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Catalent Pharma Solutions Packaging Room Lead (1st or 2nd Shift) in Kansas City, Missouri

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

The role reports directly to the Production Supervisor.

Shift(s)/Schedule(s):

  • 1st: Monday-Thursday 5:00am-3:30pm

  • 2nd: Monday-Thursday 3:00pm-1:30am

The Kansas City Clinical Supply Services 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 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 the potent packaging areas. This position reports to the Production Supervisor but will also receive instruction from the CSS Team Lead.

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

  • 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

  • Assist production associated with QA questions and concerns

  • Support supervisors in daily activities

  • 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 record 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

  • May be required to oversee multiple on-going production operations and effectively delegate tasks to ensure completion

  • Must be able to clear a Drug Enforcement Agency (DEA) background check for handling controlled and special security drug substances

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

The Candidate

  • High School degree or equivalent

  • 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 maintain the highest level of quality in all work performed

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually

  • Potential for career growth within an expanding team

  • Defined career path and annual performance review and feedback process

Catalent’s Standard Leadership Competencies

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

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 www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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