IT Manager - GxP Systems & Compliance
About the job
- A bachelor’s degree in information technology, Computer Science, Engineering, Life Sciences, or equivalent relevant experience is required; an advanced degree is a plus.
- 5–8 years of experience supporting IT systems in a GxP-regulated pharmaceutical, biotechnology, CDMO, manufacturing, or quality control environment.
- Hands-on experience supporting GxP manufacturing, QC laboratory, automation, or IT/OT systems, including instrument-connected PCs, networked devices, servers, applications, and validated systems.
- Working knowledge of cGXP, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, computerized system validation, change control, deviation/CAPA, and audit readiness expectations.
- Experience with GxP systems and platforms such as LIMS, CDS, MES, BMS, SCADA, Empower, laboratory instruments, manufacturing systems, Veeva Vault, eQMS, ERP, or similar regulated applications.
- Experience with system administration, access management, backup and restore processes, patching coordination, disaster recovery, periodic reviews, audit trail support, and controlled documentation.
- Ability to troubleshoot technical issues across applications, endpoints, infrastructure, laboratory instruments, and manufacturing support systems while maintaining compliance with approved procedures.
- Strong documentation skills, including experience creating or maintaining SOPs, work instructions, runbooks, validation documentation, support records, incident records, and audit-ready evidence.
- Ability to partner with Manufacturing, QC, QA, Validation, Automation, Facilities, Cybersecurity, Infrastructure, and vendor teams in a regulated operating environment.
- Ability to work outside standard business hours occasionally to support GxP activities, system implementations, upgrades, maintenance, audits, inspections, and critical issue resolution.
- Ability to lift, carry, push, and/or pull equipment and materials weighing up to 25 pounds occasionally.
- Ability to wear required personal protective equipment and comply with safety, security, and GxP requirements in regulated environments.
- Ability to work in office, regulated laboratory, manufacturing, and data center environments.
- Provide daily IT operational support for GxP manufacturing, QC laboratory, and technical operations systems, including application issues, instrument-connected workstations, networked devices, infrastructure components, and user access requests.
- Maintain reliable, compliant, and secure operation of GxP systems such as LIMS, CDS, MES, BMS, SCADA, Empower, laboratory instruments, cleanroom systems, manufacturing systems, and related GxP applications.
- Partner with Manufacturing, QC, QA, Validation, Automation, Facilities, and business stakeholders to triage incidents, resolve service requests, manage escalations, and minimize operational disruption.
- Support GxP change control activities, including impact assessment, implementation planning, testing coordination, validation deliverables, deployment readiness, and post-implementation verification.
- Assist with computerized system validation and qualification activities, including IQ/OQ/PQ, user acceptance testing, traceability, periodic reviews, system retirement, and maintenance of audit-ready documentation.
- Lead or support deviation, incident, problem, CAPA, and effectiveness check records related to GxP computerized systems and ensure timely completion of assigned actions.
- Manage system administration processes for GxP applications, including user access provisioning, role-based access, periodic access reviews, audit trail support, backup and restore oversight, and data integrity controls.
- Coordinate patching, vulnerability remediation, endpoint maintenance, server support, disaster recovery testing, and business continuity activities for GxP systems in alignment with IT and quality procedures.
- Develop, maintain, and improve SOPs, work instructions, support runbooks, knowledge articles, system inventories, configuration records, and operational support procedures for GxP systems.
- Manage relationships with vendors and external service providers to ensure timely support, compliant service delivery, effective issue escalation, and completion of maintenance or qualification activities.
- Track and report GxP support metrics, system health indicators, recurring issues, service levels, and continuous improvement opportunities.
- Support internal audits, external inspections, vendor audits, and quality reviews by preparing documentation, responding to findings, and driving remediation activities related to GxP IT support operations.
- An advanced degree is a plus.
About the company
Rocket Pharmaceuticals develops gene therapies for severe and rare inherited diseases. It uses an AAV (Adeno-Associated Virus) platform to deliver corrected genes directly into patients, with the goal of producing a therapeutic protein in targeted cells of the heart, liver, eye, or central nervous system to modify the disease. The therapy work involves engineering AAV constructs so the corrected gene is expressed in diseased cells. The company aims to create first-in-class or best-in-class treatments and generates revenue through partnerships with larger pharma companies, grants, and potential future sales of approved therapies. Core values include Trust, Generosity, Curiosity, and Elevation, guiding a patient-centric approach that puts families first and supports ongoing scientific advancement. Overall goal: provide life-changing gene therapies for patients with few options and expand treatment options for rare genetic disorders.
Company Size
201-500
Company Stage
IPO
Headquarters
Cranbury Township, New Jersey
Founded
2015
Get referred to Rocket Pharmaceuticals
See people who can refer or advise you
Simplify's Take
What believers are saying
- KRESLADI commercialization starts in Q4 2026 across specialized treatment centers.
- Rocket sold its PRV for $180 million, extending runway into Q2 2028.
- FDA alignment on September 15, 2026 removes a major overhang for RP-A501.
What critics are saying
- RP-A501 needs nine more Danon patients by mid-2027, limiting trial speed.
- A 2025 capillary-leak death already triggered an FDA clinical hold.
- If RP-A501 fails or KRESLADI underperforms, Rocket's valuation collapses to one-product dependence.
What makes Rocket Pharmaceuticals unique
- KRESLADI became Rocket's first FDA-approved therapy in March 2026.
- Rocket owns proprietary AAV cardiovascular gene therapy manufacturing and clinical know-how.
- FDA alignment on RP-A501, September 15, 2026, validates its Danon program design.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Company Match
Paid Vacation
Paid Holidays
Wellness Program
Company Equity
Growth & Insights and Company News
6 month growth
-1%1 year growth
-3%2 year growth
0%Rocket Pharmaceuticals has secured a credit facility of up to $150 million from Hercules Capital to support its pivotal Phase 2 study of RP-A501 for Danon disease and advance its cardiovascular pipeline. The commercial-stage biotechnology company received $35 million at closing and may draw an additional $35 million during specified periods. A further $30 million becomes available upon achieving a specified Danon clinical milestone, whilst an additional $50 million is subject to Hercules' investment committee approval. The facility has an initial 30-month interest-only period and 48-month maturity, with possible extensions. As of 30 June 2026, Rocket had $283.7 million in cash and investments. Combined with the initial facility drawdown, the company expects to fund operations into the third quarter of 2028, with potential extension into 2029 through additional borrowings.
Lexeo Therapeutics completes strategic acquisition: deal analysis and market outlook. Wednesday, September 30, 2026 Lexeo Therapeutics has finalized a transformative acquisition, marking a pivotal expansion in its clinical-stage genetic medicine pipeline. Detailed in a recent SEC filing, this strategic move aims to strengthen the company's competitive moat and drive accelerated pipeline development. Here is its in-depth analysis of the transaction structure, market implications, and future outlook for LXEO. Lexeo Therapeutics' (NASDAQ: LXEO) formal disclosure of a completed acquisition under Item 2.01 of Form 8-K signals a decisive step in the company's targeted expansion strategy. Operating at the complex intersection of cardiovascular genetics and central nervous system (CNS) therapeutics, the clinical-stage biotechnology firm is navigating a macro environment characterized by rigorous capital discipline and a flight to high-conviction clinical assets. By executing this transaction, Lexeo not only expands its technical or clinical footprint but also underscores a broader shift among mid-cap biotech operators toward strategic consolidation as a means of pipeline de-risking and platform enhancement. Strategic rationale: targeted expansion in adeno-associated virus (AAV) biology. The strategic core of this transaction aligns directly with Lexeo's overarching mandate: advancing proprietary adeno-associated virus (AAV) gene therapies for genetically defined diseases with substantial unmet medical need. Historically anchored by lead programs - including LX2006 for Friedreich's ataxia (FA) cardiomyopathy and LX1001 for APOE4-associated Alzheimer's disease - Lexeo has balanced high-prevalence neurological targets with high-probability monogenic rare diseases. This acquisition serves several strategic imperatives: * Consolidation of Proprietary Technology: The integration of supplementary intellectual property or complementary pipeline assets bolsters Lexeo's competitive moat in capsid engineering and vector design, an increasingly vital differentiator against both legacy gene therapy developers and emerging non-viral delivery platforms. * Pipeline Synergies: By acquiring complementary clinical or preclinical technology, Lexeo effectively compresses development timelines, bypassing years of de novo discovery work to augment its core competencies in rare cardiovascular disease. * Manufacturing and Translatability: Scale and vector yield remain persistent bottlenecks across the AAV landscape. Incorporating platform improvements or upstream manufacturing efficiencies allows the company to reduce cost-of-goods-sold (COGS) expectations ahead of late-stage pivotal trials. In an AAV sector historically plagued by safety and delivery constraints, acquiring specialized vector biology or targeted preclinical programs offers Lexeo an avenue to accelerate translational milestones while preserving its fundamental clinical focus. Deal architecture and capital discipline. While full financial schedules in early 8-K filings often omit localized line-item values, the transaction's architecture reflects current norms within biotechnology dealmaking. Clinical-stage biotechs currently trade under the scrutiny of an unforgiving cost-of-capital environment, where outright cash exits are rare. Instead, recent corporate acquisitions across the sector have increasingly prioritized deferred consideration, back-loaded milestone payments, and equity-based compensation to align incoming stakeholders with long-term enterprise value creation. From a balance sheet perspective, Lexeo's ability to close the transaction without triggering immediate, punitive dilution is critical. The market has heavily penalized gene therapy biotechs that overextend their cash runways on high-beta platform acquisitions. By leveraging structured consideration - typically split between upfront equity, near-term regulatory milestones, and commercial earn-outs - Lexeo maintains operational flexibility for its ongoing Phase 1/2 reads. The transaction demonstrates disciplined corporate development: acquiring strategic capabilities while keeping the primary cash burn directed toward clinical execution. Competitive repositioning and market implications. The broader implications for the genetic medicine ecosystem are tangible. Over the past twenty-four months, mid-cap biopharmas have been compelled to transition away from horizontal exploration - amassing sprawling discovery engines - toward vertical integration that solves specific clinical or delivery vulnerabilities. * Re-evaluating the Rare Disease Arbitrage: By deepening its hold on rare cardiac and neurological genetics, Lexeo strengthens its positioning against established peers such as Rocket Pharmaceuticals and Sarepta Therapeutics. As the regulatory frameworks at the FDA continue to evolve favorably toward biological surrogates in monogenic diseases, owning robust, turnkey assets becomes an acute strategic advantage. * Big Pharma In-Licensing Dynamics: Large pharmaceutical players face historic patent cliffs toward the end of the decade, particularly in oncology and immunology, driving renewed interest in rare genetic platforms that demonstrate clean safety profiles and clear biomarker engagement. Transactions of this nature position Lexeo not just as a standalone commercial operator, but as an increasingly attractive, coherent bolt-on candidate for global pharmaceutical companies seeking differentiated rare-disease platforms. * Sector-Wide Consolidation Pressures: The completion of this deal mirrors a continuing trend across the biotech landscape. Smaller discovery shops lacking the capital runway to reach the clinic are increasingly receptive to being rolled up by better-capitalized peers with access to public market liquidity. Strategic outlook: execution on clinical inflections. The integration of the acquired assets will be measured directly against Lexeo's upcoming clinical milestones. For investors, the primary scrutiny will center on operational throughput: how seamlessly the newly incorporated technology or pipeline targets interface with Lexeo's current development framework, and whether the integration introduces unexpected regulatory complexity or cash burn. If management effectively harmonizes this asset within its existing infrastructure, Lexeo stands to capture enhanced programmatic optionality. With key data readouts looming across its cardiac and CNS pipelines, the company's enhanced technical foundation could prove pivotal in driving sustainable value creation, establishing a stronger foundation for clinical progression, institutional support, and long-term strategic flexibility. Ready to analyze your next deal? Upload your CIM for instant AI-powered analysis - financial extraction, risk assessment, and valuation in minutes. Analyze your own CIM. Upload a CIM and get financials, risks, and valuation in seconds.
Rocket Pharmaceuticals' FDA decision clears 'meaningful regulatory overhang,' says Needham - sees 150% upside potential in RCKT stock. Published: Sep 16 2026, 06:00 PM IST * FB * TW * Linkdin * Whatsapp * GNFollow Us Needham said the FDA outcome was better than expected because the regulator could have demanded meaningful changes to Rocket's Danon disease trial. * Needham upgraded Rocket Pharmaceuticals to 'Buy' from 'Hold' with a $9 price target, according to The Fly. * The FDA said that Rocket could continue enrolling and dosing patients in the Phase 2 study at a recalibrated dose. * Last year, the FDA placed the study on clinical hold after one patient died from complications related to capillary leak syndrome. Rocket Pharmaceuticals (RCKT) was on investors' radar on Wednesday after the biotech firm received an upgrade from Needham following its alignment with the U.S. Food and Drug Administration on a pivotal study for its experimental genetic disease therapy. Needham upgraded Rocket Pharma to 'Buy' from 'Hold' with a $9 price target, according to The Fly. This implies an upside of around 150% from current levels. The stock has a consensus 12-month price target of $8.84, according to Koyfin data, while six of the 14 analysts covering the stock have rated it a 'Buy,' six 'Hold,' and two 'Sell.' At the time of writing, RCKT stock was up 7.6% and was on track for its best day so far this month. Needham says FDA outcome was better than expected. On Tuesday, the FDA confirmed that Rocket can continue enrolling and dosing patients in the Phase 2 study of RP-A501 at a recalibrated dose. The firm is testing its therapy on patients with Danon Disease, a rare, inherited genetic disorder that can cause severe damage to the heart and muscles. Rocket expects to complete dosing by mid-2027. The study will assess patients after 12 months to determine whether the treatment increases LAMP2 protein levels in the heart and reduces abnormal heart muscle thickness by at least 10%. The results could support a potential accelerated FDA approval. Needham said the FDA update removed a "meaningful regulatory overhang," adding that the outcome was better than expected because regulators could have demanded meaningful changes to the study. Why The FDA decision matters. Last year, the FDA placed the study on clinical hold after two patients experienced serious complications related to capillary leak syndrome, with one patient dying following an acute systemic infection. The FDA lifted the hold in August, allowing the study to resume at a lower recalibrated dose. Retail's take on RCKT. Retail sentiment surrounding RCKT on Stocktwits turned 'neutral' from 'bearish' over the past 24 hours, amid an 800% surge in message volume. One user pointed out that the "key efficacy catalyst" could be more than two years away. View this Stocktwits post RCKT shares have climbed around 2% so far in 2026. Also read: NVO To Present Fresh Data From Blockbuster Wegovy Pill At European Conference As Rival Eli Lilly Readies Its Own Obesity Updates For updates and corrections, email newsroom[at]stocktwits[dot]com.< Stay updated with all the latest Business News, including market trends, Share Market News, stock updates, taxation, IPOs, banking, finance, real estate, savings, and investments. Track daily Gold Price changes, updates on DA Hike, and the latest developments on the 8th Pay Commission. Get in-depth analysis, expert opinions, and real-time updates to make informed financial decisions. Download the Asianet News Official App from the Android Play Store and iPhone App Store to stay ahead in business. 0 Comments / 0 New
Rocket Pharmaceuticals shares fell on Friday after the company reported first-quarter 2026 results that missed expectations. The company posted a loss of 42 cents per share, wider than the Zacks Consensus Estimate of 41 cents, and recorded no revenues during the quarter. General and administrative expenses declined 39.8% year over year to $17.1 million, whilst research and development expenses fell 12.2% to $31.5 million, reflecting disciplined spending following organisational restructuring. The company ended the quarter with $144.4 million in cash and investments. In March, the FDA granted accelerated approval to Rocket's gene therapy Kresladi for treating severe leukocyte adhesion deficiency-I. The company also recently agreed to sell its Priority Review Voucher for $180 million to support its cardiovascular pipeline.
Rocket Pharmaceuticals reported first quarter 2026 financial results, highlighting progress across its cardiovascular gene therapy pipeline. The company received FDA accelerated approval for KRESLADI for severe leukocyte adhesion deficiency-I in March 2026 and subsequently sold its Rare Pediatric Disease Priority Review Voucher for $180 million in April. The company has reinitiated dosing in its pivotal Phase 2 study of RP-A501 for Danon disease following a clinical hold lift, with a programme update expected in the second half of 2026. First patient dosing for RP-A701 in BAG3-associated dilated cardiomyopathy is anticipated mid-2026. First quarter net loss was $47.6 million, down from $61.3 million year-over-year. Cash, cash equivalents and investments totalled $144.4 million as of 31 March 2026, which together with PRV proceeds extends the expected cash runway into the second quarter of 2028.