Catalent Pharma Solutions Room Lead - Drug Substance Downstream Days in Bloomington, Indiana
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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
Catalent Pharma Solutions in Bloomington, Indiana is a state of the art, GMP manufacturing facility, providing one million sq/ft of a drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients 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.
This role has a 12 hour rotating Shift - 6:00am-6:30pm
A room lead’s primary duty is to oversee production activities in a specific room(s) and perform a variety of operational tasks in accordance with current GMP's. Responsibilities include: work with scheduling, assign personnel to daily work, communicate pertinent and timely information, ensure quality, safety, and output are met, work with Value Stream Supervisor to maintain efficiency and implement continuous improvement processes, follow accurately all GMP documents (Batch records, SOPs, protocols, etc), operate in a clean room environment within required gowning, aseptic behaviors, and proper flow procedures, must work effectively in a team environment to achieve company goals.
Downstream: The cell mass from the upstream are processed to be purified to meet desired quality requirements. Process includes liquid chromatography, tangential flow filtration, and single use viral filtration.
Has developed expertise typically developed through a combination of job-related training and considerable on-the-job experience
Typically acts as a lead, coordinating the work of others – but not a people manager
Works autonomously within established procedures and practices
Provide leadership to manufacturing personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistance
Take a leadership role in the investigation of procedural deviations, SOP revisions and non-conformances, working closely with Quality Assurance counterparts to develop and execute robust CAPAs.
May lead shift handover or act as a shift lead in the absence of a supervisor
Leadership (Supervisory/Management) experience preferred
Must have in depth understanding and usage of Operational Excellence concepts and tools
Computer efficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include LIMS, SCADA, EDMS, Trackwise, etc.)
High School/GED with 3+ years manufacturing or leadership experience OR
Associate degree with 1+ year manufacturing or leadership experience OR
GMP experience strongly preferred
Must be able to read and understand English-written job instructions and safety requirements
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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
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
On-site fitness center and wellness programs
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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .
Catalent Pharma Solutions
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