Job description

Title: Specialist, QC Bioassay

Location: Norwood MA

Responsibilities:

• Support bioassay testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies.

• Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities, including Sequencing and qPCR assays as required.

• LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS

• Lead special projects as Bioassay SME in support of clinical operations.

• Conduct technical assessments of deviations and investigations.

• Train junior laboratory staff on Molecular Biology methods.

• Review SOPs, protocols, and reports.

• Troubleshoot issues related to equipment, laboratory procedures and assay performance

• Perform general laboratory support activities including reagent preparation, equipment maintenance, etc.

• Establish and maintain a safe laboratory working environment.

• Accept, complete, and report on assignments within the agreed upon timeframe.

• Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations.

Qualification:

• BS in a relevant scientific discipline with a minimum of 2-5 years (or MS in a relevant scientific discipline with 0-2 years)

• Quality Control experience in a cGMP organization with a focus in Molecular Biology and DNA Sequencing.

• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations

• Knowledge and hands-on experience performing and troubleshooting Sanger Sequencing and qPCR.

• Demonstrated knowledge of method qualifications.

• Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way.

• Proven ability to conduct investigations.

Best Regards,

Vivek Kumar

IDC Technologies, Inc

Job Type: Full-time

Salary: $60,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Norwood, MA 02062: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Molecular biology (Preferred)

Work Location: One location

seankuhnke.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, seankuhnke.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, seankuhnke.com is the ideal place to find your next job.