Sr. Manager, Bioanalysis

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
Bachelor’s degree in life sciences, healthcare, or closely related discipline is required. An advanced degree (MS or PhD) is highly desirable.

Experience
•    Minimum of five (5) years of pharmaceutical industry experience (Sponsor and/or CRO) in the bioanalysis of large and small molecule therapeutics.
•    Three (3) or more years of hands-on experience at a bioanalytical CRO or in conducting vendor oversight to support clinical development programs across all phases; experience with early-phase programs is strongly preferred.
•    Proven experience in preparing strategic regulatory communications and developing reports and summary documents for regulatory submissions.
•    Demonstrated ability to manage expedited sample analysis timelines while ensuring high-quality data delivery.
•    Experience in authoring and reviewing Work Instructions, Manuals, and/or Standard Operating Procedures (SOPs).

Technical Skills
•    Strong familiarity with bioanalytical assay methodology including ligand-binding and cell-based assays, LCMS/MS, and novel technologies. 
•    Strong analytical skills to resolve technical issues. 
•    Ability to effectively use tables, figures, and listings for data review (adequacy of bioanalysis) and cleaning (no missing samples).
•    Advanced knowledge of guidance documents issued by ICH and local regulatory agencies such as FDA, EMA, PMDA, Health Canada.
•    Familiarity with critical reagents lifecycle management. 
•    Basic proficiency in MS Office Suite

Working Conditions:
Requires up to 10% domestic and international travel

The anticipated salary for this position will be $155,000 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