Senior Writer, CMC Process Development
Arrowhead Pharmaceuticals, Inc, Verona, WI, United States
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
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.
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
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
Preferred
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
$120,000 — $140,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
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.
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
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
Preferred
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
$120,000 — $140,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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