AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

 

SUMMARY:

The Technical Writer (I, II, Senior) - Manufacturing  acts to support Manufacturing operations by planning, collaborating, and implementing timelines to generate and maintain GMP documents related to GMP operations while ensuring compliance with established processes and standards.

 

PRINCIPAL RESPONSIBLITIES:

  • Maintain safe work environment
  • Write and revise GMP documentation such as Master Production Records (MPRs)
  • Participate in and lead technical writing projects and related meetings for Manufacturing operations and Technical Operations with cross-functional teams
  • Ensuring collaboration among all applicable departments (e.g. Manufacturing, Quality Control, MS&T, etc.)
  • Maintain Good Documentation Practices (GDP) including company error prevention practices for document management
  • Communicate statuses, risks, and timelines effectively to management
  • Follow and adhere to company policies and procedures

 

Technical Writer I - Manufacturing:

  • Perform the responsibilities above under direct supervision

 

Technical Writer II - Manufacturing:

  • Drive implementation of error prevention systems and practices
  • Create and maintain templates, trackers, and metrics for documents and projects
  • Develop a strong understanding of the manufacturing process and products

 

Technical Writer, Senior - Manufacturing:

  • Drive implementation of error prevention systems and practices
  • Create and maintain templates, trackers, and metrics for documents and projects
  • Develop a strong understanding of the manufacturing process and products
  • Ensure collaboration and develop cross-functional experience across applicable departments (EX: MFG, QA, QC, etc.)
  • Manage and drive technical writing projects and deliverables
  • Provide guidance for members of the technical writing team
  • Act as a tech writing representative between departments and for client interactions

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Ability to apply GMP requirements as they relate to manufacturing operations and quality management systems
  • Demonstrated experience with technical writing and GMP documentation
  • Experience with process complexity and progressing multiple priorities
  • Ability to work interdepartmentally effectively with good interpersonal skills
  • Strong technical writing and communication skills
  • Strong computer literacy required (e.g. MS Office Suite, etc.)

 

EDUCATION/EXPERIENCE:

  • BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline preferred
  • Experience using quality management systems software (e.g. TrackWise) preferred
  • Equivalent education and experience may substitute for stated requirements

 

Technical Writer I - Manufacturing

  • No minimum experience in quality management systems, conducting investigations and/or root cause analysis working in a regulated or GMP environment

Technical Writer II - Manufacturing

  • Minimum 2 years’ experience in quality management systems, conducting investigations and/or root cause analysis working in a regulated or GMP environment required

Technical Writer, Senior - Manufacturing

  • Minimum 5 years’ experience in quality management systems, conducting investigations and/or root cause analysis working in a regulated or GMP environment required

 

COMPENSATION RANGE:

$23.31 - $49.55 per hour, depending on level and experience

 

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.

 

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

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