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Sr. Manager, Bioanalysis

Princeton, New Jersey

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. 

Essential Functions:

•    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.

Requirements:

Education
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.

Experience
•    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.
Technical Skills
•    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.

Working Conditions:

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $150,000 to $170,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

  • 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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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