GMP Technical Writers

Location
Osong, South Korea
Posted
Jul 13, 2018
Required Education
Bachelors Degree
Position Type
Full time

Job Description

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!
 

Scope of Work

Consultants to provide three cGMP technical writers to develop master batch records and SOPs for the following production areas:

  • Cell culture
  • Purification
  • Drug product, including media fill operations
  • And, Document Control (for document approval process)

A team of up to three technical writers will be assigned to the above areas.

The project is expected to be 9 months with a month on site per quarter, starting Aug 20 through Q2 2019. The travel is 4 weeks onsite, 8 weeks work from home.

Responsibilities

Develop master batch records (MBRs) and associated SOPs for the drug substance and drug product manufacturing facilities. Technical writers to provide full technical writing services and contribute technical and cGMP subject matter expertise throughout document development.
 

Working in partnership and close collaboration with the facility commissioning team to:

  1. Develop and implement batch records and SOPs for equipment, unit operations, subassemblies, solutions (media and buffer), and equipment preparation as applicable. Ensure documents:
    1. Are in synch unit operations
    2. Mitigate deviations/discrepancies and support good documentation practices
    3. Align with SOPs and forms/logs
  2. Develop documents to address cGMP compliance requirements, appropriate level of detail, and to minimize inefficiencies.
  3. Ensure automation and electronic systems are aligned with the batch records and SOPs.
  4. Partner closely with validation engineering team to ensure matter batch records and SOPs reflect validated state.
  5. Create generic batch records in place of product-specific batch records where practical.
  6. Apply cGMP and biologics manufacturing knowledge and expertise when developing the documentation.
  7. Follow-up with subject matter experts, reviewers, and stakeholders to ensure documents meet project timelines.
  8. Coach and mentor internal staff on documentation requirements and best practices.
  9. Serve as document project manager:
    1. Foster positive team dynamics and adoption of new documents
    2. Documentation meeting leadership, facilitation, agenda setting, minutes
    3. Document reviews, redline reconciliation, draft document user testing, final approval and implementation
    4. Document status tracking and reporting
    5. Adherence to documentation schedule
    6. Decision history and escalation pathway
    7. Presentation to senior management as needed
  10. Train client operations staff on approved documents.
  11. Work to be performed both onsite and offsite. In order to ensure documents advance transparently and proactively:
    1. Attend documentation team teleconferences
    2. Participate in larger project team meetings
    3. Schedule meetings for key decisions/milestones
    4. Attend equipment/process walk-throughs and shadow operations as needed.
  12. Support technician and stakeholder trainings as needed

 

Deliverables as assigned by client during project execution:

  1. Approved product MBRs and templates
  2. Approved generic MBRs
  3. Approved SOPs
  4. Approved data forms and logs
  5. Approved Document Control SOP

Required Experience:

  • +10 years in biologics
  • Excellent writing skills, ability to write from scratch
  • 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