Associate Director Manufacturing Operations

Job Description Job Description Associate Director, Manufacturing Operations Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet customer demand. This role will be responsible for maintaining and overseeing the site Operations scheduling and training capacities for a time period looking ahead to the next 3-6 months. The Associate Director, Manufacturing Operations will understand upcoming needs and constraints and help drive strategy accordingly. This includes the management of all Operations scheduling, training and compliance resources. The Associate Director, Manufacturing Operations is also responsible for assessing the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible. 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.

• Meeting client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts
• Looking out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs
• Manages all training and compliance activities in the Operations organization
• Responsible for creating, enforcing and measuring Operator training schedules in order to ensure that all production schedules can be carried out
• Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all Associates
• Supporting and driving special long-term projects and identified and assigned by the PPU Head
• Responsible for creating maintaining and communicating all Operations based KPI’s
• Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices
• Approving job specific curriculum for the training and professional development of department staff
• Responsible for streamlining the batch record review process
• Responsible to understand the profit and loss for the PPU’s as well as all related documentation, and how these items impact Operations
• Driving continuous improvement
• Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others
• Set team expectations and goals and assists in delivering the business direction for the PPU
• Aligning departmental goals, processes and resource allocation with the organizational strategy
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Direct reports: Associate Manager Training, Associate Manager, Compliance, Scheduling Associate, Quality Engineer Associates. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

REQUIREMENTS

• Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering).
• 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience.
• 5-10 years of leadership experience or equivalent combination of experience.
• Deep Understanding of cGMP and cGLP
• Working knowledge of financial operations and budget development
• Relevant IT skills (able to work with Microsoft Office and corporate scheduling system)
• Competencies/Candidate Profile
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
• Flexible and able to adapt to company growth and evolving responsibilities
• Accountability, integrity, and strong dedication to regulatory compliance
• Strong business and personnel management acumen
• Strong emotional intelligence
• Ability to think strategically and tactically (detail-oriented)
• Strong analytical and problem-solving skills
• Strong written and verbal communication skills
• Drive to create and maintain order in a fluid, technically complex environment
• Continuous improvement mindset
• Ability to multi-task is essential
• Must have the ability to work in a team-oriented environment and with clients
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.

Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.Duties, responsibilities, and activities may change at any time with or without notice