Sr. Manager/ Associate Director - Analytical Validation and Quality Control

We are seeking an experienced Analyticalprofessional for the position. Responsible for overseeing analytical methods validationand quality control testing ofbulk protein drug substance, finishedprotein drug product and raw materials performed at contract sites. Major duties include: Technicalreview of analytical protocols, reports, raw data, deviations, investigationsand specifications for technical accuracy and cGMP compliance. Support changecontrol for analytical testing related issues.  Support release, characterization, andstability of bulk protein and finished protein product at contract sites.Contribute to PAIs; INDs/BLAs and responses to regulators from analyticalperspectives. Test Methods are biochemical, cell-based and microbiological.Assays can be qualitative, quantitative and investigational in nature and areperformed by contract sites in compliance with applicable compendia, productspecifications, cGMPs, and regulatory requirements. This position reports to theSenior Director of Chemistry, Manufacturing, Controls and Quality. It islocated in Malvern, PA.

 

Responsibilities:

  Support management of contract testing organizations that handle analytical methods development/validation, and quality control testing. Perform technical reviews of quality control release and stability data; characterization assays, comparability protocols/reports; analytical test methods development, and methods validation protocols/reports for bulk protein and finished protein drug product and raw materials. Support definition of specifications for bulk protein drug substance and fill/finish protein drug products. Review assay results for raw materials, process intermediates, environmental samples, process validation and cleaning validation samples, and production batch records. Support technical review of quality control testing related laboratory investigations and deviations. Support change controls for analytical testing related issues. Occasionally travels to contract manufacturing sites for analytical data review and audits. Requires up to 15% travel. Drafts/reviews analytical protocols/reports, SOPs, production records for analytical accuracy. Reviews/prepares analytical sections of regulatory submissions and responses to comments. Reviews data for unusual trends and potential problems. 

 

Qualifications:

  PhD or MS/BS in Chemistry, Biochemistry, Biology or equivalent degree and a minimum of 5 to 12 years with PhD and 10 to 17 years with MS/BS experience in Analytical Validation and/or Quality Control function in the Biotech Industry. Analytical experience with all phases of biotechnology drug development, with the ability to resolve complex strategic and analytical regulatory issues. Demonstrated Quality Control and Methods Validation experience in analytical testing for characterization, release and stability assessment of proteins. Prior experience in a small biotech company environment and IND and BLA submissions is highly preferred. Proficiency in analytical methods validation and testing at contract sites is highly desired. Familiarity with cGMP, ICH, FDA and EMEA required.

 

AdditionalQualifications:

  Ability to work with limited supervision.  Accountable for accuracy, validity, and timeliness of reviews. Excellent written and verbal communication skills and multitasking skills. Strong flexibility in daily duties and changes in assignments, and extensive team work.

 

If you are interested in learning more about thisopportunity, or know of someone to recommend, please contact us at recruiting@ceptiontx.com