Supervisor, Form/Fill

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.

Primary – 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.

Secondary – The Secondary Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include manual, semi-automated and automated inspection, complex and bulk packaging. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

Drug Substance - The Drug Substance - Operations department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

Production Support - The Drug Product Support department is responsible for supporting the Operations Team in the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. This includes Primary and Secondary Operations. Manufacturing cGMP production support activities include audit preparation, audit performance, documentation and metric tracking, documentation review, deviation identification and authoring, Corrective Actions, Change Management, and process improvements. The department is comprised of three distinct, but integrated, channels. The Manufacturing Auditing team oversees internal and external audits. The Analyst Team reviews batch production records, forms and logs. The third team is Process Specialists and Investigators that investigate and author deviations, implement corrective actions and process improvements.

The Position

In general, the position is responsible for increasing the ratio of value to non-value activities and eliminating waste in the overall production and supply chain from start to finish, for a defined area or operations, while being held accountable for processes, personnel, safety, compliance and meeting or exceeding the client requirements within their operational area.

Night Shift position: 6PM - 6:30AM; Friday - Sunday and every other Thursday

Relationships

Reports to: Manager or above

Direct Reports: 5 – 30

Essential Functions

• Supervises the daily activities of business, technical support or production team
• Typically manages 5-30+ employees
• Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors for up to 2+ months in advance
• Decisions are guided by policies, procedures and business plan; receives guidance and oversight from manager
• Typically, does not perform the work supervised
• Collaborates and communicates with support functions
• Schedules employees and manages workload for operational area
• Reviews and approves GMP documentations while ensuring safety and GMP quality compliance
• Supports and leads continuous improvement projects
• Hires, trains, motivates, leads, develops, and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state, and local regulations. Consults with Human Resources Department as appropriate
• Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results

Qualifications

• Education/Experience:
  • High School Diploma/GED with a 2 - 4 years relevant experience required
  • Bachelor’s degree with 1-2 years relevant experience required
  • Leadership experience preferred
  • GMP experience preferred
• Technical Requirements:
  • Excellent written and verbal communication skills with internal and external customers
  • Ability to communicate complex technical information to non-technical audiences
  • Maintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines
  • Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution
  • Able to combine and interpret data from multiple disciplines and an understanding of the full Biologics process with respect to specific area of expertise
  • Begin to provide reliable and defendable interpretations of regulatory guidance for the customer
  • Well organized with ability to handle and direct multiple activities within the group simultaneously
  • Maintains staff by recruiting and hiring, employees, developing personnel growth opportunities, supporting employee motivation and providing strategic alignment with Quality Assurance Department and site initiatives

• Behavioural Requirements:
  • Positions views and arguments appropriately to win support
  • Convinces others to take action
  • Negotiates professionally in tough situations
  • Responds effectively to the reactions and positions of others
  • Understands internal and external stakeholder requirements, expectations, and needs
  • Balances the interests of multiple stakeholders within team
  • Acts fairly despite conflicting demands of stakeholders (client programs and team)
• Leadership Requirements (if applicable):
  • Uses comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead projects within a department, group, or team in a single function or focus
  • Applies technical and functional knowledge to design projects that contribute to overall direction of department or discipline
  • Manages day to day activities with individual team
  • Focuses on and regularly communicates to team about team priorities and sets aside identified less critical tasks
  • Makes implementation plans and assignments that allocate resources appropriately to complete objective
  • Looks for obstacles and develops effective contingency plans with input for department initiatives and team's projects
  • Uses milestones to diligently track and manage the progress of the team and own work

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.

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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.