Associate Scientist IV, Clinical QC Analytical Development & Clinical QC

This is what you will do: 

The Associate Scientist IV reporting to the Head of Clinical QC will have a primary responsibility for clinical stability, inventory and gLIMS/Sample management for GMP activities (inclusive of the clinical reference programs and certificate generation) as well as responsibility performing assigned experimental tasks to support compendial testing of manufacturing processes (i.e., performing analytical/characterization methods for GMP stability and release testing) for Alexion| AstraZeneca Rare Disease biotherapeutic candidates.  The Associate Scientist IV 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 demanding environment where product development supports unmet needs of patients with rare diseases. 
• Responsible for cGxP operations in support of early stage - PIII biologics  
• Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records. 
• GMP shipping and handling support for incoming shipments, receipt, inventory, sample management and gLIMS data entry.  
• Clinical Stability laydown and sample aliquoting of drug substance and drug product material (bulk bag, vial, PFS, AI etc) for testing 
• Oversee and document all Laboratory Investigations (EQV) for Clinical QC 
• Manage the batch release and stability testing certificates (CoA/CoT)  
• Assist the compliance team with change controls, deviations, CAPA’s. 
• Supervise and lead subordinates as needed. 
• Ensure compliance to legal regulations and company policies. 
• Represent Clinical QC-ADQC on cross departmental project teams and provide technical input as required.  
• Perform testing for in-process, drug substance and drug product release and stability samples (i.e., Compendial: Protein Concentration, Appearance, pH, freeze-point/ vapor-pressure Osmolality, sub-visible particulate (LO) and device functionality testing as assigned.)  
• Aid in 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.  
• 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.  
• Review laboratory data and documentation as qualified and assigned by area management.  
• Perform other related duties as assigned. 
• Global role requiring domestic and international travel (up to ~5%) 

You will need to have: 

• A BS degree in Immunology, Biochemistry, Chemistry, Chemical Engineering, or related discipline from an accredited university
• 7+ years of relevant experience or equivalent combination of education and experience is required. 
• In depth knowledge of GMPs and their application in the environment is needed.
• The individual in this position is expected to have an in depth understanding of the Biological Chemistry laboratory environment and be familiar with all laboratory equipment / instrumentation, procedures, and responsibilities.  
• Understand and follow written procedures when conducting experiments and applying methods. 
• Ability to 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 is required.  
• The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions, is expected. 
• 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. 

We would prefer for you to have: 

• Experience with Veeva Vault ECMS, ELN, gLIMS, Lean 6 Sigma 
• Experience with domestic and international shipping requirements  

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.