Development Scientist II

Development Scientist II

The Development Scientist II serves as a primary point of contact with the client regarding pharmaceutical development and clinical manufacturing project related activities. The Development Scientist II 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 Development Scientist II is responsible for all formulation and process development of several ongoing projects including project management and customer contact.

The Role

* Responsible for GMP compliance in formulation and process development.

* Responsible for assisting with planning and operating within a budget for the pharmaceutical area.

* Work directly with customers and potential customers to agree on development approaches and scope of work.

* Independently assist manufacturing group with batch manufacture and packaging/labeling, including set-up and cleaning.

* Lead efforts in solving formulation and process problems.

* Directly support with writing batch records, SOPs, IQ/OQ/PQ documents, development/technical reports, and CMC sections for regulatory submissions as directed.

* Ensure that all work is accurate, precise, properly documented and, when appropriate, performed within GMP guidelines.

* All other duties as assigned.

The Candidate

* Bachelor's degree in Pharmacy, Chemistry, Biology or related field with eight or more years of experience in pharmaceutical development with focus on solids formulation required or;

* Master's degree in Pharmacy, Pharmaceutics, Industry Pharmacy, or related field with six or more years of experience in pharmaceutical development required or;

* Ph.D. in Pharmacy, Pharmaceutics, Industry Pharmacy or related field with four or more years of experience in pharmaceutical development required or;

* Some exposure to hazardous chemicals and other active chemical ingredients.

* Position requires the capacity to handle and manipulate objects using hands and arms.

* Requires 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 Work At Catalent

* Spearhead exciting and innovative projects

* Fast-paced, dynamic environment

* High visibility to members at all levels of the organization

* 152 hours of PTO + 8 paid holidays

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 Disabili This option is reserved for individuals who require accommodation due to a disability.…