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Associate Principal Scientist, ADCs - Analytical
4314 AstraZeneca Pharmaceuticals LP Company Gaithersburg, MD

Associate Principal Scientist, ADCs - Analytical

4314 AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
Expired: April 11, 2024 Applications are no longer accepted.
  • Full-Time

As the Associate Principal Scientist of Antibody Drug Conjugate (ADC) Analytical, you will be responsible for developing, characterizing and validating ADC analytical methods within our biologics Global Technical Operations (GTO). You will work closely with BioPharmaceutical Development, Quality Control and members of the New Modalities Team within GTO to build the requisite technical knowledge to plan and execute activities internally and/or at third parties.

Essential Skills/Experience:
Degree in biology, chemistry or related field. 12+ years of experience with Bachelors degree; 9+ years with Masters; and 6+ years with Ph.D.
Excellent problem-solving abilities.
Strong interpersonal, organizational, collaboration and communication skills.
Demonstrated ability to develop, characterize and qualify/validate analytical methods per ICH Q2 (R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development.
Deep knowledge of ADC conjugation chemistries (mabs, linkers and payloads) and a broad range of analytical methods to characterize the totality of product quality including:
ADC Drug to Antibody Ratio (DAR) determination strategies and techniques.
Strategies and techniques for free drug determination.
Potency - cell-based assays like cell cycle arrest mediated by the cytotoxic payload.
HPLC (affinity, ion exchange, hydrophobic, RP).
CGE, CZE, cIEF
ELISAs.
Higher order structure by methods such as near-UV CD, DSC DLS, SEC-MALS.
LC-MS.
Knowledge of current Good Manufacturing Practices (cGMPs) and relevant SHE (Safety, Health & Environmental) laws, regulations, and guidances, especially those pertaining to cytotoxic payloads.
Experience leading a project with cross-functional internal and external teams.

Desirable Skills/Experience:
Ph.D. degree is preferred.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?
In Operations we have a big ambition. To deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking. We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people's lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalisation and sustainable practices.

Are you ready to embrace a long-term, varied career in a fast-paced, growing environment? With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace. Apply today!

Date Posted

14-Mar-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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

Address

4314 AstraZeneca Pharmaceuticals LP Company

Gaithersburg, MD
USA

Industry

Science

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