Analytical Scientist I

Job Description

Job Summary:

• Assist in the development and execution of methods related to the testing and characterization of biotherapeutics using analytical instrumentation and methodologies.
• Under minimal supervision, may be responsible for method feasibility, method development, method optimization, method transfers, method qualifications, method validations and routine testing under both R&D and cGMP environments.
• Additionally, will be responsible for client interaction, interpretation and reporting of data of assigned research projects.

Duties and Responsibilities:

• Perform and troubleshoot laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics through use of analytical testing and characterization instrumentation and methodologies.
• Review, interpret, analyze, evaluate, integrate and present experimental data with the assistance of senior technical staff as appropriate.
• Perform tabulation and statistical analyses of study data, as required.
• Prepare high quality final reports appropriate for assigned study, including integration of supporting subcontractor(s)’s reports into final reports as required, with assistance from Senior personnel.
• Assist in the technical review of procedures and data and documentation.
• Assist in long-term projects (redesign of SOPs, CTMs, basic research procedures or report formats).
• Interact with clients regarding project design, scheduling and conduct as requested.
• Collaborate with appropriate departments to coordinate performance of projects, discuss issues and prepare reports.
• Attend scientific meetings, conferences and training courses to enhance job and professional skills.
• For both cGMP and R&D grade routine testing, generate analytical data and technical report(s) on-time with respect to internal and client deadlines.
• Maintain a weekly schedule to ensure all timelines are met.
• Actively participate in laboratory instrumentation and equipment preventative maintenance and qualification programs.
• Maintain a safe working environment by adhering to Company policies or procedures.
• Actively participate in laboratory maintenance.
• Comply with all pertinent regulatory standards regarding environs, equipment and testing services.
• Perform equipment troubleshooting and repair (as applicable) with minimal guidance from senior members of the group.
• Make detailed observations and maintain clear, accurate and timely documentation of all laboratory work.
• Independently compose quality documentation including deviation reports and change control documentation with no/minimal guidance.
• Create, review and edit SOPs, protocols and other data Forms and testing documentation.
• Follow all SOPs, CTMs and cGMP as they relate to specific tasks.
• Assist in training and provide technical support of Junior staff.
• Participate in transferring and training of analytical technical staff on methodology for which qualification has been successfully completed.
• Maintain up to date training records on all procedures and protocols applicable to work duties.
• Ability to work in a structured and regulated environment
• Work productively in group situations as well as independently.
• Perform all other related duties as required.

Perform routine testing techniques, such as the following, with a high degree of reliability, efficiency and accuracy:

• Chromatographic Analyses including Process Related Residuals.
• Quantitative Monosaccharide and Sialic Acid Analysis.
• ELISA/ Immunoassay Analyses.
• Process Residual/Drug Product Excipient Analyses.
• N- Terminal Sequencing.
• Amino Acid Compositional Analysis/Extinction Coefficient Determination.
• Use of Empower and Chromeleon Software.

Education:

• Bachelor’s degree (B.A. /B.S.) or equivalent in Chemistry/Biotechnology or related scientific discipline. M.S. or Ph.D. preferred.

Experience:

• Minimum 3 year’s relevant experience within a contract research, academic or pharmaceutical industry, including experience in the core competencies of characterization and analysis of biotherapeutics.
• An equivalent combination of education and experience with contract research or the pharmaceutical industry may be accepted as a satisfactory substitute for the specific education and experience listed above.

Knowledge, Skills and Abilities:

• Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.
• Ability to work on problems of moderate Product where analysis of situation or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Demonstrated ability to operate typical laboratory equipment, specifically HPLC, Plate Reader, CE, spectrophotometer and other laboratory equipment required.
• Ability to handle multiple projects, prioritize work and meet deadlines within a cGMP environment.
• Capable of data interpretation of basic characterization and analysis of biotherapeutics (glycoproteins and pep Products) using analytical laboratory tools and methodologies Capable of anticipating and recognizing potential problems.
• Demonstrated independent analytical and problem-solving abilities.
• Must possess excellent interpersonal skills to maintain communication across functional groups.
• Ability to collaborate effectively within a group environment.
• Able to communicate (verbal and written) effectively in a small group or one on one setting.
• Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software.
• Ability to understand and use internal software programs such as LIMS required.

Work Environment / Physical Demands:

• General laboratory working conditions.
• Regularly wears protective clothing (cap, gloves, scrubs, lab coat, and safety glasses).
• Regularly works with or near toxic or caustic chemicals.
• May be exposed to fumes or airborne particles.
• Regularly works in a chemical fume hood.
• Occasionally works near moving mechanical parts.
• Frequently works with biohazards.
• May be exposed to unpleasant odors.
• The employee may work with sharp objects (i.e. needles, glass pipettes, pipet tips).
• The noise level in the work environment is usually moderate.
• Must be able to remain in a stationary position 50% of the time while performing laboratory tasks.
• Regularly observes, inspects, and interprets laboratory experiments, requiring close vision and the ability to adjust focus and detect and differentiate colors.
• Frequently required to walk, sit, stand, reach with hands and arms, and use hands to finger, handle, or feel objects, tools, or controls.