Job Description
Manager Manufacturing Operations
Allendale, NJ
Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical, and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU) Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for managing client projects at the site and for delivering results within project scope, timelines, contract requirements, revenue targets, as well as compliance and regulatory standards. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will focus on revenue delivery. This role also involves driving individual and team development to ensure a prepared and empowered workforce, making the company the provider of choice in the industry.
Responsibilities include:
Meet client process demands through planning, scheduling, manufacturing, and delivery.Oversee the manufacturing of clinical cell therapy products according to established procedures, regulations, and contracts.Ensure manufacturing documentation is completed in a timely manner in compliance with regulations and contractual obligations.Ensure capacity availability of resources (room, equipment, staff) for clinical manufacturing per contract.Track process hours to meet contract and revenue targets.Maintain mechanisms to troubleshoot problems with clients, suggest improvements, and advocate for value-added projects.Keep manufacturing space clean, validated, and compliant with GMP and other regulations.Implement on-the-job training programs for new and existing staff.Ensure a safe work environment for all employees.Ensure departmental compliance with HR, safety, and business policies.Approve training curricula for staff development.Hold regular staff and 1:1 meetings to promote corporate culture, morale, and development.Manage profit and loss for the PPU and deliver on revenue targets.Ensure budget compliance.Coordinate with support groups such as supply chain, quality, and business development.Partner with clients and project management to drive account management.Set team expectations, goals, and business direction for the PPU.Establish and track KPIs and ROI targets monthly.Develop PPU strategy in collaboration with leadership.Drive continuous improvement initiatives.Collaborate with Business Development to ensure compliance and contract fulfillment.Supervise staff responsibilities, including hiring, training, performance appraisal, and discipline. Directly supervise roles such as Associate Manager, Manufacturing, and others.Requirements:
Bachelor's degree in Biology, Biotechnology, Bioengineering, Chemical Engineering, or related field.5-7 years of experience in a cGMP environment, including aseptic processing, mammalian cell culture, cell processing, and cryopreservation.5-7 years of leadership experience or equivalent.Strong business acumen and understanding of cGMP and cGLP.Working knowledge of financial operations and budget management.Proficiency in IT tools such as Visio, Microsoft Project, and Excel.Strategic and tactical thinking skills, detail-oriented.Collaborative, influencing skills, and ability to work in cross-functional teams.Analytical and problem-solving skills.Excellent written and oral communication skills.Meeting management and facilitation skills.Ability to multitask and adapt to growth and evolving responsibilities.Integrity, accountability, and dedication to regulatory compliance.Commitment to continuous improvement.Completion of required training such as aseptic techniques, gowning, GMP, and manager training.Ability to work in a team and with clients, including working weekends and holidays as required.Ability to work in a cleanroom environment and with hazardous materials, using PPE as required.Please note this job description is not exhaustive and duties may change as needed.
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