Position Summary:The Manager, Kit Production will provide day-to-day management, technical, performance leadership and long-term development of Kit Production at Precision for Medicine Central Laboratory. This role will manage Team Leads and support staff to ensure the successful implementation and execution of new/ongoing Clinical Trials Kit Building, while maintaining adherence to global standard operating procedures and quality control guidelines. Extended work hours may be necessary in order to meet business Demands.Essential functions of the job include but are not limited to:Management of Kit Production Team: Direct oversight of staff involved in the assembly and shipping of consistently high quality visit specific kits to investigator sitesProvides close leadership to meet or exceed required ship dates for kits, and communicate any delays related to production or suppliesLiaise with Inventory Control staff to ensure appropriate supplies are available to support demandLiaise closely with the Project Management and Study Coordinator to ensure effective preparation and implementation of start-up processes for new protocolsLead employees through changes impacting daily work, including new system deployment supported by corporate resources Promote and Drive “Right the First Time Quality” and participate/lead cross-functional process improvement activitiesEscalates risks/issues in a timely mannerMaintain high level of operational awareness of safety procedures related to kit productionGlobal HarmonizationCollaborate with leadership teams at Precision for Medicine Central Laboratories to ensure cross-site harmonization in operating procedures, develop and share solutions to issues encountered, and facilitate inter lab Best PracticesCommunications & Reporting: Collection, understanding and Action of Key Performance Indicators/Metrics Measurement and ImprovementAssist clients and collaborators in the design and implementation of new studies by developing logistical plans that optimize quality and efficiency in the areas of Kit ManufacturingCommunicate with clients and collaborators regarding Manufacturing, Inventory and Shipping procedures for KitsPrepare detailed reports and correspondence regarding ongoing/historical work to clients and collaborators, and department director as requiredResolve complex issues that may arise in the daily operations and assist in resolution of issues that may arise in other areas of our organization. Communicate resolutions in a professional and logical manner.Employee Development:Ensure successful onboarding and training of staff members on applicable duties; ensure that all documentation of training is accessible and up to date for all staff members (including oneself). Training will be performed in accordance with global guidelines to ensure cross-site consistency in operator knowledge and skillsets.Supervise and manage staff in keeping with expressed objectives and corporate culture, and in doing so provide a workplace where ideas are sought and considered, initiative is encouraged, success is rewarded, and employees are treated fairly, with respect and recognitionConduct regular one-on-one meetings with direct reports, as needed. Share and document information promptly with manager and Human Resources as appropriateAs a member of management, lead through example as well as require adherence to policy, procedure, and professional standards at all times, including interactions of direct reports outside of work and on-line.Professionally and positively represent the Company by endorsing and supporting company decisions to influence staff "buy in" without conflictLead and be actively engaged in Department Stand Up Meetings to ensure management presence and influence is effective and to maintain a high-performance work cultureProvide coaching to supervisors and team leads (as applicable) on effective management of staff. Evaluate leadership and other skills of individual team members and provide appropriate tools and insight for professional developmentMiscellaneous:Attend required in-house management and employee training seminars as scheduledCarry out other duties/projects as assignedEdit / Develop SOPs/POPsPrepare and generate process trainings/demonstrations as requiredInitiate documentation of non-conformances/complaints when observedMaintain training matrix for departmentOther duties as assignedQualifications:Minimum Required:Bachelor’s degree or equivalent combination of education and experience3 years relevant laboratory experience1 years of supervisory experienceOther Required:Understands management approaches such as work scheduling, prioritizing, coaching and process executionIn-depth knowledge of Kit Production for clinical trialsWorking knowledge of applicable hazardous goods shipping regulations (IATA)Attention to detailAbility to work in a fast-paced environmentAbility to establish and maintain effective working relationships with coworkers, managers andDemonstrated skills in MS Office software applications and possess strong computational skills, such as experience with Word, Excel, Power Point, etc.Experience writing and executing process and performance validation plansExperience in writing technical grant or contract proposal responsesExcellent communication, interpersonal, organizational, and multi-tasking skillsPrior leadership role of managing and coordinating large/complex projectsDemonstrated experience mentoring and developing team membersStrong computer skills including Microsoft Office SuiteExcellent use of judgment and discretionAble to travel both domestically and internationally including overnight staysMust have and maintain a safe driving record and provide proof of such on an annual basis.Must be able to read, write, speak fluently, and comprehend the English languagePreferred:Master’s degree in a related field; Manufacturing and/or Production related experience
