City: Somerset
State: NJ
JOB DESCRIPTION:
1. Coordinate projects and perform development of oral drug dosage forms utilizing techniques including blending, encapsulation, suspension, solutions, wet/dry/fluid bed granulation, tablet compression, coating, milling and spray drying;
2. Develop, test, and validate processes for a product's clinical trials and commercialization;
3. Coordinate with multi-disciplinary project teams that include quality, analytical chemists, formulation specialists, and manufacturing operations;
4. Develop solution based approaches to project issues to manage customer relationships;
5. Utilize deep foundation in pharmaceutical science to identify, highlight, coordinate, and mitigate risks to Pharmaceutical Consumer Health (PCH) and Clinical & Development Supply (CDS) development execution;
6. Coordinate PCH and CDS projects from award stage to completion ensuring correct planning timelines are generated, monitored and tracked to ensure successful adherence and completion based on drug development expertise;
7. Assist in the preparation and regular review of Standard Operating Procedures (SOPs); and
8. Apply knowledge of FDA current good manufacturing practices (cGMP) to meet technical outcomes and project deliverables.
EDUCATION AND EXPERIENCE: Requires a Bachelor's degree in Pharmaceutical Sciences and 5 years of experience in job offered or 5 years of experience in Related Occupation
RELATED OCCUPATION:
Sr. Validation Associate or any other job title performing the following job duties:
1. Developing, testing, and validating processes for a product's commercialization;
2. Coordinating with multi-disciplinary project teams that include quality, analytical chemists, formulation specialists, and manufacturing operations;
3. Developing solution based approaches to project issues to manage customer relationships;
4. Assisting in the preparation and regular review of Standard Operating Procedures (SOPs); and
5. Applying knowledge of FDA current good manufacturing practices (cGMP) to meet technical outcomes and project deliverables.
JOB TIME: Full Time
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 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.
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