Room LeadPosition SummaryCatalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.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 Pharma Solutions in Kansas City, MO is hiring a Room Lead role. The Room Lead, 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 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 the potent packaging areas. This position reports to the Production Supervisor but will also receive instruction from the Packaging Team Lead.This is a full-time position: Hourly Role. Onsite. Monday – Sunday: Thursday: 10:30pm-7:00amCatalent 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. Adhere to cGMP and GDP when completing and reviewing production batch records
Alert management of any potential deviations or infractions in a timely manner
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
Required a High School Diploma or Equivalent
A minimum of 2 years of clinical trial packaging experience or related manufacturing/operations experience preferred
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
Required Leadership skills include excellent interpersonal and communication skills with all levels of stakeholders, the strong ability to lead, mentor, train, motivate, direct and empower a team, influence and lead change, contribute strategic, analytical insight for problem solving and partner with cross functional teams to identify gaps, develop and implementation of continuous improvement ideas
Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required
Ability to work well with people of diverse cultures preferred
Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds
Occasional requirement to work in cold environment to fill orders (walk-in refrigerator/freezer)
Why you should join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
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
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
WellHub- program to promote overall physical wellness
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 [email protected] . 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 [email protected] 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) .