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

Our biotechnology client seeks an Associate Director, MSAT Analytics to lead team focused on effective delivery of MSAT analytically-focused services for GMP manufacture of client’s cell therapy products, including production support and technology transfer.

• Direct MSAT Analytics group in the planning and execution of projects and activities aligned with the function profile for MSAT
• Execute improvement projects, drive continuous improvement activities to improve departmental efficiency, resource utilization and quality compliance
• Design and deploy practices, processes and procedures which allow the team to meet the expectations and requirements of internal and external customers
• Lead the MSAT Analytics teams in delivering services in alignment with client contracts while delivering a positive client experience.
• Accountable for delivery of services on time and on budget
• Execute strategic planning and implementation of MSAT functions
• Accountable for method qualifications, transfers, validations
• Accountable for raw material testing plans and material assessments
• Drive growth and expansion of MSAT Analytics
• Assess new opportunities based on departmental capabilities, facilities, and resources
• Possess accountability for the upselling process
• Manage efficient utilization of resources
• Facilitate inter/intra-departmental communication
• Escalate issues as needed regarding communications with the project manager, account manager and /or director
• Escalate issues as needed regarding communications with the client
• Direct, develop, and mentor staff.
• Provide an environment that enables collaboration and effective teamwork
• Identify and facilitate change for increased organizational effectiveness and competitive advantage.
• Accountable for the oversight and quality of MSAT Analytics documentation, for example:
• Review and sign off on:
• Experiment protocols
• Method qualification/transfer/validation reports
• Risk assessments
• Root cause analysis documentation
• Analyzed data
• Materials assessments 

Provide technical leadership of client products during technology transfer and manufacturing, for example: 

• Direct technical communication with clients
• Act as subject matter expert for client’s product during manufacturing operations.
• Troubleshoot problems and suggest potential improvements
• Managing resources across MSAT Analytics in collaboration with peers
• Ownership of resource allocation within team and managing hiring needs
• Advocate for hiring and identify skills sets needed
• Assess new opportunities by evaluating process for technology transfer readiness; establish client relationships
• Demonstrate leadership and mentorship
• Demonstrate the ability to align with functions
• Direct Reports: MSAT Associates/Senior Associates, MSAT Scientists/Engineers, MSAT Senior Scientists/Engineers
• Perform team building for effective internal information transfer 

REQUIREMENTS 

• Degree in relevant life science or engineering discipline
• 7+ years of experience in cell therapy or related field
• Working knowledge of Good Manufacturing Practice (GMP) and related environments
• Proven ability to lead, coach, and motivate employees, clearly, communicate job requirements and effectively manage the performance of assigned staff with a minimum of 3 years in a management position.
• Proven ability to deliver projects to specific timelines and budgets
• Proven ability in technical writing and the preparation of, protocols and reports, presentations and/or other communications
• Ability to deliver technical presentations internally and externally to clients and at conferences
• Understanding of the technical principles, theories, and concepts of cell therapy or similar products
• Competencies: Collaboration, Accountability, Adaptability, Can-do, Leadership, Technical Capacity, Problem Solving, Customer-centric, Communication, project management, and presentation skills.
• Working knowledge of GMP, aseptic processing, degree in scientific field
• 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 have the ability to work with specialized equipment
• Must be able to handle the standard/moderate noise of the manufacturing facility
• May work with hazardous materials and chemicals
• Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.
• Aseptic Processing Standards: This position will oversee laboratory processing which requires aseptic technique.