Senior Scientist - Chemical Engineer for API Manufacturing Process Development

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Job Overview

The Senior Scientist - Chemical Engineer for API Manufacturing Process Development at myGwork will be responsible for leading and optimizing the development of active pharmaceutical ingredient (API) manufacturing processes. This role is essential for enhancing production efficiency and product quality while ensuring compliance with industry standards and regulations. The candidate will collaborate with cross-functional teams to design experiments, analyze data, and implement innovative strategies that drive the advancement of API technologies.

Job Responsibilities

• Lead the development and optimization of API manufacturing processes, ensuring adherence to quality standards.
• Design, execute, and interpret laboratory experiments to assess process viability and scalability.
• Collaborate with multidisciplinary teams, including formulation scientists and quality assurance professionals, to facilitate effective process development.
• Conduct risk assessments and implement improvements to reduce potential hazards in manufacturing procedures.
• Prepare detailed technical documentation, including process development reports and standard operating procedures (SOPs).
• Present findings and recommendations to stakeholders, both internal and external, effectively communicating complex scientific concepts.
• Stay current with industry trends and regulatory changes to ensure compliance and competitiveness.

Qualifications

• Ph.D. in Chemical Engineering, Chemistry, or a closely related field with a focus on pharmaceutical applications.
• A minimum of 5 years of experience in API manufacturing process development, preferably within a pharmaceutical setting.
• Proficiency in design of experiments (DOE), statistical analysis, and data interpretation.
• Strong understanding of GMP regulations and quality assurance processes.
• Excellent troubleshooting skills and ability to work in a fast-paced, dynamic environment.
• Demonstrated ability to lead projects and mentor junior scientists.
• Effective communication skills, both written and verbal, with a strong attention to detail.

Technologies & Tools

The Senior Scientist will utilize a variety of technologies and tools, including statistical software (e.g., Minitab, JMP), process simulation software (e.g., Aspen Plus), and advanced laboratory equipment such as HPLC, GC-MS, and FTIR for analytical assessments. Familiarity with electronic laboratory notebooks (ELNs) and data management systems is also essential to maintain documentation integrity and facilitate collaboration.

Ideal Candidates

Ideal candidates for this position are innovative thinkers with a passion for scientific discovery and a commitment to excellence in API manufacturing. They possess strong analytical and problem-solving skills, enabling them to navigate complex challenges with ease. Candidates should demonstrate a collaborative spirit, fostering inter-departmental teamwork and communication. An inherent curiosity and proactive approach to learning are highly valued, ensuring they remain at the forefront of industry advancements and regulatory compliance.