Engineer II, Injectable Drug Product Development

New Haven, Connecticut

Posted in Pharmaceuticals

This job has expired.

Job Info

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, peptides
  • Implement 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
  • Writing 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:
  • 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 mechanisms
  • Strong partnership skills and attention to timelines
  • A 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 ELN
  • Ability to work in a collaborative setting with focus on timelines
  • The 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 BS
  • Understanding 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.

Date Posted

Closing Date
02-May-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

This job has expired.

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