FUJIFILM Biotechnologys - Technical Product Lead (TPL)
FUJIFILM Biotechnologies
Dato: for 1 dag siden
By: Hillerød, Region Hovedstaden
Kontrakttype: Entreprenør
FUJIFILM Biotechnologys: Job Title: Technical Product Lead (TPL)
Dive into an extraordinary role as a Technical Product Lead, where you'll wield your technical expertise to steer commercial programs within FUJIFILM Biotechnologys Denmark. Play a pivotal part in late stage product manufacturing and life-cycle management commercialization.
About The Position
The Technical Product Lead (TPL) holds a prestigious role within FDBD, providing technical oversight and ownership throughout a product's journey into commercialization. As a recognized expert in biopharmaceutical process validation and regulatory requirements, you'll define PPQ strategies, ensure technical readiness, and act as the liaison between our organization, regulatory bodies, and customer CMC teams. Your technical savvy will drive performance and enable the utilization of prior knowledge across portfolios, while your collaboration ensures seamless response to technical queries and audits. Responsibilities include oversight of process performance, supporting regulatory filings, authoring CPV plans, engaging in PAIs and inspections, and maintaining process validation procedures.
Qualifications
Your esteemed qualifications will leverage your capability to command this multifaceted role, ensuring exceptional product development and commercialization:
Required Qualifications
Joining FUJIFILM Biotechnologys Denmark means becoming part of a team where your insights will shape the future. You will thrive in a culture that celebrates innovation, continuous growth, and collaboration, united in our mission to advance biopharmaceutical solutions that impact global health.
Application Instructions
To step into this influential position, please submit your CV detailing your relevant experience and qualifications. Applications should be sent to [Contact Person’s Email] by [Application Deadline]. We anticipate your application and the unique insights you can bring to our team.
FUJIFILM Biotechnologys is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.
Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.
Shape the future with us—your drive meets boundless opportunity here https://fujifilmdiosynth.com/
FUJIFILM Biotechnologys Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, or any other protected class.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Dive into an extraordinary role as a Technical Product Lead, where you'll wield your technical expertise to steer commercial programs within FUJIFILM Biotechnologys Denmark. Play a pivotal part in late stage product manufacturing and life-cycle management commercialization.
About The Position
The Technical Product Lead (TPL) holds a prestigious role within FDBD, providing technical oversight and ownership throughout a product's journey into commercialization. As a recognized expert in biopharmaceutical process validation and regulatory requirements, you'll define PPQ strategies, ensure technical readiness, and act as the liaison between our organization, regulatory bodies, and customer CMC teams. Your technical savvy will drive performance and enable the utilization of prior knowledge across portfolios, while your collaboration ensures seamless response to technical queries and audits. Responsibilities include oversight of process performance, supporting regulatory filings, authoring CPV plans, engaging in PAIs and inspections, and maintaining process validation procedures.
Qualifications
Your esteemed qualifications will leverage your capability to command this multifaceted role, ensuring exceptional product development and commercialization:
Required Qualifications
- Exceptional customer acumen with excellent customer relations skills
- Strong communication and partnering skills across stakeholder matrices
- Solid understanding of large molecule drug substance manufacturing
- Independent working style with expertise in leading cross-functional teams
- Proficiency in providing matrix leadership within an organization
- Strong analytical abilities with adeptness in scientific dataset analysis
- Deep knowledge of cGMP, FDA/EMA regulations, and process validation lifecycle
- MS with 10 years’ experience or BA/BS with 13+ years relevant experience in the Biotech / Biopharma industry
- Experience in innovative biopharm or biotechnology industries
- Ability to navigate complex project environments and drive optimization
- Expertise in digital tools that enhance regulatory processes
Joining FUJIFILM Biotechnologys Denmark means becoming part of a team where your insights will shape the future. You will thrive in a culture that celebrates innovation, continuous growth, and collaboration, united in our mission to advance biopharmaceutical solutions that impact global health.
Application Instructions
To step into this influential position, please submit your CV detailing your relevant experience and qualifications. Applications should be sent to [Contact Person’s Email] by [Application Deadline]. We anticipate your application and the unique insights you can bring to our team.
FUJIFILM Biotechnologys is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.
Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.
Shape the future with us—your drive meets boundless opportunity here https://fujifilmdiosynth.com/
FUJIFILM Biotechnologys Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, or any other protected class.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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