Overview:
Jazz Pharmaceuticals is an international biopharmaceutical company
focused on improving patients lives by identifying, developing and
commercializing meaningful products that address unmet medical needs.
We are continuing to expand our commercial product portfolio and our
research and development pipeline in therapeutic areas that can
leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology
areas in which we have a deep understanding of the patient journey and
a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If
youre looking to be a part of a company with an unwavering commitment
to improving patients lives and being a great place to work, we hope
youll explore our career openings and get to know Jazz
Pharmaceuticals.
Responsibilities:
BRIEF DESCRIPTION:
* Reporting into the Exec Director Manufacturing Sciences within the
Process Development and Manufacturing Sciences (PDMS) group the role
will provide scientific and technical leadership to our external
commercial partners for large and/or small molecule DS/DP
manufacturing.
* This position is responsible for providing strong scientific
leadership for all aspects of technology transfer, process scale-up,
process monitoring, and process troubleshooting to drug substance,
drug product and finished product manufacturing activities for large
and/or small molecules. This responsibility includes all process
validation activities.
* Other responsibilities will include cross-functional team
leadership and / or membership, authoring technical reports and
supporting CMC aspects of regulatory dossiers. The role will involve
significant cross functional collaboration with other functions
including R&D, external manufacturing and Quality, working towards
existing and new product introduction and ensuring all processes are
understood, robust, efficient and in control.
* The role works in close collaboration with the product teams
Project lead who is the primary owner of the team processes, tools,
metrics and all aspects of project management to ensure successful
manufacture and supply of product to Patients.
ESSENTIAL FUNCTIONS
* Demonstrated technical proficiency, scientific creativity,
collaboration with others and independent thought in suggesting
experimental design to support process development/ support objectives
* Lead development, maintenance and continuous improvement of
process validation program for all DS and DP manufacturing processes.
Provide technical input to Process Development for defining the
critical process parameters of new processes
* Experience of CMC regulatory requirements for pharmaceutical
products and the evolving opportunities offered by application of QbD
principles
* Key member of the product External Manufacturing Product Team.
Prioritizes technical or manufacturing issues for discussion &
decision by the team
* Works to the guidelines set out in the Product team charter.
* Lead the technical agenda & relationship between the team and with
the relevant CMOs technical team at the site of manufacture.
* Clearly and effectively communicate ideas and results, written and
verbal, to technical and non-technical audiences.
* Highly flexible, works well in a team environment, and has
necessary skills to organize, mobilize, communicate, influence and
lead.
* Support other Product/Process Development and Manufacturing areas
to ensure a smooth transfer of technologies and products to contract
sites.
* Ensure that all processes are in line with health, safety,
environmental and quality requirements including regulations,
policies, applicable guidelines and procedures.
* Take ownership of planning, executing and reporting for all life
cycle management projects and technology transfers in support of
process improvement and new product introductions.
* Lead the development of knowledge of new pharmaceutical
manufacturing processes as required in line with Jazz business
objectives
* In conjunction with Quality Operations ensure that CMOs are
qualified and approved
* Ensure Drug Substance, Drug Product, label & packaging and primary
product contact materials are manufactured on time to the required
quality
* Collaborates with Development Team Leads to map the transition of
responsibility for manufacturing from the development team to External
Manufacturing Product Team as planning for Phase III supplies begins
* Lead the Product team to identify and drive manufacturing process
improvements and change management within CMOs
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
* Wide-ranging experience in pharmaceutical manufacturing with a
strong background in large and/or small molecule manufacturing
technologies.
* Excellent organizational, verbal, communication and presentation
skills
* Ability to effectively lead and participate on multi-disciplinary
teams
* Strong understanding of project management processes, risk
management processes, pharmaceutical quality management systems and
pharmaceutical regulations
EDUCATION, EXPERIENCE AND LICENSES
* BSc in life sciences or engineering
* Advanced degree (MSc, PhD) desirable
* Experience working in cross functional teams in a pharmaceutical
industry environment
* Strong record of achievement in pharmaceutical manufacturing
environment
* Proven hands-on experience in GMP manufacturing and validation
activities
* Experience of both small and/or large molecule technologies, with
demonstrated technical expertise in process development and new
product introduction
* Demonstrated track record of training and coaching colleagues to
improve overall team process knowledge
* Proven project management skills for technical programs ideally
complemented with Project Management qualification
* Experience in defending processes, procedures and investigations
during FDA/EMA inspections is desirable.
DESCRIPTION OF PHYSICAL DEMANDS
* Responsibilities may require working outside of normal hours, in
order to meet business demands.
Jazz Pharmaceuticals is an Equal Opportunity Employer. Position: Associate Director, Manufacturing Sciences (PDMS)
Overview:
Jazz Pharmaceuticals is an international biopharmaceutical company
focused on improving patients lives by identifying, developing and
commercializing meaningful products that address unmet medical needs.
We are continuing to expand our commercial product portfolio and our
research and development pipeline in therapeutic areas that can
leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology
areas in which we have a deep understanding of the patient journey and
a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If
youre looking to be a part of a company with an unwavering commitment
to improving patients lives and being a great place to work, we hope
youll explore our career openings and get to know Jazz
Pharmaceuticals.
Responsibilities:
BRIEF DESCRIPTION:
* Reporting into the Exec Director Manufacturing Sciences within the
Process Development and Manufacturing Sciences (PDMS) group the role
will provide scientific and technical leadership to our external
commercial partners for large and/or small molecule DS/DP
manufacturing.
* This position is responsible for providing strong scientific
leadership for all aspects of technology transfer, process scale-up,
process monitoring, and process troubleshooting to drug substance,
drug product and finished product manufacturing activities for large
and/or small molecules. This responsibility includes all process
validation activities.
* Other responsibilities will include cross-functional team
leadership and / or membership, authoring technical reports and
supporting CMC aspects of regulatory dossiers. The role will involve
significant cross functional collaboration with other functions
including R&D, external manufacturing and Quality, working towards
existing and new product introduction and ensuring all processes are
understood, robust, efficient and in control.
* The role works in close collaboration with the product teams
Project lead who is the primary owner of the team processes, tools,
metrics and all aspects of project management to ensure successful
manufacture and supply of product to Patients.
ESSENTIAL FUNCTIONS
* Demonstrated technical proficiency, scientific creativity,
collaboration with others and independent thought in suggesting
experimental design to support process development/ support objectives
* Lead development, maintenance and continuous improvement of
process validation program for all DS and DP manufacturing processes.
Provide technical input to Process Development for defining the
critical process parameters of new processes
* Experience of CMC regulatory requirements for pharmaceutical
products and the evolving opportunities offered by application of QbD
principles
* Key member of the product External Manufacturing Product Team.
Prioritizes technical or manufacturing issues for discussion &
decision by the team
* Works to the guidelines set out in the Product team charter.
* Lead the technical agenda & relationship between the team and with
the relevant CMOs technical team at the site of manufacture.
* Clearly and effectively communicate ideas and results, written and
verbal, to technical and non-technical audiences.
* Highly flexible, works well in a team environment, and has
necessary skills to organize, mobilize, communicate, influence and
lead.
* Support other Product/Process Development and Manufacturing areas
to ensure a smooth transfer of technologies and products to contract
sites.
* Ensure that all processes are in line with health, safety,
environmental and quality requirements including regulations,
policies, applicable guidelines and procedures.
* Take ownership of planning, executing and reporting for all life
cycle management projects and technology transfers in support of
process improvement and new product introductions.
* Lead the development of knowledge of new pharmaceutical
manufacturing processes as required in line with Jazz business
objectives
* In conjunction with Quality Operations ensure that CMOs are
qualified and approved
* Ensure Drug Substance, Drug Product, label & packaging and primary
product contact materials are manufactured on time to the required
quality
* Collaborates with Development Team Leads to map the transition of
responsibility for manufacturing from the development team to External
Manufacturing Product Team as planning for Phase III supplies begins
* Lead the Product team to identify and drive manufacturing process
improvements and change management within CMOs
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
* Wide-ranging experience in pharmaceutical manufacturing with a
strong background in large and/or small molecule manufacturing
technologies.
* Excellent organizational, verbal, communication and presentation
skills
* Ability to effectively lead and participate on multi-disciplinary
teams
* Strong understanding of project management processes, risk
management processes, pharmaceutical quality management systems and
pharmaceutical regulations
EDUCATION, EXPERIENCE AND LICENSES
* BSc in life sciences or engineering
* Advanced degree (MSc, PhD) desirable
* Experience working in cross functional teams in a pharmaceutical
industry environment
* Strong record of achievement in pharmaceutical manufacturing
environment
* Proven hands-on experience in GMP manufacturing and validation
activities
* Experience of both small and/or large molecule technologies, with
demonstrated technical expertise in process development and new
product introduction
* Demonstrated track record of training and coaching colleagues to
improve overall team process knowledge
* Proven project management skills for technical programs ideally
complemented with Project Management qualification
* Experience in defending processes, procedures and investigations
during FDA/EMA inspections is desirable.
DESCRIPTION OF PHYSICAL DEMANDS
* Responsibilities may require working outside of normal hours, in
order to meet business demands.
Jazz Pharmaceuticals is an Equal Opportunity Employer.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
