Lead, Form/Fill (Prep) - (Weekend PM Shift)

Novo Nordisk A/S; Bloomington (IN); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Lead for Form/Fill operations in a state-of-the-art facility. This role involves coordinating manufacturing processes, ensuring compliance with GMP standards, and leading a team in a cleanroom environment. The successful candidate will leverage their expertise to improve operational efficiency and assist in onboarding new employees. With a commitment to employee growth and a focus on making a difference in diabetes care, this position offers a unique opportunity to contribute to impactful healthcare solutions while enjoying competitive pay and comprehensive benefits.

Benefits

Generous paid time off

Health Insurance

Dental Insurance

Vision Insurance

401K contribution

Paid parental leave

Tuition Assistance

Life Insurance

Employee Referral Awards

Qualifications

• 2 years of direct pharmaceutical manufacturing experience preferred.
• Proficient in Excel and Word; familiarity with quality management software.

Responsibilities

• Coordinate the work of others and assist in problem-solving.
• Ensure compliance with batch record documentation and training.

Skills

GMP experience

Communication Skills

Problem Solving

Time Management

Detail Oriented

Education

High School/GED

Associate’s degree or higher

Tools

Excel

Word

TrackWise

ComplianceWire

JD Edwards

Chromatography

Job description

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Lead, Form/Fill (Prep) - (Weekend PM Shift)

Facility: Manufacturing

Location: Bloomington, IN, US

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:

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

Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, material staging, and aseptic filling. Product in this area is filled into vials, syringes, or cartridges inside sterile isolator barriers. The sterile barrier isolator provides a physical barrier between the manufacturing equipment and the personnel controlling the machine. The Drug Product Primary Manufacturing area is a cleanroom environment. Personnel working in this area are required to wear scrubs and/or coveralls, gloves, hairnet, safety glasses, and steel toed shoes.

The Position

Relationships

Reports to: Manager, Form / Fill

Essential Functions

• Has developed expertise through a combination of job-related training and considerable on-the-job experience
• Typically acts as a lead, coordinating the work of others – but not a people manager
• Works autonomously within established procedures and practices
• Assist manufacturing personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistance
• Has expertise over area procedures and provides recommendation for improvement and changes
• Advise management on proposed Corrective Actions
• Must have in depth understanding and usage of Operational Excellence concepts and tools
• Communicating of goals and delegating tasks for the shift to team members
• Escalates to Supervisor as expected
• Ensuring batch record documentation is performed; reviewed throughout shift and turned in for review in expected timeframe
• Coordinating tasks with supporting groups (Quality, MS&T, Maintenance, etc)
• Ensuring training for team members complies for work that is being performed
• Electronic verification of allocated materials for processing
• Assists in onboarding of new employees

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. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.

Qualifications

• Education/Experience:
  • High School/GED required
  • Associate’s degree or higher preferred
  • 2 years of direct pharmaceutical manufacturing experience, preferred
  • 2 years of GMP experience, required
• Technical Requirements:
  • Proficient in Excel, Word, and other office systems
  • Ability to learn and use quality, operations and/or scientific management software such as TrackWise, ComplianceWire, JD Edwards, Chromatography (i.e. Unicorn), etc.
  • Ability to understand and apply CGMPs to everyday work
  • Demonstrates basic understanding of the work tasks assigned
  • Executes procedures with high quality
  • Basic understanding of pharmaceutical production operations
  • Capable of learning unfamiliar principles or techniques with training
  • Contribute to deviation investigations and corrective / preventative actions
  • Ability to interpret data, analyze trends, and participate in solutions
  • Participate in technical calls and discussions regarding investigations or other issues
  • Applies best practices to work activities
• Behavioral Requirements:
  • Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary
  • Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
  • Ability to cooperate with coworkers within an organized team environment or work alone
  • Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines
  • Ability to put aside personal opinions and focus on business needs, department needs or group needs
• Leadership Requirements (No Direct Reports):
  • Lead by example according to Catalent's values and culture
  • Develops contacts and builds relationships with peers
  • Seeks to learn from others
  • Takes initiative when necessary to address changes in scope or procedural errors
  • Builds trust and respect for self and department

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.