Product Development Group Leader

Product Development Group Leader

Position Summary

Catalents Greenville N.C. facility specializes in endtoend turnkey solutions for oral solid dosage forms including integrated formulation development analytical services commercial manufacturing and packaging. This stateoftheart facility has had over $100M of investments in recent years and features fitforscale capacity with potent handling capabilities ideal for orphan or targeted drug development. Catalent is committed to a Patient First culture through excellence in quality andcompliance and to the safety of every patient consumer and Catalent employee.

The Product Development Group Leader will lead projects and innovations as well as builds and leads a team focused on the development and characterization of oral solid dosage products. The primary formulation platforms include tablets capsules and immediate release and extendedrelease dosage forms. The Product Development Group Leader researches and introduces new formulation technology to produce and characterize drug products and will be the primary point of client contact for formulation strategy compliance and troubleshooting. The position supports department initiatives evaluates new technologies to expand site service offerings and ensures overall timelines and client expectations related to pharmaceutical projects are met.

Catalent 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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.

The Role

• Provide technical leadership and oversight of formulation and process development activities within group.

• Responsible for GMP compliance in all aspects of batch manufacturing and documentation.

• Create and develop innovative drug formulations.

• Perform and train others on a variety of formulation techniques including but not necessarily limited to: blending encapsulation wet/dry/fluid bed granulation tablet compression coating milling and multiparticulates.

• Perform and train others on a variety of characterization techniques related to powder and dosage form development including but not limited to bulk/tap density testing sieve analysis and more advanced techniques including powder rheometry solid fraction and advanced techniques such as SEM and compaction simulation.

• Responsible for transfer of projects to external manufacturers or late stage/commercial manufacturing team at the local site and other sites within the company.

• Stay abreast of current scientific technologies to maintain the stateoftheart nature of our services and will evaluate new technologies to expand our technical service offering.

• Provide input to Commercial Operations and Project Management for new business development including service estimate generation due date assignments and revenue recognition for group activities.

• All other duties as assigned.

The Candidate

• Bachelors degree in Pharmacy Chemistry Biology or related field with at least 9 years of experience in drug product development or;

• Masters in Pharmacy Chemistry Biology or related field degree with at least 7 years of experience in drug product development or;

• PhD in Pharmacy Chemistry Biology or related field with at least 4 years of experience in drug product development.

• At least 5 years of oral solid dosage pharmaceutical experience.

• At least 3 years of leadership experience with demonstrated management skills (e.g. business knowledge leadership communication ability to analyze technical issues conflict resolution) and ability to motivate employees.

• Thorough knowledge of cGMPs and other government regulations appropriate to pharmaceutical manufacturing.

• Majority of work day is performed while sitting standing walking.

• Some exposure to hazardous chemicals other active chemical ingredients dust fumes and gases.

• Requires ability to occasionally lift items in excess of 20 pounds.

• Ability to occasionally stoop bend twist push pull and have full range of motion in upper and lower extremities.

• Ability to handle and manipulate objects using hands and arms.

Why You Should Join Catalent

• Competitive medical benefits and 401K

• 152 hours of PTO 8 Paid Holidays

• Dynamic fastpaced work environment

• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 lifesaving and lifeenhancing 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 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.

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