Associate Director, Regulatory Affairs Strategy

Organization
Sun Pharma
Job Location
Philadelphia, PA
Job Description

 

The Assay Development Associate - Vector Shedding/Bio Distribution will: 
•With guidance and supervision from the group leader or supervisor, conduct clinical and preclinical sample analysis per SOPs and generate data with high scientific quality to meet GLP regulatory expectations. 
•Participate in validation of bioanalytical assays such as immunoassays and cell-based assays. 
•Implement new assays or optimize existing assays based on in-depth knowledge of laboratory techniques. 
•Participate in sample management activities such as receiving, processing, storage and shipping clinical and preclinical samples. 
•Work with senior staff to ensure the availability of adequate laboratory materials and qualify new reagents, as needed. 
•Participate in instrument maintenance and qualification. 
•Maintain accurate, timely and detailed records of work.

RESPONSIBILITIES:
30% of the time 

•Sample processing and testing
20% of the time 

•Assay validation
20% of the time 

•Sample management
10% of the time 

•Assay optimization and troubleshooting
10% of the time 

•Instrument maintenance/qualification
10% of the time 

•Reagent inventory, ordering, preparation and qualification

Requirements: 
QUALIFICATIONS:
•Ability to learn new techniques, perform multiple tasks simultaneously 
•Ability to work independently after initial training as well as being part of a team; possess self-motivation, adaptability, and a positive attitude 
•Excellent organizational, communication and collaborations skills 
•Keep accurate records, follow instructions, and comply with company policies. Familiarity of Electronic Lab Notebook (ELN) and Laboratory Information Management Systems (LIMS) a plus...cont.

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