Operations Group Leader

4 weeks ago

Somerset, United States Catalent Pharma Solutions Full time

Position Summary:

Catalent Pharma Solutions in Somerset, NJ is hiring a 2nd shift Operations Group Lead for the Manufacturing Group. This position will lead the daily processing activities in support of the manufacturing of clinical and commercial products according to cGMPs in a timely manner in accordance with business unit objectives. The group leader will assist in the delegating of employee assignments and the monitoring of all processing activities. The group leader will also report delays or concerns to direct supervisor.

This is a full-time 2nd shift position: Monday – Friday, 3:00PM-11:30PM

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 in Somerset, NJ is home to oral solid dose manufacturing operations as part of the Oral and Specialty Delivery (OSD) business unit. On site we have our state-of-the-art laboratory, clinical, and commercial manufacturing plant for oral dose forms in addition to being the Catalent Center of Excellence for handling Highly Potent Active Pharmaceutical Ingredients.

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

  • Actively lead manufacturing operations and work with manufacturing technicians to ensure productive and compliant operations on the production floor
  • Monitor projects to ensure agreed upon customer and department timelines are met and reports progress of projects to manufacturing leadership
  • Demonstrate technical proficiency and ability to independently troubleshoot complex manufacturing and equipment related problems
  • Lead and perform unit operations (work centers) consisting of and not limited to Hot Melt Extrusion, Fluid Bed, Roller Compaction, Encapsulation, Compression, Coating, Milling, Blending, Sifting, Dispensing, and other processes where assigned
  • Ensure document accuracy via completion of batch records, phase reviews, logbooks, label verification, and raw material verification
  • Check for accuracy all materials delivered from the dispensing area as well as all in-process materials from the prior unit operation as per current SOP
  • Release rooms and equipment following cleaning validation sampling, facilities maintenance, or other activities
  • Assign equipment and room cleaning when required
  • All other duties as assigned;

The Candidate

  • High School Diploma or GED required
  • 3+ years working in a pharmaceutical, biotech, or food manufacturing environment
  • Must be able to assemble, disassemble, operate, clean, troubleshoot, document, and train on 3 or more of the following: Weigh & Dispense, Blending, Milling, Bulk Packaging, Hot Melt Extrusion, Roller Compaction, High Shear Granulation, Fluid Bed, Tablet Compression, Tablet Coating, and Encapsulation
  • Ability to utilize hand tools to assemble and disassemble various types of machinery
  • Experience following instructions and procedures (SOPs, cGMPs)
  • Basic Computer proficiency
  • Strong written and verbal communication skills
  • Ability to read and interpret blueprints, mechanical drawings, and technical writing
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-50 pounds;

Why you should join Catalent:

  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • 152 hours of PTO + 8 paid holidays
  • Several Employee Resource Groups focusing on D&I
  • Dynamic, fast-paced work environment
  • 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
  • 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 – Let us help you finish your degree or earn a new one
  • 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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE ) .


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