- Location:
- Frederick - NON SALES, MD 21703
- Status:
- Full Time, Employee
- Job Category:
- Biotech/R&D/Science
Associate Director/Director Manufacturing Science & Technology Validation
Title: Associate Director/Director MS&T Validation
Location: MD Frederick
Req: 01741
As part of the Manufacturing Science and Technology component the Validation Director leads the development implementation and maintenance of the validation program at the site a multi-product MCC based API facility. The director manages a team of validation scientists and engineers responsible for the qualification/validation of facilities processes and analytical methods and is responsible for their coaching technical growth and professional development. The director is responsible for developing a compliant and sustainable validation program that is aligned with company industry and regulatory standards and expectations. The director provides metrics on the status of the validation program and ensures that all studies are appropriately reviewed are technically sound and are aligned with corporate quality standards. The successful director will possess strong leadership skills and the ability to project influence in a team oriented setting. Skills should include functional expertise in the qualification/validation of process equipment clean utilities sterilization cleaning-in-place manufacturing processes analytical methods shipping and the capabilities and systems required for the operations of a multi-product MCC API plant.
Essential Job Functions:
• Manage the development implementation and maintenance of the FMC validation program.
• Lead the site validation function and supervise coach and develop the validation staff.
• Develop teach and apply in practice knowledge of validation principles regulatory standards and industry guidelines related to biotechnology and pharmaceutical applications.
• Partner in the development of validation master plans validation strategies and standard operating procedures.
• Provide oversight and guidance for the design and execution of validation studies for a multiproduct API facility.
• Manage efficient and compliant systems for the creation approval execution and archiving of validation protocols and reports.
• Deliver timely and metric driven updates on the status of the validation program.
• Assure the provision of summary reports presentations to internal and external governance groups and reviewers and sections of regulatory filings documents.
• Maintain effective communication with site leads and corporate management to allow identification/timely resolution of any validation related issues.
Additional Job Functions:
• Partner in technology transfer activities and process control strategies.
• Demonstrate and lead the continued development of excellent technical writing facilitation and verbal/written communication skills in the validation group.
• Partner in the development of sustainable business practices at the site assuring a safe productive and progressive work environment.
Educations:
Typical Education:
Ph.D. in engineering biological sciences physical sciences or equivalent focus of study is desired although candidates with B.S/B.A./M.S. level degree will also be considered.
Typical Experience:
Minimum of 10 years of validation experience in a commercial cGMP biopharmaceutical production environment. Minimum 5 years of direct supervision experience managing scientists and engineers.
Freedom to Act
Assignments are received in objective-orientated 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
Responsible for all projects assigned to the organizational unit. Acts as an advisor to subordinate supervisors or staff members to meet schedules or resolve technical or operational problems. Directly participates in establishing and administering many centralize
CLICK HERE TO APPLY
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.
Location: MD Frederick
Req: 01741
As part of the Manufacturing Science and Technology component the Validation Director leads the development implementation and maintenance of the validation program at the site a multi-product MCC based API facility. The director manages a team of validation scientists and engineers responsible for the qualification/validation of facilities processes and analytical methods and is responsible for their coaching technical growth and professional development. The director is responsible for developing a compliant and sustainable validation program that is aligned with company industry and regulatory standards and expectations. The director provides metrics on the status of the validation program and ensures that all studies are appropriately reviewed are technically sound and are aligned with corporate quality standards. The successful director will possess strong leadership skills and the ability to project influence in a team oriented setting. Skills should include functional expertise in the qualification/validation of process equipment clean utilities sterilization cleaning-in-place manufacturing processes analytical methods shipping and the capabilities and systems required for the operations of a multi-product MCC API plant.
Essential Job Functions:
• Manage the development implementation and maintenance of the FMC validation program.
• Lead the site validation function and supervise coach and develop the validation staff.
• Develop teach and apply in practice knowledge of validation principles regulatory standards and industry guidelines related to biotechnology and pharmaceutical applications.
• Partner in the development of validation master plans validation strategies and standard operating procedures.
• Provide oversight and guidance for the design and execution of validation studies for a multiproduct API facility.
• Manage efficient and compliant systems for the creation approval execution and archiving of validation protocols and reports.
• Deliver timely and metric driven updates on the status of the validation program.
• Assure the provision of summary reports presentations to internal and external governance groups and reviewers and sections of regulatory filings documents.
• Maintain effective communication with site leads and corporate management to allow identification/timely resolution of any validation related issues.
Additional Job Functions:
• Partner in technology transfer activities and process control strategies.
• Demonstrate and lead the continued development of excellent technical writing facilitation and verbal/written communication skills in the validation group.
• Partner in the development of sustainable business practices at the site assuring a safe productive and progressive work environment.
Educations:
Typical Education:
Ph.D. in engineering biological sciences physical sciences or equivalent focus of study is desired although candidates with B.S/B.A./M.S. level degree will also be considered.
Typical Experience:
Minimum of 10 years of validation experience in a commercial cGMP biopharmaceutical production environment. Minimum 5 years of direct supervision experience managing scientists and engineers.
Freedom to Act
Assignments are received in objective-orientated 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
Responsible for all projects assigned to the organizational unit. Acts as an advisor to subordinate supervisors or staff members to meet schedules or resolve technical or operational problems. Directly participates in establishing and administering many centralize
CLICK HERE TO APPLY
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.
