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Associate Scientist (Stability Associate II)

New Haven, CT 06501

Posted: 04/03/2024 Employment Type: Contract Industry: Scientific Job Number: 11657 Pay Rate: $25.00 - $30.00 Remote Friendly:

Job Description

Our client is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders.


Summary:
  • The Stability Associate II is responsible for performing assigned tasks to support stability activities for the Company's clinical phase Biological candidates. 
  • The Stability Associate II will work in collaboration with members of Analytical Sciences (AS), Biological Drug Substance Development (BDSD), Injectable Drug Product Development (IDPD), Device Development (DD), Quality Assurance (QA), and other members of Product Development and Clinical Supply (PDCS) as well as external vendors as required.

Responsibilites:
  • Responsible for all aspects of on-site stability sample storage and sample management.
  • Conduct Stability sample pulls at scheduled timepoints according to approved stability study plans.
  • Deliver stability samples to labs and perform aliquots as needed, following Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs).
  • Point-of-contact between on-site testing labs and stability group.
  • Author stability Protocols, Reports, SOPs and Quality documents as required.
  • Work with internal stakeholders to provide testing requirements and obtain completed analytical test results.
  • Track stability results generated internally and at external CMOs/ CLOs.
  • Document stability results with a strong attention to detail; able to recognize trends outside of expected results and communicate to management as required.
  • Perform data entry/verification as required.
  • Perform all job functions in compliance with cGMPs and maintain accurate and legible records.
  • Ensure training is current for all job functions performed. Attend all required Company training.

Job Requirements


What you need:
  • Bachelor’s degree with previous experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience).
  • Knowledge of GxPs and their application in the pharmaceutical environment is required.
  • Ability to interact with cross-functional teams while representing the stability group.
  • Able to navigate external vendor sites and portals for data extraction and review, as needed.
  • Able to communicate findings effectively to colleagues within and outside of the group through presentations.
  • Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint.
  • Strong working knowledge of governing documents/regulations for pharmaceutical stability preferred.
  • Knowledge of Lean Six Sigma preferred.
  • Previous technical writing experience preferred.
  • Previous experience with SAS JMP or other statistical software preferred.
  • Previous experience with Laboratory Information Systems (LIMS) preferred.
  • Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.
  • The ability to communicate verbally and in a written format is required.
  • Able to understand and follow written procedures.

Meet Your Recruiter

Melissa Politron
Recruiter

As a Compass Recruiter, Melissa "Mel" is excited about rediscovering her passion in helping candidates find opportunities that will excel their professional lives and improve their personal lives. She brings a deeply-rooted excitement to the team by understanding the people she works with and finding ways she can support them. Mel's connections with others inspires her to make a difference in the overall well being of her colleagues, candidates and clients alike. 

Outside of Compass, Mel enjoys cooking, dancing and being a mom to her three wonderful boys. She has an obsession with home organization and thoroughly enjoys solving other families' organizational needs. Mel is also very passionate about One Heart Source, a humanitarian organization that combats conditions such as poverty, diseases and illiteracy through education. She participated as a summer volunteer teacher in Tanzania and credits the organization for shaping her into the person she is today. 

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