Director Biologics and Biopharmaceutics
USA - New Jersey - Rahway
Job Description
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify and isolate a molecule that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics understanding of how formulation impacts exposure of compounds in humans spanning the oral and non-oral portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and execute a comprehensive biopharmaceutics strategy that leverages cutting edge in vitro, in vivo and in silico physiologically based pharmacokinetics (PBPK) and PK modeling tools, while advancing the underlying biopharmaceutics science within the organization and the external scientific community. The successful candidate:
Should have a vision to develop a team, demonstrated leadership skills, biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory environment
Will be responsible for sub-functional strategic planning, coordinating, and execution of initiatives supporting the interfaces between the biopharmaceutics team and various discovery and development departments
Will need to collaborate in a fast-paced, integrated, multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impact
Proactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting hypothesis-based assessment employing a rigorous integrated approach, driving the development of in vitro-in vivo relationships and preclinical-to-clinical translation in bioperformance of formulations
The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists. The successful candidate will effectively partner with …
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Tasks- Budget Management
- Collaborate with stakeholders
- Collaboration
- Communication
- Compliance
- Conduct risk assessments
- Effective Communication
- Formulation development
- Innovation
- Leadership
- Manage budget
- Planning
- Project management
- Regulatory Compliance
- Regulatory submissions
- Resourcing planning
- Risk Assessment
- Risk assessment strategies
- Strategic Planning
Access Animal Health Animal Health Products Biologic Biologics Biopharmaceutical Biopharmaceutics Budget management Business Operations Clinical CMC Collaboration Commercial Commercialization Communication Compliance Creativity Critical thinking Data Design Development Drug Development Drug Products Education Effective Communication Execution Formulation Formulation Development Growth Mindset Healthcare Inclusion Influencing Innovation Innovative Thinking Integration Law Leadership Management Manufacturing Medical Methodology Modeling Operational Operational Excellence Operations Organizational Partnerships Pharmaceutical Pharmaceutical Development Pharmaceutical Sciences Pharmacokinetics Planning Predictive models Product Development Project Management Promotions Quality Regulatory Regulatory Affairs Regulatory Compliance Regulatory filings Regulatory Submissions Research Research and development Risk Assessment Science Scientific Excellence Scientific Methodology Scientific publications Scientific research Self-Motivation Small Molecules Strategic planning Strategy Talent Acquisition Team Leadership Teams Technical Technical Expertise Technology Vaccines Writing Written communication
Experience8 - 10 years
EducationAnimal health Business Management Pharmaceutical Sciences Science Technology
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9