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Lead Scientist, Analytical Development

Lykan Bioscience
Hopkinton, MA
Closing date
Nov 26, 2022

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Science, Pharmaceutical, Laboratory
Organization Type
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Lykan Bioscience is a fast-growing and innovative contract development and manufacturing organization (CDMO) focused on cell-based therapies. Cell therapy, one of the most transformative innovations in modern biotechnology, holds enormous potential for treating patients suffering from a variety of diseases. We are on a mission to improve patients' lives by innovating and delivering advanced cell-based therapies.
Working at Lykan is not just a job, it's an opportunity to work with a great team with diversified backgrounds and top-tier innovative biotechnology companies to contribute to the development and manufacture of revolutionary, life-saving treatments. Our team's passion for patients uniquely defines us. It's not about what we do; it's about why we do what we do.
Here at Lykan, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Innovation, Excellence, Teamwork, Integrity, Trust, and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success, at Lykan we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.
The Lead Analytical Development Scientist will be responsible for method development and qualification to support Quality Control, Process Development, and MS&T, including release testing and stability activities for cell therapy pharmaceutical drug product programs. You will apply your knowledge of biological assays and analytical fundamentals to guide the development of pharmaceutical products and lead research and development activities in collaboration with project teams. This includes assisting with equipment planning, analytical method development, and technology transfer plans for Lykan's client processes, including working with key stakeholders in Manufacturing, Process Development, Quality, and Operations departments. As a technical subject matter expert, you will support routine QC and characterization testing through training of technicians, troubleshooting instruments and assays, investigating deviations, and supporting producing disposition evaluations. The position will play a key client-facing role in optimizing test methods, continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization.

* Perform development studies to support client and Lykan initiatives
* Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project strategies and goals
* Critically assess experimental data and provide interpretation of results
* Prepare technical reports, summaries, and protocols in a GMP environment
* Prepare detailed scientific presentations for clients, colleagues, and management
* Participate in data reviews and client discussions
* Partner with Lykan staff and contractors in Operations, Quality Control, and Quality Assurance, as well as external clients and suppliers, to plan equipment setup and qualification, method development, qualification, and validation
* Support QC with analytical troubleshooting, deviation impact assessments, OOS investigations, corrections and CAPA, as needed
* Execute feasibility testing of new or alternative technologies and consult with key stake holders to ensure technology development alignment with Lykan and Client program requirements
* Demonstrate a high level of professional expertise in one or more technical areas
* Act as mentor/coach for junior Analytical Development Scientists and Associates

Analytical Development Scientists and Associates

* Master's/PhD degree in science or engineering with 7 - 10 years of experience relating to analytical and biological assay development (including academic research experience)
* Minimum of 3 years' experience in a GMP laboratory environment
* Expertise in flow cytometry required
* Experience with some or all of the following is required: PCR, ELISA, cell culture, cell-based assays, immunoassays, hemocytometry
* High-level expertise in method development, qualification and validation around common analytical techniques and assays
* Demonstrated ability to work successfully in a highly collaborative, team oriented, customer focused environment
* Must possess excellent verbal and written communication skills and ability to work in a dynamic and multi-disciplinary research and manufacturing environment
* Excellent technical writing and oral communication skills
* Driven individual that works well independently and within cross-functional teams

All Lykanians embrace the principles of the Lykan Bio culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.
Lykan is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.
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