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J&J Family of Companies Associate Director, External Analytics in Horsham, Pennsylvania

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, External Analytics. This position can be located within commuting distance of a Janssen site within New Jersey or Pennsylvania. Remote location within the United States may be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

The Associate Director, External Analytics within the Small Molecule Analytical Development group, will be responsible for project management and oversight of external laboratory activities based in the Americas. This individual will provide analytical oversight of external analytical suppliers ensuring that all Analytical Development (AD) related activities are conducted according to project plans and internal requirements. Assist in providing expertise and guidance in method development, chromatographic and non-chromatographic method development, validation, investigation and analytical transfer to support in all phases of pharmaceutical development including product life cycle management. Escalate potential issues to management and serve as coordinator in crisis management situations. In addition, provide technical support of analytical methods for marketed products to Janssen Supply Chain (JSC) commercial organization in the Americas and Regulatory Affairs for agreed portfolio. Support audits and regulatory submissions. Partner with production sites and other global AD groups on issues related to test methods and facilitate in the resolution. Provide support for due diligence activities providing analytical expertise for evaluation of external assets and partnerships.

Principal Responsibilities:

  • Work closely with Analytical Scientific Integrators and subteam members to develop external laboratory project workflow and timelines and ensure project deliverables are met with high quality and on time.

  • Extensive interactions with multidisciplinary and multisite groups, including external vendors and/or strategic suppliers.

  • Support Analytical projects within the Chemistry, Manufacturing and Control (CMC) Organization and interface with key stakeholders for critical analytical projects for small molecules.

  • Support strategy in a flexible global organization to meet regional customer requirements in EMEA, Asia Pacific and the United States.

  • Ensure external partners processes and supporting methods are aligned with strategic technical platforms for analytical methodologies.

  • Maintain key interactions with Scientific Integrators and other department leaders, technical groups, regulatory organizations, quality, & external partners.

  • Provide input as needed to support major and/or minor filings for new products and life cycle management.

  • Support lab events, amendments, investigations, agency responses, and other submissions.

Qualifications

  • A minimum of a Bachelor’s degree in Chemistry, Pharmacy, or related Life Science discipline is required. Advanced degree (Master’s, PhD) in Chemistry, Pharmacy or a related Life Science discipline is preferred.

  • A minimum of 10 years of pharmaceutical industry experience with a Bachelor’s degree in Chemistry, Pharmacy, or related Life Science discipline; or a minimum of 8 years of pharmaceutical industry experience with a Master’s degree in Chemistry, Pharmacy, or related Life Science discipline; or a minimum of 6 years of pharmaceutical industry experience with a Ph.D. degree in Chemistry, Pharmacy, or related Life Science discipline is required.

  • Knowledge of the functions involved within the drug development/commercialization process is required.

  • Demonstrated knowledge of analytical or biochemistry within a R&D and current Good Manufacturing Practice (cGMP) environment is required.

  • Experience with analytical testing, including dissolution and chromatographic techniques UHPLC and HPLC and nonchromatographic techniques, is required.

  • Experience working with external partners (vendors, Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), etc.) is preferred.

  • Project management experience is preferred.

  • Must have excellent communication and interpersonal skills.

  • Must have strong leadership skills.

  • Must have the ability to adapt effectively to rapidly changing organization issues, structures and dynamics.

  • The ability to execute and get results through leading in a complex, matrix environment is required.

  • This position will require up to 15% domestic and international travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Other Locations

North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105952420W

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