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Vice President Process Development

Deliver Biopharmaceutical Drug Substance Process and Analytical Development

The Vice President (VP) of Process Development (PD) will be responsible for overseeing the development and commercialization of biologic drug candidates.  The VP will provide leadership to an organization responsible for Cell Line Development (CLD), Upstream Process Development (UPD), Downstream Process Development (DPD), Analytical Development (AD), and Process Transfer (PT). The area covers both Microbial and Mammalian Cell Culture, early and late stage development. The department is also responsible for process characterization, process validation and continuous validation post licensure.  The VP of PD will be a member of the site senior Leadership Team, responsible for providing leadership and decision making to the Copenhagen site. Additionally, the VP of PD will be part of the Global Operational Team and collaborate extensively with the other PD sites and our US Based R&D Center.
 

Job Responsibilities:

• Mentor and develop staff members within the organization
• Provide leadership and strategic direction to the Process Development organization, an area of 80+ scientists and technicians organized in operational teams with 4 direct reports
• Serve as an active member of the site Leadership Team responsible for development and setting of site strategy and goals
• Oversee development operations working on projects ranging from early phase to commercial stage biologics
• Champion the development and implementation of new technologies, methodologies and systems to drive innovation in biologics development
• Develop strong relationships with AGC customers; support the creation of strategic plans with clients for the development of biologic drug candidates
• Work closely with Business Development in support of recruiting new customers and partners
• Drive development and implementation of new systems to improve project execution and data management
• Support regulatory filings (INDs, BLAs, MAAs, etc.) and associated product related inspections from regulatory agencies (FDA, EMA, etc.)
• Provide technical support to the cGMP manufacturing operation
• Develop and manage department budgets
• Ensure the department is positioned well for future growth VP Process Development
You have experience with biopharmaceutical drug substance development, technology evaluations, strategic planning and people management. You have a relevant academic background within pharmacy, biotechnology, chemical engineering or similar. You must have strong leadership skills and experience in several of the following areas:
 • Ph.D. in Science or Engineering
• Many years of experience in biopharmaceutical development with a strong background in biologics product development
• Several years of experience supporting late stage and commercial products/processes.
• Experience developing, implementing and executing strategic plans and objectives for organizations and departments
• Exceptional customer interface skills are required
• Understanding of current industry trends and regulatory expectations associated with QbD and Process Validation
• Experience supporting regulatory filings (e.g., INDs, BLAs, MAAs, etc.) and supporting product-related inspections for US and foreign regulatory agencies
 

Join an international and agile organization

AGC Biologics is one of the industry leading CMOs in reliability, technical excellence, and quality — Right and On Time.  AGC is a $12B Japanese-owned and publicly traded company based in Tokyo with over 50,000 employees in 30 countries.
With four facilities in the USA, Japan and Europe, AGC Biologics provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production.

AGC Biologics is experiencing growth in customer base and revenue, expanding personnel and manufacturing capacity as well as distinguishing itself in the market with unique technology offerings for clients.
If you have questions regarding this position, please reach out to Senior HR Director, Martin Skyum Funch at +45 4137 7927.

 

AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


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330165766Phoenix-c4a609a612020-01-28T00:00:00Vice President Process Development

Deliver Biopharmaceutical Drug Substance Process and Analytical Development

The Vice President (VP) of Process Development (PD) will be responsible for overseeing the development and commercialization of biologic drug candidates.  The VP will provide leadership to an organization responsible for Cell Line Development (CLD), Upstream Process Development (UPD), Downstream Process Development (DPD), Analytical Development (AD), and Process Transfer (PT). The area covers both Microbial and Mammalian Cell Culture, early and late stage development. The department is also responsible for process characterization, process validation and continuous validation post licensure.  The VP of PD will be a member of the site senior Leadership Team, responsible for providing leadership and decision making to the Copenhagen site. Additionally, the VP of PD will be part of the Global Operational Team and collaborate extensively with the other PD sites and our US Based R&D Center.
 

Job Responsibilities:

• Mentor and develop staff members within the organization
• Provide leadership and strategic direction to the Process Development organization, an area of 80+ scientists and technicians organized in operational teams with 4 direct reports
• Serve as an active member of the site Leadership Team responsible for development and setting of site strategy and goals
• Oversee development operations working on projects ranging from early phase to commercial stage biologics
• Champion the development and implementation of new technologies, methodologies and systems to drive innovation in biologics development
• Develop strong relationships with AGC customers; support the creation of strategic plans with clients for the development of biologic drug candidates
• Work closely with Business Development in support of recruiting new customers and partners
• Drive development and implementation of new systems to improve project execution and data management
• Support regulatory filings (INDs, BLAs, MAAs, etc.) and associated product related inspections from regulatory agencies (FDA, EMA, etc.)
• Provide technical support to the cGMP manufacturing operation
• Develop and manage department budgets
• Ensure the department is positioned well for future growth VP Process Development
You have experience with biopharmaceutical drug substance development, technology evaluations, strategic planning and people management. You have a relevant academic background within pharmacy, biotechnology, chemical engineering or similar. You must have strong leadership skills and experience in several of the following areas:
 • Ph.D. in Science or Engineering
• Many years of experience in biopharmaceutical development with a strong background in biologics product development
• Several years of experience supporting late stage and commercial products/processes.
• Experience developing, implementing and executing strategic plans and objectives for organizations and departments
• Exceptional customer interface skills are required
• Understanding of current industry trends and regulatory expectations associated with QbD and Process Validation
• Experience supporting regulatory filings (e.g., INDs, BLAs, MAAs, etc.) and supporting product-related inspections for US and foreign regulatory agencies
 

Join an international and agile organization

AGC Biologics is one of the industry leading CMOs in reliability, technical excellence, and quality — Right and On Time.  AGC is a $12B Japanese-owned and publicly traded company based in Tokyo with over 50,000 employees in 30 countries.
With four facilities in the USA, Japan and Europe, AGC Biologics provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production.

AGC Biologics is experiencing growth in customer base and revenue, expanding personnel and manufacturing capacity as well as distinguishing itself in the market with unique technology offerings for clients.
If you have questions regarding this position, please reach out to Senior HR Director, Martin Skyum Funch at +45 4137 7927.

 

AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

2020-02-17T20:50:25.687 Deliver Biopharmaceutical Drug Substance Process and Analytical Development The Vice President (VP) of Process Development (PD) will be responsible for overseeing the development and commercialization of biologic drug candidates. The VP will provide leadership to an organization responsible for Cell Line Development (CLD), Upstream Process Development (UPD), Downstream Process Development (DPD), Analytical Development (AD), and Process Transfer (PT). The area covers both Microbial and Mammalian Cell Culture, early and late stage development. The department is also responsible for process characterization, process validation and continuous validation post licensure. The VP of PD will be a member of the site senior Leadership Team, responsible for providing leadership and decision making to the Copenhagen site. Additionally, the VP of PD will be part of the Global Operational Team and collaborate extensively with the other PD sites and our US Based R D Center. Job Responsibilities: • Mentor and develop staff members within the organization • Provide leadership and strategic direction to the Process Development organization, an area of 80 scientists and technicians organized in operational teams with 4 direct reports • Serve as an active member of the site Leadership Team responsible for development and setting of site strategy and goals • Oversee development operations working on projects ranging from early phase to commercial stage biologics • Champion the development and implementation of new technologies, methodologies and systems to drive innovation in biologics development • Develop strong relationships with AGC customers support the creation of strategic plans with clients for the development of biologic drug candidates • Work closely with Business Development in support of recruiting new customers and partners • Drive development and implementation of new systems to improve project execution and data management • Support regulatory filings (INDs, BLAs, MAAs, etc.) and associated product related inspections from regulatory agencies (FDA, EMA, etc.) • Provide technical support to the cGMP manufacturing operation • Develop and manage department budgets • Ensure the department is positioned well for future growth VP Process Development You have experience with biopharmaceutical drug substance development, technology evaluations, strategic planning and people management. You have a relevant academic background within pharmacy, biotechnology, chemical engineering or similar. You must have strong leadership skills and experience in several of the following areas: • Ph.D. in Science or Engineering • Many years of experience in biopharmaceutical development with a strong background in biologics product development • Several years of experience supporting late stage and commercial products processes. • Experience developing, implementing and executing strategic plans and objectives for organizations and departments • Exceptional customer interface skills are required • Understanding of current industry trends and regulatory expectations associated with QbD and Process Validation • Experience supporting regulatory filings (e.g., INDs, BLAs, MAAs, etc.) and supporting product-related inspections for US and foreign regulatory agencies Join an international and agile organization AGC Biologics is one of the industry leading CMOs in reliability, technical excellence, and quality — Right and On Time. AGC is a $12B Japanese-owned and publicly traded company based in Tokyo with over 50,000 employees in 30 countries. With four facilities in the USA, Japan and Europe, AGC Biologics provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production. AGC Biologics is experiencing growth in customer base and revenue, expanding personnel and manufacturing capacity as well as distinguishing itself in the market with unique technology offerings for clients. If you have questions regarding this position, please reach out to Senior HR Director, Martin Skyum Funch at 45 4137 7927. AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company s team and approach are tailored to each of its client s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics innovative approach to cell line and process development. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.11Jobnetc4a609a6100000000000IDK_OFIR_02DKDanmark228DKK2020-02-29T00:00:000000https://www.epos.dk/Rek/AGCBio/Joblist/ShowJobOffer.aspx?dbalias=EposREC_AGCBio&lang=en&jobOfferEntityId=1360&joblistId=10EuropaDanmarkSjælland & øerStorkøbenhavnGladsaxe3699586AGC Biologics A/S11Vandtårnsvej 83B2860SøborgDKDanmark0
DKDanmarkDKDanmark
8Fuldtid46Permanent10000891005JobNet5105132510513210024-01-2020000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=c4a609a6https://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=c4a609a6https://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=c4a609a6&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=c4a609a6&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/Ledelse_og_HR/Ledelse/5.jpgVice President Process Development12008001Dansk3Læse/ tale122919Vice President6Ledelse364026159Martinnoreply@ofir.comDKDanmarkDKDanmarkda-DK