Associate Lead I - Biomanufacturing, Compliance, Training

Summary

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.

The 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 solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

The department is comprised of three distinct, but integrated, channels. The Manufacturing Process Execution team executes batch production records and SOPs in a cGMP environment, focusing on ‘right first time’ and on-time delivery. The Manufacturing Process Optimization team is responsible for implementation strategy and design of core processes and procedures carried out within the cGMP facility, representation of the manufacturing team during internal and external discussions, monitoring of process execution, campaign analysis, and maintenance of processes throughout a product lifecycle. The Manufacturing Process Compliance team provides support for cGMP Manufacturing operations, ensuring compliance with all applicable internal SOPs as well as regulatory and client requirements.

This is a full-time on-site position, Monday – Friday, 10:00 AM – 6:00 PM.

($2,000 Sign-On Bonus Available)

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Tracks and monitors training to ensure timely, accurate reports and compliance metrics.

• Actively leads training sessions for employees and groups.

• Provides input to assess training needs and collaborates with managers on learning issues and educational requirements.

• Assists in developing evaluations to measure the effectiveness of MFG department training.

• Helps design and develop training on job-specific tasks, SOPs, FDA cGMP, Environmental Health & Safety regulations, and general work skills.

• Provides feedback to revise training materials based on evaluation outcomes.

• Collaborates with Subject Matter Experts to identify training needs, target audience, and performance standards.

• Supports safety improvements and provides on-the-floor manufacturing assistance.

• Assists Quality Assurance with SOP training and participates in team meetings.

• Tracks and reviews training records for accuracy, while communicating policies and decisions that affect employee performance.Other duties as assigned.

The Candidate

• Requires Bachelor's Degree in a technical discipline (e.g., biology, biotechnology, engineering) or related life science field, OR

• Associate’s Degree in a technical discipline (e.g., biology, biotechnology, engineering) or related life science field with a minimum of 1 years’ related experience, OR

• High School Diploma with a minimum of 4 years’ related experience.

• Ability to use 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 systems (i.e. Unicorn®), etc.

• Ability to understand and apply CGMPs to everyday work.

• Ability to gain a basic understanding of pharmaceutical laboratory and/or production operations.

• Capable of learning unfamiliar principles or techniques with training.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 hours of paid time off annually + 8 paid holidays

• Competitive salary with yearly bonus potential

• Community engagement and green initiatives

• Generous 401K match

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .