Job Abstract

Senior Scientist/Associate Principal Scientist (Early Formulation Sciences)

Introduction to role:

Are you ready to make a profound impact in the world of biotherapeutics? We are seeking a highly motivated individual to join our Early Stage Formulation Sciences team. This position is responsible for independently designing and developing formulation and drug product presentation for Phase 1 through pivotal clinical trials of Antibody-Drug Conjugates, novel biotherapeutic molecules, other high potent modalities (OEB4+) and monoclonal antibodies. This position will also work collaboratively with Research teams for molecule selection prior to candidate drug selection. You will be expected to design, develop and execute experiments in the areas of preformulation, formulation screening and clinical/commercial product development, including fill-finish and lyophilization with minimal supervision.

Main Duties & Responsibilities:

As a Senior Scientist/Associate Principal Scientist, you will work in a state-of-the-art laboratory that is focused on development of biotherapeutic drug substance and drug product designs, formulations and fill finish process for therapeutic proteins. You will lead and support research, clinical and manufacturing teams in moving drugs from candidate drug selection to commercialization. Additionally, you will:

• Perform formulation development, biophysical characterization of proteins/ADC’s  and other high potent modalities (OEB4+).
• Perform clinical compatibility and in-use support for clinical biotherapeutic administration of products.
• Coordinates and supports lab equipment.
• Develop fit for use analytical methods for novel biotherapeutics
• Lead various activities in evaluating and advancing the science in this field.
• Make detailed experimental observations, review and analyze data, interpret experimental results, present scientific data to both internal audiences within the company and external scientific community.
• Functional representative on CMC teams and sub-teams
• Author CMC sections for regulatory filings and clinical documents
• Write reports, technical documents and present technical presentations on findings

Requirements for the Role:

Senior Scientist: 

Education: BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutics, Chemical/Biochemical Engineering or related field

Experience: BS degree with 7+, MS with 5+, or a PhD and 0+ years of related experience in biopharmaceutical industry/academic lab

Associate Principal Scientist:

Education: BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutics, Chemical/Biochemical Engineering or related field

Experience: BS degree with 10+, MS with 7+, or a PhD and 5+ years of related experience in biopharmaceutical industry/academic lab

Desirables for the Role:

• Formulation development, biophysical characterization of proteins and ADC’s (other high potent modalities (OEB4+); perform protein stability studies,
• Experience using biophysical characterization tools such as DSC, DLS, HPLC, NMR, UV, etc
• Demonstrated experience with high-throughput screening methods for proteins, design of studies supporting formulation selection for introduction into clinical trials
• Drug Substance and Drug Product processes include ultrafiltration/diafiltration, lyophilization, Karl Fisher and fill/finish operations
• Good communication skills, strong interpersonal skills, and the ability to thrive in an interdisciplinary fast paced environment are also an integral part of this position.
• Demonstrated experience working on Antibody-drug-conjugates (ADC’s) and other high potent modalities (OEB4+) or ability to work/handle high potent molecules and their components with proper care/skill.
• Familiarity with fill finish process technology, aseptic drug product manufacturing (knowledge of Drug Product dosage forms for biotherapeutics (vial, PFS, liq., lyo, etc)) process development, and cGMP knowledge is advantageous.

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?

At AstraZeneca's Biopharmaceuticals R&D, you'll be part of a community of highly qualified and motivated scientists. Here, you'll have the opportunity to apply your Biometrics expertise in a new and different way. We are always moving forward and searching for something new. Our supportive, yet challenging, approach makes for an inspiring learning environment. Every setback is seen as a chance to improve, every critique pushes us towards the next ground-breaking solution. We are courageous. We speak up, share opinions and make bold decisions that could change the course of patients' lives.

Ready to reach your potential? Apply now and join us in our mission to make a profound impact with research that makes a clear and tangible difference.

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