Associate Scientist II, Clinical QC – Immunology Analytical Development and Clinical QC

Position Summary

The Associate Scientist II will carry out assigned experiments focused on GMP stability and release testing. Additionally, they will assist with developing and improving manufacturing processes or analytical and characterization methods for Alexion| AstraZeneca Rare Disease biotherapeutic candidates. The Associate Scientist II will collaborate with other members throughout PDCS.

Job Duties and Responsibilities

• 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.
• Perform analytical methods with a focus on plate-based assays; residual impurity (i.e., residual Protein A, residual HCP, resDNA), potency/activity binding assays and compendial testing for in-process, drug substance and drug product release and stability samples.
• Aid in experimental studies, developing, optimizing, qualifying or supporting production methods or analytical techniques and approaches 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, inventory laboratory supplies.
• Assist with GMP shipping and handling responsibilities for incoming shipments, receipt and inventory as needed.
• Provide laboratory support services, clean/maintain equipment and prepare reagents/solutions.
• Ensure training is current for every role 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%) Essential

Qualifications

• A Bachelor of Science (BS) degree in Immunology, Biochemistry, Chemistry, Chemical Engineering or related rigor from an accredited university with 2-5 years of relevant experience or equivalent combination of education and experience.
• A successful candidate will typically have +2 years of experience gaining practical experience in a relevant laboratory setting
• In depth knowledge of cGMP and their application in the environment is required.
• 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 their own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on their tasks.
• The ability to communicate verbally and in a written format is required.
• Troubleshooting assays and instruments in the area of expertise, and offering solutions, is encouraged
• Communicate findings to colleagues within the group through presentations

The duties of this role are generally 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.

Preferred Qualifications

• Previous experience with Veeva Vault ECMS, ELN, gLIMS, Lean 6 Sigma
• Involvement with health authority inspections (FDA, EMA, MHRA, etc.) and experience preparing responses and/or remediation activities.
• · Proficient with various MS Office programs

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.