Specialist II

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 Manufacturing Sciences and Technology (MS&T) department's primary function is to serve as an agile technical team to support process & technology transfer (e.g., mAbs, fusion proteins, new modalities, etc.), raw materials and consumables, technical writing, and drug substance lifecycle management. The MS&T organization supports the Drug Substance area of the Bloomington facility as well as the Catalent Biologic's network through client-facing support, on-the-floor or on-call technical coverage, and continuous improvement.

The team is the technical liaison between Process Development (internal or external) and at-scale GMP manufacturing. This function includes drafting and supporting required batch documentation (i.e., gap assessments, reports, batch records, product impact), as well as process modeling and facility fit including initial bill-of-material development. Once production starts, the team provides on-the-floor-support to assist Manufacturing as questions are raised and to look for opportunities where the process could be improved.

The MS&T team provides technical support of late-phase work. The group works with a cross-functional team (including Process Development and Validation) as the program progresses through commercialization.

The Position

This role will provide on-call and on-the-floor technical support to manufacturing. This position will be client facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

Relationships

Reports to: Manager, MS&T

Essential Functions

Provide technical training to operators, provide on-the-floor oversight of the manufacturing process, as necessary

Support the technical transfer processes by reviewing and understanding the documents to be executed in the manufacturing areas

Utilize technical documentation (e.g., Master Batch Records, Equipment Drawings, Bill of Materials, Sampling Plans, Process Flow Diagrams, Process Descriptions) for project support

Provide client escort which entails interaction with client technical representatives, including Person-in-Plant observers on the manufacturing floor

Perform technical troubleshooting as needed for manufacturing issues and assist operations to mitigate risk to the product being manufactured

Identify process issues and determine whether escalation to DS - MS&T SMEs/Management is appropriate

Collect and transcribe process data into spreadsheets as part of process monitoring

Collect initial information for Deviations, and complete any immediate actions identified and owned by DS - MS&T team after the call, including the generation of protocols

Coordinate/support responses to floor issues - Ensure escalation through proper channels

Develop strong interdepartmental networks to enable prompt responses

Enter all discrepancies/inaccuracies and required hand changes to batch records into Batch Record Improvement Tracker prior to end of shift

Perform minor revisions to Master Batch Records

Communicate effectively and succinctly processing issues to SME's in DS - MS&T, Manufacturing, Process Engineering, Validation, and Quality Assurance

Enter all floor observations into the designated issues tracker, ensuring proper communication channels are followed for awareness

Perform other responsibilities to support group, site, and network-based initiatives, as required

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 be able to work in a cleanroom environment, including being able to don cleanroom gowning, for up to 4 hours continuously. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned (HVAC) controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.

Qualifications

• Education & Experience:
• Requires a minimum of a high school diploma
• Must have a minimum of 4 years of relevant experience
• At least 2 years of experience must be as a manufacturing lead, or senior role
• Must be knowledgeable operating equipment and processes used in Drug Substance
• Must be able to read and understand English-written job instructions and safety requirements

Technical Requirements:

Proficient in Excel, Word, and other office systems

Prior work experience with quality, operations and/or scientific management software such as TrackWise , JD Edwards , DeltaV , PI Vision , SCADA, Chromatography (i.e. Unicorn ), etc.

Ability to understand and independently apply cGMPs as it relates to clinical and commercial operations

Demonstrates understanding of the work tasks assigned

Executes complex procedures with high quality

Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines

Intermediate understanding of pharmaceutical laboratory and/or production operations

Capable of learning unfamiliar principles or techniques with training

Prior experience supporting/leading deviation investigations using root cause analysis tools

Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions

Update and/or approves Standard Operating Procedures (SOPs), Master Batch Records (MBRs) and reports

Seeks best practices for daily work activities

Seeks ways to implement process improvements for operations

Ability to support Risk Assessments and FMEAs

• Communication Requirements
• Excellent written and verbal communications skills with internal and external customers
• Ability to communicate basic technical information to non-technical audiences
• Ability to read, write, and speak clearly in English

Leadership Requirements:

Lead by example and follow Catalent's values, mission, and appropriate level of leadership competencies at all times

Behavioral Requirements:

Ability to see and hear

Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, memorizing, reading, social skills, speaking, stress control, writing

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, in a professional and accurate manner

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 with ability to work effectively under high pressure with multiple deadlines

Strong ability to multi-task in a fast-paced environment

Positive attitude and ability to work with others

Ability to process a large volume of work

Ability to effectively carry out and implement change

Ability to put aside personal opinions and focus on business needs, department needs, or group needs

Willingness and ability to work outside of standard work hours, including some weekends

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 . click apply for full job details