Glenmark is a leader in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries.

Glenmark employs nearly 8000 people in over 80 countries and with its twelve manufacturing facilities in four countries, five R&D centers and Front-ends in US, EU, India, Brazil and other markets worldwide, Glenmark is well placed on the road of growth and is exceedingly well prepared to take the completion head-on.

POSITION SUMMARY:

The Packaging Manager is responsible for supervising Sampling and Dispensing Team, packaging personnel of Sterile Vials and Pre-Filled Syringe processes in a cGMP environment. Accountable for achieving production targets while maintaining cost controls. Supervises and coordinates activities of production workers to ensure that products meet standards and processes are conducted in compliance with Federal, State, and local requirements by performing the following duties. Supervises production operation and work to meet production goals. Maintains floor visibility to drive Right First Time (reduce human error) and is available to discuss and address issues and concerns. Recommends measures to improve production methods, equipment performance, work conditions and quality of product. Analyzes and resolves work problems, or assists operators in solving work problems.

Develops and maintains common expectations for technical and behavioral performance of operators. Initiates or suggests plans to create a motivating work environment to achieve departmental goals. Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and Manufactures products by supervising staff; organizing and monitoring work flow. Understands and responsibly performs duties and supervises employees with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements. Ensure the deviations are investigated adequately and action taken appropriately. Ensure the necessary in process checks are in place to ensure quality of products. To maintain the overall cGMP of the production area and to coordinate with other functions/Departments for execution of exhibit batches. Enforces and interprets company policies for operators, and ensures compliance with standard operating procedures, including issues related to safety and the environment. Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s) and Work Instructions (WI’s). Provides support to Consumer Complaint investigations. Provide leadership for Aseptic area during manager absences.

OVERALL JOB RESPONSIBILITIES:

Deliver the planned productivity in AOP for Packaging Operations as amended for any approved exceptions

Participate in RFT walkthroughs and objectives. Support projects and project teams as appropriate. Provides input in developing strategy and departmental business plan. Effectively manage Operations Associate performance and development to support company policies, procedures and goals.

Responsible for achieving day-to-day process outcome and delivering process results. Thinks analytically to understand a situation or problem – makes metrics-based decisions

Focus on efficiency of process, reduced changeovers, customer service goals, compliance, cost management and training. Supports departmental budgets, efficiencies, and compliance metrics. Analyze the operations against Unit Fill Rate, Standard Operating Procedures (SOP’s), etc. to ensure compliance and proactively identifies gaps and presents solutions to resolve. Change agent and continuous improvement champion.

Education :

Bachelor’s degree in Engineering; BS/BA Degree in Science Preferred or Equivalent Experience

Experience:

• 3-5 years of operations experience required or 3 years of supervisory experience, preferred.
• Work experience in pharmaceutical industry, preferred

• Experience in developing and executing tactical plans.
• Ability to drive action.
• Analytical software proficiency to support metric development.
• Technical knowledge of supply chain process.
• Technical writing ability.
• Must have the ability to comprehend packaging processes and equipment.
• Must have good verbal and written skills, and proven analytical ability.
• Proven ability to develop people.
• Ability to gather information, analyze it and develop tactical plan.
• Acts decisively, setting clear priorities.
• Demonstrated leadership and influencing skills.
• Drives accountability.
• Strong organizational, oral and written communication skills.
• Successfully completes regulatory and job training requirements on time (cGMP, ISO14001, OSHA, DEA, etc.).
• Writes procedures and reviews batch records.
• Contributes to the CAPA process.
• Drives the deviation processes to completion, including determining root cause, writing the deviations, driving improvements, etc.
• Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
• Ensures that manufacturing data are entered into systems in a timely manner for production, regulatory, and financial accounting with the use of SAP ERP system.
• Drives production schedule attainment without compromising Right First Time.