Sr. Scientist - Analytical

Job Summary

Serve as the Principle Investigator Senior Scientist responsible for the development and execution of highly complex method development and characterization studies related to the testing characterization and analysis of biotherapeutics using analytical instrumentation and methodologies. Independently responsible for conducting and guiding method feasibility, development, optimization, method transfers, qualifications and ICH validations, and for conducting routine testing in both R&D and cGMP environments.  Responsible for guidance and oversite of Jr. Staff performing same.  Additionally, will be responsible for management of projects including client interaction, interpretation and reporting of data for   assigned research projects.  May be responsible for oversite of Laboratories and Scientific staff.

Essential Duties

•    Functioning independently as the Principle Investigator/Sr. Scientist and technical expert on highly complex studies, develop, 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.
•    Generate and finalize high quality method and study protocols for sponsor and internal characterization and sample testing programs.  Ensure that study protocols are amended to accurately reflect any changes in, scope of work or deliverables, in a timely fashion.
•    Function as the primary contact for the planning and execution of Sponsor interaction related to proposal management, research and method development, and for the design, scheduling, conduct and reporting of studies.
•    Provide oversight of laboratories and mentor and/or supervise scientific staff in the development and execution of studies to generate high quality scientific data within accepted regulatory compliance.
•    Provide mentoring and technical guidance to resolve analytical challenges in a timely fashion. 
•    Implement techniques to improve productivity, increase efficiencies and maintain laboratory state-of-the-art practices. 
•    Perform routine testing techniques, such as the following, with a high degree of reliability, efficiency and accuracy:

o    Biologics ChromatograpyChromatography Analyses 
o    Process Related Residuals Chromatographic Analyses
o    Quantitative Monosaccharide and Sialic Acid Analysis
o    ELISA/ Immunoassay Analyses
o    Drug Product Excipient Analyses
o    N- Terminal Sequencing
o    Amino Acid Compositional Analysis/Extinction Coefficient Determination
o    Use of Empower and Chromelion Software

Responsibilities

•    Independently review, interpret, analyze, evaluate, integrate, present and discuss experimental data with research staff and Sponsor.
•    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 minimal assistance
•    Assist in the technical review of procedures and data and documentation.
•    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.
•    Provide scientific and technical leadership within Biologics to resolve analytical challenges in a timely fashion, including research and development of new methodologies in study conduct.
•    Manage improvement projects (e.g. redesign of SOP’s, research procedures or report formats).
•    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..guidance.
•    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.

Job Qualifications

•    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 7 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.
•    Certification/Licensure: None.
•    Other: Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred. Ability to work on problems of complex scope 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 peptides) using analytical laboratory tools and methodologies. Capable of anticipating and recognizing potential problems. Demonstrated independent analytical and problem-solving abilities. Experience with Sponsor interaction and business development.  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 and one-on-one settings.  Computer proficiency in MS Word, Excel, Outlook, instrumentation and data analysis software. Ability to understand and use internal software programs such as LIMS required.

Physical Demands

•    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.
•    Frequently and accurately operate laboratory pipettes.
•    Regularly lift and/or move up to 10 pounds and may occasionally lift and/or move up to 50 pounds. 
•    Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. 
•    Must regularly communicate with employees; must be able to exchange accurate information. 

WORK ENVIRONMENT:
•    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.

COMMENTS: 
•    This position may require overtime, weekend, holiday, and/or after hours shift coverage, as needed.
 

Compensation Data

The pay range for this position is $120,000 to $130,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

Competencies