Senior Associate Scientist - Product Characterization
Senior Associate Scientist - Product Characterization
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Job Description
Your Role:
The Senior Associate Scientist will oversee a wide variety of safety testing required to manufacture clinical and commercial products. The Scientist will be the primary scientific resource for a given study with the Product Characterization lab within the overall Biologics department. The Senior Associate Scientist is responsible for making observations and ensuring all documentation is in compliance with procedures and regulations.Perform analysis of testing performed within the Product Characterization Laboratory. May act as subject matter expert in bioassay development for studies performed in the Product Characterization laboratory. Will develop/validate and perform GMP methods.
- Provides day to day technical support to the laboratory.
- Performs analysis and interpretation of data.
- Prepares/ reviews protocols and final reports.
- May serve as study director and ensures timely initiation and completion of all studies.
- Ensures testing is performed in accordance with SOPs and regulations
(cGMP and GLP)for custom/non routine and new services. - Participate and/or drive assay development/ assay transfer and/or assay validation activities.
- Justify business needs and drive implementation of new services.
- Operates and maintains lab equipment as required by SOPs and testing procedures.
- Responsible for resolving deviations/ completing event records.
- Liaise with Quality Assurance and appropriate crossfunctional departmental areas to close the events and corrective actions identified during GxP laboratory testing.
- Maintains high level knowledge of lab procedures and assays.
- Responsible for creating revising SOPs laboratory records and other related documentation.
- Coaches/ trains others on developing and enhancing day to day laboratory techniques.
- Contributes ideas and suggestions to improve standard laboratory techniques protocols processes and equipment.
- Regarded as a subject matter expert (SME)
- Provide technicaladvice and support for internal and external interactions such as client and regulatory audits/inspections meetings teleconferences.
- Promote a culture of continuous improvement within Biologics; act as champion on initiatives and/or projects to drive improvement in quality and / or client service. Contributes/ authors scientific publications and presents at conferences/ seminars. Leads projects that cross multiple disciplines.
- Complies with company health and safety regulations and procedures.
- Performs other duties as assigned
Who You Are:
Minimum Requirements:
- Ph.D. in scientific discipline (i.e. Chemistry Biochemistry etc. with 1 years working laboratory experience OR
- Masters degree in scientific discipline (i.e. Chemistry Biochemistry etc. with 2 years working laboratory experience OR
- Bachelors degree in scientific discipline (i.e. Chemistry Biochemistry etc. with 5 years working laboratory experience
Preferred Requirements:
- Relevant working knowledge and Experience with development of assays with some or all the following technical disciplines;
- Flow Cytometry
- Host Cell Protein ELISA
- ELISA
- Cell based assay experience
- SPR Platforms
- Developing and validating assays in GMP environment
- Usage of following software/equipment:
- SoftMax Pro
- BD Facs Diva
- Cytiva/GE Biacore (T200/8K system)
- Usage of automated cell counter
RSRMS
Required Experience:
Senior IC
Employment Type
Full Time
