Associate Scientist III, Clinical QC - Protein Chemistry Analytical Development and Clinical QC
Alexion

Job Info

---

This is what you will do:

This Associate Scientist III position will be a high level team member for the Protein Chemistry group within the Clinical QC department. Responsible for leading experimental tasks in chromatographic and electrophoretic assays to support the development and optimization of manufacturing processes or analytical/characterization methods as well as GMP stability and release testing for Alexion| AstraZeneca Rare Disease biotherapeutic candidates. The Development Associate III will work in collaboration with other members of Product Development and Clinical Supply (PDCS) Organization as well as across other functional areas throughout Alexion and AstraZeneca and external vendors..

You will be responsible for:

• Working in a fast-paced environment where product development supports unmet needs of patients with rare diseases.
• Responsible for cGxP operations in support of early stage - PIII biologics manufacturing.
• Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records.
• Take the lead on incoming analytical methods with a focus on Protein Chemistry assays; CE-SDS, iCE, H/UPLC, UV spectrophotometry for in-process, drug substance and drug product release and stability samples.
• Lead experimental studies, developing, optimizing, qualifying, or supporting manufacturing processes or analytical/characterization methods for biotherapeutic candidates
• Write and review methods, SOPs, qualification and validation protocols and reports, and technical reports as assigned.
• Compile data and information related to assay and instrument performance.
• Recognize aberrant test and sample conditions and report to them to the area supervisor / manager.
• Maintain knowledge of current scientific principles and theories and train other lab personnel as assigned in areas of competence.
• Order, stock, and receive, label, log, and inventory laboratory supplies.
• Assist with GMP shipping and handling responsibilities for incoming/outgoing shipments, receipt, and inventory.
• Provide laboratory support services, clean/maintain equipment and prepare reagents/solutions.
• Ensure training is current for all job functions performed. Attend all required Company training.
• May be qualified and assigned to review laboratory data or documentation upon qualification.
• Perform other related duties as assigned
• Global role requiring domestic and international travel (~5-10%)

You will need to have:

Requirements:

• A successful candidate will hold a BS degree in Immunology, Biochemistry, Chemistry, Chemical Engineering, or related discipline from an accredited university; plus have a minimum of 3+ years of relevant experience.

• A successful candidate will need a minimum of 3 years of experience working in a cGMP laboratory
• Knowledge of GMPs and their application in the environment.
• Have a strong working knowledge of the Biological Chemistry laboratory
• Understand and follow written procedures when conducting experiments and applying methods
• Document procedures and data in peer-reviewed laboratory notebooks and/or LIMS
• Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual can provide updates and tracking on his/her tasks.
• The ability to communicate verbally and in a written format.
• The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions.
• Communicate findings to colleagues within the group through presentations

The duties of this role are conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to 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:

• Previous experience with Laboratory Information Systems (LIMS).
• Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint as well as SAS JMP statistical software.

Date Posted
19-Dec-2024

Closing Date
26-Jan-2025Alexion 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 accommodations@Alexion.com. Alexion participates in E-Verify.

---