Kit Production Manager Lead
Vor 2 Tagen
Job Overview:
The Kit Production Manager Lead is a pivotal role within the Precision Medicine Group, responsible for overseeing the day-to-day management of Kit Production at our Central Laboratory. This position entails providing technical leadership, performance guidance, and long-term development to ensure the successful implementation and execution of Clinical Trials Kit Building.
About the Role:
This position manages Team Leads and support staff to guarantee the effective preparation and execution of new/ongoing Clinical Trials Kit Building while adhering to global standard operating procedures and quality control guidelines. The Kit Production Manager Lead must possess excellent communication and interpersonal skills to foster collaboration with Inventory Control staff, Project Management, and Study Coordinators.
Main Responsibilities:
- 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 communicates any delays related to production or supplies
- Liaise with Inventory Control staff to ensure appropriate supplies are available to support demand
- Liaise closely with 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
- Escalate risks/issues in a timely manner
- Maintain a high level of operational awareness of safety procedures related to kit production
Cross-Site Harmonization:
- Collaborate with leadership teams at Precision Medicine Group to ensure cross-site harmonization in operating procedures, develop and share solutions to issues encountered, and facilitate inter-lab best practices
Key Performance Indicators (KPIs):
- Collection, understanding, and action of KPIs/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
Other Responsibilities:
- 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 year of supervisory experience
Other Requirements:
- 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 clients
- Demonstrated skills in MS Office software applications and possess strong computational skills
- 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 Qualifications:
- Master's degree in a related field; Manufacturing and/or Production related experience
Salary and Benefits:
We offer a competitive salary range of $80,000 - $110,000 per annum, depending on experience. Additionally, our benefits package includes comprehensive health insurance, retirement savings plan, and generous paid time off.
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