Engineer II, Injectable Drug Product Development

This is what you will do:

The Engineer II will design and implement experiments to develop injectable drug product formulations and process characterization studies, including analyzing samples and authoring technical reports. Work on an impactful dynamic team and routinely collaborate to innovate 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.
• Drive 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 implemented 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:

• Firsthand experience on developing phase appropriate drug product formulations and fill finish processes.
• Basic principles of protein chemistry and stability, and biologic therapeutic degradation mechanisms.
• Proven success working with cross functional partners.
• Firsthand 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 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:

• BS or MS degree in Biochemistry, Chemistry, Chemical Engineering or related field from an accredited university with 1+ years of experience for MS or 2+ years of experience with BS.
• Excellent interpersonal and collaboration skills!
• Understanding of the biotechnology products life cycle and factors impacting product stability.

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.

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.