Associate Director - Analytical & Technical Support

• Lead the activities of the Analytical & Technical Drug Product group which supports formulation development and manufacture of protein and lipid based surfactant drug products.  May require hands-on capability up to 30% at times. 
• Recommends specifications for impurities and degradation products, drug product, APIs and raw materials, as well as specifications for packaging components and devices.
• Approves and/or prepares technical reports/summaries for all work performed within his/her groups (e.g. testing protocols and reports, analytical methods, specifications, investigations, deviations, OOSs, etc.). 
• Provides analytical support for new and existing drugs entities and drug products manufactured and marketed by the Company and its internal/external business partners.
• Provide technical assistance to QC, QA, Manufacturing, Materials Management, Clinical, and various offsite internal and external customers and business partners. 
• Ensures all work within his/her groups is performed in a timely manner (per project plans) and is in accordance with cGMPs, USP/NF/BP/EP compendia, safety requirements, and company’s SOPs.

• Ph.D. in Chemistry, or related pharmaceutical sciences with 5 years QC or Analytical Development experience in the pharmaceutical industry and 2 years of management experience.  MS degree requires 8 years labwork and 3 years management experience.  BS degree requires 10 years of industry experience and 5 years of management.
• Experience in performing and/or supporting drug discovery, characterization, and pre-formulation of large molecule pharmaceuticals, particularly protein and lipid pharmaceuticals, is desired. 
• Experience in R&D of degradation pathways, structural elucidation / assessments, characterization of lipids, PKA surface chemistry, preformulation assessments, standard stability and release methods and analysis.  LC/MS experience is preferred.
• Experience in a GMP or GLP environment.  
• Understanding of leading technologies and research in the above areas.

Qualified candidates should email their resume in confidence to [Click Here to Email Your Resumé].

Please view a complete list of available openings at www.chasedouglas.com.