Saturday , 18 May 2013

US: Supervisor, Nanotechnology Operations

POSITION SUMMARY
Responsible for the overall supervision, direction, and coordination of the NT Formulation area and the surrounding controlled environmental area. Responsible for carrying out Company objectives at the lowest cost consistent with quality requirements. This position supervises 7-21 direct reports accountable for compounding bulk product and equipment cleaning to meet delivered production schedules and compliance regulations. Ensure that proper systems, equipment, material and resources are in place to meet production demands, and that products are manufactured to specification and in complete accordance with SOPs, DEA, OSHA and cGMP rules and regulations. Effectively develops resources to maintain production goals and efficiencies. Recommends and implements Process Improvement Programs.
ESSENTIAL FUNCTIONS
·         Ensures adequate systems are in place to effectively manufacture Bulk product, and clean/store/prepare equipment and compounds.
·         Ensures all area SOPs are reviewed/revised to encompass any changes in procedure and/or two-year review.
·         Ensures adequate resources are available to clean and prepare equipment.
·         Ensures all area personnel are current in their training requirements; Trains employees to area-specific Curricula and company policies and procedures. Ensures a safe work environment and that all personnel work in a safe manner.
·         Schedules, verifies and troubleshoots the operation of the NT Formulation Areas.
·         Ensures corrective actions for investigations and audit observations are completed in a timely manner. Ensures all documentation is correct and addresses errors effectively and expeditiously. Completes Batch Record review foe area.
·         Works closely with HR on policy changes, interpretation and execution, hiring of new employees, employee disciplinary action, performance appraisals and performance management.
·         Works with Technical Services/Maintenance to reduce downtime and improve equipment reliability; Assists with design of new systems/facilities related to the department.
·         Works closely with Material Management and Quality regarding component problems and inventory maintenance.
·         Works closely with Environmental, Maintenance, Metrology, and Validation to ensure area environmental monitoring, PM, calibration, and re-qualification schedules are met.

EDUCATION/EXPERIENCE REQUIREMENTS
·BS/BA in Science related discipline or equivalent.
·2-3 years of pharmaceutical experience.
·Minimum of 5 years supervisory experience in a highly regulated environment desired.
·Working knowledge of SOPs, DEA, OSHA, and cGMP rules and regulations.
REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES
·         Ability to manage multiple duties, assignments and projects.
·         Strong oral and written communication skills.

# of Openings : 1
Division/Department : Manufacturing Operations
Shift/Hours : Third Shift (Night)
% of Travel Required : 0-10%

City: Melrose Park
State: Illinois
Country: USA
Zipcode: 60160
Company Name: Abraxis BioScience
Employer Job code: 109
Job Category: Manufacturing/Production

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