Manager of Operations

Client is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Client develops, manufactures and packages pharmaceutical and other products for customers in nearly 100 countries, employs approximately 8,000 employees at 30 facilities worldwide and generates more than $1.7 billion in annual revenue. Among its core offerings, develops and manufactures oral and sterile pharmaceuticals in nearly all major dosage forms, and offers proprietary technologies used in many well-known prescriptions and over-the-counter products. Client is also the largest contract packager of pharmaceuticals.

• Assuming the responsibility and authority for managing Supervisors and their related staff to ensure effective deployment. Duties included are selection, performance evaluation and counseling, routine discipline and grievance resolution.
• Oversee daily performance against established standards and schedules. Resolve workflow and processing technical issues.
• Liaise positively with Supply Chain, support groups and Quality Assurance to establish efficient schedules and quality products especially smoothly processing the flow of material and paperwork.
• Making personnel recommendations, as required, in the areas of staffing needs, wage recommendations and performance reviews.
• Assuring compliance within the Manufacturing department with all cGMP and safety regulations.
• Ensuring that the facility is kept "tour ready" at all times and people/material/flow/cleaning and zone concepts are maintained at all times.
• Management of governmental agencies and customer representatives as required facilitating audits, preparing and completing corrective action plans and of-site visits.
• Assuring that Supervisors and operators are trained and following the operating and cleaning standard operating procedures and any other applicable regulations.
• Ensuring batch records are complete and accurate first time.
• Interfacing with Materials Management and other warehouse staff as related to raw material inventory control issues.
• Trouble shooting any processing, equipment or utilities problems.
• Overseeing all activities performed by operators and material expeditors during shift. Offering processing guidance where needed.
• Identify staffing needs and maintain staffing.
• Work with the Human Resources and training staff to encourage a highly motivated and skilled work force.
• Support 24/7 operations.
• Define necessary - Corrective/Preventive Action measures in response to internal, regulatory and customer audit requirements as well as deviation investigation. Meet commitments on time.
• Tracking appropriate metrics and reporting as necessary to senior management and operations personnel to identify and drive performance improvements.

• Candidates must be capable of creating and working within an operating plan framework and budget.
• Must have a thorough knowledge of the equipment and processes used in the facility and within the pharmaceutical industry.
• Must have a thorough knowledge of cGMP, FDA and DEA guidelines and how to apply them effectively.
• Candidates should have a thorough knowledge of Solid Dosage manufacturing.
• Excellent computer skills.
• Able to manage priorities and projects prioritizing effectively. Must communicate clearly, and manage people well.
• Capability to work in a matrix organization.

• Individual may be required sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
• Shifts of 8 or 10 hours in duration.

• Completion of administrative duties as indicated by position.
• Data entry and use of computer user interface tools including mouse, keyboard and any other applicable instruments.
• Setting up office, desk and workstation for minimal ergonomic risk factors as deemed necessary.
• Sustaining static postures
• Sustained sitting at desk or workstation with use of phones, computers and any other office equipment required for specified position.
• Static stance/standing as required.
• Lifting and operating in an office environment
• File/Folder storage with non-repetitive light weight lifting, reaching and forward bending as necessary.
• Infrequent lifting overhead reaching less than or equal to 15 lbs. with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs.

• Must follow any applicable plant safety requirements.