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Technical Project Manager
Eingestellt von Computer Futures - London & S.E(Permanent and Contract)
Gesuchte Skills: Support, Client
Projektbeschreibung
I am looking for a Technical Project Manager for my pharmaceutical client based in Schaffhausen, Switzerland.
Job details are listed below:
POSITION SUMMARY:
The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place. Areas of key responsibility include DP Packaging technical support and oversight for the supply chain, planning and execution of DP manufacturing site level support of new product launch. The TLI is a member of manufacturing site operational teams, CMC DPD Subteam, and JSC New Product Team and leads the new production introduction team at the DP manufacturing site.
PRINCIPAL RESPONSIBILITIES:
Technical, manufacturing and packaging integration of new and re-developed drug products from PDMS into the supply chain (large and small molecule). Single point of contact for JSC plant readiness and execution from technical transfer into commercial production including launch support. Leading the DP packaging site team and pkg site representative on the CMC DPD Subteam and the New Product Team. Identifying and implementing opportunities for active decrease in DP COGs and partnering with PDMS and JSC groups to develop and implement strategies to improve the fit for plant and commercialization of new products into the supply chain. Developing the packaging site execution plan per product, in line with the overall strategy and plan as outlined by the CMC DPD Subteam and JSC New Product Team. The integrator will ensure alignment and endorsement of this strategy within the manufacturing site and TLI function. Providing required packaging technical support, document technical input, review and approval and serving as the JSC technical expert. Delivering clinical through commercial DP supply from the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met specifically for pkg processess. Optimizing the new product introduction process, making use of JSC technology platforms, accelerating development timelines, streamlining the technical transfer process. Serving as the Supply Chain technical representative on the CMC DP Subteam, site representative on the NPT, and leader of the product specific site team.
KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:COMPETENCY (KNOWLEDGE, SKILLS, ABILITIES AND EXPERIENCE REQUIRED):
* Knowledge of both pharmaceutical product R&D and Technical Operations functions and experience with both small and large molecules.
* Planning and logistics skills capable of effective integration of DP deliverables and support detailed execution at the manufacturing site level.
* Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations specially packaging.
* Knowledge of manufacturing site systems and procedures
* Demonstrated leadership in providing integration of activities and information across multifunctional groups and Matrix teams.
* Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various Matrix teams.
* Ability to influence peers, superiors, and partners.
* Motivated, self-starter able to work independently with demonstrated problem solving skills.
DEGREE: Minimum requirements: BS/BA with 3 years' experience, M.S. with 2 years' experience in pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.
LANGUAGES: Fluent in written and spoken English and German
SPECIFIC SYSTEMS: Document mgmt. systems suchs as DocSpace, Pharmadoc SAP, MS Office applications TrackWise Clarity Minitab or similar statistical software
PHYSICAL REQUIREMENTS/WORKING CONDITIONS: Travel: Min 5% - project dependent
If you feel that this position is for you, please respond with a copy of your CV.
STHREE ARE COMMITTED TO ENSURING EQUAL OPPORTUNITIES, FAIRNESS OF TREATMENT, DIGNITY, WORK-LIFE BALANCE AND THE ELIMINATION OF ALL FORMS OF DISCRIMINATION IN THE WORKPLACE FOR ALL STAFF AND JOB APPLICANTS. WE WELCOME APPLICATIONS FROM ALL SUITABLY QUALIFIED PERSONS, REGARDLESS OF THEIR RACE, SEX, DISABILITY, RELIGION/BELIEF, SEXUAL ORIENTATION OR AGE.
Job details are listed below:
POSITION SUMMARY:
The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place. Areas of key responsibility include DP Packaging technical support and oversight for the supply chain, planning and execution of DP manufacturing site level support of new product launch. The TLI is a member of manufacturing site operational teams, CMC DPD Subteam, and JSC New Product Team and leads the new production introduction team at the DP manufacturing site.
PRINCIPAL RESPONSIBILITIES:
Technical, manufacturing and packaging integration of new and re-developed drug products from PDMS into the supply chain (large and small molecule). Single point of contact for JSC plant readiness and execution from technical transfer into commercial production including launch support. Leading the DP packaging site team and pkg site representative on the CMC DPD Subteam and the New Product Team. Identifying and implementing opportunities for active decrease in DP COGs and partnering with PDMS and JSC groups to develop and implement strategies to improve the fit for plant and commercialization of new products into the supply chain. Developing the packaging site execution plan per product, in line with the overall strategy and plan as outlined by the CMC DPD Subteam and JSC New Product Team. The integrator will ensure alignment and endorsement of this strategy within the manufacturing site and TLI function. Providing required packaging technical support, document technical input, review and approval and serving as the JSC technical expert. Delivering clinical through commercial DP supply from the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met specifically for pkg processess. Optimizing the new product introduction process, making use of JSC technology platforms, accelerating development timelines, streamlining the technical transfer process. Serving as the Supply Chain technical representative on the CMC DP Subteam, site representative on the NPT, and leader of the product specific site team.
KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:COMPETENCY (KNOWLEDGE, SKILLS, ABILITIES AND EXPERIENCE REQUIRED):
* Knowledge of both pharmaceutical product R&D and Technical Operations functions and experience with both small and large molecules.
* Planning and logistics skills capable of effective integration of DP deliverables and support detailed execution at the manufacturing site level.
* Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations specially packaging.
* Knowledge of manufacturing site systems and procedures
* Demonstrated leadership in providing integration of activities and information across multifunctional groups and Matrix teams.
* Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various Matrix teams.
* Ability to influence peers, superiors, and partners.
* Motivated, self-starter able to work independently with demonstrated problem solving skills.
DEGREE: Minimum requirements: BS/BA with 3 years' experience, M.S. with 2 years' experience in pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.
LANGUAGES: Fluent in written and spoken English and German
SPECIFIC SYSTEMS: Document mgmt. systems suchs as DocSpace, Pharmadoc SAP, MS Office applications TrackWise Clarity Minitab or similar statistical software
PHYSICAL REQUIREMENTS/WORKING CONDITIONS: Travel: Min 5% - project dependent
If you feel that this position is for you, please respond with a copy of your CV.
STHREE ARE COMMITTED TO ENSURING EQUAL OPPORTUNITIES, FAIRNESS OF TREATMENT, DIGNITY, WORK-LIFE BALANCE AND THE ELIMINATION OF ALL FORMS OF DISCRIMINATION IN THE WORKPLACE FOR ALL STAFF AND JOB APPLICANTS. WE WELCOME APPLICATIONS FROM ALL SUITABLY QUALIFIED PERSONS, REGARDLESS OF THEIR RACE, SEX, DISABILITY, RELIGION/BELIEF, SEXUAL ORIENTATION OR AGE.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges