Bioprocess Specialist - Downstream Operations
BioProcess Specialist - Downstream
Do you want to have an opportunity to make a difference? Then we would love to have you on the Galli Manufacturing Continuous Improvement Team. Galli Manufacturing produces enzyme replacement therapies for patients with rare genetic disorders and we’re currently deploying a 5-year transformational change initiative to realize our vision of ‘Achieve Manufacturing Excellence Every Day, Every Lot, for Every Patient’.
The Downstream BioProcess Specialist will work closely with representatives from the Floor Staff, Manufacturing Science & Technology, Engineering, Automation, Validation, etc. to support day to day plant operations, drive CAPA selection and closure, and execute continuous improvement projects. As a member of our downstream process team you will influence technical strategy and project prioritization.
You will be considered the front-line Subject Matter Expert (SME) for your assigned products. As a SME, you will know how the pieces of the system (procedures, batch records, automation, equipment, biological processes) work in combination with the operator to deliver quality product supply while using your creativity and technical acumen to troubleshoot in real time and develop plans to transform and mature those systems and processes.
We will work together to strengthen core skills and capabilities to not only make you successful in this role, but also prepare you for future opportunities. Your efforts will lead to the development of a mature processes within the Galli Manufacturing organization improving the lives of our manufacturing associates and improving our ability to reliability supply the patients we serve.
- 3+ years of relevant experience in pharmaceutical or biopharmaceutical manufacturing
- 2+ years of supporting chromotography operations, buffer operations, CIP, SIP, disposables, and other aspects of downstream processing in a ‘front-line’ capacity (Change Control, Corrective/Preventative Actions, Troubleshooting, etc.)
- B.A./B.S. in Science, Engineering, or acceptable equivalent combination of education and experience
- Working knowledge of process automation and associated equipment
- Familiarity with the underlying scientific principles that drive biologic protein clarification and formulation
- Understanding of FDA/EMEA cGMP guidelines pertaining to biopharmaceutical or aseptic processing and GMP compliance
- Proven project management, leadership and communication skills
- Self-motivated individual, able to work well in a team environment
- Demonstrated Ability to
- Solve complex technical problems
- Handle multiple tasks concurrently and be flexible and adaptable, as needed
- Meet deadlines and drive projects without direct authority as the primary change agent
- Strong technical writing ability
- Create and administer technical trainings
- Expert at coaching others to drive for results; guides team members in the way that best suits their work style, actively seeking to offer support while nurturing self- directedness
- Effective at exploring alternatives and positions in negotiations to reach outcomes that gain the support and acceptance of all parties
- Promotes requirements for sound decision making and holds key decision makers accountable
- Skilled at asking penetrating questions to define the problem accurately