Job Title: Senior Development Scientist

City: Greenville

State: NC

JOB DESCRIPTION:

• Lead and support formulation and process development activities while serving as a primary point of contact with the client regarding pharmaceutical development and clinical manufacturing project related activities.

• Design, coordinate, and execute all product development activities including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records/protocols, scale-up, QbD, and registration batch activities.

• Write all the required documentations including batch records, protocols, product development reports, risk assessments, and campaign summaries.

• Manage the projects and work with suppliers/vendors, logistics and planner/buyers to help ensure that an adequate inventory of raw materials is maintained at all times.

• Work closely with analytical scientists, project management, quality, and commercial operations to ensure that formulation and process development are appropriate and timely.

• Collaborate with quality and analytical groups in performing robust quality event investigations and proposing sound CAPAs.

• Trouble shoot manufacturing scale up issues during different stages of product development.

• Work with schedulers to design an efficient schedule of equipment and resources to minimize machine down times and maximize usage of high demand equipment.

• Maintain competence and training documentation for relevant equipment and processes.

EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Master’s degree in Pharmaceutical Science and 4 years of experience in job offered or 4 years of experience in the Related Occupation.

RELATED OCCUPATION:

Sr. Scientist or any other job title performing the following job duties:

• Designing, coordinating, and executing all product development activities including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records/protocols, scale-up, QbD, and registration batch activities.

• Writing all the required documentations including batch records, protocols, product development reports, risk assessments, and campaign summaries. Managing the projects and working with suppliers/vendors, logistics and planner/buyers to help ensure that an adequate inventory of raw materials is maintained at all times.

• Working closely with analytical scientists, project management, quality, and commercial operations to ensure that formulation and process development are appropriate and timely.

• Collaborating with quality and analytical groups in performing robust quality event investigations and proposing sound CAPAs.

• Trouble shooting manufacturing scale up issues during different stages of product development.

• Maintaining competence and training documentation for relevant equipment and processes.

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.

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.

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 spam@catalent.com for us to investigate with local authorities.

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