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:
- Performs a variety of complex tasks in accordance with CGMP, CGDP, SOPs, and Batch Records
- 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.
- Provides detailed observations, analyzes data and interprets results. Communicates these results to staff and upper management
- Initiates deviations, assists in assessing product quality impact and assists with proposals for Corrective and Preventive Actions (CAPAs)
- Ensure the proper set-up and operation of processes and equipment.
- Writes, reviews SOPs, Master Batch Records, Specifications, and other applicable cGMP documentation for Manufacturing
- Prepares technical reports, batch summaries, protocols, batch records, specifications, and quantitative analyses
- Ensures proper execution of Master Batch Records, standard operating procedures, and validation protocols.
- Ensure completion of equipment logs and batch record.
- 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 4 years’ experience in a GMP pharmaceutical environment
- Experience in manufacturing of small molecules in a GMP environment
- Direct hands-on experience with large scale extractions, crystallizations, evaporations and lyophilizations.
- Experience with cGMP manufacturing operations and GxP principles.
- Understanding and application of cGMP requirements.