Catalent Pharma Solutions

Room Lead, Packaging

Position Summary:

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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 Kansas City, MO Clinical Supply Services Room Lead, Packaging supports clinical trial projects through the packaging of clinical trial supplies, ensuring work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).

The CSS Room Lead, Packaging is key to ensuring the quality of outputs, adherence to the production schedule, and delegation of job-specific tasks. This position oversees the execution of all clinical and commercial batch records in primary, secondary and the potent packaging areas.

This position reports to the Production Supervisor but will also receive instruction from the CSS Team Lead.

First Shift: 6:30am – 3:00pm

The Role:

• Will lead assigned team members and work alongside them to successfully complete clinical trial and commercial packaging jobs on a daily basis; Responsible for the safety, quality, delivery and cost (SQDC) of all clinical and commercial outputs

• Perform Gemba walks

• Ensure that all employee batch records are reviewed, corrected, and submitted timely

• Alert management of any potential deviations or infractions in a timely manner

• Ensure that the production room is set up to ensure efficiently produced, high-quality outputs

• Adhere to cGMP and GDP when completing and reviewing production batch records

• Will implement and enforce 5S principles with guidance from Team Leads,

• Understands and enforces GMP gowning and de-gowning requirements for each production area (primary, secondary and potent packaging suites)

• Other duties as assigned

The Candidate:

• High School degree or equivalent, required

• 2+ years of clinical trial packaging experience or related manufacturing/operations experience preferred

• Highly active containment area (Potent Drug Facility) (respirator fit testing and pulmonary physical required)

• Must be available to work occasional overtime

• 20/20 corrected vision

• Able to distinguish all colors

• Position requires ability to spend extended periods of time in the following GMP environments:

• Controlled Room Temperature 68 degrees F – 77 degrees F (15 degrees C – 25 degrees C)

• Refrigerator 35 degrees F – 46 degrees F (2 degrees C – 8 degrees C)

• Freezer -4 degrees F (-20 degrees C)

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-50 pounds

Why You Should Join Catalent:

• Several Employee Resource Groups focusing on D&I

• Potential for career growth within an expanding team

• Diverse, inclusive culture

• 152 hours of PTO + 8 Paid Holidays

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 (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) .