The Senior Analytical Scientist/Analytical Scientist is responsible for the following:
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
Conduct GMP analyses of raw materials, in-process materials, finished bulk, and stability samples
Complete GMP documentation needed to support release of raw materials, intermediates, and final products
Develop and validate methods for use in GMP environment
Evaluate analytical methods and procedures and recommend improvements
Execute GMP testing for campaigns with a focus on accuracy as well as timeliness of results
Typically, BS w/ 10+ years relevant experience, MS w/ 5+ years relevant experience, or PhD. w/ 3+ 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
About Flamma 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 the USA to deliver a stable, reliable supply chain.
We specialize in the cGMP manufacturing of:
• 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, and we have a variety of niche generic products.
FLAMMA has four state of the art cGMP manufacturing facilities, each with its own R&D staff and labs.
1. Flamma Chignolo has 120 m3 capacity
2. Flamma Isso has 130 m3 capacity
3. Flamma Honkai is located outside of Dalian, China with 200 m3 of capacity
- Flamma Honkai provides the security of constant Italian management
& oversight. It is like having an Italian facility in China.
...4. Flamma USA is located in Malvern, PA outside of Philadelphia
- Flamma-delpia features a cGMP Pilot Plant, 6 standard cGMP kilo lab suites, 1 cGMP HPAPI kilo lab suite, 22 fume hoods, an analytical development lab as well as a QC lab, and additional space for future expansion for any necessary analytical, chemistry, and/or warehouse needs.
Flamma works on both early stage pre-clinical development of small molecules (multi-kilo) as well as large-scale commercial manufacturing (MT) bringing value to those in the pharmaceutical industry. With over 600 employees and a total capacity of 450 m3 and the flexibility to use three different manufacturing sites and four different R&D labs, see why Flamma is the “go to” contract manufacturer of the pharma industry. Experience the FLAMMA difference today!
FLAMMA- The Thinking CDMO™