GMP Operator (Chemistry)
Location: Bristol, PA
The successful candidate will be responsible for performing large-scale chemistry processes for cGMP manufacturing projects. Performs functions related to the development and processing of drug substances, APIs and intermediates ensuring product compliance and multiple tasks that ultimately provide Good Manufacturing Practices and on time delivery to the customer. The individual must be able to communicate production status, communicate problems to proper personnel and understand how it affects other aspects of the operation.
Typical Duties Include:
The successful candidate will work in a highly collaborative and fast-paced environment, and will be directly involved in the cGMP manufacture. This includes the hands-on execution of chromatographic purifications, lyophilization, evaporation, crystallization as well as authoring of relevant documentation (process development reports, batch records, and SOPs), and perform in-process analytical characterization (HPLC, UPLC, LC-MS, NMR, etc.) of products.
- Works in GMP environment and ensures regulatory compliance.
- Perform Manufacturing activities including:
- Batch Documentation/Record Generation
- Materials sampling, staging, dispensing, and return
- Equipment and Room set-up, operation, and cleaning
- Use of appropriate personal safety equipment and engineering controls
- In-process inspection and sampling
- Support investigational and quality systems activities.
- Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment.
- Participate in continuous improvement activities
- Interface and consult with Analytical, Quality Control and Quality Assurance.
- Summarizes data in reports; records document experimental work/in-process testing accurately utilizing established best practices.
- Communicates with good writing and critical analysis skills and presents process optimization and trouble-shooting activities, findings and recommendations to his/her supervisors.
- Ensure the proper set-up and operation of processes and equipment.
- Ensures proper execution of Master Batch Records, standard operating procedures, and validation protocols.
- Ensure completion of equipment logs and/or lab notebooks.
- Ensures cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s).
- Ensures accuracy of Standard Operating Procedures (SOP’s).
- Train on and understand all policy and procedures including Regulatory, Safety, SOPs, Work Instructions, etc.
Required Experience and Skills:
- A minimum of 2 years’ experience in CMC environment, active in manufacturing campaigns.
- Experience in process development and manufacturing of small molecules
- Direct hands-on experience with large scale extractions, crystallizations, evaloprations and lyophilizations.
- Experience with cGMP manufacturing operations and GxP principles.
- Knowledge of recording experimental procedures, data and findings according to cGMP standards.
- Understanding and application of cGMP requirements.
Preferred Experience and Skills:
- Understanding of common chemical reactions and approaches.
- Experience with organic and synthetic chemistry principles.
- Have a strong working knowledge of cGMP compliance.
- Possesses advanced technical skills, time management and communication competencies, and a commitment to innovation and efficiency.
- Strong communication and problem solving skills.
- Team-oriented with the flexibility to adapt to changing work priorities.
- Willingness to work flexible hours, including weekends, as needed.
- Bachelor’s degree in Chemistry or related field with minimum of 2 year experience is preferred, however, candidates with strong mechanical aptitude and a solid background in Chemistry will be considered.
- Ability to stand for extended periods of time, and lift heavy objects.
- Less than 10% of occasional weekend work may be required.