Senior Formulation Development Scientist
5 days ago
KEY DUTIES AND RESPONSIBILITES:
· Formulation Development Leadership: Lead the design, development, and optimization of complex pharmaceutical formulations, ensuring they meet project objectives and regulatory requirements.
· Project Management: Oversee multiple formulation development projects, managing timelines, resources, and budgets. Ensure projects are completed on time and within scope.
· Technology Transfer: Manage technology transfer activities from R&D to manufacturing, ensuring seamless transition and scalability of processes.
· Experimental Design and Execution: Design and execute complex experiments to support formulation development, process optimization, and troubleshooting. Analyze and interpret data to draw meaningful conclusions.
· Technical Documentation: Prepare and review comprehensive technical documents, including formulation development reports, batch records, technology transfer documents, and regulatory submission documents.
· Collaboration: Work closely with cross-functional teams, including Analytical Development, Quality Assurance, Quality Control Regulatory Affairs, Manufacturing, Engineering and Supply chain to drive project success.
· Compliance and Quality: Ensure all laboratory activities comply with regulatory guidelines, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), internal quality standards and safety policies.
· Innovation and Continuous Improvement: Stay abreast of industry trends, scientific advancements, and technological innovations to drive continuous improvement in formulation development practices.
· Mentorship: Mentor and guide junior scientists, fostering a collaborative and innovative work environment.
Education:
· Scientist: Master’s or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
Experience:
- Senior Scientist: 5 to 8 years of experience in pharmaceutical formulation development, including project management and technology transfer.
- Hands-on experience with formulation and process development for various dosage forms (e.g., tablets, capsules, injectables, topical formulations).
- Proficiency in analytical techniques such as HPLC, GC, spectroscopy, and microscopy.
- Familiarity with regulatory guidelines (e.g., FDA, EMA) and quality systems (e.g., GLP, GMP).
Preferred Qualifications:
- Experience with advanced drug delivery systems (e.g., nanoparticles, liposomes).
- Knowledge of statistical tools and software for experimental design and data analysis (e.g., Design of Experiments (DOE), Minitab, JMP).
- Previous experience in preparing regulatory submission documents (e.g., IND, NDA, ANDA).
Tell employers what skills you have
FDA
Spectroscopy
Data Analysis
Design of Experiments
HPLC
Microscopy
Formulation
Drug Delivery
IND
Chemistry
Experimental Design
Analytical Techniques
Laboratory
Manufacturing
Chemical Engineering
GLP
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