Manages, plans, and directs the activities of the Laboratory Operations departments for issues related to routine production, stability, complaints, site transfer products, alternate vendor approval, validation protocols, and methods validation by performing the following duties personally or through subordinate staff support.
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Provides managerial support, direction and coaching to subordinates; maintains departmental employee recruitment, selection, training, development, safety, promotion and retention levels to ensure proper and effective staffing.
Responsible for over 100 direct and indirect staff members.
Provides assistance to the Site Head of Quality; prepares and presents staff reports and other necessary correspondence.
Directs the work activities of analytical testing groups to assure product and components comply with specifications; also reviews, evaluates/modifies, as needed, test methods and procedures.
Oversees Laboratory Investigations (analytical & micro).
Reviews and prepares annual budget for assigned areas of responsibility in the Laboratory Operations department.
Reviews and approves new and revised Standard Operating Procedures (SOP's) and other laboratory documents.
Directs the work activities of the Training and Review group to assure that all documentation is complete and accurate and that new employees are properly trained.
Qualifications
Minimum Requirements Required:
Excellent leadership experience and abilities, having successfully managed large lab operations in pharmaceuticals.
Background in GMP's and Operational Excellence/Lean/Six Sigma and experience with HPLC, GC and LIMS.
Very strong communication skills required.
Minimum Educational Requirements: Bachelor's Degree in Chemistry, Pharmaceutical Science or related field from an accredited college or university,(PhD or MS preferred) and a minimum of eight (8) to ten (10) years of progressive management experience in the pharmaceutical industry preferably with modified/extended release products.
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