Location:
Frederick - NON SALES, MD 21703
Status:
Full Time, Employee
Job Category:
Biotech/R&D/Science
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Associate Director Manufacturing Science & Technology Business Operations
Title: Associate Director Manufacturing Science & Technology Business Operations
Location: MD Frederick
Req: 01740

The Associate Director of MS&T Operations leads a team responsible for non-molecule specific MS&T activities such as technology transfer process changeover statistical process control continuous improvement project management and technical training activities at the Frederick Manufacturing Center. This individual assures the development of infrastructure tools and systems required to enable the site to enhance technology transfers streamline process changeovers and deliver effective project management. The scope of these tools and systems will include design and creation of process/equipment flow diagrams process descriptions validation master plans technology transfer plans/reports schedules budgets and other related deliverables. This Associate Director will also oversee the implementation of robust technical training and continuing education programs at the site including an enhanced program of statistical thinking in the workplace. Success in all these areas will require strong leadership skills knowledge of commercial biotechnology technology transfer project management and adult learning principles and the ability to project cross-functional influence..





Essential Job Functions:
• The Associate Director of MS&T Operations is a member of the MS&T Lead Team at the Frederick multi-product API manufacturing facility.
• Leads a team of professionals team responsible for technology transfer statistical process control continuous improvement project management and technical training.
• Enable metric driven non-molecule specific business practices such as workflows tools and templates for technology transfer and business planning exercises.
• Prioritize the development and deployment of job-specific training programs including on the job training instructor led classroom training continuing education and e-learning solutions
• Administer supporting budgets and participate in planning for the site and function.

Additional Job Functions:
• Hire develop and motivate staff in a manner that fosters a team environment.
• Partner with other members of Site Leadership to assure that MS&T Operations group integrates sustainable business practices with those of other functional areas to achieve site business goals.
• Build and maintain strong relationships with site leads corporate management and other stakeholders to ensure effective communication of business plans and issues
• Prioritize projects and resources to meet business goals applying sound business concepts and techniques as they relate to human resource management accounting budget objectives and appraisals
• Partner in organizational development initiatives and change agency as it relates to training technology transfer and business practices within MS&T.


Educations:
Typical Education:
Ph.D. in engineering biological sciences physical sciences or equivalent field of study. Candidates with B.S/B.A./M.S. level degree will also be considered.

Typical Experience:
Minimum of 10 years of experience in a cGMP biotech/pharmaceutical production environment with focus in one or more of the following areas: technology transfer manufacturing validation technical traning project management or operational excellence. Minimum 5 years of direct supervision experience managing scientists and engineers. Certification as an Operational Excellence Black Belt or Master Black Belt is desirable.

Freedom to Act
Assignments are received in objective-oriented terms. Provides guidance to subordinates based on organizational goals and company policy. Work is reviewed in terms of meeting the organizations objectives and schedules. Establishes operating policies and procedures that affect subordinate organizational units. Interprets executes and recommends modifications to organizational policies.

Supervisor Relationships
Accomplishes results through subordinate supervisors or exempt specialist employees. Subject to approval modifies the organizational structure of centralized functions and units. Often responsible for managing a staff function of the company.

Operations Involvement / Direct Work Involvement

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MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.