Manager Manufacturing Operations

Job Description

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 the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry.

• Meet client process demands through planning, scheduling, manufacture and delivery.
• of clinical cell therapy products according to established procedures, regulations and contract.
• Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract.
• Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract.
• Ensures process hours are charged - tracked to meet contract and revenue targets.
• Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects.
• Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations
• Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff.
• Ensures a safe work environment for employees.
• Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice.
• Approves job specific curriculum for the training and professional development of department staff.
• Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion.
• Responsible for the profit and loss for the PPU
• Deliver on revenue
• Assures compliance with budget
• Liaison with support groups – supply chain, training, quality systems, and business development
• Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients
• Sets team expectations and goals and delivers the business direction for the PPU
• Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly.
• Coordinates with PPU leadership and team meetings and determines PPU strategy development
• Accountable for driving the spirit of continuous improvement
• Collaborates with Business Development to ensure compliance and contract requirements
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance Investigators

REQUIREMENTS

• Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering).
• 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience.
• 5-7 years of leadership experience or equivalent combination of experience.
• Strong business acumen
• Deep understanding of cGMP and cGLP
• Working knowledge of financial operations and budget development
• Relevant IT skills (Visio, Microsoft Project and Excel)
• Ability to think strategically and tactically (detail-oriented)
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
• Analytical and problem-solving skills
• Strong written and oral communication skills
• Meeting management/facilitation skills/teamwork
• Ability to multi-task team is essential
• Flexible and able to adapt to company growth and evolving responsibilities
• Drive to create and maintain order in a fluid technically complex environment
• Integrity, accountability and strong dedication to regulatory compliance
• Continuous improvement mindset
• List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc.
• Must have the ability to work in a team-oriented environment and with clients
• Must be able to work during the weekend, holidays and as required by the company
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
• Must have the ability to work in the cleanroom environment for extended period of time
• Must have the ability to work with specialized equipment
• May work with hazardous materials and chemicals
• Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.