What are the responsibilities and job description for the Quality Control Analytical Development position at JMD Technologies Inc.?
Scientist, Quality Control Analytical Development
Location: Greater Milford, MA Area (Onsite, Full-Time)
Employment Type: Contract (6 Months, W-2)
Status: Accepting Candidates
About the Role
We are supporting a leading biopharmaceutical organization seeking a Scientist to join the Quality Control Analytical Development group. This role focuses on method qualification and validation for biologic drug substances, with hands-on assay execution and documentation under cGMP. You will work closely with cross-functional teams to prepare analytical methods for transfer into QC labs.
Key Responsibilities
- Support qualification & validation of analytical methods for biologics and process-related impurities
- Execute validation experiments for ELISAs (HCP, Protein A), relative potency assays, molecular biology methods, and qPCR
- Perform analytical method development, qualification, and validation under cGMP with QC
- Apply molecular biology, cell biology, and immunochemistry across analytical procedure lifecycle
- Participate in method transfer into QC, including method development, transfer, and validation
- Review/revise SOPs; author protocols, reports, and documentation
- Collaborate with internal labs to prepare methods for GMP QC release testing
- Provide technical training and work direction to team members as needed
Qualifications
- Bachelor’s degree with 5 years related experience OR Master’s with 2 years in a cGMP environment
- Hands-on experience with SpectraMax M5/M2 and SoftMax GMP software
- Strong understanding of molecular biology assays supporting biologics QC
- Experience with analytical characterization of biologics
- Strong communication, documentation, and time-management skills
- Knowledge of analytical development quality requirements & lab safety
- Preferred: experience with monoclonal antibodies, drug substances/products
- Bonus: biophysical characterization (CE-SDS, SEC, RP/IEX-UHPLC, SDS-CGE, iCIEF, CIEX, peptide mapping)
Compensation (MA Pay Transparency)
- $50–$70/hr (W-2)
- Final rate determined based on experience and interview results
Salary : $50 - $70