Development Scientist II

Catalent Pharma Solutions LLC; Greenville (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

152 hours PTO + 8 paid holidays

On-site facility with advanced scale

Job summary

Catalent, Inc. is seeking a Development Scientist II for its Greenville, NC site to advance formulation and process development across multiple projects.

The role emphasizes direct client contact, collaboration with manufacturing, and rigorous documentation within GMP guidelines. The position focuses on supervision, planning within budgets, and delivering development and technical reports while supporting regulatory submissions.

Qualifications

• 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.
• Master’s degree in Pharmacy, Pharmaceutics, Industry Pharmacy, or related field with six or more years of experience in pharmaceutical development required.
• Ph.D. in Pharmacy, Pharmaceutics, Industry Pharmacy or related field with four or more years of experience in pharmaceutical development required.

Responsibilities

• Responsible for all formulation and process development of several ongoing projects including project management and customer contact.
• 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.

Skills

GMP compliance

Formulation

Process development

Documentation

Customer contact

Project management

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology or related field

Master’s degree in Pharmacy, Pharmaceutics, Industry Pharmacy, or related field

Ph.D. in Pharmacy, Pharmaceutics, Industry Pharmacy or related field

Job description

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.

Responsibilities

• Responsible for all formulation and process development of several ongoing projects including project management and customer contact.


• 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.

Qualifications

• 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.


• Master’s degree in Pharmacy, Pharmaceutics, Industry Pharmacy, or related field with six or more years of experience in pharmaceutical development required.


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


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

Physical Requirements

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


• Ability to occasionally lift items in excess of 50 pounds.


• Respirator must be worn for your safety; employment is contingent upon completion of a medical evaluation with satisfactory results, 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.

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 [e-mail]. 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.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

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 life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality 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 life-enhancing and life-saving treatments for patients annually.