Summary/Purpose of Job
To manufacture and adequately document Active Pharmaceutical Ingredients (APIs), Intermediates, regulatory starting materials and other chemicals according to approved batch records (or other laboratory records) under close supervision.
Essential Duties/Responsibilities
- Manufacturing APIs, intermediates, and regulatory starting materials according to approved batch production records
- Assisting in the development and approval of cGMP batch records and other cGMP process documentation
- Setup, use and cleaning of process equipment and maintenance of corresponding equipment logs, as applicable
- Ensuring a secure supply of raw materials from reliable and qualified vendors
- Dispensing and use of raw materials, and maintenance of corresponding material logs, as applicable
- Maintaining schedule of manufacture activities
- Participating in research and development activities under close supervision
- Scaling up development processes for cGMP or non-GMP manufacture
- Maintaining accurate cGMP records and R&D lab records
- Preparing project reports and/or data summaries, as needed
- Understanding of and compliance with appropriate SOPs
- Ensuring safety and cleanliness of laboratory work areas
- Cleaning glassware
- Helping create a positive work environment
- Other reasonable duties may be assigned as necessary
Qualification Requirements
- Bachelor’s degree in chemistry or equivalent formal training
- 2 years’ experience in cGMP environment strongly preferred
- Ability to scale-up processes with guidance
- Knowledge of synthetic and purification techniques
- Appropriate knowledge of cGMP regulations
Physical Demands/Work Environment
- Ability to work with large glassware
- Ability to safely handle hazardous materials
- Ability to move/lift 50 pounds
- Ability to bend to reach floor level
- Ability to wear a respirator
