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DIRECTOR, BIOTHERAPEUTICS R&D
Descrizione dell'offerta di lavoro
Johnson & Johnson Innovative Medicine Research & Development (J&J IM R&D) is recruiting for a Director, Biotherapeutics R&D, Analytical Development, located in Cork.
Within JJ&J IM R&D, the Biotherapeutics R&D organization is accountable for the development, clinical supply, marketed product support and technical LCM of biological pharmaceutical products.
Analytical Development Cork is in charge of the Clinical Stability Program Management, Clinical Release and Stability analysis of drug substance and drug product for Large Molecules and local site investigational support.
The Analytical Development Director in Cork will lead a team of approximately 75 J&J employees and 80 contractors, maintaining oversight of internal flex resources and of the outsourced activities.
The function has a global reporting line.
Key Responsibilities.
Lead the AD Cork department in support of the entire development portfolio.
Prioritize, innovate, and handle knowledge to deliver outstanding operational performance as well as scientific excellence, in line with the vision and strategy of the global Analytical Development organization.
Develop and implement the strategy for running development stability programs, data analysis & trending.
Lead Clinical Release and Stability activities performed at AD Cork and at our development partners.
Provide regulatory support for IND and BLA submissions.
Ensure continuous improvement using Process Excellence and Lean methodologies.
Ensure cGMP compliance of the department.
Champions innovation.
Exhibits integrity and trust.
Values diversity, equity and inclusion, Handle the departmental operational and portfolio budget.
Responsible for hiring and developing the required talent.
Qualifications Qualifications Education.
Ph.
.
or Master Degree in Biochemistry, Biotechnology, or Analytical Sciences or related subject area with 8 years of confirmed experience in biopharmaceutical development or related field.
Experience and Skills.
Required.
Confirmed experience within the pharmaceutical industry in Large Molecule Analytical Development.
Consistent track record in leading a scientific team(s) and direct and/or indirect people management experience is required.
Ability to lead and operate in a global dynamic environment.
Strong scientific knowledge in separation and bioassay methods, experience in conducting stability studies, good understanding of Regulatory requirements, and experience in Quality Systems.
Proactive approach to understand and translate customer needs.
Experience with regulatory submission writing and review (ie.
INDs, BLAs, etc) is required.
Takes accountability and ownership.
Other.
Travel.
up to 20% Strong task prioritization, organization, problem solving skills, and attention to details Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
Within JJ&J IM R&D, the Biotherapeutics R&D organization is accountable for the development, clinical supply, marketed product support and technical LCM of biological pharmaceutical products.
Analytical Development Cork is in charge of the Clinical Stability Program Management, Clinical Release and Stability analysis of drug substance and drug product for Large Molecules and local site investigational support.
The Analytical Development Director in Cork will lead a team of approximately 75 J&J employees and 80 contractors, maintaining oversight of internal flex resources and of the outsourced activities.
The function has a global reporting line.
Key Responsibilities.
Lead the AD Cork department in support of the entire development portfolio.
Prioritize, innovate, and handle knowledge to deliver outstanding operational performance as well as scientific excellence, in line with the vision and strategy of the global Analytical Development organization.
Develop and implement the strategy for running development stability programs, data analysis & trending.
Lead Clinical Release and Stability activities performed at AD Cork and at our development partners.
Provide regulatory support for IND and BLA submissions.
Ensure continuous improvement using Process Excellence and Lean methodologies.
Ensure cGMP compliance of the department.
Champions innovation.
Exhibits integrity and trust.
Values diversity, equity and inclusion, Handle the departmental operational and portfolio budget.
Responsible for hiring and developing the required talent.
Qualifications Qualifications Education.
Ph.
.
or Master Degree in Biochemistry, Biotechnology, or Analytical Sciences or related subject area with 8 years of confirmed experience in biopharmaceutical development or related field.
Experience and Skills.
Required.
Confirmed experience within the pharmaceutical industry in Large Molecule Analytical Development.
Consistent track record in leading a scientific team(s) and direct and/or indirect people management experience is required.
Ability to lead and operate in a global dynamic environment.
Strong scientific knowledge in separation and bioassay methods, experience in conducting stability studies, good understanding of Regulatory requirements, and experience in Quality Systems.
Proactive approach to understand and translate customer needs.
Experience with regulatory submission writing and review (ie.
INDs, BLAs, etc) is required.
Takes accountability and ownership.
Other.
Travel.
up to 20% Strong task prioritization, organization, problem solving skills, and attention to details Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
Vedere l'offerta completa
Dettagli dell'offerta
Azienda
- Imprecisato
Località
- Tutta l'Italia
Indirizzo
- Imprecisato - Imprecisato
Data di pubblicazione
- 11/04/2024
Data di scadenza
- 10/07/2024
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