The ideal candidate will develop and implement analytical control strategies for complex biological and bio-organic custom projects. The role will also involve transfer of analytical methodologies to GMP quality control groups. The team lead will lead, train and develop a small team and will be responsible for customer interactions. He/ she will be part of an expert team focused on delivering new insights and technologies in the pharmaceutical and/or specialty chemical industries.
Essential position responsibilities
Deliver required analytical data for routine analyses, and method development and optimization to enable efficient process and analytical development.
Lead analytical project efforts, deliver project milestones on-time and on-quality, and represent analytical on cross-functional project core teams with representatives from Project Management, Process / BioProcess Chemistry, Engineering, Manufacturing, QC, and QA.
Qualify and evaluate analytical methods for the transfer to cGMP Quality Control laboratories for method validation.
Master the technical and theoretical aspects of new analytical techniques and contribute to critical path needs of various project development teams.
Consistently demonstrate attention to detail in the planning, execution and documentation of experimental work.
Deliver timely and comprehensive written (laboratory notebooks, SOPs, and development and qualification protocols / reports) and oral communications to both internal and external stakeholders.
Continually enhances the skill level of his/her organization by investing in the development and learning of the organization's employees, and by actively participating in the selection of external tale
Promotes a climate of positive employee relations by fostering two-way communication and by resolving employee issues in a timely manner.
Who You Are
Ph.D. in a Scientific Discipline with 3-4 years of academic, or industrial experience, prior supervisory experience highly preferred.
Masters in a Scientific Discipline with 6 years of industrial experience with prior supervisory experience will be considered.
Bachelors in a Scientific Discipline with 8 years of industrial experience with prior supervisory experience will be considered.
Knowledge and demonstrated skills in bioanalytical chemistry, biophysical chemistry, biochemistry, protein chemistry and/or molecular biology highly preferred.
Well-organized and detail oriented, able to effectively prioritize, interact cooperatively and effectively with others in a matrix organization and consistently demonstrate reliability, responsibility and independence..
Essential and Critical Skills
Proven ability to lead a team in technical excellence, project completion and people development.
Demonstrated skills in general and advanced laboratory techniques (theory and practice) to enable the development of novel approaches to solve complex analytical problems on fast-paced projects with changing priorities.
Current knowledge of small molecule or bio-therapeutics drug development process. Experience with antibody-drug conjugation is a plus.
A genuine desire to translate new science into new therapeutic technologies and the ambition to succeed in an innovation driven environment.
Demonstrated success in contributing to the advancement of projects, project teams, and process improvements.
Well-versed in regulatory requirements to assure appropriate design and execution of drug development and manufacture.
Extensive hands-on experience and in-depth knowledge of 5 or more of the following bio/analytical technologies including: chromatography (HPLC/GC/IC/UPLC/LC-MS/GC-MS/SEC/HILIC/), electrophoresis (capillary CGE or iCE and traditional gel techniques), SDS-PAGE, immunoassays (ELISA, western blot, and dot blot), enzyme kinetics, and plate-based biochemical assays, absorption spectroscopy, slope spectroscopy, protein characterization, protein functional assays, FTIR, NMR, wet chemistry and/or USP methodologies.
Excellent time management, attention to detail and strong communication skills (both written and verbal). Customer-facing experience is vital.
Champion new analytical technologies that can be applied to process and drug development. Propose strategy and manage development, qualification, documentation, and transfer of assays.
Automation (medium to high-throughput) experience in an analytical setting and instrument maintenance / troubleshooting highly desirable.
Working knowledge of Microsoft Word, Excel, and PowerPoint, as well as experience with advanced data acquisition and/or statistical software systems.
As part of a multidisciplinary team, the candidate should be able to efficiently communicate concepts to both specialist and general audiences.
Ability to coordinate information exchange and manage data generated by contract testing labs.
Comply with SAFC safety policies, practices and SSOP
Job Requisition ID: 181155
Location: St. Louis
Career Level: D - Professional (4-9 years)
Working time model: full-time
Job Segment: Biochemistry, Analytics, Biology, Developer, Pharmaceutical, Science, Management, Technology