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Engineer II, Injectable Drug Product Development - New Haven, United States - The Chemical Engineer
Description
This is what you will do:The Engineer II will join Injectable Drug Product Development group to support the development of Alexion's bio-therapeutic candidates.
Design and drive experiments to develop injectable drug product formulations and process characterization studies, including analyzing samples and authoring technical reports.
Join a dynamic and collaborative team with multi-functional business partners within Product Development and Clinical SupplyYou will be responsible for:
Execution of formulation screening and stability studies for injectable drug products including proteins, siRNAs, peptides
Implement supporting analytical methods and analysis for samples
Supporting process development and tech transfer of GMP fill finish processes to internal and external manufacturing organizations
Defining drug product processes, scale up studies, transferring information between development and manufacturing sites, as well as preparation of required tech transfer document
Knowledge of cGMP and quality guidelines is required
Writing internal technical reports on the performed studies
Assisting in preparation of external regulatory submissions for the Alexion product candidates
Participate in department meetings and other technical and team building activities
You will need to have:
Hands-on experience on developing phase appropriate drug product formulations and fill finish processes
Basic principles of protein chemistry and stability, and biologic therapeutic degradation mechanisms
Ability implement and deliver timelines
Hands-on experience with liquid chromatography methods (e.g., SEC, IEX, HIC) and capillary methods (e.g. iCE, LabChip GXII Touch)
Experience with analytical software (e.g. Empower, JMP) and electronic record keeping software, like (ELN)
The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees are required, 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/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours
We would prefer for you to have:
BS or MS degree in Biochemistry, Chemistry, Chemical Engineering or related field with 1+ years of experience for MS or 2+ years of experience with BS
Excellent interpersonal and Partnership ability
Understanding of the biotechnology products life cycle and factors impacting product stability.
High level proficiency in MS Office software including Word, Excel, Outlook, and PowerPoint
Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.
AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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