Company Overview: Our client is a pharmaceutical company specializing in the development and production of high-quality tablets and encapsulated products.
Our commitment to innovation, excellence, and patient safety drives our operations and continuous improvement efforts.
We are dedicated to delivering effective and safe pharmaceutical products that meet the highest industry standards.
As part of our growth and commitment to quality, we are seeking a skilled Process Chemist to join our team.
Position Overview: The Process Chemist will play a critical role in the development, optimization, and scale-up of manufacturing processes for tablets and encapsulated products.
Reporting to the Senior Process Development Manager, the Process Chemist will work closely with cross-functional teams to ensure robust and efficient processes that meet regulatory and quality standards.
The ideal candidate will have a strong background in pharmaceutical process chemistry, excellent problem-solving skills, and a commitment to innovation and continuous improvement.
Key Responsibilities: Develop and optimize manufacturing processes for the production of tablets and encapsulated products, ensuring scalability and reproducibility. Conduct laboratory experiments to evaluate and improve process parameters, formulations, and technologies. Collaborate with formulation scientists, analytical chemists, and manufacturing engineers to transfer processes from the laboratory to pilot and commercial scale. Perform process validation activities, including the design and execution of validation protocols, and analyze data to ensure compliance with regulatory requirements. Investigate and troubleshoot process-related issues, identifying root causes and implementing corrective and preventive actions (CAPAs) to resolve issues and prevent recurrence. Prepare technical reports, batch records, standard operating procedures (SOPs), and other documentation to support regulatory filings and manufacturing operations. Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory standards and guidelines. Participate in cross-functional project teams, providing expertise in process chemistry and contributing to the overall success of product development and manufacturing projects. Stay current with industry trends, advancements in process technologies, and regulatory changes, and apply this knowledge to drive process improvements and innovation. Support continuous improvement initiatives within the manufacturing department, identifying opportunities to enhance process efficiency, product quality, and cost-effectiveness.
Qualifications: Bachelor's degree in Chemistry, Chemical Engineering, or related field; advanced degree (M.S.
or Ph.D.) preferred. 2-5 years of experience in pharmaceutical process chemistry, with a focus on tablet and encapsulation manufacturing. Strong knowledge of pharmaceutical manufacturing processes, including granulation, blending, compression, coating, and encapsulation. Experience with process development, optimization, and scale-up from laboratory to commercial production. Familiarity with regulatory requirements and guidelines (e.g., FDA, ICH, GMP) related to pharmaceutical manufacturing. Proven ability to conduct root cause analysis, implement CAPAs, and troubleshoot process-related issues. Excellent technical writing skills, with the ability to prepare detailed reports, SOPs, and regulatory documentation. Strong analytical and problem-solving skills, with a detail-oriented approach to work. Effective communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders. Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and experience with laboratory and manufacturing software systems.
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