Senior Manager, Inspection/Packaging

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.

 

Our state-of-the-art facility in Bloomington, Indiana provides a fully integrated model from process and formulation development to clinical and commercial biomanufacturing and drug product fill/finish and packaging. Bloomington’s main campus has been recognized as Facility of the Year in both 2007 and 2017 by the International Society of Pharmaceutical Engineers (ISPE), INTERPHEX, and Pharmaceutical Processing magazine.

 

 

 

The Position

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.

 

Relationships

Reports to: Director or above

Direct Reports: 5 – 12

 

Essential Functions

• Typically manages 5-12+ professional employees and/or supervisors
• Is accountable for the performance and results of multiple related teams
• Develops departmental plan, including business, production and/or organizational priorities up to 3-6+ months in advanced
• Decisions are guided by policies, procedures, resource availability and functional objectives.
• Provides technical guidance to employees, colleagues and/or customers
• 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 matter that affect their performance, attitudes, and results
• Able to act as a delegate for the Director on critical and strategic decisions

 

Qualifications

• Education/Experience:
• Bachelor’s degree or relevant experience required
• 4-6 years direct supervision experience required
• GMP experience required

Technical Requirements:Excellent written and verbal communication skills with internal and external customers

Ability to communicate complex technical information to non-technical audiencesAble to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolutionMaintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelinesAble to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics processExperienced in most aspects of drug development and life cycle support, and able to develop useful strategies and tactics to meet regulatory milestonesWell organized with ability to handle and direct multiple activities across departments simultaneously

Behavioural Requirements:Shares own ideas in a compelling manner that gains commitment from others

Inspires and persuades others to voluntarily follow directionNegotiates skillfully and professionally and persuades others to approach issues in the same mannerAnticipates reactions and positions of others and plans accordingly.  Mentors team to do the sameTakes a proactive approach to shape and influence internal and external executive stakeholder expectationsServes as a liaison between different stakeholder groups across departmentsEffectively aligns and influences the interests of multiple stakeholders (client programs and company) with different priorities to quickly drive complex decisions

Leadership Requirements: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 disciplineManages strategic or continuous improvement activities with the team, across teams within the department, or across multiple departments within the site. Coordinates with teams in other departments and across the business unitHelps identify department objectives to align with site goals. Regularly communicates to team, department, and company about department priorities and how alignedMakes implementation plans and assignments that allocate cross functional resources appropriately to complete objective and provide development opportunitiesAnticipates challenges and opportunities and adjusts contingency plans for department initiatives and team's projectIdentifies initiatives with relevant milestones and schedules to effectively manage the progress and performance of the team and own work developing metrics to monitor performance to goal 

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.