Engineer II, Injectable Drug Product Development

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 implement experiments to develop injectable drug product formulations and process characterization studies, including analyzing samples and authoring technical reports. Work on a dynamic and collaborative team and routinely collaborate with 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, peptidesImplement supporting analytical methods and analysis for samplesSupporting process development and tech transfer of GMP fill finish processes to internal and external manufacturing organizationsDefining drug product processes, scale up studies, transferring information between development and manufacturing sites, as well as preparation of required tech transfer documentKnowledge of cGMP and quality guidelines is requiredWriting internal technical reports on the implemented studiesAssisting in preparation of external regulatory submissions for the Alexion product candidatesParticipate 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 mechanismsStrong partnership skills and attention to timelinesA multi-functional approach!Hands-on experience with liquid chromatography methods (e.g., SEC, IEX, HIC) and capillary methods (e.g. iCE, LabChip GXII Touch)Solid understanding of analytical software (e.g. Empower, JMP)Experience with electronic record keeping software, like ELNAbility to work in a collaborative setting with focus on timelinesThe 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/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 BSUnderstanding 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. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.