Associate Scientist III, Analytical Development and QC

This is what you will do:

The Associate Scientist III position is a technical positionconducting criticalanalytical testing and troubleshooting to support the development of Alexion’s biotherapeutic candidates. Under supervision, this position is also involved indevelopment and optimization of release and stability methods including process residuals, excipient analysis(e.g., PS80)and physiochemical chromatography (size exclusion, ion-exchange, reversed phase, hydrophobic interaction, etc.) for clinical and commercial biotherapeutics. Participation in method validation and transfer or troubleshooting of methods to internal and external laboratories may also be required.  In addition, this position is expected to interact with scientific staff in other Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups.

You will be responsible for: 

• Performassigned analytical testing tasks in a timely mannertosupport the development and optimization of manufacturing processes, or analytical/characterization methods as well as stability and release testing for Alexion| AstraZeneca Rare Disease biotherapeutic candidates.

• Develop and optimize custom (U)HPLC chromatographic methods to evaluate key quality attributes for therapeutic proteins (SEC, RP-HPLC, Ion-Exchange, HIC, etc.)under the supervisionof LC team lead.

• Participate in the operation, maintenance and troubleshooting of analytical instrumentation (e.g. UPLC, HPLC along with various detectors includingELSD, FLR, UV and QDA).

• Follow and execute defined methods, SOPs. Under direct supervision, author SOPs, study plans, protocols, and method development reports.  

• Work with various Research and Development teams to support transfer of analytical test methods for development and clinical support.

• Maintain knowledge of current scientific principles and theories.  Train other lab personnel as assigned in areas of expertise and participate in cross-functional process development teams

• Ensure training is current for all job functions performed. Attend all required Company training. 

• Perform other related duties as assigned.

You will need to have:

• Direct experience in (U)HPLC and general knowledge of protein chemistry. Eager to learn and ability to take initiative in problem solving and bring independent, scientific approach to method development.

• B.S. or Master degree from an accredited university isrequired. Working experience in the pharmaceutical or biotech industry is preferred. 

• The individual in this position will be able to organize his/her own work on a routine basis with no supervision as well provide troubleshooting and investigative efforts.

• Ability to travel up to 10% to support on-site training and troubleshooting.

• The duties of this role are generally conducted in an 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. Perform all job functions in compliance with cGXPs and maintainaccurate and legible laboratory records with a close attention to detail. 

We would prefer for you to have:

• A successful candidate will typically hold a BS. or M.S. degree in Chemistry, Biochemistry, or a biological science with 3+ years of relevant industry experience; or equivalent combination of education and experience.

• Practical knowledge of method development and optimization for protein therapeutics.

• The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods.

• Knowledge of current regulatory guidelines and cGMP requirements.

• Engage in problem solving and non-linear thought, analysis, and dialogue.

• High emotional intelligence, excellent interpersonal skills, and effective communication skills.

• The individual is expected to have several areas of expertise and is expected to collaborate within the laboratory.

• The individual is expected to recognize aberrant test and sample conditions and provide adequate guidance to team with an assessment of the circumstances and corrective action.