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Job #02654

About our client Our client is a biopharmaceutical company based in Wisconsin. They are known worldwide as the supplier of high-quality pharmaceutical ingredients. The company has been a leader in its field of expertise for the last 3 decades. It has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Associate Director, Quality Control Waunakee, Wisconsin Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage all QC laboratory functions in support of marketed products and products in development 2) Ensure prompt, accurate and cGMP/ICH-compliant reporting of data for raw materials release, in-process tests, finished product release, stability, investigations and others 3) Establish departmental priorities to meet company and regulatory requirements 4) Monitor work and evaluate the performance of QC Chemistry and Microbiology supervisors and/or analytical staff for compliance with GMPs, current analytical compendia, including the USP and company SOPs 5) Communicate with contract laboratory facilities and investigate out of specification results generated by contract labs 6) Validate instruments and analytical methods in the QC Department 7) Manage personnel with respect and provide education and mentoring, as necessary to meet the continually changing needs of the QC Laboratory in the pharmaceutical industry 8) Document and report data for raw materials release, in-process tests, finished product release, investigations and other analytical support for marketed products and contract manufacturing products at various stages of pharmaceutical development 9) Act as the primary signing authority for all QC procedures 10) Initiate, evaluate, document, complete and communicate all Analytical Laboratory Investigations (ALI) and external laboratory investigations in support of potential Out-of-Specification (OOS) investigations Requirements 1) Ph. D. in Chemistry, Biology or a related Life Science 2) Minimum 10 years of working experience in a pharmaceutical laboratory in support of a manufacturing environment along with at least 5 years of successful management experience in a pharmaceutical environment 3) Proficiency in using at least four of the following analytical techniques: HPLC, GC, mass spectroscopy, agarose gel electrophoresis, protein/enzyme 4) Knowledge of and experience in pharmaceutical cGMP and ICH guidelines 5) Effective personnel and project management skills of the QC Chemistry, QC Microbiology, QC Polymerase Chain Reaction and QC Instrumentation Laboratory functions 6) Experience in conducting pharmaceutical laboratory investigations of specification results to FDA standards 7) Familiarity with the United States Pharmacopoeia/National Formulary (USP/NF), (Food and Drug Administration) FDA’s Code of Federal Regulations (CFRs) parts 210 and 211, ICH Guidelines Q1, Q2, Q3, Q6, Q7, Q8 8) Ability to manage multiple technical projects and personnel efficiently while documenting and communicating to internal and external customers to the pharmaceutical standards 9) Demonstrated leadership ability 10) Effective interpersonal skills 11) Skills in translating theoretical knowledge into practical application and providing training for less experienced personnel 12) Computer experience in word-processing, databases, spreadsheets and email software (Microsoft preferred)