Senior Writer, CMC Process Development
About The Position
The Senior Writer works in the Chemistry, Manufacturing, and Controls Group focusing on the technical documentation for process validation and other aspects of small-molecule and macromolecule process development. There is a particular emphasis on group data review and technical report generation and maintenance. This is an ideal position for an individual with an organic chemistry or pharmaceutical background who has an interest in projects related to novel technology in synthesis, purification and characterization of oligonucleotides and bioconjugates, with a focus on process validation.
Requirements
- Ph.D. with at least 2+ years, M.S. with at least 7+ years, or B.S. with at least 10+ years of relevant industrial or academic experience, in Chemistry or related field
- Proficiency with Microsoft Office
- Experience with synthetic organic chemistry
- Excellent verbal and written communication skills
- Strong problem-solving skills
- Strong attention to detail
- Can perform tasks assigned with minimal supervision
Nice To Haves
- Experience working with both small molecule or large molecule synthetic targets either in an academic or industrial setting
- Prior experience with regulatory writing and filings
- Prior experience and familiarity with GLP/GMP regulations and process validation
- Experience with small-molecule or macromolecule analytical techniques (e.g., HPLC, UV-Vis spectrophotometry, mass spectrometry, etc.)
- Experience with JMP or similar statistical analysis software
- Be able to perform complex math functions and be able to draw and interpret graphs and charts
Responsibilities
- Prepare and maintain Process Development technical reports, characterization reports, presentations, SOPs, and policies and procedures
- Serve as the group lead for characterization and validation technical data and notebook review
- Track progress against project timelines, generate regular status updates, and communicate progress and issues to management, including presentation of findings at team meetings
- Work independently or with senior scientists to develop statistical synthetic approaches to desired compounds while keeping an eye toward large-scale synthesis and process validation
- Lead and collaborate with unit operation characterization efforts of small molecules and macromolecules with a focus on developing robust procedures
- Collaborate with other scientists in the group to prepare complex organic constructs
- Interpret analytical data pertaining to small-molecule and macromolecule targets
- Begin providing recommendations to troubleshoot experiments
- Maintain a well-documented laboratory notebook
- Analyze experimental data with statistical software and discuss appropriate follow-up with supervisor
- Mentor and coach team members, promoting a culture of continuous learning and improvement
Benefits
- Arrowhead provides competitive salaries and an excellent benefit package.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
251-500 employees
