Arrowhead Pharmaceuticals, Inc. is a Nasdaq listed (ARWR), Russell 3000 company that develops medicines to 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’s dynamic and innovative environment offers our employees the opportunity to advance revolutionary treatments for serious and intractable diseases. Our employees are smart, creative, professionals who work collaboratively to meet our business and scientific challenges. Arrowhead’s R&D facility is located in the Research Park in Madison, WI.
Arrowhead is seeking a senior process development scientist to join our oligonucleotide group within the Chemistry Department. The successful candidate will be tasked with leading a team focused on developing and scaling methods for the manufacturing of oligonucleotides to support toxicological testing of investigational drug substances. S/He will be expected to:
- Design, supervise, and conduct laboratory scale experiments to develop conditions for the manufacturing of oligonucleotides on the hundreds of grams scale.
- Work closely with our analytical scientists to monitor and understand the impact of process changes on the yield and impurity profile of developmental oligonucleotides.
- Write procedures for the scale up manufacturing of oligonucleotides following GLP protocols.
- Contribute to and oversee the GLP manufacturing of oligonucleotides on the hundreds of grams scale.
- Develop a thorough understanding of both the small and large scale equipment, including scaling factors necessary for success during scale up manufacturing.
- Prepare comprehensive developmental reports summarizing both laboratory development and manufacturing experiments.
- Track progress against project plans, generate regular status updates, and communicate progress and issues to management.
- Be creative and innovation in problem solving.
The successful candidate should have a M.S. degree with at least 8 years of experience in the pharmaceutical industry or a PhD degree with experience at least 4 years of experience in pharmaceutical industry. A thorough understanding of and experience in manufacturing materials under GLP protocols.
Experience working with oligonucleotide manufacturing and with large molecule drug candidates. Understanding of the drug development process and governing regulations. Hands-on experience manufacturing drug products under GMP protocol. Prior experience in contributing to or writing the CMC sections of regulatory documents.
All applicants must have authorization to work for Arrowhead in the U.S.
Please send resumes to firstname.lastname@example.org. Include a cover letter that highlights your qualifications and matches our requirements.