Pharmaceutical Development Senior Associate Scientist I
Catalent
Summary
Support formulation design and development of oral solid drug products. Train others in clinical trial manufacturing operations using sound pharmaceutical principles and ensure all work complies with regulatory requirements, good manufacturing practices, and standard operating procedures.
Job description
Position Summary
Support formulation design and development of oral solid drug products. Train others in clinical trial manufacturing operations using sound pharmaceutical principles and ensure all work complies with regulatory requirements, good manufacturing practices, and standard operating procedures.
The Role
- Train others on procedures and laboratory techniques.
- Execute efficiency improvement projects with guidance.
- Apply knowledge of principles and concepts within the discipline.
- Use technical and functional knowledge to perform duties on most projects or assignments within the team.
- Conduct work in a Good Manufacturing Practice (GMP) area under minimal supervision.
- Other duties assigned.
The Candidate
- Maintain high-quality laboratory documentation in accordance with applicable regulatory guidance and site standard operating procedures.
- Draft technical documents such as laboratory notebook writeups, protocols, and batch records.
- Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Perform parallel review of GMP documents and laboratory notebooks and may become qualified to conduct compliance technical reviews.
- Execute procedures, methods, and manufacturing processes with minimal complexity, high quality, and limited supervision.
- Propose deviations from established procedures and methods based on sound judgment.
- Demonstrate mathematical and scientific reasoning ability.
- Assist with process efficiency under significant supervision.
- May contribute material to publications and/or external presentations.
- Stand, walk, sit, use hands to manipulate, and reach with hands and arms for up to 8 hours per day.
- Able to work with respirator (P100, PAPR, etc.).
- Occasional lifting and/or moving up to 50 pounds.
Preferred Skills & Background
Previous solids development experience preferred.
Requirements
- Master's degree in a related life science or physical science field with 0+ years of related work experience preferred, or Bachelor's degree in a related life science or physical science field with 2+ years of related work experience preferred
- Maintain high-quality laboratory documentation in accordance with applicable regulatory guidance and site standard operating procedures
- Draft technical documents such as laboratory notebook writeups, protocols, and batch records
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Perform parallel review of GMP documents and laboratory notebooks
- Execute procedures, methods, and manufacturing processes with minimal complexity, high quality, and limited supervision
- Propose deviations from established procedures and methods based on sound judgment
- Demonstrate mathematical and scientific reasoning ability
- Able to work with respirator (P100, PAPR, etc.)
- Occasional lifting and/or moving up to 50 pounds
- Previous solids development experience preferred
Benefits
- Medical, Dental & Vision
- Paid Time Off
- 8 Paid Holidays
- Tuition Reimbursement
- Career Growth
- Inclusive Culture
Company overview
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) that serves as a trusted partner to pharmaceutical, biotech, and consumer health companies worldwide. Founded on a legacy dating back to 1933, Catalent has evolved into a comprehensive drug development and delivery leader with over 40 global sites. The company specializes in providing end-to-end solutions spanning oral dose formulations, biologics, specialty products, and clinical supply services. Catalent's expertise includes formulation development, analytical services, commercial manufacturing, and advanced delivery technologies such as Zydis® fast-dissolve tablets and softgel technologies. With over 1,000 active development programs at any given time, the company launches more than 100 new products and line extensions annually and has supported half of all FDA approvals over the past decade. Catalent produces over 60 billion treatment doses per year, helping approximately 200 million patients annually. Headquartered in Tampa, Florida, the company employs more than 10,000 professionals globally who are dedicated to putting patients first and championing the missions that matter in healthcare innovation.