Sr. Manager, Bioanalysis
About The Position
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Manager, Bioanalysis plays a key role in advancing Kyowa Kirin’s pipeline through providing bioanalytical support and strategy to cross-functional and cross-regional teams for early-phase and late-phase clinical studies, as a bioanalytical SME and a member of Bioanalysis sub-team of global Clinical Pharmacology department. This position involves managing regulated bioanalysis conducted at bioanalytical CROs throughout the assay lifecycle (assay validation through all phases of clinical sample analysis). The role integrates a deep understanding of regulated bioanalysis and effective communication across global cross-functional teams to support program strategy and execution.
Requirements
- Advanced degree (MS or PhD preferred) in Life Sciences, Pharmaceutical Sciences or closely related field; Bachelor’s degree with substantial industry experience in regulated bioanalysis will be considered.
- Minimum of seven (7) years pharmaceutical or biotechnology in regulated bioanalysis supporting large- and small-molecule therapeutics across clinical development phases (Phase I–IV), with strong emphasis on early-phase development preferred.
- At least three (3) years of hands-on experience within a bioanalytical CRO and/or direct oversight of bioanalytical vendors, including assay validation, sample analysis, data review, and issue resolution.
- Demonstrated experience in preparation of strategic regulatory communication and development of reports and summary documents for regulatory submission (e.g., IND/CTA, BLA/NDA).
- Proven ability to manage expedited sample analysis timelines while ensuring compliance, data integrity, and high-quality deliverables.
- Experience authoring, reviewing, and maintaining Work Instructions, Manuals, and/or SOPs in accordance with GxP requirements.
- Experience collaborating with cross-functional and cross-regional stakeholders to align bioanalytical strategy with overall clinical and program objectives.
- In-depth knowledge of regulated bioanalytical assay development, validation, and lifecycle management for ligand-binding assays (LBA), cell-based assays, and LC-MS/MS methodologies; familiarity with emerging and novel bioanalytical technologies.
- Strong technical troubleshooting and analytical problem-solving skills, with the ability to assess assay performance, investigate deviations, and drive resolution..
- Proficiency in reviewing and interpreting bioanalytical datasets, including use of tables, figures, and listings to evaluate assay performance, sample reconciliation, and data completeness.
- Advanced understanding of global bioanalytical regulatory guidance and compliance requirements, including ICH and regional health authorities (e.g., FDA, EMA, PMDA, Health Canada).
- Knowledge of critical reagent lifecycle management, including qualification, stability monitoring, and change control.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint); experience with electronic data review systems and clinical data platforms preferred.
Responsibilities
- Managing PK and immunogenicity bioanalysis conducted at CROs including on-site CRO visits and assay troubleshooting with support from internal SMEs.
- Providing bioanalytical guidance on PK and immunogenicity required for clinical projects to cross-functional global clinical study teams, including advising on bioanalytical sample collection and processing, and storage, and data transfer procedures.
- Reviewing clinical study protocols and providing bioanalytical summaries and reports for clinical pharmacology reports and CSRs.
- Developing summary documents for regulatory submission and participating in strategic communication with regulatory agencies.
- Extensive collaboration with counterparts in Japan on activities/initiatives for bioanalytical method development/transfer, CRO qualification/ selection/visits, and process improvements, including creation of work instructions (WIs) and Standard Operation Procedures (SOPs) and co-leading task forces.
- Ensuring full compliance with current global and local bioanalytical guidance and GxPs.
- Simultaneously completing tasks on multiple projects including method validation and sample analysis activities, with support from internal team members.
Benefits
- 401K with company match
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Life & Disability Insurance
- Concierge Services
- Long Term Incentive Program (subject to job level and performance)
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
