Senior Scientist, Technical Project Lead

Posted 8 Days Ago
Be an Early Applicant
27 Locations
Remote
Senior level
Biotech
The Role
Lead end-to-end technical projects including technology transfers, lifecycle management, and continuous improvement. Develop and execute project plans, lead cross-functional teams and external CMOs/CDMOs, manage timelines, budgets, risks, KPIs and governance, perform technical due diligence and site assessments, and provide on-site manufacturing support.
Summary Generated by Built In

Key Responsibilities

  • Lead end-to-end technical projects across technology transfers, product lifecycle management, and continuous improvement initiatives for assigned products and external manufacturing partners.
  • Develop and execute robust Project Execution Plans by translating technical implementation strategies into actionable project plans with clear milestones, timelines, resource requirements, and deliverables.
  • Lead cross-functional project teams consisting of technical experts from multiple disciplines and external manufacturing partners to ensure successful project execution.
  • Support project governance by proactively managing timelines, budgets, risks, issues, dependencies, KPIs, and project reporting.
  • Prepare governance documentation, business cases, decision papers, and escalation packages to support timely and effective decision-making.
  • Act as the primary technical interface towards Contract Manufacturing Organizations (CMOs) and external partners throughout project execution.
  • Foster strong collaboration through proactive stakeholder engagement, effective communication, and alignment across internal functions and external partners.
  • Support technical due diligence activities, manufacturing site assessments, and the evaluation of alternative manufacturing and sourcing strategies for APIs, drug products, starting materials, and raw materials.
  • Provide on-site support at manufacturing facilities during key project phases to monitor progress, facilitate implementation, and resolve technical challenges.


Skills & Experience

Minimum Requirements

  • Bachelor's or Master's degree (or equivalent) in Life Sciences, Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related discipline.
  • Demonstrated experience leading technical projects within the pharmaceutical, biotechnology, chemical, or related industry.
  • Experience in leading technology transfers, product/process transfers, lifecycle management, and/or continuous improvement initiatives.
  • Strong project management capabilities with the ability to independently lead complex, cross-functional projects from initiation through completion.
  • Self-driven, proactive, and able to take ownership in a dynamic environment.
  • Excellent collaboration, communication, and stakeholder management skills.
  • Experience working with external manufacturing organizations (CMOs/CDMOs).
  • Willingness to travel internationally as required.

Preferred Requirements

  • Solid understanding of GMP requirements and CMC lifecycle management
  • Technical Background in CMC Development, Technical Transfer, Process Development, Manufacturing Science, or Commercial Manufacturing.
  • Strong analytical thinking, problem-solving, and decision-making capabilities.
  • Demonstrated ability to influence stakeholders and navigate complex matrix organizations.
  • Experience working in an international, multicultural environment.
  • Fluent in English; German is considered an advantage.

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

 

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.


You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

 

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Skills Required

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline
  • Demonstrated experience leading technical projects within pharmaceutical, biotechnology, chemical, or related industry
  • Experience in technology transfers, product/process transfers, lifecycle management, and/or continuous improvement initiatives
  • Strong project management capabilities to independently lead complex cross-functional projects
  • Experience working with external manufacturing organizations (CMOs/CDMOs)
  • Self-driven, proactive, and able to take ownership in a dynamic environment
  • Excellent collaboration, communication, and stakeholder management skills
  • Willingness to travel internationally as required; provide on-site support at manufacturing facilities
  • Solid understanding of GMP requirements and CMC lifecycle management
  • Technical background in CMC Development, Technical Transfer, Process Development, Manufacturing Science, or Commercial Manufacturing
  • Strong analytical thinking, problem-solving, and decision-making capabilities
  • Demonstrated ability to influence stakeholders and navigate complex matrix organizations
  • Experience working in an international, multicultural environment
  • Fluent in English; German is considered an advantage
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The Company
HQ: Melbourne, Victoria
20,401 Employees

What We Do

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra

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