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

We are seeking an Associate Scientist II to carry out assigned experiments focused on GMP stability and release testing, and to assist with developing and improving manufacturing processes or analytical and characterization methods for Alexion| AstraZeneca Rare Disease biotherapeutic candidates. This role collaborates with other members throughout PDCS.

Responsibilities

• Work 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 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, receive, label, log, and 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.
• Domestic and international travel (~5-10%).

Requirements

• 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.
• Typically +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.
• 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. Provide updates and tracking on tasks when asked.
• Strong verbal and written communication skills.
• Troubleshoot assays and instruments in the area of expertise and offer solutions.
• Communicate findings to colleagues within the group through presentations.

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.

The duties of this role are generally conducted in an office environment. Employees must be able, with or without 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.