Job Title: Principal Formulation Scientist – Oral Solid Dosage
Location: New Jersey (Relocation Package Available)
Company Overview:
Our client, a leading pharmaceutical company specializing in the development and manufacture of oral solid dosage (OSD) forms, is seeking a Principal Formulation Scientist to join their dynamic team. The company is known for its commitment to innovation, quality, and patient-focused solutions. With state-of-the-art facilities and a collaborative culture, they provide excellent growth opportunities for professionals in the pharmaceutical field. Relocation assistance is available for qualified candidates.
Job Summary:
The Principal Formulation Scientist will play a key role in leading the formulation development and optimization of OSD products, including tablets, capsules, and powders. This individual will be responsible for driving technical projects from concept through commercialization, working closely with cross-functional teams to deliver high-quality products that meet regulatory requirements and company standards.
Key Responsibilities:
- Lead the design, development, and optimization of OSD formulations, ensuring robustness and scalability.
- Oversee formulation and process development activities, including pre-formulation, compatibility studies, and stability testing.
- Design and execute experiments to support formulation development, using QbD (Quality by Design) principles and DOE (Design of Experiments).
- Collaborate with analytical, quality, regulatory, and manufacturing teams to ensure seamless project progression.
- Troubleshoot formulation challenges and propose innovative solutions to address technical issues.
- Guide scale-up activities and technology transfer processes to internal and external manufacturing sites.
- Author and review technical documents, including formulation development reports, batch records, and regulatory submission documents.
- Mentor and provide technical guidance to junior scientists and other team members.
Qualifications:
- Ph.D. in Pharmaceutical Sciences, Chemistry, or a related field, with at least 5 years of experience in OSD formulation development; or Master’s degree with at least 8 years of relevant experience.
- Extensive knowledge of OSD technologies, including wet granulation, dry granulation, direct compression, and coating processes.
- Proven experience with QbD principles, DOE, and statistical analysis for formulation development.
- Strong understanding of cGMP, ICH guidelines, and regulatory requirements for OSD products.
- Demonstrated project management skills and the ability to lead multiple projects simultaneously.
- Excellent problem-solving skills and a proactive approach to addressing formulation challenges.
- Effective communication and interpersonal skills, with experience working in cross-functional teams.
Benefits:
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous PTO and holiday schedule.
- Relocation package to assist with the transition to New Jersey.
- Professional development opportunities and career advancement support.
- 401(k) plan with company matching contributions.
