Supervisor

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance - effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Quality Control (QC) team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups:

Microbiology: The Microbiology program ensures the safety of pharmaceutical products by testing solution(s), excipient(s), and finished products for disease-causing microorganisms. The Microbiology Program provides evidence-based and scientifically proven approaches and procedures that ensure sterility, determine antimicrobial effectiveness, detect microbial contamination/bioburden, and analyze endotoxins of manufactured product. In addition, the Microbiology Team collaborates with support groups to validate the assay methods used in testing finished products.

Environmental Monitoring: The Environmental Monitoring (EM) Program evaluates the effectiveness of microbial controls necessary to ensure that the manufacturing facility is maintained in a manner that prevents the ingress of microorganisms in low bioburden products. The EM program is part of an overall control strategy designed to ensure patient safety and incorporates facility design and maintenance, effective access controls, good cleaning procedures, validated sanitization, and disinfection procedures, reliable process controls, consistent sample collection and testing, an effective training program, and quality assurance of materials, facilities, and equipment.

Stability: Analytical testing, data analysis, document writing, and data reporting to support of ICH stability studies to determine the stability of bulk drug substance and drug product.

Release and In-Process: Analytical testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.

Method Validation: Analytical testing, data analysis, document writing, and data reporting to support phase appropriate method validation of analytical methods. These methods directly support the Stability and Release and In-Process testing teams.

Sample Management: Management and oversight for all samples that support manufacturing, stability, and method validation. Also responsible for the management of stability chambers and oversight of laboratory critical reagents.

Raw Materials: Material inspection, sampling, analytical testing, data analysis, document writing, and data reporting to support the qualification and release of raw materials and components for use in the manufacturing of bulk drug substance and drug product.

Other functions: Additional functions within the Quality Control department include technical data review, training, instrument maintenance, lead investigator, and laboratory information management system (LIMS) administration. These functions directly support the entire Quality Control department perform their specific job functions.

The Position:

Schedule: Sunday-Friday: 11:00pm-7:30am

Relationships

Reports to: Manager or above

Direct Reports: 2-12

Essential Functions

Responsible for all activities within functional area

Manage resources assigned to each functional area

Ensure employee training is executed according to defined training plans and maintain current training plans

Identify, maintain, and report functional KPIs to site management

Monitor and report project milestone completion and timing

Accountable for revenue reporting and billing

Drive continuous improvement through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and KPI performance improvements

Maintain safe and healthy work environment by establishing and enforcing organization standards and adhering to legal regulations

Review and approve data and reports

Conduct performance reviews and engage in employee hiring process

Routinely participate in customer team meetings

Assist in customer audits and regulatory inspections

Provide technical assistance for personnel

Lead team members to improve and reinforce performance of others

Take responsibility for direct reports' performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly

Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee's career development

Other duties as assigned

Microbiology

Accountable for daily operations to maintain Quality standards and project timelines, including execution of work, coordination with stakeholders, and communication with leadership

Accountable for collaboration with internal Catalent stakeholders to complete microbiological analyses, maintain effective and efficient processes, and ensure appropriate test directives are established and followed

Accountable for oversight of microbiological compendial method verification

Accountable for completion of qPCR/PCR method development, qualification, validation, and execution

Accountable for daily operations of the site's environmental monitoring program

Accountable for collaboration with internal Catalent stakeholders to complete environmental monitoring, maintain effective and efficient processes, and ensure appropriate test directives are established and followed

Accountable for trending and reporting of site environmental monitoring data

Support instrument onboarding and maintenance

Stability

Accountable for daily operations to maintain Quality standards and project timelines, including execution of stability testing, coordination with stakeholders and communication with leadership

Account for oversight of sample management team

Accountable for collaboration with internal Catalent stakeholders to complete stability analyses and reports, maintain effective and efficient processes, and ensure appropriate test directives are established and followed

Accountable for monitoring stability protocol creation, stability sample pulls, testing completion, and stability report issuance

Release and In-Process

Accountable for daily operations to maintain Quality standards and project timelines, including execution of release and in-process testing, coordination with stakeholders, and communication with leadership

Accountable for collaboration with internal Catalent stakeholders to complete release and in-process analyses and reports, maintain effective and efficient processes, and ensure appropriate test directives are established and followed

Accountable for completion of release Certificates of Analysis

Accountable for oversight of contract testing laboratories

Accountable for Quality Control data review function for routine testing

Supports instrument onboarding and maintenance

Method Validation

Accountable for daily operations to maintain Quality standards and project timelines, including execution of method validation work, coordination with stakeholders and communication with leadership

Accountable for collaboration with internal Catalent stakeholders to complete method validation and qualification work, maintain effective and efficient processes, and ensure appropriate test directives are established and followed

Accountable for completion of method qualification/validation protocols and reports

Responsible for analytical method expertise within department

Physical Requirements

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds . click apply for full job details