Bioanalytical QC Scientist (ELISA/ CAR-T) in Warren, NJ

Manage Would Like to See Candidate's with:

• 2+ years of hands-on experience with bioanalytical technique such as ELISA, Potency, Cell based assays, etc.
• 1+ Experience working in regulated environment (e.g. cGMP, cGLP)
• Previous Assay Transfer, assay validation experience
• Previous CAR-T experience preferred
• Technical understanding and troubleshooting skills
• Experience/knowledge in deviation, CAPA, Change Control
• Team player, flexible, good communication skills

Purpose:

• The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products.
• This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot.
• Additionally, when needed, this position will be able to assist with training and assay transfer.

Required Competencies: Knowledge, Skills, and Abilities

• Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS and cell-based assays.
• Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality Control group.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Technical writing skills.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to represent the interests of the group on cross-functional teams.
• Ability to set priorities of the group and manage timelines.
• Ability to work with management locally and globally.
• Ability to communicate effectively with peers, department management and cross-functional peers.

Duties and Responsibilities

• Perform testing of in-process, final product, stability samples, and method transfer.
• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Anticipate and troubleshoot problems.
• Recommend corrective actions and participate in the development of best practices.
• Understanding of regulatory guidelines.
• Complete all work in a timely manner.
• Work and communicate effectively within the team to ensure timelines are met.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
• Document training per procedural and cGMP requirements.
• Perform assigned tasks within a CAPA, deviation, or project
• Draft and review technical documents, such as SOPs and forms.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Performs other tasks as assigned.

Education and Experience

• Bachelor’s degree required, preferably in Science.
• 2-3 years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute.
• EX: if the person has a Master degree but less exp. (1-2 years), manager would still consider that candidate.

Working Conditions

• The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
• The incumbent must analyze numerical values on a daily basis.
• The incumbent will be working a laboratory setting up to six (6) hours per day.
• The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.

Additional Information:

• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
• The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
• There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
• Employees holding this position will be required to perform any other job-related duties as requested by management.

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