Arrowhead Pharmaceuticals
Develops RNAi-based gene-silencing therapies
Associate Director - External Manufacturing
Five days in the office per week are expected.
About the job
- A Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related discipline.
- At least 8 years of experience in biopharmaceutical technical operations, external manufacturing, or chemistry, manufacturing, and controls, with progressive responsibility; less experience may be accepted for Ph.D. holders.
- Demonstrated success directly managing contract development and manufacturing organization relationships as the primary technical and business owner, including technology transfer, good manufacturing practice manufacturing oversight, and performance management.
- Direct experience with synthetic oligonucleotide manufacturing, including small interfering RNA or antisense oligonucleotide manufacturing.
- Proven ability to lead and influence in a highly matrixed, cross-functional environment spanning Process Development, Analytical Development, Quality, Regulatory, and Supply Chain.
- Experience supporting late-stage clinical programs or commercial launches, including process performance qualification and activities supporting biologics license applications or new drug applications.
- Strong working knowledge of Food and Drug Administration, European Medicines Agency, and International Council for Harmonisation good manufacturing practice requirements, with experience supporting regulatory inspections at contract development and manufacturing organizations.
- Strong written and verbal communication skills, with the ability to translate technical detail into executive-level recommendations.
- Candidates must have current, valid authorization to work in the country where the role is located.
- Serve as the single point of accountability and primary technical and business interface for an assigned portfolio of 1–3 strategic contract development and manufacturing organizations supporting drug substance, conjugation, or drug product manufacturing.
- Own the day-to-day operational relationship by leading joint operating cadences, governance meetings, escalation pathways, and performance reviews, and cultivate trust-based partnerships with contract development and manufacturing organization leadership and technical teams.
- Drive on-time, in-full, in-specification delivery of clinical and commercial supply and monitor and report key performance indicators, including yield, cycle time, right-first-time performance, deviation rate, and on-time release.
- Lead and approve technology transfers from internal Process Development into the assigned contract development and manufacturing organization network, ensuring readiness, documentation, and successful demonstration runs.
- Review and approve batch records, deviations, corrective and preventive actions, change controls, investigations, risk assessments, and validation documentation generated at assigned contract development and manufacturing organizations.
- Develop and execute risk mitigation strategies for critical raw materials, secondary sourcing, and capacity contingency.
- Partner with Procurement and Legal on commercial terms, statements of work, quality agreements, and capacity reservations for assigned contract development and manufacturing organizations.
- Act as the connection between assigned contract development and manufacturing organizations and internal Process Development, Analytical Development, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, Program Management, and Clinical Supply functions.
- Represent External Manufacturing on cross-functional program teams by translating program priorities into clear contract development and manufacturing organization deliverables and contract development and manufacturing organization realities into actionable internal decisions.
- Lead through influence in a matrixed environment by driving alignment, surfacing trade-offs, and resolving conflict without relying on direct authority.
- Facilitate timely, transparent communication across functions and with contract development and manufacturing organization partners.
- Anticipate and remove cross-functional roadblocks and proactively manage handoffs between Process Development, Analytical Development, Quality Assurance, Regulatory, and Supply Chain to keep manufacturing campaigns on track.
- Build coalitions around supply strategy, risk decisions, and continuous improvement initiatives and ensure every functional voice is represented.
- Provide technical oversight of solid-phase oligonucleotide synthesis, purification using high-performance liquid chromatography and tangential flow filtration or ultrafiltration/diafiltration, lyophilization, and associated unit operations at assigned contract development and manufacturing organizations.
- Oversee ligand conjugation processes, including N-acetylgalactosamine, and other targeted delivery chemistries executed externally.
- Support drug product formulation, sterile filtration, fill-finish, and stability programs at assigned partners.
- Ensure assigned contract development and manufacturing organization operations align with platform scalability, comparability, and lifecycle management goals.
- Maintain control of critical quality attributes, including oligonucleotide purity and impurity profiles, residual solvents and reagents, conjugation efficiency, potency, and stability.
- Lead process performance qualification, validation, and commercial supply readiness activities at assigned contract development and manufacturing organizations.
- Support comparability assessments for process changes, site transfers, or scale increases.
- Partner with Supply Chain on demand planning, capacity modeling, and sales and operations planning execution for a growing pipeline.
- Drive cost-of-goods optimization and continuous improvement initiatives with assigned contract development and manufacturing organizations to support long-term commercial strategy.
- Contribute to chemistry, manufacturing, and controls sections for investigational new drug applications, clinical trial applications, biologics license applications, new drug applications, and global regulatory submissions related to assigned contract development and manufacturing organizations and products.
- Support regulatory agency interactions, pre-approval inspections, and ongoing inspection readiness at assigned external manufacturing sites.
- Partner with Quality Assurance on quality agreements, audit programs, and remediation planning for assigned contract development and manufacturing organizations.
- Champion compliance, data integrity, and continuous improvement across the external manufacturing network.
- Experience with N-acetylgalactosamine conjugates or other targeted RNA delivery technologies.
- Ability to lead and coordinate large, complex strategy projects with minimal direction.
- Experience developing operations network strategies for a growing global market.
About the company
Arrowhead Pharmaceuticals develops medicines using RNA interference (RNAi) to silence disease-causing genes. The company’s approach uses a library of RNA chemistries and delivery methods to trigger RNAi, enabling rapid and durable reduction of target gene expression in cells. This gene-silencing strategy aims to treat severe genetic diseases such as cystic fibrosis and hepatitis B by lowering disease-related proteins. Arrowhead’s products are advanced through discovery and development partnerships, licensing deals, and potential commercialization of approved therapies. The company differentiates itself through a broad RNAi platform, proprietary delivery tech, and collaborations with larger pharma firms to advance its pipeline. Its goal is to provide new treatment options for conditions with limited or no effective therapies by translating gene silencing into medicines that can halt or reverse disease progression.
Company Size
501-1,000
Company Stage
IPO
Headquarters
Pasadena, California
Founded
2004
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Simplify's Take
What believers are saying
- June 22, 2026 EU approval expanded REDEMPLO into Europe without genetic confirmation.
- August 2026 Phase III SHASTA-3 and SHASTA-4 hit endpoints, boosting SHTG sNDA odds.
- Second-quarter 2026 revenue reached $75 million, while cash and investments stayed near $1.6 billion.
What critics are saying
- If plozasiran patents fail, Arrowhead loses its first commercial franchise and Madrigal royalties.
- Central District of California litigation over US9,593,333 targets plozasiran before broader SHTG launch.
- REDEMPLO still generated only $2.4 million quarterly revenue, exposing weak launch economics.
What makes Arrowhead Pharmaceuticals unique
- Arrowhead’s TRiM platform delivered REDEMPLO, the first FDA-approved siRNA for FCS, on November 18, 2025.
- Madrigal licensed ARO-PNPLA3 on May 5, 2026, validating Arrowhead’s MASH genetics strategy.
- TRiM targets liver, lung, muscle, adipose, and CNS, broadening RNAi beyond hepatology.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
Paid Vacation
Paid Sick Leave
Growth & Insights and Company News
6 month growth
↑ 35%1 year growth
↑ 35%2 year growth
↑ 34%Arrowhead Pharmaceuticals director sells 11,600 shares for $1 million. Perry's liquidity event comes as the Arrowhead stock price surged. By Jack Delaney - Sep 6, 2026 at 5:55PM EST Key points. * The transaction was valued at $1 million. * The sale reduced the director's direct equity holdings by 9%. * Perry maintains direct ownership of approximately 111,000 shares. * 10 stocks The Motley Fool, LLC like better than Arrowhead Pharmaceuticals" Michael S. Perry, a Director at Arrowhead Pharmaceuticals (ARWR -0.17%), sold 11,600 shares of common stock on Aug. 18, 2026, according to an SEC Form 4 filing. Transaction summary. | Metric | Value | | Transaction value | $1 million | | Shares sold | 11,600 | | Post-transaction shares (directly held) | 111,459 | | Post-transaction value | $9.8 million | Transaction value based on SEC Form 4 weighted average sale price ($87.30); post-transaction value based on Aug. 18, 2026, market close ($87.90). Key questions. * What were the specific execution details of this open-market sale? The shares were disposed of in multiple transactions at prices ranging from $87.20 to $87.44, with the reporting person providing full trade data to the company and the SEC upon request. * How does this transaction impact the insider's total stake in the company? By selling 11,600 shares, the director liquidated 9% of his direct holdings. However, he remains a stakeholder with 0.0791% of the company's equity and continues to hold common stock underlying unvested restricted stock units. * What is the current market valuation context for Arrowhead Pharmaceuticals? The Pasadena-based biotechnology company maintains a market capitalization of $12.2 billion, with shares priced at $89.41 as of the Aug. 19, 2026, market close. * What are the fundamental financial metrics for the firm? Arrowhead Pharmaceuticals reported trailing twelve-month revenue of $669.5 million and a net loss of $320 million as it continues to advance a therapeutic pipeline centered on RNA interference technology. Company overview. | Metric | Value | | Share Price (as of market close 2026-08-19) | $89.41 | | Market Capitalization | $12.6 billion | | Revenue (TTM) | $669.5 million | | Net Income (TTM) | -$320 million | Company snapshot. * Arrowhead Pharmaceuticals develops innovative biopharmaceutical treatments leveraging RNA interference (RNAi) technology, with a clinical pipeline focused on complex, challenging-to-treat diseases, and generates revenue through therapeutic development and commercialization. * The company operates as a discovery-stage to clinical-stage biopharmaceutical enterprise, advancing multiple therapeutic candidates through clinical trials to achieve regulatory approval and subsequent commercialization in the United States market. * Arrowhead targets patients with rare genetic diseases and complex liver conditions, including alpha-1 antitrypsin deficiency, positioning itself in the specialty pharmaceutical and orphan drug markets where unmet medical needs remain substantial. Arrowhead Pharmaceuticals, founded in 1989 and headquartered in Pasadena, California, represents a clinical-stage biopharmaceutical company with a market capitalization of $12.2 billion and 711 employees. The company's strategic focus on RNAi-based therapeutics provides a differentiated technological platform for addressing genetic and metabolic disorders with limited treatment options. With TTM revenue of $669.5 million and continued investment in its pipeline, Arrowhead demonstrates the capital-intensive nature of biopharmaceutical development. However, the company remains positioned to capture significant value upon successful advancement and commercialization of its clinical candidates. Arrowhead Pharmaceuticals Premium Feature Moneyball Superscore Today's Change ( -0.17 %) $ -0.15 Current Price Key data points. Market Cap Day's Range $ 84.20 - $ 86.96 52wk Range $ 27.10 - $ 95.49 Gross Margin What this transaction means for investors. Over the last 12 months, the Arrowhead stock price has skyrocketed 217.7%. In comparison, over the same period, the S&P 500 has climbed 18.8%. With that context and the amount of shares sold, this appears to be a routine transaction from Perry. While he did sell 11,600 shares, he still directly holds 111,459 shares, signaling continued confidence in the company. The sale is likely just Perry taking some profits off the table, and not something shareholders should read too much into. For what's ahead for the company, analysts are bullish, but shareholders may still want to keep their expectations in check. With the stock already climbing over 217.7% over the past year, it will be difficult to keep that pace. According to CNN, all 14 who cover the stock rate it a buy. Among those analysts, the median one-year price target is $109.50, representing a 26.8% gain from the current price of $86.34. The highest price target, $126, would represent a gain of nearly 46%. 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Arrowhead Pharmaceuticals reported positive Phase III results for plozasiran in severe hypertriglyceridemia, showing triglyceride reductions of 79% to 81% and a 78% decrease in acute pancreatitis events versus placebo. The company plans to submit a supplemental FDA application before the end of 2026. The firm's REDEMPLO therapy for familial chylomicronemia syndrome is gaining traction, with prescription volume more than doubling and quarterly revenue reaching approximately $2.4 million. Over 400 prescribers are now supported. For the fiscal third quarter ended 30 June 2026, Arrowhead recorded revenue of approximately $75 million, up from $28 million year-on-year. Net loss widened to $194.3 million from $175.2 million. The company held about $1.6 billion in cash and investments.
Arrowhead Pharmaceuticals (NASDAQ:ARWR) announces quarterly earnings results. August 4, 2026 Key points. * Arrowhead missed on earnings but beat revenue expectations: The company reported a quarterly loss of $1.36 per share versus the $1.23 consensus estimate, while revenue reached $75.25 million, up 171% year over year and well above expectations. * Clinical and commercial progress provided key catalysts: Phase III SHASTA-3 and SHASTA-4 met their primary and secondary endpoints, while REDEMPLO prescriptions more than doubled sequentially and generated approximately $2.4 million in quarterly revenue. * Losses and spending continued to widen: Net loss increased to $194.3 million and operating expenses rose to about $245 million, although Arrowhead ended the period with roughly $1.6 billion in cash and investments. Analysts maintained a generally positive outlook, with a consensus "Moderate Buy" rating and a $96.92 price target. * Five stocks we like better than Arrowhead Pharmaceuticals. Arrowhead Pharmaceuticals (NASDAQ:ARWR - Get Free Report) released its quarterly earnings results on Tuesday. The biotechnology company reported ($1.36) earnings per share for the quarter, missing the consensus estimate of ($1.23) by ($0.13), FiscalAI reports. The company had revenue of $75.25 million during the quarter, compared to the consensus estimate of $44.17 million. Arrowhead Pharmaceuticals had a negative net margin of 48.38% and a negative return on equity of 55.09%. The firm's revenue was up 171.0% compared to the same quarter last year. During the same period in the prior year, the company earned ($1.26) earnings per share. Here are the key takeaways from Arrowhead Pharmaceuticals' conference call: * Phase III SHASTA-3 and SHASTA-4 both met all primary and prespecified secondary endpoints, with median triglyceride reductions of 79% and 81% and a 78% reduction in pooled acute pancreatitis events versus placebo. Arrowhead reported a 100% reduction in events among the highest-risk subgroup, though detailed data remain subject to the upcoming ESC presentation. * REDEMPLO's U.S. FCS launch continued to gain traction, with prescriptions more than doubling sequentially, over 400 unique prescribers, and approximately $2.4 million in quarterly commercial revenue. The company also reported approvals in Australia and the European Union, expanding its approved footprint to five geographies. * Arrowhead acquired a priority review voucher for $215 million, which it expects could shorten FDA review of the planned SHTG supplemental NDA from 10 months to six months. The company plans to submit the sNDA by the end of 2026 and is preparing to expand its field organization from about 5,000 to more than 20,000 healthcare-provider targets. * The pipeline has several potential catalysts, including September data for ARO-DIMER-PA and the ARO-MAPT CNS delivery program, plus fourth-quarter updates for ARO-INHBE and ARO-ALK7. Management expects 23 candidates in clinical trials by year-end, but most programs remain early-stage and carry substantial development risk. * Arrowhead's quarterly net loss widened to $194.3 million from $175.2 million year over year, while operating expenses rose to approximately $245 million as R&D and commercialization investments increased. The company held about $1.6 billion in cash and investments, but expects continued spending on clinical development, regulatory work, manufacturing, and potential SHTG launch preparation. Arrowhead Pharmaceuticals price performance. Shares of NASDAQ ARWR traded up $3.58 during midday trading on Tuesday, reaching $89.59. The company's stock had a trading volume of 2,031,077 shares, compared to its average volume of 2,464,807. The company has a debt-to-equity ratio of 1.41, a quick ratio of 6.23 and a current ratio of 6.23. The company has a market cap of $12.62 billion, a P/E ratio of -41.67 and a beta of 1.26. The business's 50 day moving average price is $79.26 and its two-hundred day moving average price is $70.85. Arrowhead Pharmaceuticals has a fifty-two week low of $15.01 and a fifty-two week high of $95.49. Analysts set new price targets. ARWR has been the topic of several research reports. Weiss Ratings downgraded Arrowhead Pharmaceuticals from a "hold (c-)" rating to a "sell (d-)" rating in a research report on Wednesday, May 20th. Sanford C. Bernstein lifted their price target on Arrowhead Pharmaceuticals from $35.00 to $46.00 and gave the stock a "market perform" rating in a report on Wednesday, May 13th. Stifel Nicolaus started coverage on Arrowhead Pharmaceuticals in a research note on Tuesday, July 14th. They issued a "buy" rating and a $98.00 price target for the company. Piper Sandler reaffirmed an "overweight" rating and issued a $126.00 price objective (up from $110.00) on shares of Arrowhead Pharmaceuticals in a report on Thursday, July 23rd. Finally, B. Riley Financial increased their price objective on Arrowhead Pharmaceuticals from $101.00 to $123.00 and gave the stock a "buy" rating in a research report on Thursday, July 30th. Nine equities research analysts have rated the stock with a Buy rating, three have given a Hold rating and one has given a Sell rating to the company. According to data from MarketBeat.com, the company has a consensus rating of "Moderate Buy" and a consensus target price of $96.92. Discover more text messages AI Stocks Report Insider transactions at Arrowhead Pharmaceuticals. In related news, Director Hongbo Lu sold 2,970 shares of the stock in a transaction that occurred on Tuesday, May 12th. The stock was sold at an average price of $76.88, for a total transaction of $228,333.60. Following the sale, the director owned 52,012 shares of the company's stock, valued at $3,998,682.56. This represents a 5.40% decrease in their ownership of the stock. The sale was disclosed in a filing with the SEC, which is available through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. 3.60% of the stock is owned by corporate insiders. Institutional trading of Arrowhead Pharmaceuticals. A number of institutional investors have recently modified their holdings of the stock. Maryland State Retirement & Pension System lifted its position in Arrowhead Pharmaceuticals by 1.8% in the 4th quarter. Maryland State Retirement & Pension System now owns 20,241 shares of the biotechnology company's stock valued at $1,344,000 after acquiring an additional 365 shares in the last quarter. Corient Private Wealth LLC boosted its holdings in Arrowhead Pharmaceuticals by 3.1% in the 4th quarter. Corient Private Wealth LLC now owns 18,226 shares of the biotechnology company's stock worth $1,210,000 after buying an additional 551 shares during the period. Empowered Funds LLC grew its holdings in Arrowhead Pharmaceuticals by 4.5% during the 4th quarter. Empowered Funds LLC now owns 18,018 shares of the biotechnology company's stock valued at $1,196,000 after buying an additional 779 shares in the last quarter. Vanguard Personalized Indexing Management LLC boosted its holdings in Arrowhead Pharmaceuticals by 10.0% in the 4th quarter. Vanguard Personalized Indexing Management LLC now owns 9,154 shares of the biotechnology company's stock valued at $608,000 after purchasing an additional 829 shares during the period. Finally, iSAM Funds UK Ltd purchased a new position in Arrowhead Pharmaceuticals during the third quarter worth about $29,000. 62.61% of the stock is currently owned by institutional investors. Arrowhead Pharmaceuticals company profile. Arrowhead Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of RNA interference (RNAi) therapeutics. Since its founding in 2008, Arrowhead has leveraged its proprietary delivery platform - known internally as the Advanced RNAi Compound (ARC) technology - to silence disease-causing genes in patients suffering from genetically defined diseases. The company's approach aims to offer durable, targeted treatments across a range of therapeutic areas. The company's pipeline includes multiple candidates in various stages of development. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Continue following MarketBeat Before you consider Arrowhead Pharmaceuticals, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Arrowhead Pharmaceuticals wasn't on the list. While Arrowhead Pharmaceuticals currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. 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Arrowhead Pharmaceuticals has transitioned from research-focused company to commercial enterprise with its first drug, REDEMPLO, now on the market. The company has written more than 400 prescriptions since launch, which management says exceeds initial expectations. The stock has surged over 500% in the past year, bringing market capitalisation to approximately $10.6 billion. It trades at a price-to-sales ratio of 17.1, significantly above the S&P 500's 3.3 multiple. The company remains unprofitable with an operating margin of -36%. Arrowhead announced today that its pivotal Phase 3 studies, SHASTA-3 and SHASTA-4, successfully met their primary endpoint for severe hypertriglyceridemia treatment. The company holds nearly $1.8 billion in cash and investments, with debt at 9.3% of market value.
The European Commission has authorised Arrowhead Pharmaceuticals' Redemplo (plozasiran) for treating adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder causing severely elevated triglyceride levels. Redemplo, already approved in the US, is an apolipoprotein C III inhibitor. Phase III PALISADE study results showed Redemplo 25mg reduced median triglyceride levels by 80% at month 10. A pooled analysis across all doses demonstrated an 83% reduction in acute pancreatitis incidence. The approval does not require genetic confirmation of FCS, potentially broadening patient access. Redemplo will compete with other apoC-III inhibitors including Tryngolza and Waylivra, though its less-frequent dosing schedule may provide competitive advantage. Future expansion into broader hypertriglyceridemia populations is possible.