
Undisclosed
Undisclosed
QA - Quality Control
Description

Company Summary: Aeglea is a clinical-stage biotechnology company that engineers next-generation human enzymes with enhanced properties and novel activity to provide solutions for diseases with unmet medical need. Aeglea is developing pegzilarginase, its lead product candidate, for the treatment of Arginase 1 Deficiency which has received both Rare Pediatric Disease and Breakthrough Therapy Designation. Aeglea has two programs in IND-enabling studies for Homocystinuria and Cystinuria and an active discovery pipeline.

Position Summary:

The incumbent will act as a CMC analytical chemistry expert resource for the organization. The director will interact with numerous internal and external positions. He or she will be responsible for drug substance characterization activities, method development, improvement, qualification, validation and transfer. In addition, he or she may provide support for GMP analytical testing such as QC release and stability. The director will be responsible for managing such activities through outsourcing.

 

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:

  • Serve as a CMC analytical expert for Aeglea
  • Provide early phase analytical support for Aeglea Research, including but not limited to early phase method development and product characterization.
  • Provide early phase analytical support for CMC Development (including Manufacturing and Quality Control).
  • Provide analytical support for process characterization, comparability studies, and analytical/manufacturing investigations.
  • Assist the department head in the development of strategic plans for CMC method development, qualification, validation, and transfer
  • Troubleshoot method issues and devise plans for method improvements
  • Critically review methods and method related reports
  • Oversee and indirectly manage resources at contract laboratories
  • Participate in the development and justification of specifications for a variety of materials
  • Prepare analytical sections of regulatory submissions
  • Remain current with large molecule analytical chemistry methodologies
  • Remain current with regulatory guidance as it relates to analytical topics
  • Other duties as assigned.
Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education/Experience: The ideal candidate will offer:

  • A combination of education and experience equivalent to: Bachelor's degree (B.S.) and 7-10 years’ experience; Master’s degree (M.S.) and 5-7 years’ experience; Ph.D. and 3-5 years’ experience.  Ph.D. is preferred.
  • Experience must be related to analytical methods for biologics.
  • Experience must include high-level technical troubleshooting of HPLC, CE, gel electrophoresis, and ELISA assays, etc.
  • Experience in a GMP environment is desirable
  • The above experience should indicate progressive levels of responsibility in the areas of product development, product characterization, analytical development, method validation, method troubleshooting, etc.
  • Some experience working in a startup and/or early phase environment would be beneficial.
  • Experience in outsourcing is preferred.
  • Experience with regulatory submission writing is preferred.

Knowledge, Skills and Abilities:

  • Must have a strong analytical aptitude
  • Must understand regulatory requirements related to biologics and analytical chemistry for INDs and BLAs
  • Must be able to manage outsourced resources effectively and efficiently
  • Should understand biomolecule manufacturing processes and analytical requirements to support the same
  • Desirable to have an understanding GMP regulations from a practical standpoint
  • Must be able to write clearly and effectively
  • Must be able to verbally communicate with technical staff in person and remotely

 

 

Work Environment: Aeglea is a high growth, fast paced, start-up organization. The ability to be productive and successful in an intense work environment is critical. Well lit, heated and/or air-conditioned indoor office setting with adequate ventilation.

 

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Light physical activity performing non-strenuous daily activities of an administrative nature. Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time. Manual dexterity sufficient to reach/handle items and work with the fingers. Use of hands to fingers for typing and other computer activity for up to 75% of your time. Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time. Ability to lift, up to 50lbs, less than 25% of the time.

Travel:

Minimal to moderate overnight travel (up to 25%) by land and/or air.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

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