Manager, Kit Production

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 sites
• Provides close leadership to meet or exceed required ship dates for kits, and communicate any delays related to production or supplies
• Liaise with Inventory Control staff to ensure appropriate supplies are available to support demand
• Liaise closely with the Project Management and Study Coordinator to ensure effective preparation and implementation of start-up processes for new protocols
• Lead 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 activities
• Escalates risks/issues in a timely manner
• Maintain high level of operational awareness of safety procedures related to kit production

Global Harmonization

• Collaborate 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 Practices

Communications & Reporting:

• Collection, understanding and Action of Key Performance Indicators/Metrics Measurement and Improvement
• Assist 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 Manufacturing
• Communicate with clients and collaborators regarding Manufacturing, Inventory and Shipping procedures for Kits
• Prepare detailed reports and correspondence regarding ongoing/historical work to clients and collaborators, and department director as required
• Resolve 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 recognition
• Conduct regular one-on-one meetings with direct reports, as needed. Share and document information promptly with manager and Human Resources as appropriate
• As 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 conflict
• Lead and be actively engaged in Department Stand Up Meetings to ensure management presence and influence is effective and to maintain a high-performance work culture
• Provide 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 development

Miscellaneous:

• Attend required in-house management and employee training seminars as scheduled
• Carry out other duties/projects as assigned
• Edit / Develop SOPs/POPs
• Prepare and generate process trainings/demonstrations as required
• Initiate documentation of non-conformances/complaints when observed
• Maintain training matrix for department
• Other duties as assigned

Qualifications:

Minimum Required:

• Bachelor’s degree or equivalent combination of education and experience
• 3 years relevant laboratory experience
• 1 years of supervisory experience

Other Required:

• Understands management approaches such as work scheduling, prioritizing, coaching and process execution
• In-depth knowledge of Kit Production for clinical trials
• Working knowledge of applicable hazardous goods shipping regulations (IATA)
• Attention to detail
• Ability to work in a fast-paced environment
• Ability to establish and maintain effective working relationships with coworkers, managers and
• Demonstrated 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 plans
• Experience in writing technical grant or contract proposal responses
• Excellent communication, interpersonal, organizational, and multi-tasking skills
• Prior leadership role of managing and coordinating large/complex projects
• Demonstrated experience mentoring and developing team members
• Strong computer skills including Microsoft Office Suite
• Excellent use of judgment and discretion
• Able to travel both domestically and internationally including overnight stays
• Must 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 language

Preferred:

• Master’s degree in a related field; Manufacturing and/or Production related experience