The Manager, MS&T, is responsible for directing and developing Associate Scientists/Engineers within the validation department.
Responsibilities include personnel scheduling, forecasting project requirements including budgetary requirements, and preparation of validation master plans.
* Assures that facilities, laboratory equipment, utility systems and processes are validated and that reports are written meeting project requirements and strategies set forth in validation master plans.
* Presents overviews of validation programs to regulatory agencies as necessary.
* Providing technical expertise in resolution of validation failures and manufacturing deviations as well as serving as the validation lead for projects.
* Maintaining/implementing governing cGMP procedures, tracking budget activities, ensuring training of employees to assure up-to-date knowledge of practices and procedures, and promoting achievement of safety goals.
Position Requirements :
Minimum of 10-13 years of cGMP biopharmaceutical production setting with a focus in large scale mammalian cell culture processes and process development required.
Working knowledge of industry standards, safety, quality, and regulatory concepts is required including the application of current cGMPs required.
B.S/B.A./M.S./PhD in engineering, biological sciences, physical sciences, or equivalent focus of study is required.
Freedom to Act
Assignments are received in task-and objective-orientated terms. Provides direction to subordinates based on general policies and management guidelines. Work is reviewed upon completion for adequacy in meeting objectives. Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies.
Accomplishes results through lower-level exempt employees who exercise latitude and independence in their assignments. Often heads a centralized functional activity.
Operations Involvement / Direct Work 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.
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.
Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling or specific phases of projects or contracts. Conducts briefings and participates in technical meetings for internal representatives concerning specific operations.
Must demonstrate excellent communication skills, both verbal and written, and effective presentation skills. Contacts are frequent with individuals representing other departments, and/or representing outside organizations. Contacts involve obtaining or providing information or data on matters of importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation.