Associate Scientist II: Clinical QC Analytical Development and Clinical QC

New Haven, Connecticut

This job has expired.

This is what you will do:

The Associate Scientist II is responsible for direct support of the shipping/receiving logistics, sample oversight and inventory managment function for GMP release and stability testing activities within Clinical Quality Control for Alexion| AstraZeneca Rare Disease biotherapeutic candidates. Additionally, this position offers a secondary opportunity performing assigned reagent/buffer preparation and experimental tasks in Clinical QC to support development and optimization of manufacturing processes (i.e., performing compendial/analytical/characterization methods for GMP stability and release testing) for Alexion| AstraZeneca Rare Disease biotherapeutic candidates. The Associate Scientist II will work in collaboration with other members of Product Development and Clinical Supply (PDCS) Organization as well as across other functional areas throughout Alexion| AstraZeneca and external vendors.

You will be responsible for:

  • Working in a fast-paced environment where product development supports unmet needs of patients with rare diseases.
  • Responsible for cGxP operations in support of early stage - PIII biologics manufacturing.
  • Perform all job functions in compliance with cGXPs following ALCOA+ principles and maintain accurate and legible laboratory records.
  • Directly support all aspects of GMP shipping and handling responsibilities for incoming shipments, receipt, inventory and sample management to ensure proper chain of custody.
  • Ensure prompt notification to testing laboratory of sample receipt/LIMS login for testing initiation.
  • Assist the compliance team with Laboratory Investigation reports, change controls, deviations, CAPA's as needed.
  • Secondary potential to perform testing for in-process, drug substance and drug product release and stability samples (i.e., Compendial: Appearance, pH, freeze-point/ vapor-pressure Osmolality; Plate-based/binding assays/chromatography, electrophoretic testing as assigned.)
  • Represent Clinical QC on cross departmental project teams and provide technical input as assigned.
  • Write and review relevant procedures/methods, SOPs, qualification and validation protocols and reports, and technical reports as assigned.
  • Recognize aberrant documentation/paperwork discrepancies and report them to the area supervisor / manager.
  • Ensure compliance to legal regulations and company policies
  • Maintain knowledge of current scientific principles and theories.
  • Order, stock, and receive, label, log, and inventory laboratory supplies.
  • Provide laboratory support services, clean/maintain equipment as required.
  • Ensure training is current for all job functions performed. Attend all required company training.
  • May be qualified and assigned to review laboratory data or documentation upon qualification.
  • Global role requiring domestic and international travel (~5-10%)

You will need to have:
  • +2 years of experience working in a relevant cGMP laboratory setting
  • Knowledge of cGMP and ALCOA+ principles and their application in the environment is required.
  • Previous experience with Domestic and International temperature controlled shipping requirements
  • The individual in this position is expected to have an understanding of the Biological Chemistry laboratory environment and be familiar with laboratory equipment / instrumentation, procedures and responsibilities.
  • Understand and follow written procedures when conducting experiments and applying methods
  • Document procedures and data in peer-reviewed laboratory notebooks and/or LIMS
  • 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.
  • The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions, is expected
  • Communicate findings to colleagues within the group through presentations
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:
  • A successful candidate will typically hold a BS degree in Immunology, Biochemistry, Chemistry, Chemical Engineering or related discipline from an accredited university with 2+ years of relevant experience or equivalent combination of education and experience.
  • Previous experience with Laboratory Information Systems (LIMS).
  • Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint.

Date Posted

Closing Date
19-Jun-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

This job has expired.

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