Production Scientist

Production Scientist

The Production Scientist supports early-phase development of Active Pharmaceutical Ingredients (APIs) by synthesizing small organic molecules and API-related impurities. In this role, you collaborate closely with lead research scientists to manufacture new and existing products during process development, optimization, technology transfer, scale-up, and process validation activities. You apply strong chemistry knowledge, follow current Good Manufacturing Practices (cGMP), and communicate effectively with multidisciplinary teams while contributing to high-quality, timely project delivery.

Responsibilities

• Perform chemical reactions on scales ranging from gram to multi-kilogram quantities to support API development and manufacturing.
• Execute chemical synthesis, isolation, and related laboratory tasks while maintaining strict attention to detail to meet safety, quality, schedule, and customer objectives.
• Operate manufacturing and laboratory equipment safely and productively in accordance with established procedures.
• Recognize processing and quality issues during production and promptly escalate concerns to project leads or appropriate team members.
• Read, understand, and comply with technical documents, batch records, and standard operating procedures.
• Perform accurate calculations using simple mathematical formulas and operations to support laboratory and manufacturing activities.
• Record experimental and production results in a neat, precise, and compliant manner following cGMP and other applicable regulations.
• Carry out equipment qualification, calibration, maintenance, and cleaning activities as required to ensure reliable and compliant operation.
• Assist with data entry, document drafting, and other laboratory documentation tasks to support project and regulatory requirements.
• Complete all required cGMP and other relevant company training in a timely manner and apply this knowledge in daily work.
• Collaborate with lead research scientists and cross-functional teams during process development, optimization, technology transfer, scale-up, and process validation.
• Support API and API-related impurity synthesis and testing in alignment with customer needs and project goals.

Essential Skills

• Strong chemistry background with hands-on experience in chemical synthesis of small organic molecules.
• Experience performing Active Pharmaceutical Ingredient (API) testing and API-related analytical work.
• Familiarity with current Good Manufacturing Practices (cGMP) and previous experience in a GMP-regulated environment, or successful completion of a GMP class as a substitute.
• Ability to conduct and monitor chemical reactions from gram to multi-kilogram scale safely and effectively.
• Proficiency in applying a full suite of analytical testing techniques to support chemistry and API testing.
• Capability to read, interpret, and follow technical documents, batch records, and standard operating procedures accurately.
• Strong attention to detail with the ability to maintain high standards of data integrity and documentation under cGMP.
• Competence in performing basic mathematical calculations required for laboratory and manufacturing tasks.
• Effective written communication skills for documenting work and contributing to technical documents.
• Ability to collaborate in a diverse, multidisciplinary team environment.

Additional Skills & Qualifications

• Experience working in a contract development and manufacturing organization (CDMO) or similar environment supporting multiple external customers.
• Exposure to process development, optimization, technology transfer, scale-up, or process validation activities for APIs.
• Comfort working with a wide variety of pharmaceutical customers and adapting to different project requirements.
• Strong organizational skills and the ability to manage multiple tasks while meeting project timelines.
• Demonstrated commitment to ongoing training and professional development in cGMP and pharmaceutical manufacturing practices.

Work Environment

This is an on-site role within a dedicated laboratory and manufacturing environment as part of a smaller team of approximately 30–40 people. You work normal business hours,…