Sr Scientist – Analytical Development: Responsible for development and optimization of the release assays and assays required to control the upstream or downstream technical projects, to provide the Process Development teams the ability to monitor and control their processes for the production of therapeutic proteins for human clinical trials and commercial launch.
N/A or may supervise team members
ESSENTIAL JOB FUNCTIONS
- For the identification of the leading candidate assay’s for use in process control, release or characterization, and for assay selection using screening studies.
- For the design, plan, and execution of analytical experiments to develop methods for the monitoring and control of the upstream and downstream processes.
- Provides QC support in troubleshooting, and atypical issue resolution.
- For the collation and provision of information that will form the basis of the technical transfer package for the method to QC.
- For supporting process optimization and characterization, as part of the overall development team.
- For conducting analytical equipment qualification within the laboratory.
- For conducting Investigations that will focus primarily on understanding of the analytical methods for our cell culture and downstream processes.
- For authoring technical reports to be used by others to support regulatory filings.
- Understanding the process control requirements from the development team and identifying analytical assays that should be considered. Considering those assays and proposing the leading candidate for development
- Execution of analytical experiments within the laboratory using a wide range of analytical techniques including but not limited to HPLC, Capillary Electrophoresis (cGE, cIEF, iCE), Mass Spectrometry, SDS-PAGE, ELISA and cell bioassays. Familiarity with carbohydrate/ glycan and peptide map analysis a plus. ELISA and Capillary Electrophoresis skills preferred.
- Support operationally and technically the transfer of the methods from customers and to QC, through the assistance in the generation of the analytical methods and protocols as well as hands on execution of side by side work in QC if required
- Draft procedures, specifications, and other relevant cGMP documents
- Must stay current with relevant technologies and forward thinking to identify new approaches
- Be aware of needs and GMP requirements for QC laboratory operation
EDUCATION AND QUALIFICATIONS
- Strong analytical and problem solving and decision making skills coupled with the ability to work both independently and in a team environment
- Ability to work within a matrix management system taking direction from a task manager for a project and a line manager for technical and personal development
- Capable of working within a team or independently with minimal direction and supervision
- Rational Persuasion
- Strong written and oral communication skills
- Strong attention to detail and concern for standards
- Has considerable knowledge in a specific analytical field.
- BS. in analytical science, biological sciences or closely related area with >4 years’ experience is required or MS >2 years experience.
- Solid foundation in the fundamentals of biochemical engineering and cell biology
- Working knowledge of GMP regulations in cGMP manufacturing environment
- Rigorous attention to the details of experimental protocols. Ability to comprehensively document in writing the details of each experimental operation.
- Routine use of MS Excel, MS PowerPoint and MS Word is essential. Routine use of statistical software and /or other statistical analysis methods will be expected.
This job description is not all inclusive, other duties may be performed as assigned.
- Ability to function in a rapidly changing environment and balance multiple priorities moving from one project to another as priorities change.
- Lifting, walking, sitting for long periods, and repetitive hand motions.
- The ability to gown and work successfully in a clean room environment.
- This role will be based in St. Louis.
Keyword: Senior Scientist – Analytical Development
From: Gallus BioPharmaceuticals
Gallus Biopharmaceuticals - 17 months ago