Analytical Development Testing Group Scientist
About The Position
Contributes as part of a team of AD scientists towards the execution of various analytical methods to support biological therapeutic product release and characterization testing in a compliance-based environment. Independently performs routine testing, such as but not limited to ELISA, Potency, Activity, HCP, qPCR assays - using established test methods, including associated protocol/report documentation and presentations. Conducts work in compliance with cGMP/GLP, safety, and regulatory requirements. Responsible for working on other non-lab-based tasks from time to time if assigned. Demonstrate independent judgment in technique and method selection, protocol and study design and execution, data analysis, and use of standard practices and procedures for a variety of problems of moderate scope and complexity to meet assigned objectives. Demonstrate troubleshooting capabilities. Responsible for the maintenance of lab equipment and participating in general lab upkeep. Occasional weekend work may be required to passage cells.
Requirements
- Candidate must have a Bachelor degree’s in Cell and Molecular Biology and Biochemistry with a minimum of 2 years of demonstrated work experience with plate-based assays like Binding ELISA and/or cell based assays
- Clear understanding of the concepts of the plate-based assays such as binding ELISA and cell-based cytotoxicity/ potency, their application to the pharmaceutical industry for Biologics, and proficiency with basic statistics.
- Experience with troubleshooting plate-based and cell-based assays
- Prior experience using software like SoftMax Pro and PLA.
- Ability to learn and cross-train on new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
- Excellent communication (oral and written), strong organizational skills and attention to detail
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Authorization to work in the United States indefinitely without restriction or sponsorship.
Nice To Haves
- Master’s degree is a plus, should demonstrate experience with plate-based assays via thesis/published literature and course-work.
- Experience with flow cytometer is a plus.
Responsibilities
- execution of various analytical methods to support biological therapeutic product release and characterization testing
- independently performs routine testing, such as but not limited to ELISA, Potency, Activity, HCP, qPCR assays
- conducts work in compliance with cGMP/GLP, safety, and regulatory requirements
- working on other non-lab-based tasks from time to time if assigned
- Demonstrate independent judgment in technique and method selection, protocol and study design and execution, data analysis, and use of standard practices and procedures for a variety of problems of moderate scope and complexity to meet assigned objectives
- Demonstrate troubleshooting capabilities
- Responsible for the maintenance of lab equipment and participating in general lab upkeep
Benefits
- comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
- Yearly goal-based bonus & eligibility for merit-based increases
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
