Scientist – Functional Method Development & Transfer (MDT)
Location:
Onsite – San Diego, CA
Duration:
6-month contract
Schedule:
Standard working hours
Pay:
40-44 USD/per hour
Must-Have Skills
- Strong attention to detail
- Advanced Excel & Microsoft Word
- GMP / Good Documentation Practices
- Lab management experience
- Molecular biology bench experience
- Next-Generation Sequencing (NGS)
- Strong interpersonal, verbal, and written communication
- Presentation skills
Nice to Have
- Equipment maintenance & onboarding
- Library preparation
- Stability testing
- Statistical analysis
- Test method validation
Job Overview
The Functional Method Development & Transfer (MDT) group
supports manufacturing by providing technical and operational leadership for:
- New product introduction (NPI)
- Process optimization to improve quality and yield
- Development and validation of functional nucleic-acid based test methods
This is a hands-on, independent role
requiring close collaboration with R&D, Quality, Production, and Engineering teams to ensure successful technology transfer into a GMP manufacturing environment.
Support with general lab management and equipment onboarding may also be required.
Key Responsibilities
- Perform laboratory work following written protocols and execute assigned test methods
- Help establish process and QC method requirements to meet product specifications
- Partner with NPI teams throughout the Product Development Process (PDP)
- Act as liaison between development and manufacturing
- Design and execute controlled experiments (DOEs, gauge R&R studies)
- Support qualification and validation activities
- Monitor and analyze results from development and pilot lots
- Investigate off-target outputs and perform root cause analysis
- Provide technical and compliance recommendations
- Present clear written and oral communications in technical meetings
- Author technical documents: protocols, reports, SOPs, and manufacturing documentation
- Support software and instrument validation for NPI transfer into Reagent QC
- Assist with general lab maintenance and equipment onboarding
Requirements
- Ability to support process and test method development activities
- Knowledge of laboratory techniques such as:
- Library preparation
- NGS workflows
- Nucleic acid methods (PCR, probe enrichment/hybridization)
- Biochemical/enzymatic assays
- Strong cross-functional communication and collaboration skills
- Ability to thrive in a fast-paced, changing environment
- Capability to take ownership of lab maintenance and onboarding tasks
Highly Desired
- Experience troubleshooting automation workflows (Hamilton / Tecan)
- Strong proficiency with library prep and NGS techniques
Education & Experience
- B.S., M.S., or PhD in Biochemistry, Chemistry, Biological Sciences, Physical Chemistry, or related field
- 3+ years of relevant experience
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