- 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.
- 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.
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