QC Stability Director

Yongin-si, Gyeonggi-do, South Korea
May 14, 2018
Required Education
Position Type
Full time
As a member of the Bulletproof family, you'll enjoy a culture that values diversity in all things - people, work, experience levels, and much more. We tackle the toughest challenges, produce impactful results, and build solid client relationships along the way - with energy, passion, and fun. If this sounds like a good fit for you, please consider this exciting opportunity with our firm!

Responsibilities: Focused on development and/or gap analysis and remediation of comparability & stability SOPs and report for biologics to bring them into cGMP compliance.
  • Author new procedures and/or significantly revise existing SOPs for commercialization and FDA PAI readiness
  • Align and imbed with industry best practices and cGMP compliance solutions
  • Apply cGMP knowledge and experience to stability processes to ensure best practices, efficiencies, and error reduction
  • Partner closely with client to help build quality culture and understanding of FDA expectations in a cGMP environment
  • Perform change control activities for all documents and activities in scope to closure
  • Meet project timelines.
  • Align with and execute work in accordance with project objectives, directives, and decisions
  • Work independently to minimize client time while building a transparent and inclusive partnership with client and co-workers.
  • Mentor clients and junior staff throughout process to build a quality mindset and encourage adoption of proposed improvements.
  • Provide additional areas support as requested

Required Experience:
  • 10-20 years in biologics manufacturing, comparability & stability-related background
  • Excellent writing skills, ability to write from scratch, leverage content from variety of sources including LIMS data, Excel spreadsheets, protocols, executed protocols, lab notebooks, PDFs, etc.
  • Experience writing spectrum of technical development reports in biologics environment.
  • Must be comfortable working under pressure in fast-paced environment with minimal guidance
  • Well-directed to work independently; cannot be high maintenance
  • Excellent interpersonal skills
  • Ability to analyze data and must have enough experience with statistics and statistics software such as Minitab, SPSS, SAS, JMP and etc for stability work
  • Must be able to work in Korea and have a valid US Passport

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