Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
Summary:
The Research Scientist I/II, Process Development will support Kyowa Kirin’s cell therapy pipeline programs in a highly collaborative environment. This position will play a key role in developing next-generation cell therapy programs from drug discovery to IND.
Essential Functions:
• Design, optimize and scale processes for pipeline projects
• Conduct experiments and analyze data to support process improvements
• Collaborate with R& D, quality assurance and manufacturing teams to ensure seamless process integration
• Maintain compliance with regulatory guidelines and internal standards
• Identify opportunities for automation and process enhancement
• Troubleshoot and resolve process-related issues in a timely manner
• Provide support for technology transfer to CMC/CRO/CDMO.
• Prepare necessary documentation for project reviews (proposals, monthly, quarterly, annual, or study reports), patent applications, publications, and/or animal, biosafety, or human subject protocols.
• Present individual research at group and project meetings and efficiently records experiments and data in laboratory notebooks, databases and monthly reports.
Requirements:
Education
Ph.D. in Biological Sciences, Immunology, Molecular Biology, Biochemistry, or closely related discipline
Experience
• Minimum five (5) years’ biotech/pharma industry or academia experience in cell therapy process development.
• Extensive knowledge of cell therapy concepts and exploration, including in vitro and in vivo study experience
• Hands-on experience in developing and characterizing cell therapy products including HSC, iPSC and/or CAR-T.
• Familiarity with synthetic biology concepts and approaches including gene and/or base editing.
• Understanding of relevant Regulatory guidelines (GMP, ISO, ICH) is preferred.
• Familiarity with FDA regulatory requirements for Cell Therapy is desired.
• Experience with handling, culturing and differentiation of human stem cells to various types of immune cells is highly preferred.
• Experience with development of potency assays and other related QC release assays is highly desired.
Technical Skills
• Strong knowledge of Immunology, Hematology and/or Cancer Biology.
• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
• Excellent written, verbal, and listening communication skills: articulate and effective communicator and presenter.
• Self-motivating and creative, able to work within a team and collaborate proficiently with colleagues to achieve program goals.
• Demonstrated familiarity with flow cytometry and other immunostaining assays.
• Experience with gene modification and genome editing technologies.
• Experience in handling viral vectors.
• Stem cell culturing and differentiation into immune cells.
• Ability to manage a high-volume workload and adapt to workload based upon changing priorities.
• Solid proficiency in Microsoft Office Suite (Excel, Word, Outlook, etc.).
Annualized base salary ranges from $105,000 - $135,000 plus short term incentive bonus; actual salaries will vary and may be above or below this range commensurate with various factors including but not limited to experience, education, training, and merit.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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