Production Manager (Tissue Processing)

Multiple Shifts:

Tuesday-Friday 7 AM-5:30 PM

Saturday-Monday 7 AM-7:30 PM

Purpose:

The Production Manager is responsible for serving as a subject matter expert for human tissue manufacturing while supervising employees and activities that support the organizations overall short term and long term strategy and goals.

 Duties & Responsibilities:
•Maintain a working knowledge and comprehensive understanding of FDA 21 CFR 1271, AATB standards, current Good Tissue Practices (cGTP), Good Documentation Practices (GDP), and other relevant industry standards

•Maintain competency in knowledge of aseptic technique and sterile fields

•Oversee production personnel and daily HCT/P production plan across morning, day, or night shift (as assigned), to include weekend overtime shifts when scheduled

•Manufacture finished product from human tissue using aseptic technique in accordance with standard operating procedures (as needed)

•Compile production metrics and provide daily reports to executive management

•Plan, manage, and coordinate lean process improvement initiatives

•Conduct adherence to established production plans to maximize manufacturing product yield

•Manage execution of cleanroom/equipment cleaning, decontamination, maintenance, calibration, environmental monitoring and validation/qualification protocols

•Support risk management of department and ensure risks/issues are identified, addressed/reported, and where appropriate, escalated

•Identify, report and investigate occurrences of deviations/nonconformances with quality control and quality assurance

•Support deviation/nonconformance and CAPA investigations as a subject matter expert

•Complete self-administered read and understand training for standard operating procedures to ensure completion by assigned due dates

•Maintain training leadership communication and hands-on skills

•Conduct and/or supervise employee training in production procedures

•Author, revise, and maintain procedures in accordance with FDA, AATB, and other regulations (as appropriate)

•File and maintain records in accordance with standard operating procedures

•Support internal and external audits

•Provide constructive feedback and guidance to develop leadership and direct reports
•Work scheduled weekend shifts when required to support planned production or product development projects

•Provide business after-hours or on-call support remotely or on-site as needed for environmental monitoring alarms, personnel issues, and/or emergency events

•Develop and maintain relationships with key stakeholders, including vendors, customers, and employees

•Attend scheduled training sessions as needed to develop and maintain competency for assigned responsibilities and processes, which may be scheduled outside of the normal assigned work shift based on department needs

•Conduct routine production scheduling for assigned shifts to meet production forecast

•Manage direct reports

•Support establishment and monitoring of objective annual goals for direct reports

•Conduct performance reviews and support establishment of performance improvement plans as needed

•Lead recruitment, interviews, and personnel selection for hire

•Complete required hours on assigned work shifts to complete assigned responsibilities and duties properly

•Attend all scheduled meetings and appointments

•Perform other administrative or related duties as assigned

Skills & Abilities:
•Excellent attention to detail and organizational skills

•Effective analytical and problem-solving skills

•Effective verbal and written communication skills

•Self-motivated with the ability to work in a team environment and independently

•Experience working with Microsoft Office (Excel, PowerPoint, Word etc.)

•Excellent documentation accuracy

•Proficient in aseptic technique

•Ability to work in a fast paced environment and manage multiple priorities

•Demonstrated positive, optimistic, success-oriented attitude and ability to positively support the organization, applicable policies, and management decisions

•Ability to secure and maintain a favorable background investigation and clearance

Education & Experience:
•High school degree or equivalent required

•Bachelor's degree in life sciences, finance, operations management, or business required

•Certification in surgical technology (CST), Certified Tissue Bank Specialist (CTBS) (or related certification) preferred

•3-6 years of hands-on aseptic or sterile environment experience required

•At least 3-6 years of experience working in an FDA regulated environment for HCT/P manufacturing environment

•Valid Class “C” drivers license

Physical Requirements:
•Ability to push, pull or otherwise transport objects or materials weighing up to 25 lbs

•Ability to perform job duties while seated or standing for 8-10 hours