Analytical Extractable and Leachable Scientist Group Leader
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. 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 Leadership Responsibilities Supports and monitors performance of team of employees Monitors the day to day operations of QC analyst staff May participate in new hire interviews Supports the on-boarding process of new employees Facilitate staff access to systems, controlled areas, etc. using approved procedures Participates in training of other employees. Performs peer review of data. May support peer group lead operations Assists in coordinating equipment maintenance and calibration. Disseminate administrative communications Demonstrate and promote the company vision Meet all quality and productivity metrics, and demonstrate strong teamwork and collaboration Participate in productivity tracking and prepares monthly metrics and quality reports. Coordinate scheduling and allocation of responsibilities, and new hire on-boarding process Coordinates training program
Requirements
- 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
- 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
- 1-2 years of previous dynamic team leadership experience
- 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
Nice To Haves
- Strong leadership and teambuilding skills
- Familiarity with Lean or 5s or Operational Excellence
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
- Supports and monitors performance of team of employees
- Monitors the day to day operations of QC analyst staff
- May participate in new hire interviews
- Supports the on-boarding process of new employees
- Facilitate staff access to systems, controlled areas, etc. using approved procedures
- Participates in training of other employees.
- Performs peer review of data.
- May support peer group lead operations
- Assists in coordinating equipment maintenance and calibration.
- Disseminate administrative communications
- Demonstrate and promote the company vision
- Meet all quality and productivity metrics, and demonstrate strong teamwork and collaboration
- Participate in productivity tracking and prepares monthly metrics and quality reports.
- Coordinate scheduling and allocation of responsibilities, and new hire on-boarding process
- Coordinates training program
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
