To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03665

About our client Our client produces biological products with a focus on pharmaceutical preparations and research. Position Location Senior Director, Analytical Technical Support Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead the activities supporting formulation development and manufacture of protein and lipid (liposomal) based pulmonary surfactant drug products for the company and internal/external business partners 2) Assess alternate supplier methods and determine/oversee implementation/actions steps 3) Perform gap assessment, design required studies to ensure all compendial and non-compendial methods related to APIs, raw materials, packaging components and devices are current and optimized 4) Assess, determine improvements and train staff on methods for drug product, APIs, raw materials, packaging components and devices 5) Design and oversee troubleshooting and investigation studies related to the group’s activities for production and laboratory issues 6) Apply scientific knowledge and technical expertise in designing and managing studies 7) Determine the analytical instrumentation needs of the laboratory and for offsite partners 8) Provide technical assistance to QC, QA, Manufacturing, Materials Management, Clinical and various offsite internal and external customers and business partners 9) Track and trend release data for drug product, APIs, raw materials, packaging components and devices 10) Recommend specifications for impurities and degradation products, drug product, APIs and raw materials, as well as specifications for packaging components and devices 11) Approve and/or prepare technical reports/summaries for all work performed within his/her groups (e.g., testing protocols and reports, analytical methods, specifications, investigations, deviations, OOSs, etc.) 12) Ensure 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 the company's SOPs 13) Act as an active and effective project team leader within and outside the department Requirements 1) Ph.D. in Chemistry, or related pharmaceutical sciences, from an accredited college/university with 8 years experience working in a pharmaceutical quality control or analytical development laboratory setting performing progressively more responsible lab work and 3 years of management, preferably 5 years recent experience dedicated to large molecules including protein/lipids 2) Master’s degree in Chemistry, or a related pharmaceutical sciences, from an accredited college/university with 10 years of working experience in a pharmaceutical quality control or analytical development laboratory setting performing progressively more responsible lab work and 5 years of management, preferably 5 years recent experience dedicated to large molecules including protein/lipids 3) BS in Chemistry, or a related pharmaceutical sciences, from an accredited college/university with 15 years experience working in a pharmaceutical quality control or analytical development laboratory setting performing progressively more responsible lab work and 10 years of management, preferably 8 years of recent experience dedicated to large molecules including protein/lipids 4) Experience in aerosolization devices for inhalation 5) Demonstrated experience in performing and supporting drug the company, characterization and pre-formulation of large molecule (biotech) pharmaceuticals, particularly protein and lipid based pharmaceuticals 6) Goodworking knowledge and understanding of current advanced techniques required for structural analysis to support characterization of protein and/lipid formulations and their large molecule constituents 7) Ability to design characterization and pre-formulation studies of protein and lipid formulations 8) Ability to understand and map out synthetic pathways and degradation processes/pathways