Associate Scientist Ii, Injectable Drug Product - New Haven, United States - Alexion Pharmaceuticals,Inc.

Alexion Pharmaceuticals,Inc.

Verified Company

New Haven, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Location:
New Haven, United States

Job reference:
R-199761

Date posted: 05/15/2024

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.
Execute 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 executed studies
Participate in department meetings and other technical and team building activities.

You will need to have:

Handson experience on developing phase appropriate drug product formulations and fill finish processes.
Good understanding of the basic principles of protein chemistry and stability, and biologic therapeutic degradation mechanisms.
Ability to work in a collaborative setting and adhere to timelines.
Demonstrated ability to work effectively in a crossfunctional settings.
Handson 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 generally conducted in an lab environment. As is typical of a labbased 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 discipline from an accredited university with with 1+ years of experience for MS or 2+ years of experience with BS.
Excellent interpersonal and communication skills.
Understanding of the biotechnology products life cycle and factors impacting product stability.
Basic knowledge of cGMP and Quality guidelines.
High level proficiency in MS Office software including Word, Excel, Outlook, and PowerPoint