Principal - Process Sciences Associate - United States
- We unite caring with discovery to make life better for people around the world.
- Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
- We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
- This position is responsible for the technical support of manufacturing operations.
- This position will interact with the engineering, manufacturing, validation, quality assurance, quality control and regulatory departments.
- Interaction may be required with other site / contract producers of products.
- Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required.
- Spreadsheet experience is required. Database experience a plus.
- Responsible for supporting manufacturing operations through the performance of the following duties and representing TS/MS on Manufacturing Process Teams:
- Monitors (trends) and analyzes production data.
- Applies process knowledge and data analysis skills to support the management of daily manufacturing operations.
- Presents process data and analyses in Manufacturing Process Team meetings
- Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor.
- Communicates issues in a timely manner. Leads process-related investigations and assesses technical impact
- Assists in the transfer of processes from process development to production facilities and from one production facility to another, anticipating and addressing scale-up issuesAuthors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies
- Writes standard operating procedures as they relate to the activities of the TS/MS group.
- Reviews and approves manufacturing batch records and other manufacturing documentation
- Works directly with the Manufacturing staff on the manufacturing floor to share process knowledge.
- Assists in process-related training of Manufacturing Process Team members.
- As required, directly gathers additional supporting data on the manufacturing floor
- As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement continuous improvements to manufacturing processes
- Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment.
- Helps to define and implement control strategies for company Branch burg processes
- As required, may lead or assist in the planning and execution of process validation activities
- As required, may own or assist in the implementation of process-related change controls
- Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP
- BS degree in Chemistry, Microbiology, Biochemistry or related science, or BS in Chemical Engineering or related engineering discipline
- Minimum of 3 years experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment
- Qualified candidates must be legally authorized to be employed in the United States.
- Our company does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
- Experience in fermentation/cell culture and/or protein purification manufacturing
- Process and equipment knowledge of cell culture or purification functions
- Thorough understanding of GMP requirements for a large scale manufacturing facility
- Process validation experience a plus
- Demonstrated leadership skills
- Excellent communication skills, both oral and written