Senior Development Scientist
The Senior Development Scientist leads and supports 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. The Senior Development Scientist is responsible for supporting these activities in the areas of supervision, process development, clinical trial batch manufacturing, packing and documentation.
Position Summary
This position is 100% on-site at the Greenville site.
Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.
The Senior Development Scientist will independently design, coordinate, and execute all product development activities including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records, scale-up, QbD, and registration batch activities
The Role
Work closely with analytical scientists, project management, quality, and commercial operations to ensure that formulation and process development are appropriate and timely.
Write all the required documentations such as batch records, product development reports, risk assessments, and campaign summaries.
Communicate effectively with internal staff, clients, and external vendors.
Responsible for GMP compliance in formulation and process development.
Support and contribute to qualification of facility and equipment.
Coordinate with logistics and scheduling groups to help ensure that an adequate inventory of raw materials is maintained at all times.
Maintain competence and training documentation for relevant equipment and processes.
All other duties as assigned.
The Candidate
Bachelor’s degree in pharmaceutical science, chemistry, engineering or related science with at least 10 years of industrial pharmaceutical experience required or;
Master’s degree in pharmaceutical science, chemistry, or related science with at least 9 years of industrial pharmaceutical experience required or;
Ph.D. in Pharmaceutical Science or related field or Pharm.D. with at least 7 years of industrial product development experience required.
Some exposure to hazardous chemicals and other active chemical ingredients.
Capacity to handle and manipulate objects using hands and arms.
Ability to occasionally lift items in excess of 50 pounds.
This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced 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 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.
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