Product Comparability Consultant

Location
Yongin-si, Gyeonggi-do, South Korea
Posted
Jun 18, 2018
Ref
1EB-1666028727
Required Education
Bachelors Degree
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 compliance/risk analysis and remediation of comparability program for portfolio of plasma-derived products.

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 comparability 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.


Deliverables:
New comparability program SOPs and governance documents
Review and remediation of executed comparability studies for compliance to regulations and newly implemented program SOPs
Development of protocols and reports for comparability studies on horizon

Required Experience:

  • +15 years in biologics manufacturing, comparability-related background
  • 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 technical development reports in biologics environment. Able to propose and justify protocol acceptance criteria.
  • Direct experience performing statistical analysis
  • Experience developing and implementing a product comparability program, including policies and associated SOPs
  • Experience presenting directly to the federal-level FDA for comparability 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
  • Must be able to work in Korea and have a valid US passport


Position Id
EB-1666028727