Room Lead - Secondary

Room Lead - Secondary

This is a full-time, hourly position. The shift is Friday - Sunday alternating Thursday, 6:00am to 6:30pm.

The Secondary Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include manual, semi-automated and automated inspection, complex and bulk packaging. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

The department is comprised of four distinct, but integrated, channels. Inspection, Packaging, Label Control, and Pit Crew. The Inspection and Packaging teams execute batch production processes in a cGMP environment, focusing on 'right first time' and on-time delivery. The Label Control team is responsible for receiving ready to execute batch records, kitting, and control of printed materials. The Pit Crew team is responsible for storage, movement, and staging of material and product.

Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of 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.

The Role:

• Has developed proficiency typically developed through job-related training and considerable on-the-job experience
• Assigns employees responsibilities and tasks to be perform for the day.
• Assist 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; Works autonomously within established procedures and practices
• Must have in depth understanding and usage of Operational Excellence concepts and tools; Operators time management including rotations.
• Escalate behavioral or non-conformance to Supervisor; Capable of working with minimal supervisor and high-level stressed environment
• Ability to work with cross functional departments; Ability to identify opportunities for improvement such as 5S, waste elimination and non-value added tasks
• Review all activities within the Master Batch Record (MBR) throughout the shift, at the end of shift and at the end of production to ensure effective and accurate communication of production activities is documented in accordance with standing procedures and ALCOA principles
• Other duties as assigned

The Candidate:

• High School/GED required
• Associate's degree or higher preferred
• 3 years of direct pharmaceutical manufacturing experience
• 3 years GMP experience

Why Join Catalent:

• 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
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly 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

About Catalent:

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com.

To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position.

Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.

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 [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.