QC Analytical Lab Technician

Bristol Myers Squibb; Harvard (MA); On-site; USD 55,000 - 75,000; Full time

Job summary

Bristol Myers Squibb in Devens, MA is seeking a QC Analytical Lab Technician to support bioanalytical testing for method validation, qualification, in-process, release and stability testing of cell therapy products.

The role requires hands-on laboratory work, strong knowledge of cGMP, and the ability to work independently in a fast-paced team environment with cross-functional collaboration. 100% onsite, shift coverage may apply, and 2+ years of industry experience is preferred.

Qualifications

• Bachelor's degree in science or related field required.
• 2+ years analytical testing or QC experience in a regulated environment preferred.
• Hands-on with bioanalytical techniques (cell-based assays, flow cytometry, ELISA, qPCR).
• Ability to follow Global Regulatory and cGMP requirements.

Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• Apply scientific principles to analytical testing methods and proper use of lab equipment.
• Ensure testing is performed in a compliant manner per procedures and cGMP.
• Review data per procedures and cGMP requirements.
• Communicate task progress and needs to management.

Skills

Pipetting technique

Assay execution

Assay - analytical testing

cGMP Knowledge

2+ years industry experience

Education

Bachelor's degree in Science

Tools

LIMS

Job description

100% onsite role

Shift: - 1 Flex shift/Mon through Friday 10am to 6PM

Top 3 to 5 Skills/Must Haves:

• Pipetting technique
• Assay - Some level of analytical chemical bench testing
• Assay execution
• cGMP Knowledge
• 1 to 2 years industry experience

Job Description:

Client is seeking a QC Analytical Lab Technician in Devens, MA. The QC Lab Technician is responsible for supporting Quality Control bioanalytical testing for method validation, critical reagent qualification, in-process, release, and stability testing of clinical and commercial cell therapy drug product. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. The QC Lab Technician role is stationed in Devens, MA and reports to the Manager, QC Analytical for the Devens.

Job Responsibilities:

• Perform routine testing of in-process, final product, and stability samples.
• Use scientific principles to assist with analytical testing methods and the proper use of laboratory equipment.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Review all data in accordance with applicable procedures and cGMP requirements.
• Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
• Support document revision, project, CAPA, and investigation/deviation related tasks.
• Perform assigned tasks within a CAPA, deviation, or project.
• May lead projects and continuous improvement efforts.
• Perform other tasks as assigned.
• Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions. This position works the following shift schedule:

Qualifications and Education Requirements:

• Bachelors degree required, preferably in Science.
• 2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Hands on experience with various bioanalytical techniques (cell based assays, flow cytometry, ELISA, qPCR) and scientific knowledge in the methods.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Strong technical writing skills.
• Strong problem-solving ability/mentality, technically adept and logical.
• Ability to represent the interests of the group on cross-functional teams.
• Ability to work independently in ahigh-paced team environment, meet deadlines, and prioritize work.
• Strong ability to communicate effectively with peers, department management and cross-functional peers. Ability to work with management locally and globally.
• Working knowledge of LIMS.