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CMC Technical Writer (cGMP – Pharmaceutical) JD818693

JD818693

DPS is looking for a knowledgeable CMC Technical Writer to support a pharmaceutical client in the Greater Boston, MA area. This individual will support process and analytical development teams in drafting technical documents and development reports in support of regulatory filings. Ideal candidates should have technical experience and be familiar with areas of antibody, antibody drug conjugate development (biologics and small molecule), and/or biomanufacturing support and have significant experience drafting technical reports, method reports, protocols, and procedures.

Category:
Miscellaneous Personnel
Location:
Massachusetts
Years of Experience Req.:
10+
Date Posted:
15/08/2019
Days Remaining:
9
Employment Type:
Full-time
Education Level Req.:
Bachelors

CMC Technical Writer (cGMP – Pharmaceutical)                  JD818693

Greater Boston, MA area

 

Summary:

 

DPS is looking for a knowledgeable CMC Technical Writer to support a pharmaceutical client in the Greater Boston, MA area. This individual will support process and analytical development teams in drafting technical documents and development reports in support of regulatory filings. Ideal candidates should have technical experience and be familiar with areas of antibody, antibody drug conjugate development (biologics and small molecule), and/or biomanufacturing support and have significant experience drafting technical reports, method reports, protocols, and procedures. 

 

Core Responsibilities:

  • Draft technical documents, development reports, and regulatory source documents to support cell culture, purification, analytical, antibody drug conjugate, small molecule, and bioanalytical development including manufacturing support.
  • Must be able to understand experimental procedures, data, and concepts relating to development for both biologics and small molecules.
  • Strong written and oral communication skills to summariz775689.557925e studies from reports, presentations, and notebooks and a demonstrated ability to document information in a clear and concise manner.
  • Will be expected to interview key stakeholders to quickly generate outlines, content, and draft reports for review.
  • Work independently with limited direct supervision.

 

Education and Qualifications:

  • Bachelor’s degree in Engineering or Sciences is preferred.
  • 10+ years of related experience in Engineering, Biochemistry, Bioengineering, or related field.
  • Strong technical experience with process and analytical development including cell culture, purification, small molecules, ADCs, analytical, bioanalytical, and/or manufacturing support.
  • Experience supporting a BLA filing is strongly preferred.
  • Significant experience and a strong ability to generate technical documents, process and method development reports, manufacturing campaign summaries, etc.
  • Self-directed and motivated individual who is able to work effectively with limited direction in a complex, fast-paced environment. 
  • Strong written and oral communication skills
  • Highly organiz775689.557925ed with effective time management (ensuring completion of work tasks)
  • Strong attention to detail.
  • Ability to work well cross-functionally with various people and groups.
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