SCIENTIST

Pay- $42.34/hr on W2



Job Description:



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.

ESSENTIAL 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.

Perform routine testing techniques, such as the following, with a high degree of reliability,

efficiency and accuracy:

o Chromatographic Analyses including Process Related Residuals

o Quantitative Monosaccharide and Sialic Acid Analysis

o ELISA/ Immunoassay Analyses

o Process Residual/Drug Product Excipient Analyses

o N- Terminal Sequencing

o Amino Acid Compositional Analysis/Extinction Coefficient Determination

o Use of Empower and Chromelion Software

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.