Development Scientist I, Analytical Development and Quality Control

This is what you will do:

The Development Scientist I position is a technical position responsible for development and optimization of release and stability methods including physicochemical methods pertaining to Imaged Capillary Electrophoresis (icIEF) as well as traditional Gel/Capillary Electrophoresis (CE-SDS, CIEF, CZE, IEF and SDS-PAGE) as well as support for chromatography charge separation (IEX) for clinical and commercial biotherapeutics. This position will also support other analytical method development related 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 may 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. The position may require working as part of a CMC team and advocating on behalf of Analytical Development and Quality Control, responding to health authority queries, and coordinating in-country testing requirements.

You will be responsible for:

• Development, optimization, and phase-appropriate qualification of custom capillary electrophoresis methods to evaluate key quality attributes for therapeutic proteins (charge heterogeneity, primary structure, PTMs, size variant, etc.)

• Organizing activities of self and others as well as supervise operation, maintenance and troubleshooting of analytical instrumentation (e.g., Revvity LabChip, Protein Simple iCE3, MauriCE, and ProteoAnalyzer)

• Supporting application of new cutting-edge technologies to improve throughput and enhance capability of cGMP testing.

• Design and optimization of platform workflows compliant with ICH Q14

• Authoring SOPs, study plans, protocols, and method development reports. Draft reports for regulatory filing

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

• Working with Analytical Technical Transfer Services (ATTS) to develop and execute validation protocols, provide support during and post method transfer (e.g. on-site training and troubleshooting as needed)

• Serve as CE subject matter expert on analytical sub-teams.

• Maintaining 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.

• Seeking out and evaluating new instruments, methods, techniques, and technology platforms to enhance analytical operations

• Developing workflows compliant with ICH Q14 and amenable to ICH Q2 (R2) requirements

• Identifying ways of utilizing AI tools to build a robust database for predicting platform fit potential of new molecules in compliance with ICH Q14 risk assessment guidelines

• Supporting CMC teams and potentially serving as analytical lead

You will need to have:

• Ph.D. degree with 0-2 years of experience or master’s with 4-6 years of experience or bachelor’s degree with 10+ years of experience equivalent level of experience, in Chemistry, Biochemistry, Chemical Engineering or related discipline.

• Analytical method development experience in protein/peptide analysis by gel/capillary electrophoresis in pharmaceutical or biotechnology company is a plus.

• Scientific and practical knowledge of protein characterization for protein therapeutics including monoclonal antibodies and glycoproteins.

• Experience with assay development, optimization, qualification, and validation for protein therapeutics is a significant plus.

• Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development.

• Knowledge of cGMP and quality guidelines is desired.

• 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.

We would prefer for you to have:

• Experience with assay development, optimization, qualification, and validation for protein therapeutics.

• Excellent interpersonal skills and a strong ability to communicate effectively.

• Knowledge of cGMP and quality guidelines (e.g., ICH Q2 (R2) and ICH Q14)

• High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint

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

• The ability to manage and lead projects independently, drive CE method development strategies, improve quality and efficiency of workflows, provide scientific guidance to team members, and train and oversee some day-to-day responsibilities of junior scientists.

• Ability to leverage AI tools to streamline troubleshooting, health authority responses, and to assess new molecules for platform fit in compliance with ICH Q14 guidelines.

• Ability to lead and participate in cross-functional development teams representing Analytical Development and Quality Control.

• Experience with authoring and reviewing CMC sections for regulatory, technical reports, department specific protocols and reports and generating operating procedures is a significant plus.

Join us!

Apply now!

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.