This is a full-time, hourly position. The shift is Tuesday – Friday, 6:00am – 4:30pm.

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fastgrowing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's.

I. Department Overview:

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.

II. Functional Specific Duties, Activities, and Responsibilities:

In general, this position’s primary duty is to support an assigned production area regarding process control, including data collection and metric reporting.

Collect and/or enter departmental data regarding the performance of people, processes, and equipment
Organize and/or create visual representations (spreadsheets, reports, slide shows, etc.) of data for multiple audiences
Complete projects and special assignments by establishing objectives, determining priorities, managing time, gaining cooperation of others, monitoring progress, problem solving and adjusting plans
Improve quality results by studying, evaluating, and redesigning processes
Implement changes and manage visual communications
Has developed knowledge and skills through formal training or considerable work experience
Works within established procedures with a moderate degree of supervision
Actively participates, suggests solutions to problems

Secondary –

Coordinate with the engineering department and operations leadership to ensure equipment downtime is documented accurately within the Digital Factory system.
Serves as the owner of the digital factory system for Drug Product Secondary; educates leaders within the department, to include Room Leads and Supervisors, on digital documentation of production activities.
Serve as an Operations representative during weekly plan v actual analysis between operations and Supply Chain planners on schedule adherence and attainment plans and projections.
Serve as a liaison between operations, engineering and Supply Chain Wizard personnel on process improvement initiatives, changes, and overall performance of the Digital Factory within Drug Product Secondary.

Drug Substance –

Perform Manufacturing review of all types of GMP Documentation including Master Batch Records, Engineering Studies, Logbooks, Forms, etc. to support timely release of material.
Comprehensive understanding of required processing area in order to execute sufficient
Manufacturing Review and materials evaluations.
Properly document department corrections in appropriate corrections tracking systems.
Proficient in GDP documentation.
Interpret and Maintain manufacturing schedules as they pertain to specific area for the purpose of material readiness, and record review.
Assists supply chain in inventory management in manufacturing areas including restock, expired materials, and availability.
Comprehensive understand of JD Edwards as an inventory management system, and how it pertains to processing area.
Comprehensive understanding of computer systems required to perform job functions (MES, JD Edwards, Power BI, Microsoft Office, LIMS).
Facilitate department meetings for deviation leveling, deviation review, and internal metrics review.
Compilation and analysis of department metrics,
Assists QA in driving timely batch release.
Works with QA, MS&T and department management on MBR improvements.
Assists cross-functional departments in issues that pertain to analyst responsibilities.
Sufficient understanding of several areas within manufacturing to support needs in other areas.
Addresses corrections to all executed documentation in a timely manner to support lot release.
Works scheduled shift and other off-shift coverage as required.
Executes other duties as assigned.
Ability to read and write English
Perform basic math skills (+, -, x, /, %, understand decimals)
Required to read, understand, and follow GMP documents.
Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry)
Works independently on limited scope issues.

III. Position Requirements:

Education/Experience:

High School/GED with 2-4 years experience OR
Associate degree with 1+ years experience OR
Bachelor’s degree
GMP experience preferred

IV. Dimensions of Position:

Scope of Responsibility:

Reports to: Supervisor or above
Direct Reports: NA

V. Physical, Safety and Behavioral Requirements of the Position:

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 (e.g. Unicorn®), etc.
Ability to understand and independently apply CGMPs to everyday work.
Demonstrates understanding of the work tasks assigned.
Executes procedures of moderate complexity with high quality.
Intermediate understanding of pharmaceutical and/or production operations.
Capable of learning unfamiliar principles or techniques with training.
Ability to interpret data and analyze trends to provide insight into potential issues.
Ability to lead technical calls and discussions regarding investigations, audits, or other issues.
Seeks best practices for daily work activities.

Behavioral Requirements:

Ability to see and hear and read and write clear English.
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.
Ability to transfer knowledge to others via training or mentoring.
Demonstrated ability to guide others thorough communication and learning.
Ability to make decisions which have moderate impact on immediate work unit.

Leadership Requirements:

Lead by example according to Catalent's values and culture.
Builds on contacts and relationships with peers.
Take initiative for personal and professional development.
Takes initiative when necessary to address changes in scope and procedural errors.
Builds trust and respect for self and department.

Safety and Environmental 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.

Business Environment:

Fast-paced
Performance driven
Customer focused
Collaborative and inclusive
Team player

About Catalent:

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com.

To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position.

Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Catalent Pharma Solutions

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