Assoc Sci I, Injectable Drug Product Development

2 weeks ago


New Haven, United States Alexion Pharmaceuticals,Inc. Full time

Location: New Haven, United States

Job reference: R-198853

Date posted: 05/03/2024

**This is what you will do**:
**You will be responsible for**:

- 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
- Participate in department meetings and other technical and team building activities.

**You will need to have**:

- 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.

**We would prefer for you to have**:

- 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

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.



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