Job Abstract

Associate Scientist/Scientist (Early Formulation Sciences)

Introduction to role:

Are you ready to take on a high exposure role and will be recognized as an expert working at the forefront of science? As an Associate Scientist/Scientist within our Early-Stage Formulation Sciences team, you will independently design and develop 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 also 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:

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 as well as lead and support research, clinical and manufacturing teams in moving drugs from candidate drug selection to commercialization. Additionally, you will:

• Perform biophysical characterization and/or analytical assays in support of protein solubility, stability, elucidation of protein degradation mechanisms, clinical compatibility, and in-use support for clinical administration.
• Functional representative on CMC teams and sub-teams, including authoring of CMC sections for regulatory filings, write reports, technical documents, and present technical presentations on findings.
• Lead activities advancing the science in this field, making detailed experimental observations, analyzing data, interpreting experimental results, presenting scientific findings to both internal audiences within the company and external scientific community.
• Coordinate and support lab equipment.
• Contribute to the preparation of manuscripts and patent applications.

Education & Experience Requirements:

Associate Scientist:

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

Experience: BS or MS degree with 0+ years of related experience in the biopharmaceutical industry/academic lab

Scientist:

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

Experience: BS degree with 5+ years or a MS degree and 3+ years of related experience in the biopharmaceutical industry/academic lab

Essentials for the Role:

• Experience/knowledge in current approaches for formulation development, biophysical characterization of proteins/ADCs, high concentration formulations, and/or spray-drying/freeze-drying process design, protein stability, process, and analytical method development
• Biophysical characterization techniques include differential scanning calorimetry, isothermal titration calorimetry, dynamic light scattering, high pressure liquid chromatography, UV/Vis spectroscopy, fluorescence spectroscopy, circular dichroism spectroscopy, Karl Fisher, particle characterization such as Nanosight, Microflow Imaging, Horizon and HIAC
• Drug Substance and Drug Product processes include ultrafiltration/diafiltration, lyophilization, and fill/finish operations
• Good communication skills, strong interpersonal skills, and the ability to thrive in an interdisciplinary fast paced environment are an integral part of this position.
• Ability to work/handle high-potency molecules and their components with proper care/skill, working in isolator environments including lyophilization and fill/finish activities.
• Experience with coordinating maintenance of general lab instrumentation and organizational systems and ability to interface with relevant external parties

Desirables for the Role:

• Demonstrated experience with high-throughput screening methods for proteins, design of studies supporting formulation selection for introduction into clinical trials
• Knowledge of clinical compatibility and in-use support for clinical biotherapeutic administration of products
• Experience working on Antibody-drug-conjugates (ADCs) and other high potent modalities (OEB4+)
• 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 is why we work, on average, a minimum of three days per week from the office. But that does not mean we are 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, you will play an essential role in helping patients who need it the most. There is no better place to apply your Biometrics expertise in a new and different way. With a restless need to keep improving, 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 always expanding our knowledge to get a broad perspective. It allows us to leverage and fuse our own skills with others to maximize impact.

Ready to make an incredible impact? Apply now and join us in our journey of discovery and development!

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