Associate scientist I, Injectable Drug Product Development
This is what you will do:
The Associate scientist II will join Injectable Drug Product Development group to support the development of Alexion's biotherapeutic candidates. This individual will design and execute experiments to develop injectable drug product formulations and process characterization studies, including analyzing samples and authoring technical reports. This individual will work in a dynamic team environment and routinely collaborate with other members of Injectable Drug Product Development as well as other groups in Product Development and Clinical Supply.
You will be responsible for:
- Execution of formulation screening and stability studies for injectable drug products including proteins, siRNAs, peptides.
- Execute 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.
- Authoring internal technical reports on the executed 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:
- BS degree, (prefer to have BS degree in Biochemistry, Chemistry, Chemical Engineering or related discipline from an accredited university with with 0-2+ years of experience).
- Direct experience on developing phase appropriate drug product formulations and fill finish processes.
- Good understanding of the basic principles of protein chemistry and stability, and biologic therapeutic degradation mechanisms.
- Ability to work in a collaborative setting and adhere to timelines.
- Demonstrated ability to work effectively in a cross-functional settings.
- Direct experience with liquid chromatography methods (e.g., SEC, IEX, HIC) and capillary methods (e.g. iCE, LabChip GXII Touch).
- Strong knowledge of analytical software (e.g., Empower, JMP).
- Experience with electronic record keeping software, like ELN.
- Ability to work in a collaborative setting and adhere to timelines is essential.
- The duties of this role are generally conducted in an 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/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:
- Excellent interpersonal and communication skills.
- Understanding of the biotechnology products life cycle and factors impacting product stability.
- Basic knowledge of cGMP and Quality guidelines.
- High level proficiency in MS Office software including Word, Excel, Outlook, and PowerPoint
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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