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API Process Development Scientist
Job Summary
Company Job ID
2031572
Job Title
API Process Development Scientist
Company:
Agilent
Location
United States
AJE Reference Number
524385152
Job Start/End Date
not provided
Job Type
Regular
Job Classification
Full Time
Hours/Week
not provided
Salary Range
not provided N/A
Education
not provided
Required Degree/Formal Training
not provided
Required Licenses/Certificates
not provided
Experience
not provided
Company Homepage
http://www.agile...

Agilent Technologies Life Science Chemical Analysis Life Sciences Solutions Unit (LSSU) is creating the tools and technologies that are changing the way we understand the world of our customer. Through a comprehensive set of lab productivity and total workflow solutions, LSSU helps scientist advance basic research, unlock the genetic causes of disease and accelerate the discovery and development of new drugs. In this role as an API Process Development Scientist, you will join the fast pace world of a highly motivated team working on fine chemical product/process development and scale up of bulk active ingredients for the pharmaceutical industry.Key responsibilities:- Interfacing with internal and external customers in the development of chemical processes for the manufacturing of oligonucleotide APIs. - Partnering with cross-functional teams to initiate and execute Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments to support design space understanding and quality by design initiatives as they relate to oligonucleotide synthesis, process chromatography and other purification and isolation techniques- Creating documentation in the preparation chemical process descriptions and technical reports to support internal technology transfer into manufacturing and preparation of client CMC submissions.- Participating at regular internal project review meetings~cb~10/20/09Requires:- PhD Chemistry, Biochemistry; or Life Science discipline or equivalent- 3+ years hands on process development experience in pharmaceutical or biotechnology industrial - Pharmaceutical pilot palnt experience desired- Downstream and purification experience desirable- Hands on experience with HPLC, GC-MS, LC-MS, MS-MS, NMR and other supporting analytical technologies for chemical synthesis -Experience with DOE, statistical process control, Process Analytic Technology (PAT) applications and Quality by Design (QbD) initiatives desired- A proven track record in product/process development of APIs that have been successfully transferred validated and approved by the FDA or corresponding regulatory authority.- Experience in development and successful transfer of safe, robust and scalable processes for the preparation of APIs.- Knowledge of ICH Q7 and cGMP guidelines highly desired- Excellent communication (oral and written), computer skills and interpersonal skills a must- Ability to interface with global cross-functional internal and external customers and partners - Track record of success in working with multiple projects in a fast pace environment managing to aggressive time lines and deliver projects on time- Available for occasional business travelGeo Location: Boulder, CO~cb~10/20/09

Job Benefits

Child Care
Clothing / Uniform Allowance
Dental Insurance
Flexible Benefits
Flexible Work Schedule
Health Insurance
Holidays
Life Insurance
401K / Retirement Plan
Sick Leave
Vacation
Vision Insurance
     
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