Senior Director TS/MS– Oral Solid Dose, Katwijk NB
Senior Director TS/MS– Oral Solid Dose, Katwijk NB
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5433 Katwijk NB, Nederland
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Geplaatst op: minder dan een week geleden
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Onthouden
Advertentietekst
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
About the Katwijk Site Eli Lilly is investing€2.6 billion in a new state‑of‑the‑art manufacturing facility in Katwijk, Netherlands. This facility will produce oral medicines for cardiometabolic health, neuroscience, oncology, and immunology, incorporating next‑generation manufacturing technologies including dock‑to‑dock automation, paperless manufacturing, and process analytical technology while achieving carbon neutrality and zero waste to landfills.
Timeline Construction begins 2026, completion targeted 2029‑2030.
Position Overview A senior leadership role responsible for the technical strategy and process excellence of drug product manufacturing at an Oral Solid Dosage manufacturing site. This includes technical oversight for drug product intermediates control strategy from spray‑dried dispersion through tablet and capsule manufacturing. Serves as the site’s authority on technology transfer, scale‑up, and manufacturing science for oral solid dose forms (tablets, capsules).
Key Responsibilities Technical Strategy&Leadership
Define and lead the site’s technical agenda and strategic direction for medium and long‑term planning
Develop and execute plans aligned with corporate goals and future product pipelines
Participate as a key member in setting strategic direction for the manufacturing site
Develop recruitment&start‑up strategies for areas under his/her responsibilities, ensuring the Site is delivered without accidents, compliant, on budget and according to schedule
Technology Transfer&New Product Introduction
Oversee the transfer of new oral solid dose formulations from development into commercial production
Ensure smooth tech transfers from R&D to manufacturing, guiding scale‑up from lab/pilot scale to full production
Conduct equipment fit assessments and process characterization
Ensure processes are robust at commercial scale
Process Optimization&Validation
Ensure all tablet/capsule manufacturing processes are optimized and remain in a validated state
Drive continuous improvement of granulation, compression, coating processes to improve yields and efficiency
Lead process validation, including initial process qualification for new products
Oversee ongoing continued process verification to meet cGMP requirements
Solve processing issues and enhance operational efficiency
Quality Compliance&Troubleshooting
Guarantee GMP compliance and regulatory readiness of all technical operations
Define control strategies for critical quality attributes including drug product intermediates from spray‑dried dispersion, blend uniformity, tablet hardness, and dissolution profiles
Support preparation of regulatory submissions
Provide front‑line scientific support for troubleshooting manufacturing issues and investigations
Drive risk management and CAPA initiatives
Cross‑Functional Collaboration
Build strong technical partnerships with Formulation Development/R&D, Global TS/MS network, Operations, Quality, Engineering, and external partners
Represent TS/MS in site leadership forums and decision‑making committees
Ensure technical considerations shape business decisions
Liaise with Contract Manufacturing Organizations as needed
Documentation&Reporting
Oversee generation and timely completion of all technical documents and reports
Ensure compliant documentation including process development reports, validation documentation, technical protocols, and annual product reviews
Maintain audit readiness and knowledge management standards
Team Development&Leadership
Lead and mentor the TS/MS team of scientists and engineers
Ensure the organization has appropriate capability and capacity through recruiting and developing talent
Allocate resources effectively and build a culture of technical excellence
Coach team members, manage performance, and prepare future technical leaders
Qualifications and Requirements Education
Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field (strongly preferred)
Master’s degree acceptable with significantly higher experience
Experience
Experience: Minimum 10 years in production, engineering, technical services, or supply chain (At least 10 years in the pharmaceutical or chemical synthesis industry with a strong focus in manufacturing operations); 5 of those years should be in management positions
15+ yearsin pharmaceutical manufacturing and development roles
Significant leadership experience in TS/MS, MS&T, Process Development, Tech Services, or Manufacturing Science functions
Prior roles in technical support of manufacturing, leading tech transfer projects, validation, or process engineering
Progressive responsibility with experience managing large technical teams or projects
Preferred:
Experience in API manufacturing, spray‑dried dispersion (SDD) processing, or chemical plant manufacturing environments. Candidates combining chemical plant manufacturing experience with OSD expertise are particularly well‑suited for this role
Technical Expertise
Subject matter expertise in drug product manufacturing
In‑depth knowledge of OSD processes: blending, granulation (wet/dry), tablet compression, coating, and capsule filling
Fluency in process validation, scale‑up principles, and Quality by Design (QbD)
Knowledge of regulatory guidelines for oral solid dose production
Experience troubleshooting and improving OSD processes (content uniformity, coating optimization, etc.)
Expertise in technology transfer and regulatory compliance
Preferred:
Knowledge of spray‑dried dispersion (SDD) processes, API manufacturing, or process‑scale manufacturing (PSM) operations
Leadership&Soft Skills
Strategic thinking and decision‑making abilities
Excellent stakeholder management and cross‑functional collaboration skills
Ability to influence teams and articulate technical issues in business terms
Strong communication abilities for interfacing with senior leaders, global functions, and regulators
Capability to manage changing priorities under tight timelines
Cultural leadership to drive operational excellence
Additional Requirements
Fluent knowledge of cGMP regulations
Experience participating in regulatory inspections or audits
Experience with Continuous Improvement methodologies (Lean/Six Sigma) applied to manufacturing science
Willingness to travel and collaborate globally (~5% travel)
Ability to interface with other manufacturing sites and development labs
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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About the Katwijk Site Eli Lilly is investing€2.6 billion in a new state‑of‑the‑art manufacturing facility in Katwijk, Netherlands. This facility will produce oral medicines for cardiometabolic health, neuroscience, oncology, and immunology, incorporating next‑generation manufacturing technologies including dock‑to‑dock automation, paperless manufacturing, and process analytical technology while achieving carbon neutrality and zero waste to landfills.
Timeline Construction begins 2026, completion targeted 2029‑2030.
Position Overview A senior leadership role responsible for the technical strategy and process excellence of drug product manufacturing at an Oral Solid Dosage manufacturing site. This includes technical oversight for drug product intermediates control strategy from spray‑dried dispersion through tablet and capsule manufacturing. Serves as the site’s authority on technology transfer, scale‑up, and manufacturing science for oral solid dose forms (tablets, capsules).
Key Responsibilities Technical Strategy&Leadership
Define and lead the site’s technical agenda and strategic direction for medium and long‑term planning
Develop and execute plans aligned with corporate goals and future product pipelines
Participate as a key member in setting strategic direction for the manufacturing site
Develop recruitment&start‑up strategies for areas under his/her responsibilities, ensuring the Site is delivered without accidents, compliant, on budget and according to schedule
Technology Transfer&New Product Introduction
Oversee the transfer of new oral solid dose formulations from development into commercial production
Ensure smooth tech transfers from R&D to manufacturing, guiding scale‑up from lab/pilot scale to full production
Conduct equipment fit assessments and process characterization
Ensure processes are robust at commercial scale
Process Optimization&Validation
Ensure all tablet/capsule manufacturing processes are optimized and remain in a validated state
Drive continuous improvement of granulation, compression, coating processes to improve yields and efficiency
Lead process validation, including initial process qualification for new products
Oversee ongoing continued process verification to meet cGMP requirements
Solve processing issues and enhance operational efficiency
Quality Compliance&Troubleshooting
Guarantee GMP compliance and regulatory readiness of all technical operations
Define control strategies for critical quality attributes including drug product intermediates from spray‑dried dispersion, blend uniformity, tablet hardness, and dissolution profiles
Support preparation of regulatory submissions
Provide front‑line scientific support for troubleshooting manufacturing issues and investigations
Drive risk management and CAPA initiatives
Cross‑Functional Collaboration
Build strong technical partnerships with Formulation Development/R&D, Global TS/MS network, Operations, Quality, Engineering, and external partners
Represent TS/MS in site leadership forums and decision‑making committees
Ensure technical considerations shape business decisions
Liaise with Contract Manufacturing Organizations as needed
Documentation&Reporting
Oversee generation and timely completion of all technical documents and reports
Ensure compliant documentation including process development reports, validation documentation, technical protocols, and annual product reviews
Maintain audit readiness and knowledge management standards
Team Development&Leadership
Lead and mentor the TS/MS team of scientists and engineers
Ensure the organization has appropriate capability and capacity through recruiting and developing talent
Allocate resources effectively and build a culture of technical excellence
Coach team members, manage performance, and prepare future technical leaders
Qualifications and Requirements Education
Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field (strongly preferred)
Master’s degree acceptable with significantly higher experience
Experience
Experience: Minimum 10 years in production, engineering, technical services, or supply chain (At least 10 years in the pharmaceutical or chemical synthesis industry with a strong focus in manufacturing operations); 5 of those years should be in management positions
15+ yearsin pharmaceutical manufacturing and development roles
Significant leadership experience in TS/MS, MS&T, Process Development, Tech Services, or Manufacturing Science functions
Prior roles in technical support of manufacturing, leading tech transfer projects, validation, or process engineering
Progressive responsibility with experience managing large technical teams or projects
Preferred:
Experience in API manufacturing, spray‑dried dispersion (SDD) processing, or chemical plant manufacturing environments. Candidates combining chemical plant manufacturing experience with OSD expertise are particularly well‑suited for this role
Technical Expertise
Subject matter expertise in drug product manufacturing
In‑depth knowledge of OSD processes: blending, granulation (wet/dry), tablet compression, coating, and capsule filling
Fluency in process validation, scale‑up principles, and Quality by Design (QbD)
Knowledge of regulatory guidelines for oral solid dose production
Experience troubleshooting and improving OSD processes (content uniformity, coating optimization, etc.)
Expertise in technology transfer and regulatory compliance
Preferred:
Knowledge of spray‑dried dispersion (SDD) processes, API manufacturing, or process‑scale manufacturing (PSM) operations
Leadership&Soft Skills
Strategic thinking and decision‑making abilities
Excellent stakeholder management and cross‑functional collaboration skills
Ability to influence teams and articulate technical issues in business terms
Strong communication abilities for interfacing with senior leaders, global functions, and regulators
Capability to manage changing priorities under tight timelines
Cultural leadership to drive operational excellence
Additional Requirements
Fluent knowledge of cGMP regulations
Experience participating in regulatory inspections or audits
Experience with Continuous Improvement methodologies (Lean/Six Sigma) applied to manufacturing science
Willingness to travel and collaborate globally (~5% travel)
Ability to interface with other manufacturing sites and development labs
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#J-18808-Ljbffr
Belangrijke informatie
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BedrijfsnaamDormont Manufacturing Co
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PositieSenior Director TS/MS– Oral Solid Dose
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