Room Lead, Packaging

Position Summary:
Catalent Pharma Solutions in Kansas City, MO is hiring a Room Lead to support 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 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 potent packaging areas. This position reports to the Production Supervisor but will also receive instruction from the CSS Team
This is a full-time role position: Shift/Schedule: 2nd shift: Mon- Fri. 2:30PM-11:00 PM
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's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.
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

• Ensure that during all packaging operations, the site's safety, quality, and compliance metrics are met or surpassed as well as corporate metrics; Responsible for the safety, quality, delivery and cost (SQDC) of all clinical and commercial outputs
• Will lead assigned team members and work alongside them to successfully complete clinical trial and commercial packaging jobs on a daily basis
• Support supervisors in daily activities and assist production associated with QA questions and concerns
• Understand, interpret, and communicate organizational metrics and goals and lead assigned team members to consistently reach team and organizational goals
• Ensure that all employee batch records are reviewed, corrected, and submitted timely; Review of batch records with the room team prior to job start
• Alert management of any potential deviations or infractions in a timely manner
• Adhere to cGMP and GDP when completing and reviewing production batch records
• Will implement and enforce 5S principles with guidance from Team Leads, Supervisors, and as required by company best practices
• Assess operator strengths and weaknesses and leverage this information when assigning tasks during batch execution and may be required to oversee multiple ongoing production operations and effectively delegate tasks to ensure the completion
• Must be able to clear a Drug Enforcement Agency (DEA) background check for handling controlled and special security drug substances and understands and enforces GMP gowning and de-gowning requirements for each production area (primary, secondary and potent packaging suites)
• All other duties as assigned

The Candidate

• High School degree or equivalent required
• A minimum of 2 years of clinical trial packaging experience or related manufacturing/operations experience preferred
• Demonstrated ability to motivate and lead others while working alongside them to complete tasks to reach organizational goals
• Proven written and verbal communication skills
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Ability to lead a team and encourage strong working relationships
• Above-average organizational skills in alignment with 5S principles
• Ability to work effectively under pressure to meet competing workplace demands while maintaining the highest level of quality in all work performed
• Individuals may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 19 days of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with quarterly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.