Seeking a strong leader to grow and manage a team of analytical chemists to complete the development, validation, and execution of methods to ensure the completion of GMP campaigns.
location: Malvern, Pennsylvania
job type: Permanent
salary: $120,000 - 125,000 per year
work hours: 9 to 5
- Manage multiple projects and the analytical chemists that are executing R&D on these projects.
- Provide analytical chemists with guidance and training as necessary to support their growth and maximize their success.
- Have the knowledge to be able to guide analytical chemists or oversee contract technicians to calibrate, validate, maintain and operate laboratory equipment such as HPLC, GC, HS-GC, FTIR, UV-Vis, pH meter, balances, KF, DSC, TGA, NMR, LCMS, and GCMS.
- Oversee the execution of GMP analyses of raw materials, in-process materials, finished bulk, and stability samples.
- Review and sign off on GMP documentation needed to support release of raw materials, intermediates, and final products.
- Oversee development and validation of methods for use in GMP environment.
- Evaluate analytical methods and procedures and recommend improvements.
- Oversee the execution of GMP testing for campaigns with a focus on accuracy as well as timeliness of results.
- Collaborate with process chemists, operations staff, and QA to ensure successful completion of campaigns and release of raw materials, intermediates, and final products for both GMP and non-GMP projects
- In coordination with QA, develop and ensure compliance with SOPs related to the analytical group.
- MS w/ 10+ years relevant experience, or PhD. w/ 6+ years relevant experience.
- Knowledge of analytical equipment/instruments such as HPLC, GC, HS-GC, FTIR, UV-Vis, pH meter, KF, DSC, TGA, NMR, LCMS, and GCMS is required.
- Familiarity with GMP regulations required.
- Excellent organizational and communication skills required.
- Management experience is required.
- Small molecule drug substance experience strongly preferred.
skills: Analytical Chemistry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.