Jobs at Astellas Pharma

Leads market development across the Mountain West for ophthalmology therapies, building advocacy among retina, ophthalmology, and optometry thought leaders. Develops customer engagement plans, supports peer-to-peer education and speaker programs, gathers market insights, collaborates with sales, medical, reimbursement, and marketing teams, and represents the company at conferences. Requires strong clinical and product knowledge, cross-functional leadership, regulatory compliance, and extensive travel.

Leads market development across the Northeast by building advocacy for Izervay among ophthalmology and optometry thought leaders. Develops customer engagement plans, represents the company at conferences, gathers customer insights, collaborates with sales, medical, reimbursement, and marketing teams, supports peer-to-peer education, and maintains compliance. The role requires extensive regional and national travel and strong pharmaceutical or biotechnology experience.

Leads a regional team of Ophthalmics Business Specialists, translating national strategy into regional business plans and achieving commercial objectives. Responsibilities include recruiting, coaching, developing, and retaining talent; guiding customer engagement; understanding ophthalmology, retina, access, reimbursement, and buy-and-bill dynamics; collaborating cross-functionally; supporting product launches; ensuring compliance; and driving regional execution and accountability across an assigned field-based territory.

Performs GMP environmental monitoring and microbiological testing in classified cleanrooms supporting pharmaceutical manufacturing. Collects air, surface, particle, and personnel samples; processes and documents samples; supports cleanroom and gowning qualification; follows aseptic, safety, and cGMP procedures; maintains laboratory equipment and inventory; escalates excursions and documentation issues; and participates in training and continuous improvement.

Leads market development for Izervay and geographic advocacy among retina, ophthalmology, and optometry thought leaders. Builds customer relationships, gathers insights, supports brand strategy, coordinates peer-to-peer education and speaker programs, collaborates with sales, medical, reimbursement, and marketing teams, and represents the company at conferences. Ensures regulatory compliance while traveling extensively throughout the assigned region and occasionally across the United States.

Manages the planning, preparation, publishing, submission, tracking, and archiving of regulatory dossiers and correspondence worldwide. Ensures adherence to submission standards and regulatory pathways, supports affiliates and partners, coordinates timelines with project teams and vendors, and maintains filing-status communications. Provides regulatory guidance interpretation, system and process training, document quality control, and operational support. May supervise external staff, contribute to system requirements and testing, and represent regulatory publishing on project teams and with health authorities.

Leads QC analytical operations for cell products in a cGMP manufacturing environment. Responsibilities include analytical method development, qualification, validation and transfer; routine release, in-process and stability testing; data integrity; investigations; CAPAs; SOP and technical report authoring; equipment validation; regulatory support; commercial readiness; and cross-functional SME leadership.

Lead US brand communications for priority pharmaceutical brands, developing external and internal campaigns for patients, healthcare professionals, regulatory milestones, data announcements, and scientific congresses. Manage media engagement, influencer partnerships, spokesperson training, issues and crisis communications, and stakeholder alignment. Establish campaign metrics, provide strategic counsel to brand teams, and collaborate with Corporate, R&D Communications, Medical Affairs, and Investor Relations.

Manage day-to-day operations of assigned clinical trials including planning, setup, execution, vendor and site oversight, data review, TMF quality, budget and timelines in compliance with ICH/GCP and regulatory requirements.

Executes FP&A operations including month-end close, management reporting, variance analysis, budgeting, forecasting, financial scenario modeling, and dashboard preparation. Partners with business finance partners, accounting, systems, and reporting teams to ensure data accuracy, compliance, timely reporting, and actionable insights. Supports financial planning processes, system implementations, internal controls, and coordination of financial calendar adjustments across markets and regions.

Manages national GPO and key account relationships for oncology and retina products. Responsibilities include negotiating and implementing contracts, driving account pull-through and sales performance, developing executive partnerships, creating account business plans, coordinating cross-functional initiatives, monitoring budgets and contract requirements, analyzing competitive trends, and presenting clinical and commercial information. This field-based role requires extensive travel and collaboration with market access, sales, marketing, medical, health systems, vendors, and external healthcare stakeholders.

Designs and characterizes next-generation antibodies, T-cell engagers, ADCs, engineered cytokines, and other biologics. Applies antibody engineering, structural biology, biophysics, biochemistry, and AI/ML-enabled protein design through iterative discovery and optimization cycles. Conducts molecular biology, purification, and assay development; analyzes experimental and computational data; collaborates with global research teams and CROs; and contributes to reports, publications, patents, and preclinical therapeutic programs.

Leads upstream marketing for IZERVAY, developing integrated strategies to increase Geographic Atrophy awareness, diagnosis, patient identification, and referral among optometrists and ophthalmologists. Owns segmentation, positioning, messaging, personal and non-personal promotion, digital engagement, peer-to-peer education, congress strategy, customer insights, agency management, budgets, KPIs, and cross-functional execution across commercial and medical teams.

Leads advanced omnichannel analytics for pharmaceutical brand and pipeline strategies, including campaign measurement, ROI, tactic optimization, promotional mix, and next-best engagement. Provides stakeholder consulting, reporting governance, actionable insights, statistical modeling, and process automation. Manages analytical projects, vendors, resources, timelines, and deliverables while collaborating cross-functionally in an Agile environment. The role also develops analytical methodologies, mentors colleagues, and ensures data quality, privacy, and compliance.

Performs QA compliance activities for GMP manufacturing programs, including reviewing QC, batch, raw material, and calibration records; supporting deviations and CAPA investigations; assisting internal audits; authoring SOPs; tracking compliance metrics; driving continuous improvement; and supporting oversight of contract manufacturing organizations.

Develop and advance U.S. pharmaceutical policy positions, analyze policy impacts on business and product access, and advise Federal Government Affairs, Market Access, brand teams, and business leaders. Lead cross-functional policy initiatives, collaborate with Government Communications and external stakeholders, and represent Astellas as a policy thought leader. The role requires government strategy or policy expertise, pharmaceutical industry knowledge, strong influencing and communication skills, project leadership, and up to 20% travel.

Executes advanced bulk, single-cell, and targeted-capture NGS workflows using Illumina and Oxford Nanopore platforms. Performs molecular biology methods, primary human cell culture, and laboratory automation with liquid-handling systems. Develops, optimizes, and troubleshoots assays and sequencing workflows; reviews QC and experimental data; documents results; maintains laboratory readiness; and communicates findings to cross-functional scientific teams.

Supports GMP compliance and operational readiness for a Cytogenomics laboratory. Responsibilities include document control, change management, quality records, training compliance, laboratory system administration, equipment lifecycle management, vendor qualification, audit preparation, inspection readiness, and corrective action tracking. The role partners with Quality Assurance, Validation, laboratory teams, and vendors to maintain compliant documentation, systems, equipment, and processes under FDA and EMA requirements.

Administer, maintain, configure, integrate, and support global QC laboratory systems including LIMS, CDS, SDMS, and ELN platforms. Serve as system owner and subject-matter expert for validated GxP and non-GxP environments, supporting audits, upgrades, user management, integrations, troubleshooting, training, vendor relationships, and continuous process improvements. Ensure system compliance, reliability, performance, and effective collaboration across manufacturing QC labs and business units.

Conducts laboratory research on antibody-drug conjugates and other bioconjugates, including design, synthesis, conjugation, purification, and characterization. Develops and optimizes workflows, troubleshoots technical challenges, manages multiple projects, and collaborates with chemistry, protein science, biology, pharmacology, and ADME teams. Communicates scientific findings, maintains compliant laboratory records, and contributes to patents, publications, and technical reports. The role supports oncology discovery programs through candidate selection and early development.