Sr. QC Analyst, Cell Therapy

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.

Job purpose

The Sr. QC Analyst, Cell Therapy will be Lykan QC’s subject matter expert for analytical methods such as qPCR, ELISAs, flow cytometry and related methods. This position provides scientific support to the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing. This is a hybrid role, with part time spent in the laboratory educating and training staff and executing assays and part time collaborating with Lykan Analytical Development and partner representatives.

This position is highly visible in the organization and requires the ability to interface with multiple groups, and the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot.

Duties and responsibilities

• Operate and maintain flow cytometer and qPCR instrumentation.
• Perform immune-staining for multi-color flow assays and generate, analyze and interpret flow cytometry data.
• Provide scientific guidance, training, and support for method transfers/qualification/validation and routine testing of in-process, final product, and stability samples.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Review all data in accordance with applicable procedures and cGMP requirements.
• Author, review, and/or approve SOPs, Test Methods, and other procedures required to operate a QC laboratory.
• Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
• Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.
• Support the QC raw material program. This includes QC sampling, physical inspection, and testing of incoming raw materials, reagents, and components.
• Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Communicate effectively with cross-functional peers, department management, and Lykan’s partner representatives.

Direct reports

this is an Individual Contributor position

Qualifications

• Bachelor’s Degree in scientific discipline.
• 3-5 years of relevant Analytical Development or QC experience, preferably in a regulated environment.
• Hands-on experience with various analytical techniques such as qPCR, ELISAs, flow cytometry and scientific knowledge in the characterization and transfer of analytical methods.
• Technical background and expertise with flow cytometry platforms a plus.
• Knowledge of cGMP/ICH/FDA regulations
• Ability to independently prioritize/manage activities.
• Works well both independently and as part of a team. Collaborative skills and effective partnering skills.
• Proficient in MS Office applications and information technologies that support documentation and data management systems.
• Strong troubleshooting and problem-solving skills.
• Excellent oral and written skills.
• Ability to multi-task and interact with multiple groups in a team-oriented environment.

Working conditions

This role will split time between the office and the laboratory as required to meet partner production schedules. Shift work may be required.

Physical requirements

Job may require ability to lift up to 50 pounds, stand for extended periods of time, and complete repetitive tasks.

With decades of biopharmaceutical industry experience, Lykan offers a full range of development and manufacturing services for cell-based therapies. Our state-of-the-art, purpose-built, clinical, and commercial manufacturing facility offers eight independent manufacturing suites and is uniquely designed to fully integrate cGMP principles and advanced software solutions to enable real-time testing and release of products.

Located in Hopkinton, Massachusetts, 25 miles southwest of downtown Boston and close to four international airports, Lykan is ideally situated to deliver life-saving treatments to patients on behalf of our partners.

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