Environmental Monitoring (EM) Team Lead

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well.

Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.

Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.

POSITION SUMMARY:

The QC Microbiology/EM Team Lead provides direct oversight and guidance in the Quality Control Microbiology and Environmental Monitoring (EM), including applicable support and storage areas, to ensure manufactured products are appropriately measured and monitored according to Glenmark Monroe quality system requirements and regulatory guidelines (e.g., FDA 21 CFR, USP, EU Annex-1).

This position is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry. QC Microbiology/EM Team Lead is a key position with expected knowledge and comprehension of subject matter related to EM and microbiological laboratory testing related to sampling and analysis of Utilities (e.g., Compressed gases, Water for Injection, Purified Water, Pure Steam). They are responsible for ensuring microbiological and EM testing is performed in compliance with procedures and GDP requirements including growth performance, antimicrobial neutralization and contamination checks, bioburden and environmental monitoring sampling/testing of water, surface, air, and cleaning. This position requires a 100% on site presence.

Operational Excellence :

• Models the principles and behaviors of Glenmark and ensures personnel follow the company code of conduct.
• Leads strategy implementation and monitors progress of team through KPI (Key performance indicators), which align with company and site objectives.
• Communicate progress, status, and roadblocks as required.
• Drive projects, assignments, and complete presentations within timelines and budgets. Create and maintain relevant metrics for department/site.
• Spreadsheets and databases will be leveraged for departmental and company metrics, presentations, and data/testing tracking/verification. The QC EM Team Lead is involved in making key decisions for the Microbiology and EM laboratories, projects, and resource allocation/scheduling.
• Motivates and inspires colleagues to achieve top performance.
• Inspires and promotes employee growth and development within the team
• Ability to perform routine testing of samples submitted to the laboratory as appropriate. Schedules and participates in cleaning, inventory, and maintenance tasks in the lab.
• Accountable for inventory management and ordering/stocking of all QC department laboratory supplies.
• Ensures laboratory equipment is in compliance with procedures and GLP requirements. The QC EM Team Lead is responsible for making sure all laboratory instrumentation is appropriately validated, calibrated, and monitored for compliance.
• Troubleshoots laboratory issues related to all EM instrumentation. Recommends potential corrective and/or preventive actions and implements these actions within the laboratory.
• Performs GMP review of test data to ensure that test results meet all specifications. Trends data and analyzes trends to proactively mitigate equipment and reagent performance issues. Verifies laboratory equipment and associated equipment logs to ensure proper operation.

Compliance:

• Maintain current knowledge of regulatory and industry standards, trends and advancements.
• Responsible for ensuring compliance to systems and procedures in the EM/Microbiology laboratory and cleanroom areas. And prepare the lab for internal and external audits.
• Support Continuous Improvement initiatives by providing support on updating SOPs, WIs, and OJTs
• Perform investigation of the quality events assigned using root cause analysis tools, maintain timelines for closure of investigations and identify/initiate CAPAs
• Complete and maintain certified investigator training requirements
• Tracks quality system metrics and effectively communicates KPIs to Microbiology leadership
• Ensure Quality Systems are compliant with cGMPs and internal/external regulations and procedures
• Evaluates and assists in the implementation of new changes at the site
• Provide support to collect and prepare EMPQ reports, EM Trend reports, QMR board presentations with associated documentation.
• Performs regular self-audits of the Microbiology and EM laboratory areas (including storage areas) and assists/leads activities to address audit findings.

Stakeholder???????:

• Works collaboratively with other department stakeholders to ensure the services provided to the site are developed, tested, and delivered according to established procedures and regulations.

Innovation???????:

• Purchasing QC EM laboratory supplies. Makes sound, well considered decisions to make the most of available funds and resources. Monitors lab supply costs and looks for ways to work with suppliers to reduce consumables cost when appropriate.
• Consults with management, when appropriate, about laboratory supply variances. Demonstrates the ability to assess upcoming laboratory supply needs and prepare accordingly. Makes realistic and actionable plans to address supply chain issues.
• Demonstrates the ability to use available tools and technologies to track laboratory supply expenditures and usage. Coordinates efforts with suppliers to ensure inventory replenishment and avoid expiry.
• Keeps management informed anytime laboratory supplies or externally provided services exceed budget projections. Analyzes laboratory supply usage patterns to anticipate upcoming needs.
• Maintains the QC department ordering system to reduce costs and waste due to expiry. Keeps current on physical and computerized tracking systems for materials and supplies.

Safety:

• Ensures the team complies with all safety policies and procedures at all times.
• Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties

Education:

Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology or equivalent

Experience:

Minimum of 4 years

Knowledge and Skills :

• Strong organizational skills. Displays the ability to prioritize work and manage multiple tasks independently.
• Excellent written communication and technical writing skills. Clearly demonstrates competence in the selection and use of root cause analysis tools and techniques (e.g., 5 Whys, Pareto Analysis, 5M E).
• Displays strong interpersonal skills and ability to work with all levels of an organization. Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing Microbiology/EM laboratory tasks.
• Demonstrates the ability to read, understand, author, redline and execute standard operating procedures (SOPs).
• Displays ability to achieve Glenmark Monroe QE investigator certifications for product/process/testing/facility issues with product and non-product impact.
• Exhibits both analytical and problem-solving skills. Proven ability to problem solve/troubleshoot and provide solutions for laboratory issues.
• Demonstrates proficiency in human resource management for the efficient and effective management of direct reports and team development.
• Able to assess safety and environmental risks to ensure laboratory tasks adhere to EHS management system.

Leadership / Managerial Attributes:

The ability to work independently and within team structure and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must be a technical expert and have excellent written and oral communication as well as interpersonal relationship skills.

Other requirements :

Ability to lift 30 lbs.’ and work within different extreme temperature / humidity environments as encountered in the various Incubator conditions.