US-NH-South (Manchester): Director / CMC Development (8496366)
Berlex
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Company: Berlex
Title: Director / CMC Development
Location: US-NH-South (Manchester)
Job ID: CS0610DD
Category: Biotechnology / Pharmaceutical
Status: Permanent / Full Time
Salary: Not Entered
Education: Doctorate
Experience: Five plus Years
Travel: Up to 25%
Relocation: Some Assistance
Contact: Berlex
Email: john_...@berlex.com
Phone: 603-621-7387
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Job Description / Details . . .
Director & 8211; 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 & 8217;s Domestic and
European research and development groups.
Requirements:
Ph.D. in Chemistry, Bio - Chemistry, Medicinal Chemistry or Associated Sciences
5 years of previous Industrial CMC experience in Parenteral Pharmaceutical Product
development.
Experience with Radiopharmaceuticals, Radio-imaging, Radiolabeling, Synthetic
Peptide development is desirable.
Current knowledge of cGMPs, ICH guidelines and FDA regulations
To be considered for these openings please submit your resume to
john_...@berlex.com ,
603-437-8977 or Via Mail:
Diatide / Berlex Laboratories
9 Delta Drive
Londonderry, NH 03053
603-621-7387
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