Analytical Development Scientist

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Job description

Working at Lykan is not just a job but an opportunity to impact the lives of people with serious health conditions. You will have the ability to innovate and contribute to the development of revolutionary treatments. The Lykan team is comprised of over a century of experience in the industry. At Lykan, we have a shared purpose.

As an Analytical Development Scientist, you will be responsible for method development and qualification to support process development, tech transfer, release testing and stability activities for cell therapy pharmaceutical drug product programs. You will apply your knowledge of biological assays and analytical fundamentals in an experimental setting to guide the development of pharmaceutical products, lead research and development activities in collaboration with project teams, interfacing with internal teams and external clients. 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, Quality, Information Technology, and Operations departments. As a technical subject matter expert, the position 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 role in optimizing test methods, continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization.

Duties and responsibilities

• 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 Manufacturing and QC with process or analytical troubleshooting, deviation impact assessments, OOS investigations, corrections and CAPA, as needed
• Plan feasibility testing of new or alternative technologies and consult with key stake holders to ensure technology development alignment with Lykan and Client program requirements
• Document all experiments and results thoroughly with detailed observations
• Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project strategies and goals
• Perform development studies to support client and Lykan initiatives 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
• Demonstrate a high level of professional expertise in one or more technical areas
• Act as mentor/coach for junior Research Chemists and Engineers

Direct reports

Individual Contributor

Qualifications

• Bachelor's/Master's degree with 2-5 years of experience relating to analytical and biological assay development
• MS or additional certifications in science, engineering, or cGMP operations with 5+ years in a GMP environment
• Experience with some or all of the following is required: flow cytometry, PCR, ELISA, cell culture, cell-based assays, immunoassays, hemacytometry
• Experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain, mycoplasma)
• Working knowledge in method development, qualification and validation around common analytical techniques and assays

• Good Manufacturing Practices (GMP) laboratory experience
• 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, multi-disciplinary, research and manufacturing environment
• Excellent technical writing and oral communication skills
• Driven individual that works well independently and within cross-functional teams

Working conditions

Work is primarily M-F during regular business hours with some remote work is encouraged and scheduled around business and laboratory needs. Evening or weekend work may be required occasionally for limited duration to support key project activities.

May serve in an "on call" capacity to respond remotely to urgent issues.

Physical requirements

Most work will occur in a laboratory or office. Personal protective equipment is provided. Must be able to successfully gown for clean room access, as needed.

Lykan is an equal opportunity employer with a commitment to diversity. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Job Type: Full-time

Pay: From $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Supplemental Pay:

• Bonus pay

Education:

• Bachelor's (Required)

Work Location: One location