Director, Bioanalytical Sciences
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: June 19, 2022
Job Description:
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious diseases
- often with limited or no therapeutic options. We have a diverse
portfolio of marketed medicines and novel product candidates, from
early- to late-stage development, in neuroscience and oncology. We
actively explore new options for patients including novel
compounds, small molecules and biologics, and through cannabinoid
science and innovative delivery technologies. Jazz is headquartered
in Dublin, Ireland and has employees around the globe, serving
patients in nearly 75 countries. For more information, please visit
www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. The
Director, Bioanalytical Sciences will report to the Head of DMPK
and Bioanalytical Sciences within the Clinical Pharmacology and
Nonclinical Safety Department and will provide organizational and
scientific leadership for US-based members of the Bioanalytical
Sciences group, as well as contribute to the scientific and
strategic direction of the global Bioanalytical Sciences group (US
and UK) at Jazz. The Bioanalytical Sciences group directs CROs in
the development and validation of bioanalytical methods to measure
drug concentrations and immunogenicity in all nonclinical and
clinical studies across the entire pipeline of small molecules and
biologics at Jazz.Key Responsibilities:
- Direct and manage the activities of US staff within
Bioanalytical Sciences
- Plan/oversee budgets and resources within the US Bioanalytical
Sciences group to ensure alignment with project and corporate goals
and objectives
- As a member of the global Bioanalytical Sciences Leadership
Team, contribute to the strategic and scientific direction of the
Bioanalytical Sciences group across all Jazz sites
- Attract and retain key talent to build and maintain
bioanalytical capabilities at Jazz
- Drive alignment with project teams, functional leadership, and
governance committees on bioanalytical strategies and resourcing
for Jazz s small molecule and biologic programs
- Serve as the bioanalytical subject-matter expert on
cross-functional drug discovery and development project teams
- Provide oversight of bioanalytical CROs to facilitate the
transfer, development, and validation of regulated (GLP/GCP)
bioanalytical methods and ensure quality data and reports are
delivered within specified timelines
- Manage CRO contracts and bioanalytical aspects of project
budgets
- Contribute to the preparation of study protocols, reports, and
bioanalytical sections of regulatory submissions (e.g., IND, NDA,
BLA) and address relevant queries from regulatory agenciesRequired
Knowledge, Skills, and Abilities
- A minimum of 10 years of experience in the pharmaceutical
industry supporting bioanalysis in non-clinical and clinical
studies
- Extensive experience developing and validating bioanalytical
and immunogenicity methods for small molecules and biologic
therapies
- Experience preparing bioanalytical sections of regulatory
submission documents (e.g., IND, NDA/BLA) and bioanalytical
components of nonclinical and clinical study protocols
- Strong knowledge in GLP/GCP regulations and regulatory guidance
documents that apply to bioanalysis
- Excellent written and oral communication skills
- Excellent leadership skills
- Demonstrated ability to effectively influence without authority
in a matrix organization
- Proven ability to prioritize and deploy resources appropriately
to align with project and corporate objectivesRequired/Preferred
Education and Licenses
- Doctorate degree in chemistry, analytical sciences,
pharmaceutical sciences, or a related fieldJazz Pharmaceuticals is
an equal opportunity/affirmative action employer and all qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex, national origin, disability status,
protected veteran status, or any characteristic protected by law.
Associated topics: aseptic, drug, health, industrial hygienist,
pharmacology, pharmacometrics, protein, therapy, toxicologist,
transfection
Keywords: Jazz Pharmaceuticals, Palo Alto , Director, Bioanalytical Sciences, Executive , Palo Alto, California
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