Associate Scientist II (Injectable Drug Product Development)

Alexion • New Haven, CT

12h • Onsite

About The Position

The Associate Scientist II candidate will be a part of the Injectable Drug Product Development (IDPD) team within the Pharmaceutical Development and Clinical Supply (PDCS) department at Alexion-AstraZeneca Rare Disease . The job entails experimental work on various aspects of drug product formulation and process development activities in support of drug product manufacturing , characterization, including analytical and biophysical compa rability testing . The ability to work with minimal supervision as well as being part of a collaborative team is essential. The position entails study design, execution, and preparation of development reports and other required documentation.

Requirements

• BS or MS degree in Biochemistry, Pharmaceutical Science, Chemical Engineering , or relevant field .
• Minium of 1 + years of relevant work experience with a pharmaceutical or biotechnology company
• Scientific and practical knowledge of protein /peptide biochemistry, protein formulation , lipid-based nanoparticle (LNP) development, and stability are essentia l.
• Experience of working with imaged capillary electrophoresis ( iCE /Maurice), H/UPLC’s (IEX, SEC), DLS, CD, DSC, AUC, and NanoTemper
• Experience with gene editing pro duct development (mRNA based and LNP process development ) is highly desirable.
• Abi l ity to execute experiments with minimal supervision is .
• The individual must be able to work in a collaborative setting and has ability to adhere to timelines is essential.
• Excellent interpersonal, collaborative and communication skills
• Ability to take initiative in problem solving and finding solutions to scientific challenges .
• Experience with various software packages like MS Office programs, including Word, Excel, Outlook, and PowerPoint
• 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 and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

Nice To Haves

• Hands-on experience with process development , scale up, tech transfer , and manufacturing .
• Experience working with sub-visible part icle testing and characterization.
• Experience of working with biophysical and analytical testing
• Familiarity with regulatory guidelines.
• High level proficiency in MS Office software including Word, Excel, Outlook, and PowerPoint.
• Experience with electronic record keeping software, like ELN, EndNote, e-logbooks; maintenance of laboratory instrumentation (organizing PMs, data backup, SW upgrade, etc.) will be a plus.

Responsibilities

• With some supervision, design and execute formulation and process development studies for clinical biologic candidates.
• Execute drug development studies including physico -chemical characterization and stability studies for clinical and commercial drug products.
• Characterize conformational and colloidal stability using industry standard methodology (e.g., circular dichroism, d ifferential scanning fluorimetry, analytical ultracentrifugation, size-exclusion chromatography with multi-angle light scattering detection, etc.)
• Maintain organized records and use team tools to keep multiple assignments on track.
• Assist in the p repar ation of internal technical reports on executed studies with minimal supervision.
• Participate in cross-functional development teams.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level