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Posted 5-14-02:

Senior CMC Development Chemist 

Diatide Research Laboratories a division of Berlex Laboratories, Diatide a specialty pharmaceutical company founded in 1990. Diatide Research Laboratories is engaged in the discovery and development of proprietary disease-specific radiopharmaceuticals that are utilized in the diagnosis and treatment of life threatening conditions such as cardiovascular disease, cancer and infection. Diatide Research Laboratories currently has an opening for Senior CMC Development Chemists.

 Responsibilities:

• Efficient CMC development of new radiopharmaceutical products with an emphasis on speed to market and while remaining within budget.

• Insure accurate and timely filing of all NDA CMC sections leading to drug approval, as well as successful filings of IND’s or equivalent.

• Develop industry leading analytical methods for raw materials, finished product as well as insuring timely and suitable manufacture of clinical trials supply.

• Work with Quality to insure compliance with stability programs and clinical trial supply release regulations.

 Requirements:

1.  Ph.D. or MS in Chemistry, Bio – Chemistry, Medicinal Chemistry or an Associated Science

2.  Previous Industrial experience in Pharmaceutical Product development.

3.  Experience with Radiopharmaceuticals, Radio-imaging, Radiolabeling, Synthetic Peptide development is desirable. 

Senior Medicinal / Peptide Chemist 

Diatide Research Laboratories a division of Berlex Laboratories, Diatide a specialty pharmaceutical company founded in 1990. Diatide Research Laboratories is engaged in the discovery and development of proprietary disease-specific radiopharmaceuticals that are utilized in the diagnosis and treatment of life threatening conditions such as cardiovascular disease, cancer and infection. Diatide Research Laboratories currently has an opening for several Senior Medicinal / Peptide Chemists. 

Responsibilities: 

• Conduct SAR and SBR studies around target molecules in both in vivo and in vitro models as well as plan subsequent synthetic targets on the basis of in vivo and in vitro data. 

• Partner with pharmacologists to test and develop promising drug targets. 

• Prepare presentations and reports to support the patents, as well as FDA required filings 

• Utilizing modern techniques of isolation, purification and characterization of organic compounds such as analytical and column chromatography, proton and carbon NMR, IR, mass spectral analysis.

•  Share R&D efforts across Schering AG worldwide to achieve corporate-wide technological, scientific and operational synergies.

 Requirements:

1. Ph.D. in Chemistry, Medicinal Chemistry, Bio-Chemistry or an MS with 5 years of industrial experience working as a Medicinal Chemist.

2. Documented success in the areas of Medical Chemistry and Organic Synthesis

3. Hands on ability to operate and interpret spectra from NMR, IR, and MS instrumentation.

4. Previous experience with Radio pharmaceuticals is helpful.

Director – CMC Development

 Diatide Research Laboratories a division of Berlex Laboratories, Diatide a specialty pharmaceutical company founded in 1990. Diatide Research Laboratories is engaged in the discovery and development of proprietary disease-specific radiopharmaceuticals that are utilized in the diagnosis and treatment of life threatening conditions such as cardiovascular disease, cancer and infection. Diatide Research Laboratories currently has an opening for a Director of CMC Development. 

Responsibilities:

• Efficient CMC development of new radiopharmaceutical products with an emphasis on speed to market and while remaining within budget.

• Oversee product formulation and analytical development studies, processing scale-up studies and stability studies to support current and new formulations, writing technical reports to support FDA submissions and assembly of CMC documentation. 

• Supervise the comprehensive and timely filing of all CMC sections for regulatory submissions and responses leading to drug approval, as well as effective post-approval CMC LCM support.

• Develop industry leading analytical methods for raw materials, finished product as well as insuring timely and suitable manufacture of clinical trials supply.

• Hire, manage and retain superior product development staff.  

• Build relationships and partnerships within Schering AG ’s Domestic and European research and development groups.

Requirements: 

1. Ph.D. in Chemistry, Bio - Chemistry, Medicinal Chemistry or Associated Sciences

2. 5 years of previous Industrial CMC experience in Parenteral Pharmaceutical Product development.

3. Experience with Radiopharmaceuticals, Radio-imaging, Radiolabeling, Synthetic Peptide development is desirable.

4. Current knowledge of cGMPs, ICH guidelines and FDA regulations

Posted 5-06-02:

ArQule, Inc www.arqule.com

At ArQule, our Parallel Track(tm) drug discovery program integrates critical technologies for faster, more efficient lead generation, quali