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 Associate Director, MS&T will lead teams of scientists, engineers, and documentation specialists to facilitate process transfer and scale-up activities from Process Development and Discovery to the Arrowhead internal manufacturing team. This team will also support new technology implementation, process troubleshooting, deviations/CAPAs, process validation, and process improvements as applicable.
Responsibilities
- Lead and coordinate the goals and activities of the process engineering, tech transfer, and process validation teams for Arrowhead internal oligo manufacturing operations
- Oversee GMP document generation functions for technology transfer and process validation activities
- Ensure all GMP documents within teams are prepared and maintained through compliant change control processes
- Manage teams of direct and indirect reports to ensure timely completion of high-quality work
- Collaborate with cross-functional teams to ensure seamless and timely process transfer
- Lead troubleshooting and assessments when unexpected manufacturing issues occur
- Provide regular status updates to stakeholders on project milestones
- Display consistently exceptional leadership qualities including but not limited to talent recruitment, leading with integrity, humility, empowerment, and flexibility
- Oversee the evaluation and optimization of manufacturing processes to improve efficiency, scalability, and compliance
- Remain current with latest advancements in oligonucleotide and related technologies, incorporating industry best practices into the technology transfer process
- Ensure compliance with all relevant regulatory agencies' requirements, such as FDA, EMA, and ICH guidelines
- Provide guidance and mentorship to team members, including development and career planning, knowledge sharing and learning opportunities, and professional growth
Requirements
- PhD in Organic Chemistry or closely related field and 6+ years industrial experience, MS in Organic Chemistry or related field with 10+ years industrial experience, or BS in Chemistry or related field and 12+ years industrial experience in development, scale-up, and/or manufacturing of GMP drug substance
- Experience in scale-up of chemistry processes, preferably oligonucleotide synthesis, in a regulated environment.
- Experience with process validation on drug substance manufacturing processes
- Experience developing technology transfer procedures and systems
- Full understanding of analytical methods such as HPLC-MS, UV, NMR, etc.
- 12 years’ experience in synthetic organic chemistry and/or technology transfer, within a GMP-regulated environment preferred
- Ability to work in a fast-paced environment and manage multiple priorities simultaneously
- Ability to work independently on complex assignments
- Strong safety background, with prior experience serving on facility safety committee a plus
- Successful in implementing ideas and influencing people in a team environment. Recognized for organized, effective, and professional communication skills. Strong ability to independently resolve interpersonal conflicts
- In-depth knowledge of GMP guidelines, ICH Q7, and relevant regulatory requirements for API manufacturing
- Strong project management skills, with a track record of successful technology transfer execution
- Excellent interpersonal skills to collaborate effectively with internal and external partners
- Exceptional written and verbal communication skills. Ability to interpret and communicate scientific results and to interact productively with scientists and engineers on the team
- Foster creative spirit to facilitate effective and collaborative problem solving
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit and work with hands. The employee is occasionally required to stand; walk; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
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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Skills Required
- PhD in Organic Chemistry or related field with 6+ years of industrial experience; or MS with 10+ years; or BS with 12+ years in development, scale-up, and/or GMP drug substance manufacturing
- Experience scaling up chemistry processes, preferably oligonucleotide synthesis, in a regulated environment
- Experience with process validation for drug substance manufacturing processes
- Experience developing technology transfer procedures and systems
- Understanding of analytical methods including HPLC-MS, UV, and NMR
- 12 years of experience in synthetic organic chemistry and/or technology transfer within a GMP-regulated environment
- Ability to work in a fast-paced environment and manage multiple priorities
- Ability to work independently on complex assignments
- Strong safety background
- Prior experience serving on a facility safety committee
- Experience implementing ideas and influencing people in a team environment
- Strong organization, communication, conflict-resolution, interpersonal, written, and verbal communication skills
- In-depth knowledge of GMP guidelines, ICH Q7, and regulatory requirements for API manufacturing
- Strong project management skills and successful technology transfer execution
- Ability to collaborate effectively with internal and external partners
What We Do
Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients. Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety. Our employees are nimble, science-driven, and innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline. Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, and toxicology. Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations. Our HQ, clinical and regulatory operations are located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains, Pasadena is known for its natural scenic beauty, vibrant cultural and academic environment and rich architectural setting.
