Biology Scientists (In Vitro) II

In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.
With moderate supervision while demonstrating significant independent ownership of key program tasks, the scientist will:

• Execute release and stability testing in support of the biologics program using standard and specialized orthogonal analytical methodologies for proteins/peptides (e.g. liquid chromatography, capillary electrophoresis, SDS-PAGE, UV/Vis, fluorescence, light scattering, mass spectrometry, immunochemical and cell based assays, biophysical characterization techniques) within a GXP laboratory.
• Independently design and execute experiments and draw appropriate conclusions from experimental data.
• Independently author high-quality technical reports and protocols.
• Qualify and/or validate analytical methods to support clinical product testing.
• Transfer analytical methods to and from the Biosimilars Pharmaceutical Sciences GMP testing laboratory to support in-process, lot release and stability testing of clinical and/or commercial biologics products.
• Collaborate with process development and/or formulation development scientists or operations personnel to plan and execute testing to support drug substance/drug product development and/or product manufacturing.
• Reliably meet project or initiative timelines and revise work plans as needed to address changes in project scope, priorities or timing.

ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
The scientist will execute these tasks within a matrixed team environment that includes but is not limited to other groups within their department and other global Client sites as well as third party laboratories and vendors.

EDUCATION AND EXPERIENCE

Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
• Minimally a BS degree, with MS or PhD preferred.
• 3 to 5 year’s previous pharmaceutical industry experience (GMP compliance preferred).
• Experience in handling, testing and support of biopharmaceuticals (proteins) is required.

TECHNICAL SKILLS REQUIREMENTS
Indicate the technical skills required and/or preferred, as applicable.
• Microsoft Office Applications (e.g. Word, Excel, and Outlook) is required.
• EMPOWER chromatography software is preferred.
• Attention to detail and strong GDP documentation experience is required.
• Excellent verbal/written communication skills and the ability to work well in cross functional and/or multi-geography teams is required.
• Strong project management and organizational skills is required.
• Strong background in standard and specialized methodologies for biologics products is preferred.
• Experience with the qualification/validation of analytical methods for biologic products is preferred.


PHYSICAL POSITION REQUIREMENTS
Note the physical conditions in which work will be performed, if applicable to the position. Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc. Please include any hazardous materials or non-standard working environment the contractor will have exposure to which may require additional medical testing and/or apparatus fitting for OSHA compliance.
Ability to perform standard laboratory work (e.g. preparing samples, solutions, performing assays, operating standard laboratory equipment, etc.) and office work (e.g. experimentation documentation, writing/reviewing/approving protocols and reports, performing data analysis, etc.).
This will require sitting or standing for several hours at a time and ability to lift up to 40 pounds.
Potential exposure to air contaminants from active pharmaceutical ingredient powder and solvents may require the use of respiratory protective equipment that is provided upon completion of medical clearance and respirator fit testing.

What is the minimum education experience required?:

Minimally a BS degree, with MS or PhD preferred.

• 3 to 5 year’s previous pharmaceutical industry experience (GMP compliance preferred).

• Experience in handling, testing and support of biopharmaceuticals (proteins) is required.