Senior Stability Consultant

Location
Yongin-si, Gyeonggi-do, South Korea
Posted
May 14, 2018
Ref
21EB-5856987982
Required Education
Other
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 stability programs and product stability plans for plasma-derived 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:
  • +15 years in biologics manufacturing, with particular focus on stability
  • Excellent writing skills, ability to write from scratch, leverage content from variety of sources including lab management systems, Excel, executed protocols, lab notebooks, PDFs, etc.
  • Experience writing spectrum of protocols and stability reports in biologics environment. Able to propose and justify protocol acceptance criteria.
  • Direct experience performing statistical analysis.
  • Experienced in successfully identifying and justifying product expiry/shelf-life dating.
  • Experience developing and implementing a product stability program, including policies and associated SOPs
  • Experience presenting directly to the federal-level FDA for stability studies and related information
  • 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
  • Ideal candidate is adept at Minitab or comparable statistical analysis tool
  • Must be able to work in Korea and have a valid US passport


Position Id
EB-5856987982