Eurofins BPT - Columbia is looking for aPrincipal Scientist to join our Biotech team which provides a comprehensive range of biopharmaceutical services from analytical physical-chemical characterization to routine release and stability testing utilizing well-established techniques including HPLC, capillary electrophoresis, light scattering, ELISA, and mass spectrometry.
The Principal Scientistposition is an advanced level professional position involved in planning own work and supervising the day-to-day activities in a laboratory setting under prescribed processes (protocols, standard operating procedures, methods, etc.). Completes complex work for research and development, CGMP and/or GLP studies and documents and reports data in a timely manner according to regulatory guidelines.
Plans the conduct of a study; monitors study procedures to ensure data accuracy and report quality; conducts complex analysis and experimentation on substances, for purposes such as product and process development and application, quantitative and qualitative analysis and improvement of analytical methodologies. Typically serves as technical leader within group and may also be the project leader/study director on complicated projects.
Principal Scientist responsibilities include, but are not limited to, the following:
- Designs, carries out, and performs non-routine and complex experiments and procedures in accordance with all applicable regulatory (e.g. DEA, EPA, FDA, FIFRA, OECD, etc.) requirements as defined by protocol, method, and standard operating procedures (SOPs).
- Serves as an expert and point of contact for technical issues for staff and external customers appropriate.
- Adheres to schedule according to Eurofins or contracting organization’s timetable and establishes daily or weekly routines necessary to ensure on-time delivery.
- Designs and conducts most procedures independently using laboratory equipment, computer resources, and institutional libraries.
- Conducts studies to determine and deliver results involving the composition, structure, properties, relationships, and all critical parameters of the material contracted for testing.
- Depending on need, may assist business development team assess potential clients and/or projects for upcoming projects or studies.
- Likely to work on several projects concurrently and may monitor and direct activities of other staff performing work in area of expertise.
- Conducts training of staff on techniques necessary to perform laboratory assignments.
Basic Minimum Qualifications:
- BS in relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field. 15+ years of post-academic experience with biochemistry methods used in protein and antibody molecules.
- MS in relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field. 8+ years of post-academic experience with biochemistry methods used in protein and antibody molecules.
- PhD in relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field. 3+ years of post-academic experience with biochemistry methods used in protein and antibody molecules.
- Expertise in performing and interpreting protein characterization techniques such as protein chromatography, capillary electrophoresis, IEF. Experience working with antibody drug conjugates (ADCs) Experience working under GLP (21 CFR Part 58) and/or GMP (21 CFR Part 210 and 211) regulations.
- Authorization to work in the United States indefinitely without restriction or sponsorship
The ideal candidate would possess:
Specialized Knowledge, Skills, or Training
Expert knowledge of scientific discipline; basic relevant technical skills; ability to read and understand protocols, SOPs, and technical guidelines. Compliance with, and knowledge of, regulatory guidelines and company SOPs (CGMP, GLP) is required. Skill with laboratory equipment is necessary. Good organizational skills; ability to follow direction and good communication skills are required. Ability to instruct and provide technical direction to others is required. Ability to consult with clients and knowledge of date submission requirements for clients is necessary. Mechanical aptitude is a plus. Expert skill in handling radioactive or toxic chemicals may be required.