Scientist 1 Biophysical 1

Job Summary

Serve as the Scientist responsible for the development and execution of moderately complex testing and characterization of biotherapeutics using biophysical instrumentation and methodologies.  May be independently 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 management of projects including client interaction, interpretation and reporting of data of assigned research projects.

Essential Duties

•    Develop, perform, and troubleshoot analytical laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics, through use of biophysical testing and characterization instrumentation and methodologies. 
•    Generate 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 a 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.
•    Assist in oversight of laboratory and mentor technical staff in the development and execution of studies to generate high quality scientific data within accepted regulatory compliance.
•    Implement techniques to improve productivity, increase efficiencies and maintain laboratory state-of-the-art practices. 
•    Perform routine testing in techniques such as the following with a high degree of reliability, efficiency and accuracy:

o    Analytical Ultracentrifugation (AUC)
o    Size Exclusion HPLC-MALLS (SEC-MALLS)
o    Differential Scanning Calorimetry (DSC)
o    Intrinsic Tryptophan Fluorescence (ITF)
o    Fourier transform Infrared (FTIR)
o    Dynamic Light Scattering (DLS)
o    Protein Binding via SPR-Biacore
o    Circular Dichroism (CD)

Responsibilities

•    Review, interpret, analyze, evaluate, integrate, and present experimental data with minimal assistance from senior scientific staff.  
•    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 guidance within Biologics to resolve analytical challenges in a timely fashion, including research and development of new methodologies in study conduct.
•    Manage or assist with 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 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 other related duties as assigned. 

Qualifications

•    Education:  Bachelor’s degree (B.S.) or equivalent in biochemistry, chemistry or related discipline.
•    Experience:  1 to 3 years related industry experience in a biophysical science area in the Pharmaceutical, Biotech or contract (CRO) laboratory environment.  
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Certification / Licensure: None
•    Other:  Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.  Knowledge of basic protein /peptide biophysical techniques and ability to operate typical laboratory equipment, specifically HPLC, spectrophotometer, dialysis/buffer exchange via SPE, and other laboratory equipment a plus.  Strong organizational and prioritization skills required. Attention to detail and accuracy a must.  Must possess excellent interpersonal skills to maintain communication across functional groups. Ability to collaborate effectively within a group environment. Able to communicate effectively (verbal and written) in a small group or one on one setting. Basic Microsoft Office skills are required. 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, safety glasses).
•    Regularly works with or near toxic or caustic chemicals.
•    May be exposed to fumes or airborne particles.
•    Regularly works at a chemical fume hood.
•    Occasionally works near moving mechanical parts.
•    May work with biohazards.
•    Occasionally 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 $110,000 to $120,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

Competencies