Analytical Extractable and Leachable Scientist
About The Position
Using GC-MS, LC-MS, and/or ICP-MS to support commercial and clinical testing of extractables and leachables for pharmaceutical manufacturing following all pertinent protocols and standard operating procedures (SOPs). Generate, compile, and process complex data. Reviews test results to ensure compliance with standards; reports any quality anomalies. Use processed and historical data to support conclusions and author technical summary documents of test results. Calibrates or verifies calibration of instruments/devices prior to use. Troubleshooting instrumentation and lab techniques when appropriate. Comply with all pertinent regulatory agency requirements. Follows all current cGxP (e.g. good manufacturing processes, good documentation practices, etc.) Participates in required training activities as both trainee and trainer. Mains laboratory supplies, safety, and compliance. Interacts with outside vendors and/or functional peer groups in a professional manner. May assist in validation of methods Excellent communication (oral and written) and attention to detail. Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Requirements
- Bachelor’s degree in chemistry (or other science related degree concentration) with 2+ years of industry experience, or Master's degree with any industry experience
- Experience in GC-MS, LC-MS, and/or ICP-MS
- Experience operating inside of a GMP lab space
- Strong computer, scientific, and organizational skills
- Experience writing and reviewing detailed technical documents
- Experience with an electronic laboratory information management system
- Authorization to work in the United States indefinitely without restriction or sponsorship
Responsibilities
- Using GC-MS, LC-MS, and/or ICP-MS to support commercial and clinical testing of extractables and leachables for pharmaceutical manufacturing following all pertinent protocols and standard operating procedures (SOPs).
- Generate, compile, and process complex data.
- Reviews test results to ensure compliance with standards; reports any quality anomalies.
- Use processed and historical data to support conclusions and author technical summary documents of test results.
- Calibrates or verifies calibration of instruments/devices prior to use.
- Troubleshooting instrumentation and lab techniques when appropriate.
- Comply with all pertinent regulatory agency requirements.
- Follows all current cGxP (e.g. good manufacturing processes, good documentation practices, etc.)
- Participates in required training activities as both trainee and trainer.
- Maintains laboratory supplies, safety, and compliance.
- Interacts with outside vendors and/or functional peer groups in a professional manner.
- May assist in validation of methods
- Excellent communication (oral and written) and attention to detail.
- Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Benefits
- comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
- Yearly goal-based bonus & eligibility for merit-based increases
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
