Production Scientist

Job Title:

Production Scientist

Job Description

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, typically Monday through Friday from 8:00 a.m. to 5:00 p.m., with some flexibility as needed to support project timelines. The facility operates as a contract development and manufacturing organization (CDMO) that partners with a wide variety of mid-size to large pharmaceutical companies on their API pipeline.

You will work in a regulated cGMP setting, using standard laboratory and manufacturing equipment for chemical synthesis, analytical testing, and API production, and you follow appropriate laboratory safety practices and attire suitable for a GMP laboratory environment.

Job Type & Location

This is a Contract position based out of Cary, NC.

Pay and Benefits

The pay range for this position is $30.00 - $30.00/hr.

Eligibility requirements apply to…