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Source: National Labor Exchange
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Source: National Labor Exchange
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Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
Roehl Transport
Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Truck Driver on-the-job CDL Training
Source: National Labor Exchange
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Otsuka America Pharmaceutical Inc.
Manager, Regulatory Operations
Source: National Labor Exchange
Otsuka America Pharmaceutical Inc.
Senior Director, Small Molecule Drug Substance Development
Source: National Labor Exchange
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Source: National Labor Exchange
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Job ID #68021
Otsuka America Pharmaceutical Inc.
Senior Director, Small Molecule Drug Substance Development
location_on
Jefferson City, MO
work_outline
Full-Time
description
Summary
Remote
Full time
R12944
Position Summary
The Senior Director, Small Molecule Drug Substance Development provides strategic, scientific, and operational leadership for the development, optimization, scale-up, and manufacture of small molecule active pharmaceutical ingredients (APIs) from candidate nomination through commercial readiness. The position is accountable for establishing and executing comprehensive drug substance development strategies for Otsuka's small molecule assets that enable robust, scalable, compliant, and cost-effective manufacturing processes throughout the product lifecycle.
The Senior Director leads a team of scientists and process chemists responsible for the execution of drug substance development activities through all phases of development while ensuring technical excellence, operational efficiency, and regulatory compliance in a fully virtual model. The individual works closely with the global external manufacturing group to select and manage contract development manufacturing organizations (CDMOs) and leads drug substance development activities for assigned portfolio programs and contributes to portfolio planning.
Key Responsibilities
Drug Substance Development Strategy
+ Develop and execute phase-appropriate drug substance development strategies from candidate nomination through commercial readiness.
+ Develop and execute API development plans aligned with program, portfolio, and corporate objectives.
+ Provide scientific and technical leadership in route selection, process chemistry, process optimization, impurity control, scale-up, and manufacturing strategy.
+ Drive development of safe, robust, scalable, and commercially sustainable manufacturing processes.
+ Establish development strategies that support clinical supply, regulatory submissions, process validation, and commercial launch readiness.
+ Identify and escalate technical and operational risks and implement mitigation strategies to support program timelines and organizational objectives.
+ Provide scientific oversight for process characterization activities and development of process control strategies.
+ Lead technical evaluations of novel technologies and manufacturing approaches that improve process robustness, productivity, safety, and cost efficiency.
+ Provide strategic oversight and technical guidance for technology transfer, scale-up, and manufacturing activities performed by CDMOs.
+ Contribute scientific and technical expertise to due diligence, business development assessments, and portfolio evaluations.
+ Contribute to departmental planning, performance metrics, and resource strategies.
+ Manage departmental budgets, external development expenditures, and consulting resources.
CMC and Regulatory Support
+ Author, review, and approve drug substance sections of regulatory submissions including INDs, IMPDs, CTAs, NDAs, MAAs, and related global filings.
+ Provide strategic input into drug substance regulatory strategies and health authority interactions.
+ Present and defend drug substance development approaches during regulatory inspections, audits, and agency meetings as required.
+ Ensure drug substance development documentation is scientifically rigorous and development activities are aligned with current regulatory expectations and industry best practices for small molecule drug substance development.
Cross-Functional and Team Development Leadership
+ Partner closely with drug product development, analytical sciences, quality assurance, regulatory affairs, supply chain, and other cross-functional stakeholders to ensure alignment of drug substance development activities with overall program objectives, regulatory requirements, clinical and commercial supply needs, product development strategies, and successful advancement from candidate nomination through commercial readiness.
+ Lead, mentor, and develop a high-performing team of process chemists, scientists, and drug substance development professionals.
+ Build technical capabilities within the drug substance development team to support progression of programs from candidate nomination through commercial readiness.
+ Foster a culture of scientific rigor, innovation, accountability, collaboration, and continuous improvement.
Qualifications
Education
+ PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline preferred.
+ Master's degree with significant relevant industry experience may be considered.
Experience
+ 15+ years of progressive experience in pharmaceutical or biotechnology drug substance development.
+ Demonstrated leadership experience in small molecule process chemistry and API development.
+ Minimum of 5 years of experience leading scientific teams and managing people.
+ Proven success advancing multiple small molecule programs from candidate nomination through late-stage clinical development and commercial readiness.
+ Significant experience leading process chemistry, technology transfer, scale-up, and API commercialization activities.
+ Extensive experience managing CDMOs and external development partners.
+ Demonstrated ability to lead cross-functional programs within a matrixed organization.
+ Experience managing departmental budgets and resource planning.
Technical Expertise
+ Deep expertise in synthetic organic chemistry and pharmaceutical process development.
+ Strong understanding of route selection, process optimization, scale-up, technology transfer, process characterization, process validation, and commercial manufacturing.
+ Comprehensive knowledge of global drug substance CMC requirements and applicable regulatory guidelines.
+ Experience with impurity control strategies, genotoxic impurity management, and process control strategies.
+ Strong understanding of pharmaceutical development principles from early development through commercialization.
+ Familiarity with contemporary manufacturing technologies and external manufacturing business models.
Leadership Competencies
+ Strategic thinker with strong scientific judgment and business acumen.
+ Demonstrated ability to build, inspire, and lead high-performing technical organizations.
+ Strong project management and prioritization capabilities.
+ Proven ability to influence stakeholders and drive decision-making across complex organizations.
+ Excellent verbal, written, and presentation skills.
+ Strong interpersonal skills with the ability to develop productive relationships internally and externally.
+ Ability to operate effectively in a fast-paced and evolving development environment.
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in ...
Full time
R12944
Position Summary
The Senior Director, Small Molecule Drug Substance Development provides strategic, scientific, and operational leadership for the development, optimization, scale-up, and manufacture of small molecule active pharmaceutical ingredients (APIs) from candidate nomination through commercial readiness. The position is accountable for establishing and executing comprehensive drug substance development strategies for Otsuka's small molecule assets that enable robust, scalable, compliant, and cost-effective manufacturing processes throughout the product lifecycle.
The Senior Director leads a team of scientists and process chemists responsible for the execution of drug substance development activities through all phases of development while ensuring technical excellence, operational efficiency, and regulatory compliance in a fully virtual model. The individual works closely with the global external manufacturing group to select and manage contract development manufacturing organizations (CDMOs) and leads drug substance development activities for assigned portfolio programs and contributes to portfolio planning.
Key Responsibilities
Drug Substance Development Strategy
+ Develop and execute phase-appropriate drug substance development strategies from candidate nomination through commercial readiness.
+ Develop and execute API development plans aligned with program, portfolio, and corporate objectives.
+ Provide scientific and technical leadership in route selection, process chemistry, process optimization, impurity control, scale-up, and manufacturing strategy.
+ Drive development of safe, robust, scalable, and commercially sustainable manufacturing processes.
+ Establish development strategies that support clinical supply, regulatory submissions, process validation, and commercial launch readiness.
+ Identify and escalate technical and operational risks and implement mitigation strategies to support program timelines and organizational objectives.
+ Provide scientific oversight for process characterization activities and development of process control strategies.
+ Lead technical evaluations of novel technologies and manufacturing approaches that improve process robustness, productivity, safety, and cost efficiency.
+ Provide strategic oversight and technical guidance for technology transfer, scale-up, and manufacturing activities performed by CDMOs.
+ Contribute scientific and technical expertise to due diligence, business development assessments, and portfolio evaluations.
+ Contribute to departmental planning, performance metrics, and resource strategies.
+ Manage departmental budgets, external development expenditures, and consulting resources.
CMC and Regulatory Support
+ Author, review, and approve drug substance sections of regulatory submissions including INDs, IMPDs, CTAs, NDAs, MAAs, and related global filings.
+ Provide strategic input into drug substance regulatory strategies and health authority interactions.
+ Present and defend drug substance development approaches during regulatory inspections, audits, and agency meetings as required.
+ Ensure drug substance development documentation is scientifically rigorous and development activities are aligned with current regulatory expectations and industry best practices for small molecule drug substance development.
Cross-Functional and Team Development Leadership
+ Partner closely with drug product development, analytical sciences, quality assurance, regulatory affairs, supply chain, and other cross-functional stakeholders to ensure alignment of drug substance development activities with overall program objectives, regulatory requirements, clinical and commercial supply needs, product development strategies, and successful advancement from candidate nomination through commercial readiness.
+ Lead, mentor, and develop a high-performing team of process chemists, scientists, and drug substance development professionals.
+ Build technical capabilities within the drug substance development team to support progression of programs from candidate nomination through commercial readiness.
+ Foster a culture of scientific rigor, innovation, accountability, collaboration, and continuous improvement.
Qualifications
Education
+ PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline preferred.
+ Master's degree with significant relevant industry experience may be considered.
Experience
+ 15+ years of progressive experience in pharmaceutical or biotechnology drug substance development.
+ Demonstrated leadership experience in small molecule process chemistry and API development.
+ Minimum of 5 years of experience leading scientific teams and managing people.
+ Proven success advancing multiple small molecule programs from candidate nomination through late-stage clinical development and commercial readiness.
+ Significant experience leading process chemistry, technology transfer, scale-up, and API commercialization activities.
+ Extensive experience managing CDMOs and external development partners.
+ Demonstrated ability to lead cross-functional programs within a matrixed organization.
+ Experience managing departmental budgets and resource planning.
Technical Expertise
+ Deep expertise in synthetic organic chemistry and pharmaceutical process development.
+ Strong understanding of route selection, process optimization, scale-up, technology transfer, process characterization, process validation, and commercial manufacturing.
+ Comprehensive knowledge of global drug substance CMC requirements and applicable regulatory guidelines.
+ Experience with impurity control strategies, genotoxic impurity management, and process control strategies.
+ Strong understanding of pharmaceutical development principles from early development through commercialization.
+ Familiarity with contemporary manufacturing technologies and external manufacturing business models.
Leadership Competencies
+ Strategic thinker with strong scientific judgment and business acumen.
+ Demonstrated ability to build, inspire, and lead high-performing technical organizations.
+ Strong project management and prioritization capabilities.
+ Proven ability to influence stakeholders and drive decision-making across complex organizations.
+ Excellent verbal, written, and presentation skills.
+ Strong interpersonal skills with the ability to develop productive relationships internally and externally.
+ Ability to operate effectively in a fast-paced and evolving development environment.
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in ...
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