- Execution of formulation screening and stability studies for injectable drug products including proteins, siRNAs, peptides.
- Supporting analytical method development and optimization
- Supporting development and tech transfer of GMP fill finish processes to internal and external manufacturing organizations.
- Writing 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.
- With some supervision, design and execute phase appropriate formulations and fill finish processes.
- Good understanding of protein chemistry and stability, and degradation mechanism.
- Ability to work in a collaborative setting and adhere to timelines.
- Demonstrated ability to work effectively in a cross-functional settings.
- Hands-on 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.
- 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 and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- BS or MS degree in Biochemistry, Chemistry, Chemical Engineering or related discipline from an accredited university with with 0-2 years of experience.
- Excellent interpersonal and communication skills.
- Understanding of the biotechnology products life cycle and factors impacting product stability.
- Knowledge of cGMP and quality guidelines.
- High level proficiency in MS Office software including Word, Excel, Outlook, and PowerPoint
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Assoc Sci I, Injectable Drug Product Development - New Haven, United States - Alexion Pharmaceuticals, Inc.
Description
This is what you will do:
The Associate Scientist I will join Injectable Drug Product Development group to support the development of Alexion's biotherapeutic candidates.
This individual will develop injectable formulations with fit for purpose analytical methods, perform analytical testing, and draft reports for the executed studies.
This individual will work independently 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:
You will need to have:
We would prefer for you to have:
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.
