Development Scientist , Analytical Development and QC

Development Scientist I

The Development Scientist I position is a technical position responsible for development and optimization of release and stability methods including process residuals, excipient analysis and physicochemical 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. In addition, 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.

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.)
• Organize activities of self as well as supervise operation, maintenance and troubleshooting of analytical instrumentation (e.g. UPLC, HPLC along with various detectors including UV, FLR, ELSD, CAD, RI and MALS)
• Support application of new cutting-edge technologies to improve throughput and enhance capability of cGMP testing
• Apply automated liquid handling and sample preparation platforms to increase throughput, improve consistency and reduce hands-on time.
• Author SOPs, method documents (METs), study plans, protocols, and method development and qualification reports. Draft reports for regulatory filing
• Support change control, deviations and laboratory investigations, including assessment of impact and definition of corrective action.
• Perform data and document review of work generated by other analysts, including verification of chromatographic integration, calculations and transcription against source data.
• Work with various Research and Development teams to support transfer of analytical test methods for development and clinical support.
• Maintain current knowledge of relevant analytical techniques, compendial methods and regulatory expectations. Train other lab personnel as assigned in areas of expertise and participate in cross-functional process development teams
• Seek out and evaluate new instruments, methods, techniques and technology platforms to enhance analytical operations

You will need to have:

• Ph.D. or M.S. degree in Chemistry, Biochemistry, or a biological science with 2+ years of relevant industry experience; or equivalent combination of education and experience
• 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.

• Ability to provide technical content for regulatory submissions with respect to analytical sections.
• The individual in this position will be able to organize his/her own work on a routine basis with no supervision as well as provide lead troubleshooting and investigative efforts.
• Ability to travel up to 20% to support on-site training and troubleshooting
• Working proficiency with chromatography data systems (Empower), electronic laboratory notebooks, and electronic document management systems.
• Sound understanding of the statistics that underpin method qualification, including precision (%
  RSD), linearity, accuracy, range, LOQ, and the basis for setting acceptance criteria.
• Demonstrated commitment to data integrity and ALCOA+ principles, with clear traceability from raw data through calculation to reported result.
• 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 cGXPs and maintain accurate and legible laboratory records with a close attention to detail.

We would prefer for you to have:

• The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods
• Strong 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 strong communication skills.
• The individual is expected to have several areas of expertise and is expected to mentor other…