Scientist 3, Analytical Development with strength in chromatography with MS detection.
Responsible for acting as an individual contributor, having some level of project management responsibility. Individual should have the technical knowledge for the execution of experiments pertinent to the projects. Individual will be expected to provide advice to technical teams on resolution of analytical issues. Individual should be able to work in a complex environment, on multiple projects simultaneously with direct interaction with internal and external clients.
Individual will be asked to evaluate scientific processes and fundamental techniques.
Individual will be responsible for the design, development and hands-on execution of analytical studies to support method and formulation development, structural characterization, comparability, forced degradation, and other development activities of biopharmaceuticals at all stages of clinical development as well as for writing development plans, reports and protocols. Individual will be also responsible for successful transfer/establishment of analytical methods from clients in development and QC environments, troubleshooting and improvement of existing analytical methods, support of method qualifications, oversight of routine sample analysis in support of process development and establishment. Understanding of regulatory environment and knowledge of GMPs would be a plus.
The analytical techniques include, but are not limited HPLC, UPLC chromatography with Empower software and various detection modes, especially mass-spectrometry, peptide mapping. Glycan analysis would be aplus. Mammalian cell culture experience is a plus. Comprehensive understanding of protein degradation mechanisms as it relates to drug development would also be important. Maintenance of laboratory notebook and review of others' notebooks will be required.
- Design/Execute experiments, troubleshoot equipment and method issues, and establish existing and develop new methods.
- Manage process development projects and/or support commercial and clinical manufacturing. Activities include but are not limited to managing daily laboratory activities, support scale-up activities, bench scale work and acting as a strong technical resource responsible for the resolution of technical issues.
- Represent the group in multi-department meetings.
- Research and implement new scientific methods.
EDUCATION AND QUALIFICATIONS:
- BS in Biochemistry, Molecular Biology, Analytical Chemistry or other relevant discipline with 3+ years of experience working in the biotechnology industry.
- Expertise in Microsoft Office including MS Project is required
- Proficiency in statistical software and DOE is required
- Experience in development, transfer and validation of analytical methods
- Excellent oral and written communication skills.
- Knowledge and experience with a variety of analytical techniques used for determination of quality attributes in addition to chromatography: capillary and gel electrophoretic methods and spectrophotometry.
- Advanced knowledge of various aspects or specialized aspects of a discipline and working knowledge of other relevant disciplines, including expertise in all specialized equipment applicable to area of expertise.
- High level of understanding of analytical techniques pertinent to area of expertise.
- Demonstrated ability to successfully lead projects to their completion.
- Recognized as a technical resource and effective leader within the team and across the company.
- Demonstrated ability to make decisions that require developing new opinions to solve complex problems within the group and outside of the group.
- Strong ability to write plans, protocols, reports, and procedure manuals.
- Demonstrated ability to utilize Design of Experiments and statistical software to optimize a method is desired
- Ability to manage several diverse projects simultaneously, with consideration to resource loads and personnel management.
- Extensive knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment.
- Excellent communication skills
- Extensive experience with chemical/biochemical and biological testing in research and development is necessary.
- Expert knowledge of scientific principles and concepts.
- Possess knowledge of regulatory guidelines pertaining to assay development/qualification/validation including design of experiments, and protocol and report writing, perform assays or supervise other analysts for assay development and routine testing.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.