Senior Manufacturing Technology Associate
Rockville, MD 20847
The Senior Manufacturing Technology Associate provides technical support to biopharmaceutical drug substance manufacturing operations for late-stage clinical and commercial programs. The position will work in partnership with Manufacturing Operations and BioPharmaceutical Development to support technology transfers, process and equipment validations, and routine manufacturing at both internal and external sites.
Responsibilities and Job Duties
- Leads investigations of deviations to determine root cause and product impact. Develops and implements approved corrective action plans at cGMP manufacturing facilities.
- Performs detailed data analyses and root cause analyses to identify solutions to complex problems. Makes recommendations for action plans to solve issues and minimize recurrences.
- Leads continuous process monitoring efforts and applies statistical tools to identify and improve productivity, efficiency, and robustness in manufacturing.
- Actively engages in the identification, sharing, facilitating implementation, and adaptation of best practices cross-functionally and between manufacturing sites.
- Champions and implements continuous improvement and operational excellence methods to improve the overall productivity and efficiency of manufacturing operations.
- Champions and implements change controls, leads selection and implementation of new equipment and materials at manufacturing facilities to improve existing and new processes.
- Drives technology transfer activities to internal and external manufacturing sites and corporate partners and serves as the technical expert in supporting manufacturing at CMOs.
- Performs fit-to-plant projections and plan for new processes and implements processes in multiple manufacturing facilities.
- Guides technical development early in the product lifecycle to ensure facility/operational considerations are factored into process decisions.
- Collaborates with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes.
Education & Experience
- Bachelor’s degree in Biology, Chemistry, Biochemistry or related life sciences or engineering field and a minimum of eight years relevant experience; or
- Master’s degree in Biology, Chemistry, Biochemistry or related life sciences or engineering field and a minimum of five years relevant experience
- Direct hands-on experience with commercial scale biopharmaceutical manufacturing support for mammalian cell culture and/or purification processes
- Experience authoring and reviewing technical reports
- Experience with Deviation, CAPA and Change Control systems
Knowledge, Skills and Abilities
- Solid understanding of overall manufacturing process, and strong technical knowledge of either upstream or downstream unit operations
- Knowledge of current Good Manufacturing Practices and US/EU regulations
- Demonstrated ability to solve technical and scientific problems in a collaborative environment
- Ability to critically analyze data using statistical tools for process performance to compile technical reports and other documentation
- Ability to collaborate with cross functional teams resulting in creative and positive outcomes
- Strong verbal, presentation and writing skills to communicate effectively internally and externally
- Excellent organizational skills, ability to prioritize multiple projects, and attention to detail
- Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
- Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding
- Displays a clear willingness to listen to others
- Solid proficiency in the use of Microsoft software (Word, Excel, PowerPoint)
- Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment
- Ability to occasionally work flexible hours, including off-hours/weekends
- Ability to travel up to 10% of time