- Grow and manage a team of analytical chemists to complete the development, validation, and execution of methods to ensure the completion of GMP campaigns.
- Provide analytical chemists with guidance and training as necessary to support their growth and maximize their success.
- Have the ability 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 if facility work load requires.
- 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.
- In coordination with QA, develop and ensure compliance with SOPs related to the analytical group.
- Typically, BS w/ 15+ years relevant experience, 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 strongly preferred.
Responsibility and compensation:
In this hands-on position, you will contribute to the R&D team. You will report directly to the Head of Operations.
The Flamma Group is a growing CDMO. You will join a growing company that has established a solid reputation worldwide. As part of our collaborative Malvern team, you will be able to enjoy a satisfying career as a Analytical Chemist. You will work directly with Flamma management located in Italy, France, and the USA as well as customers located in Europe and the USA.
Starting salary will be based on experience. This is an excellent opportunity for someone looking to be part of a ground floor opportunity as Flamma grows their presence in the USA.
FLAMMA is a CDMO with Headquarters near Milan, Italy. As a fully integrated CDMO, we can leverage our 100% self-owned, self-managed facilities, in Italy, China, and USA to deliver a stable, reliable supply chain. We specialize in the cGMP manufacturing of APIs, NCEs, RSMs, & Advanced intermediates (NCEs and generics). We use our expertise in high value chiral materials (specifically amino acid related materials) to provide solutions to customers who not only have need for chiral materials but also clients who have other requirements with a various type of chemistries. In addition, we also manufacture specialty compounds and advanced intermediates for the nutraceutical and cosmetic industries. We also have a variety of niche generic products.