Scientist I, Injectables Drug Product Development

Remote Full-time
AstraZeneca is a global biopharmaceutical company focused on developing life-changing medicines. The Scientist I role involves coordinating multi-functional initiatives in scientific studies to evaluate biotherapeutic drug candidates, formulating drug products, and leading drug candidate development utilizing computational tools. Responsibilities Leads drug product development teams with multiple multi-functional collaborators, as well as understand the multi-functional implication of project activities and decisions on project and corporate objectives. Makes scientific/technical proposals based on corporate or project objectives The candidate must have the ability to communicate effectively with senior management, external partners, and/or regulatory agencies. Actively participates in department and team meetings including assuming ownership and delivering on assign action items Understands "big pictures" for projects and tasks involved and prioritize work of self and others accordingly. Prioritizes multiple work you're doing and projects and leads project teams consisting of one or more junior team members. The ability to work independently as well as part of the team is essential Perform in-depth data analysis. Write technical reports and sections of clinical and commercial regulatory filings. These documents cover accomplished studies for Alexion drug product candidates Be current with the literature about drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations Skills PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 0-2 years, a MS with 9+ years or BS with 10+ years of relevant experience Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred Scientific and practical knowledge of protein biochemistry, protein formulation/stability, protein engineering or protein purification as well as biopharmaceutical development is essential Hands-on experience with developing and utilizing computational tools for protein engineering, protein solution behavior prediction, manufacturing process design and scale-up or automation Experience in biotherapeutics development as well as understanding of the biotechnology products life cycle Understanding of the biotherapeutics engineering, drug development and analytical or in-silico tools used to test drug candidates or processes is desirable Makes strategic scientific/technical proposals based upon corporate or project objectives and has the ability to take initiative in problem solving and finding solutions to scientific challenges The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential Excellent interpersonal skills are required, as is the strong ability to communicate effectively, as well as mentor and motivate others within the department and as part of actively participating in cross-functional teams The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro, would be an advantage Experience with in-silico tools such as GROMACS, NAMD, BioLuminate, MOE, Python ML libraries, gPROMs or related tools Experience with programming languages such as Python, C++, Fortran, R or related languages Knowledgeable in Global Regulatory guidances, cGMPs, and Quality/Compliance expectations for the development of parenteral drugs Benefits Eligibility for various incentives—an opportunity to receive short-term incentive bonuses Equity-based awards for salaried roles Commissions for sales roles Qualified retirement programs Paid time off (i.e., vacation, holiday, and leaves) Health, dental, and vision coverage in accordance with the terms of the applicable plans Company Overview AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor. It was founded in 1999, and is headquartered in Cambridge, Cambridgeshire, GBR, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship AstraZeneca has a track record of offering H1B sponsorships, with 2 in 2021, 11 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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