Description
Will be responsible to develop bio-analytical methods for testing and characterization of protein Therapeutics (including monoclonal antibodies) using bio-analytical techniques like ELISA, SPR and cell-based bioassays. The scientist will be a key technical resource responsible for developing methods under the guidance of other senior scientists, generating reliable and interpreting data, using analytical instrument that include plate-readers UV/Vis spectrophotometer, plater readers, cell-counters, Real-time PCR and microscope. You will be expected to develop cell-based and ELISA (Enzyme-Linked Immunosorbent assay) based assays to determine potency of various biological molecules including recombinantly derived protein therapeutics like monoclonal antibodies. You will be expected to develop a close working relationship with Technical personnel at all levels within the organization to provide technical support needed in meeting R&D milestones and goals.
This position is also responsible for designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.
Essential Duties & Responsibilities
Develop and validation of bio-analytical methods for drug substances, drug products, and related-substances.
Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.
Write protocols, reports, methods, standard operation procedure, and submission documents.
Provide analytical support for formulation and process development.
Perform independent scheduling and coordination of activities.
Conduct instrument troubleshooting.
Conduct laboratory investigation and prepare laboratory investigation report.
Maintain and order laboratory inventory for reagents and chemicals.
Performs other functions as required or assigned.
Complies with all company policies and standards.
Requirements
Education
Master's degree in Chemistry or related discipline with minimum of 2 years of experience, or a PhD.
Specialized Knowledge and Skills
Should have good understanding of instruments like plate-readers, SPR, FACS etc. and should be aware statistical tools.
Good understanding of biochemistry and cell-biology to design and develop bio-analytical assays.
Good understanding of USP methodologies, ICH Guidelines, cGMP and FDA regulations.
Hands on experience in wet biochemical techniques and cell-culture techniques (preferred).
Good verbal and written communication skills.
Attention to details and accurate record keeping.
Ability to plan, schedule and work independently in a fast-paced environment. Self-motivation, adaptability, and a positive attitude.
Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
Ability to work under pressure and meet deadlines.
Work Environment & Physical Demands
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Some travel may be involved.
Employment Type: Contractor
Salary: $ 40.00 Per Hour
