Responsible for directing the development, planning, implementation and maintenance of manufacturing methods, processes, and operations pertaining to new or existing products and technologies.  Ensure the effective use of material, equipment and personnel in producing quality products throughout the product value stream. May monitor and control labor and capital expenditures.  Assist in developing budgets, formulates and recommends manufacturing policies, procedures, and programs.  Also responsible for assisting with the efficient, safe and profitable operation of the department; for advising and making recommendations to the Production Manager with respect to these activities. Performs assignments while continually developing professional work knowledge and may represent Director/Manger in key operational meetings.

Responsibilities

• Aligns staffing requirements with company demands to ensure production schedules can be met efficiently. Establishes or adjusts work schedules to meet requirements.


• Participates in process/product troubleshooting in order to correct/maintain desirable output (quality, yields, cycle time, etc.)


• Completes all quality records on time.


• Works closely with support departments (QC, QA, product release, planning, warehouse, etc) to ensure that production goals and timelines are met.


• Conducts investigations of non-conforming events by using data and problem solving skills.


• Interprets company or area policies and procedures to employees, enforces safety and compliance to environmental control procedures and regulations


• Recommends and implements measures to improve methods, equipment performance, layouts, yields and quality of output.


• Establishes actions to increase efficiency and reduce costs


• Motivates employees to achieve work-related goals


• Responds to and participates in corrective action implementation to observations identified in internal audits


• Analyzes and resolves work problems and assists employees in solving these problems


• Audits area for cGMP, safety and environmental compliance and participates in corrective action implementation


• Maintains time, output and quality records


• Estimates, requisitions, and inspects materials


• Confers with other supervisors to coordinate inter-and intra-departmental activities


• Trains and certifies employees to processes/documentation, regulatory requirements and company policies


• Revises documentation as appropriate


• Reports machine and equipment malfunctions, participates in troubleshooting and coordinates equipment repair to ensure least amount of downtime


• Represents department on new product development teams by providing scheduling assistance, technical input and process development work


• Organizes and/or leads cell teams to address/resolve departmental issues


• Participates in investigation/corrective action efforts during production interruption circumstances


• Responsible for training on and ensuring compliance with health, safety and environmental procedures listed in SOPs Responsible for the investigation of all health, safety and environmental-related incidents for the completion of corrective actions related to these incidents


• Performs other duties as assigned

Qualifications

Competencies:

Manage non-exempt employees and may supervise lower level exempt employees.  Will have responsibility for the overall direction, coordination, and evaluation of assigned department.  Will carry out supervisory responsibilities in accordance with company policies and applicable laws.  Responsible for interviewing, hiring and training employees; planning, assigning and directing work; troubleshooting and technical support of process; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Education / Experience:

Bachelor degree with a minimum four (4) years of related work experience or training, within the pharmaceutical industry, preferred or equivalent work-related experience of (8) years.  Must have experience reading and interpreting production schedules, SOPs, cGMPs, and FDA guidelines. Knowledge with the various aspects of the Transdermal manufacturing preferred. Technical knowledge of the manufacturing environment and specific knowledge related to assigned department.  Demonstrate the basic understanding of engineering/scientific fundamentals that are applicable to area under supervision and flexible to work different shifts/schedules.  Computer literate with the ability to use various computer and related software programs to perform duties.  Ability to facilitate teams of exempt/non-exempt employees to audit work areas, identify non-compliance of requirements, and develop/oversee action plans for corrective action. Six-Sigma Green belt certification a plus.        

Judgment / Decision Making:

Personnel evaluation and selection using established guidelines

Work Environment:

Production/plant floor – pharmaceutical products, may require working with potent controlled substances.

Physical Demands:         

The employee will be occasionally required to climb or balance; stoop, kneel, crouch, or crawl; and smell.  The employee must be able to lift and/or move at least 50 pounds.