Minnnesota Bioscience Jobs

Job Information

WuXi AppTec Customs Study Director in St. Paul, Minnesota

WuXi AppTec US-MN-St. Paul Job ID 2021-7709 Overview Responsible for all aspects of custom studies performed within In-Life Services (ILS) at WuXi AppTec. The Study Director - Customs interfaces between the St. Paul facility, Subcontract Laboratories and the Sponsor in terms of study planning, organization, execution, data analysis and final report construction. They will handle all resource planning and sponsor communication to complete the assigned studies on time. Responsibilities * Responsible for all aspects of assigned custom projects * Maintains up-to-date knowledge of applicable guidelines and regulations * Performs data analysis, data interpretation and reporting of results * Ensures all aspects of the study are compliant with appropriate SOPs, GLPs, and applicable regulatory guidelines * Interacts with Verbal and Written communication with internal and external clients * Consult, advise on complex non-clinical or research/discovery experimental designs * Generate and maintain client and IACUC protocols * In charge of study initiation and closure * Manage and monitor multiple customized projects simultaneously * Frequently interact with technical staff to ensure study validity and protocol compliance * Develop expertise in applicable guidance interpretation * Identify and implement process improvements and best practices * Contributes scientific and technical expertise with high attention to detail * Demonstrates efficient and organized project management skills, effective communication skills, strategic and critical thinking as well as problem solving abilities * Thrives in a fast paced, multitasking environment, showing both leadership and team building skills * Ability to work in a team environment and independently as required * Contributes to the overall operations and to the achievement of departmental goals * Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures. * Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices * Other duties as assigned * May be required to assist in other departments Qualifications Job Requirements: Experience / Education * Minimum 5 years of relevant experience or equivalent * PhD or MSc in toxicology, pharmacology, microbiology, biological sciences, or related field. Experience may be substituted for education (e.g., Bachelor's in biological sciences plus 5 or more years of relevant experience) * Preferred (Ex. AALAC certifications, SPHR) Knowledge / Skills / Abilities: * Proficient in Oral and Written communication skills * Need to be able to read, write and understand English * Strong Customer Services Skills * Experience with Statistical analyses * Experience with small animal studies * Knowledge of medical device and/or biologics testing requirements, preferable * Experience with GLP, preferable * Experience in a regulatory environment, preferable * Experience in technical writing or formal data presentation, preferable * Proficient in Microsoft (Excel, Word, Outlook) Physical Requirements: * Must not have animal allergies to applicable species in this facility * Must be able to work in environment with variable noise levels * Ability to stand /sit/walk for long periods of time * Ability to lift X lbs routinely * Ability to crouch, bend, twist, and reach * Ability to push/pull X lbs routinely/ often / occasionally * Clarity of vision * Ability to identify and distinguish colors * Must be able to perform activities with repetitive motions An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assig