Get new jobs for this search by email

Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-POKMA1 Cherokee STL Technical Operations 2
Recruiter:Kathy Lewison

This information is for internals only. Please do not share outside of the organization.

Your Role:
The Technical Writer is responsible for the creation of batch records for use in GMP manufacturing of new and existing custom bioconjugation products. This technically sound position works cross-functionally at multiple manufacturing facilities with Manufacturing, Process and Analytical Development, Quality, Project Management, and customers to develop robust manufacturing batch records from Tech Transfer documents. We’re looking for a candidate with strong composition skills and comprehensive technical knowledge and understanding of manufacturing equipment and production processes. The position will be based in at our Cherokee site in St. Louis, Missouri.

Key Responsibilities:

• Authorship of new product MMFs and associated technical documents
• Manage MMF priorities based on schedule and project requirements
• Participate in process design flow efforts
• Provide logical explanations and potential solutions for roadblocks to GMP
• Collaborate with other departments andexternal customers
• Interface with management, other departments and customers to collaborate, identify, and implement tech transfer activities
• Write and modify procedures consistent with quality guidelines and review other procedures as requested
• Participate and assist deviation investigations from Technical Operations perspective
• Identify and mitigate safety hazards with transferred manufacturing processes

Who You Are:
Minimum Qualifications:

• Bachelor’s Degree in Biology, Chemistry, Biochemistry or other life science discipline
• 1 + years’ experience in GMP Operations, manufacturing or production operations

Preferred Qualifications:

• Excellent attention to detail in written instruction and communication
• Strong composition skills
• Ability to convey technical, safety, and GMP compliance information and instruction through writing
• Comprehensive technical knowledge and understanding of GMP manufacturing equipment and production processes
• Ability to effectively communicate with internal departments and customers

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.