Manager is responsible for supporting method transfer, validation, and method life-cycle support at the MA Biologics Operations (MA Bio Ops) quality laboratories. Technical areas supported include Microbiology disciplines. The labs are accountable for the on-time delivery of data in support of in-process, release and stability activities. The individual will drive accountability to deliver to targets for commercial and clinical method introduction and remediation of defined site-based and external programs, engage with peers across the Lexington site (and larger network, as needed) to influence method selection and filing strategy, and collaborate on continuous improvement (CI) activities. This leader will ensure that new method introduction and support is performed with a customer focus that includes consideration for reliability, sustainability, data integrity and general GMP-compliance. Direct resources to support daily operations of the labs such as critical reagent supply and method trending/performance. In addition, the introduction of new technology to improve sustainability and compliance is expected. The role requires direct management of individuals, including goal setting, performance feedback, skills development, and mentoring.
Job Summary/Operations Involvement:
Functions as an advisor to a unit regarding tasks, projects, and operations. Becomes actively involved in daily operations only when required to meet schedules or to resolve complex problems.
Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.
Ensures that projects are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources, and funds.
Specific QC Focus Area:
Microbiology: Area focuses on techniques such as bioburden, endotoxin testing, growth promotion studies, environmental monitoring testing, microbial identifications.
Receives assignments in the form of objectives and establishes goals to meet objectives.
Provides guidance to subordinates to achieve goals in accordance with established policies.
Work is reviewed and measured based on meeting objectives and schedules.
Establishes and recommends changes to policies which effect subordinate organizations.
50% - Management of daily/weekly/monthly and longer term activities of staff and operational oversight of group, data review, scheduling, oversight of group training
20-40% - GMP documentation related activities (ex. SOP revisions, quality systems related events, method related project documents as required), oversight of group metrics
10-30% - Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
Education and Experience Requirements
Typically requires a minimum of 10+ years of related experience. (Science related degree is preferred)
Additional Specific Experience:
Relevant supervisory experience preferred.
Excellent communication, interpersonal and organizational skills.
Proactive at keeping current with literature and latest technologies.
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask.
Conducts work in compliance with cGMPs, safety and regulatory requirements
Key Skills, Abilities, and Competencies
Manages through subordinate supervisors the activities of a section or department with responsibility for results in terms of costs, methods and employees.
May be responsible for a functional area and may not have subordinate supervisors, or employees, or may manage highly skilled professional employees.
Strong and effective people management skills
Technical expertise in QC area of oversight
Clear and concise oral and writing communication skills
Strong knowledge of GMP regulations
Highly flexible and adaptable
Knowledge on financial management
Ability to drive for continuous improvement and results-driven
Ability to work both in collaborative teams as well as the capability to influence/negotiate/compromise within cross-functional teams as required to move initiatives forward
Complexity and Problem Solving
Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Acts as advisor to subordinates to meet schedules and/or resolve technical problems.
Develops and administers budgets, schedules, and performance requirements.
Expected to escalate issues as appropriate in a timely fashion.
Internal and External Contacts
Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts.
Conducts briefings and participates in technical meetings for internal and external representatives concerning specific operations.
Other Job Requirements
The following physical abilities are required in order to fulfill the job duties:
Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
Ability to work around chemicals (if working around the laboratories)
Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
Ability to walk and stand for periods of time
Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours
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