Our Biotechnology client seeks a "Director of Clinical Manufacturing Operations" who will be responsible for managing day to day operations of the department to ensure timely delivery of client-sponsored projects. Incumbent is a change agent responsible to interact with clients, provide strong technical leadership and collaborate effectively across groups within the organization. The incumbent is responsible for leading the organization into a data driven, team-oriented culture that embraces continuous improvement and drives quality, supply, and financial performance of the Clinical Operations team. 

This managerial role provides leadership on the GMP and non-GMP facility environments and contributes to management goals and improvements.

Responsible for developing and adhering to Operations resource models, input into the development of prospective / existing client proposals, Manufacturing Service Agreement (MSA) and Scope of Work (SOW). Execute agreements ensuring both client expectations are met and agreed upon for the profitability and success of the project.

• Member of Site Leadership Team. Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations.
• Ensures safe, quality, and timely manufacturing of biopharmaceutical products for pre-clinical, clinical, and commercial use.
• Lead all aspects of the Production Planning for the site
• Ensures that all production operations are controlled and executed within GMP regulatory guidelines.
• Develop and implement facilities policies and practices (SOPs).
• Deliver departmental goals and objectives based on compliance, milestones, and revenue targets.
• Accountable for the tracking, trending, and improvement of the Operations KPIs, driven by cost-effective and efficient output of client’s products
• Provide strategic direction and set objectives to meet financial and operational requirements that are aligned with Site and Regional targets
• Work directly with internal and external stakeholders on projects of existing and prospective clients to ensure appropriate capacity, improve quality, adequate sourcing of critical deliverables
• Work directly with Quality Assurance, Quality Control, MSAT, Project and Account Management and Manufacturing Support groups to ensure smooth tech transfer of client-sponsored projects
• Works with Quality organization to set the standard for a quality mindset within the Operations organization. Ensures accountability to the quality culture fostered at the site
• Ensure all processes and procedures related to Operations are in full accordance with GMP, CFR, site quality systems, company policies and promote a culture of quality, compliance, and excellence
• Set expectations for operation excellence and Right First Time (RFT) execution
• Ensure staff is trained and qualified in GMP regulations and all SOPs related to performance of duties through training programs; create and monitor training curricula
• Represent Operations during audits and visits.
• Works collaboratively with Quality Assurance, Quality Control, MSAT, Project Management, Business Development, Supply Chain, Facilities and Engineering to ensure the site and corporate goals are met. 
• Ensures Operations area is kept in a cGMP state through coordination of preventive maintenance and cleaning activities with the Facilities department.
• Provides leadership to direct reports and Clinical Operation team by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best
• Drive education and execution of company mission and vision within the Operations.
• Lead by example and emulate the company’s core leadership values
• Lead a High-Performance Team culture within the Operations Leadership team.
• This role drives individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry.
• Ensure staff has the proper training, skill set, and personal development opportunities to assure their ability to carry out assigned tasks in compliance with Minaris procedures and policy as well as local, federal, and global regulations and industry standards.
• Lead a learning environment whereby team members are enabled to increase their skills and contributions to the Operations KPIs.
• Collaborate within the organization to manage the interface between cross-functional teams to align the functional strategy with the site and regional goals
• Provide direction and leadership for change management initiatives
• Enable teams through mentoring and coaching
• Responsible for achieving of financial goals for the site/facility
• Recommends and manage capital requirements to maximize financial returns
• Actively involved with Sales and Account Management teams
• Responsible for productivity and staffing that is appropriate to achieve regional/site/facility fiscal g goals
• Monitor compliance to project budgets
• Maintain and support client satisfaction at a level that ensures account retention
• Develop a mechanism to capture and track benefits/savings associated with operational improvement initiatives
• Monitor business and project activity to assure organizational improvement efficiency gains and cost savings
• Identify areas of fiscal waste; develop mitigation strategies

 REQUIREMENTS 

• Bachelor’s degree or higher in relevant life science discipline
• 2+ years’ experience working in cell processing, cell culture, cell analytics, and related GMP technologies, preferably for the manufacture of cell therapy products; Hands on experience with autologous and/or allogeneic cell therapy manufacturing processes is preferred
• 8-10+ years’ direct experience working in a GMP regulated facility in the pharmaceutical or biotech manufacturing environment is a must
• Experience in strategic planning, process improvement, project execution, and data/business analytics
• Understanding of the technical principles, theories, and concepts of low complexity technology transfer and the manufacturing of cell therapy or similar products
• Ability to provide technical solutions to a variety of technical problems of low complexity scope and the ability to suggest improvements and adaptations to methodologies, processes, products
• Detailed knowledge of manufacturing technology, industry trends and requirements associated with the introduction of new equipment/methods into a manufacturing setting
• Excellent oral and written communication skills including proven track record in meeting facilitation, training and presentation
• Demonstrated success initiating change and influencing at all levels
• Comprehensive understanding and extensive practical experience with GMP quality systems and procedures
• Ability to adapt and evolve quickly in an ever changing and dynamic environment
• Self-awareness, integrity, authenticity, and a growth mindset 
• Collaborates with other team members and demonstrates outstanding interpersonal skills; Ability to effectively interface with peer groups in the site and work collaboratively to achieve site goals
• An innovative, motivated, and independent leader with proven ability to work cross-functionally and drive accountability, proactive problem-solving skills
• Demonstrated ability to work creatively and effectively in a fast-paced CDMO environment
• Demonstrated leadership abilities, and the ability to work in a matrixed and collaborative environment; Ability to lead through influence
• Strong business acumen to handle internal and external stakeholders
• Ability to think strategically and act tactically (detail-oriented)
• Strong interpersonal, communication, and analytical skills, capable of producing executive-ready presentations with little guidance
• Comfortable translating ambiguous direction and high-level goals into actionable projects/initiatives
• Bias for action and solutions; Ability to partner with leadership, managers, and process owners to execute on cross-functional goals
• Recognized skills for ability to develop efficient operations with robust processes and implementation of operational KPIs focused on Right First-Time and On-time delivery.
• Strong attention to detail while having the ability to work simultaneously on multiple priorities
• Excellent customer interaction skills
• Excellent oral and written communication, presentation, and interpersonal skills
• Excellent skills using Microsoft Office Suite
• Must have the ability to work in a team-oriented environment and with clients
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
• Ability to be comfortable in a clean room environment
• Must utilize proper personal protective equipment (PPE)
• Must be able to handle the standard/moderate noise of the manufacturing facility
• Some extended hours as required to meet deadlines and other team commitments
• Must be able to work during the weekend, holidays and as required by the company
• May be required to travel to other sites
• Understand Aseptic Processing Standards 

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. 

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey.

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