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Senior Scientist, Downstream Process Development Specialist
hace 4 semanas
We're seeking a highly skilled Senior Scientist to join our Process Development team in the field of Downstream Process Development. As a key member of our team, you will be responsible for developing and implementing purification processes for sterile, injectable gene therapy materials.
Key Responsibilities:- Develop and optimize purification processes for gene therapy materials, ensuring high standards of purity and quality.
- Manage external partners to scale up bench-scale processes through pilot, engineering, and manufacturing stages.
- Evaluate and implement novel chromatography and filtration techniques to enhance product purity.
- Oversee experimental planning, execution, analytical testing, data analysis, and reporting.
- Author and review technical documents, including study protocols, reports, and regulatory submissions.
- Collaborate with cross-functional teams to achieve top-tier product purity and potency.
- Mentor and provide technical guidance to junior scientists and team members.
- Strong scientific expertise in Biochemical Engineering, Biochemistry, Chemical Engineering, or a related field.
- Substantial experience in developing purification processes for gene therapy or protein products.
- Hands-on experience with AKTA systems and Unicorn automation.
- Proficient with various filtration strategies, including ATF, TFDF, TFF, NFF, and related control systems/skids.
- Demonstrated ability to work effectively within cross-functional teams and manage multiple priorities.
- Adaptable and resourceful problem solver with a proactive attitude.
- Excellent written and verbal communication skills, with strong attention to detail and organizational capabilities.
- A hybrid workplace with flexibility to work in the office or remotely.
- A team-focused environment with a top-notch benefits package, including health, dental, flexible PTO, and commuter benefits.
- A collaborative and inclusive workplace that values talent development and meeting company goals.
Kelonia Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status, or any other basis protected by applicable law.
