Development Scientist II, Analytical Development and QC

This is what you will do:

The Development Scientist II position is a technical position responsible for development and optimization of release and stability methods including process residuals, excipient analysis and physio-chemical chromatography (size exclusion, ion-exchange, reversed phase, hydrophobic interaction, etc.) for clinical and commercial biotherapeutics. This position will also support other analytical method development pertaining to characterization and investigation efforts, as well as conduct testing for Alexion’s biotherapeutic products when required. Participation in method validation and transfer or troubleshooting of methods to internal and external laboratories will be required. This position is expected to interact regularly with scientific staff in other Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups. In addition, serving as analytical pillar lead to support Alexion drug development, driving analytical deliverables and communication with other functions are also key aspects of this position.

You will be responsible for:

• Development, optimization, and phase-appropriate qualification of custom (U)HPLC chromatographic methods to evaluate key quality attributes for therapeutic proteins (SEC, RP-HPLC, Ion-Exchange, HIC, etc.)
• Prioritize activities of self as well as supervise operation, maintenance and troubleshooting of analytical instrumentation (e.g., UPLC, HPLC along with various detectors including CD, ELSD, FLS, UV)
• Support application of new innovative technologies to improve efficiency and enhance capability of cGMP testing
• Author SOPs, study plans, protocols, and method development reports. Draft reports for regulatory filing
• 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
• Lead ADQC analytical support in drug development cycles, work with other function leads to meet key roadmap and milestones
• Seek out and evaluate new instruments, methods, techniques, and technology platforms to enhance analytical operations
  
  
  

You will need to have:

• Experience in (U)HPLC and practical knowledge of method development and optimization for protein therapeutics are required. Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development.
• Ph. D or Master degree is required. Working experience, especially CMC in the pharmaceutical or biotech industry is preferred. Academic candidates with strong technical and problem-solving skills are also encouraged.
• Ability to provide technical content for regulatory submissions with respect to analytical sections.
• This role involves independently running tasks, leading troubleshooting, and conducting investigations.
• Ability to travel up to 20% to support on-site training and troubleshooting
• The duties of this role are generally conducted in a 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 gaps and maintain accurate and legible laboratory records with a close attention to detail.
  
  
  

We would prefer for you to have:

• A successful candidate will typically hold a Ph.D. 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.
• The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods
• Solid understanding of regulatory guidelines (e.g., ICH Q2 and Q14) 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 mentor other analysts 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.