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Lykan Bioscience
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1 - 25 Results of 46
Lykan Bioscience
Hopkinton, Massachusetts, United States
5 days ago

Description

WHO WE ARE

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 grow the accessibility of these treatments to those who need them.

OUR PASSION

Working at Lykan is not just a job, it’s an opportunity to work with a great team with diversified background 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. 

THE LYKAN WAY

Here at Lykan, our team has the ability to contribute to the development of revolutionary treatments. We live everyday 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, a attractive benefits package, and an emphasis on work-life balance. Knowing our people are the key to our success, at Lykan we focus on developing our corporate culture, growth, and ability to impact patients. 

WHAT YOU WILL DO

The Quality Control/ Raw Material Sr. Analyst will be responsible for working under guidance of a QC Manager and He/she will support equipment qualification, the inspection and release of various incoming raw materials for use in the manufacturing of cell therapy products, including authoring material specifications, in compliance with all applicable quality systems and current cGMPs. He/she may also support routine QC laboratory and testing support activities as needed and will be responsible for analytical method analysis and/or qualification associated with cGMP production of cell therapy products. He/she will be responsible for writing protocols, standard operating procedures (SOPs), and reports in support of analytical testing. 

Main Responsibilities

  • Support QC Raw Materials program by performing raw material risk assessments, development of specifications, testing and release
  • Develop programs for raw material qualification and monitoring of compendial updates
  • Write and/or review protocols, test methods, and reports in support of analytical methods for cell therapy products
  • Perform non-routine/routine QC testing for analytical methods in support of cGMP manufacturing of cell therapy products (in-process, raw material, final product or stability) as needed
  • Support analytical equipment installation and qualification, ensuring 21 CFR Part 11 compliance
  • Support implementation of QC laboratory systems/technologies (i.e. LIMS)
  • Participate as analytical method subject matter expert (SME) in investigations, deviation, change controls, and CAPAs to support cGMP operations
  • Work collaboratively with cross functional departments including but not limited to Analytical Development, Quality Assurance, and Program Management
  • May interact with external partners on technical matters in relation to analytical methods
  • Execute sampling and QC Sample Management activities per procedure or written protocols.
  • Write/revise QC specific procedures and protocols
  • Participate in OOS investigations, change controls and CAPAs, as needed
  • Perform Inspection and sampling (as needed) on all incoming raw materials, packaging components following detailed written procedures
  • Possess the ability to evaluate certificate of analysis of chemicals/raw materials/packaging components
  • Adhere to compliance of Warehouse area in terms of Isolation of Quarantine and Released materials
  • Other duties as assigned by management


Requirements

QUALIFICATIONS

  • Bachelor’s degree in scientific discipline
  • 4+ years of GMP QC laboratory experience (raw material testing/release is a plus)
  • Knowledge in ANSI.ASQ Z1.4 sampling plans
  • Knowledge of analytical method industry guidances (e.g., ICH)
  • Experience in qPCR, Flow Cytometry, ELISA, and/or cell-based assays is a plus
  • Excellent/Effective written and verbal communications skills
  • Developed troubleshooting and problem-solving skills
  • Ability to adhere to timelines for testing and reporting of data
  • Possess strong organization, communication, writing, people skills/teamwork, and detail oriented
  • Experience working in a team environment, facilitating a team approach, and communicating effectively

Working conditions

Position is primarily M-F during regular business hours. Evening or weekend work may be required occasionally for limited duration to support key project activities.

~~~~~~~~~~~~~~~~~~~~~~~

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.   Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth. Lykan is proud to be an equal opportunity employer, seeking 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.

Job Information

  • Job ID: 65004472
  • Location:
    Hopkinton, Massachusetts, United States
  • Position Title: Sr. QC Analyst - Raw Materials
  • Company Name For Job: Lykan Bioscience
  • Job Function: Laboratory
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 1-2 Years
  • Required Travel: None

Please refer to the company's website or job descriptions to learn more about them.

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