Manufacturing Operations Director
16 hours ago
Lynkx Staffing LLC is seeking a seasoned professional to fill the role of Associate Director, Manufacturing Operations. This position is responsible for ensuring the efficient utilization of Operations resources to meet customer demand.
Key Responsibilities- Develop and implement strategies to optimize Operations scheduling and training capacities.
- Collaborate with cross-functional teams to drive business growth and improve operational efficiency.
- Manage all Operations scheduling, training, and compliance resources.
- Assess company needs and contribute to the big picture by ensuring daily operations run smoothly and efficiently.
- Drive individual and team development to ensure a prepared and empowered workforce.
- Meet client process demands through planning, scheduling, manufacture, and delivery of clinical cell therapy products.
- Look ahead 3-6 months to ensure capacity and availability of resources to perform clinical manufacture.
- Manage all training and compliance activities in the Operations organization.
- Create, enforce, and measure Operator training schedules to ensure production schedules can be carried out.
- Develop and maintain a process to ensure personnel schedules are accurately and fairly assigned.
- Support and drive special long-term projects assigned by the PPU Head.
- Responsible for creating, maintaining, and communicating all Operations-based KPIs.
- Ensure department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices.
- Approve job-specific curriculum for the training and professional development of department staff.
- Responsible for streamlining the batch record review process.
- Understand the profit and loss for the PPU's and related documentation, and how these items impact Operations.
- Drive continuous improvement.
- Liaise 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 assist in delivering the business direction for the PPU.
- Align departmental goals, processes, and resource allocation with the organizational strategy.
- Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.
- Bachelor's degree in a relevant field (e.g., Biology, Biotechnology, Bioengineering, Chemical Engineering).
- 5-10 years of experience in a 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.
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