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Associate Director/ Head of Analytical TT Strategy Recombinant (m/f/x)

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CSL

9d ago

  • Job
    Full-time
    Expert Level
  • Science
    Research & Development
  • Melbourne

AI generated summary

  • You need a postgraduate degree in Chemistry/Biological Science, 10+ years in Analytical Development, experience in protein therapeutics, and knowledge of GMP regulations for clinical programs.
  • You will manage strategic contracts for analytical services, oversee BPD projects, lead tech transfers, ensure stakeholder compliance, support due diligence, and identify cost-saving opportunities.

Requirements

  • Post graduate qualification in a relevant branch of Chemistry or Biological Science
  • At least 10 years hands-on experience in Analytical Development and related process development activities.
  • Understanding of and experience in the production and technology transfer of protein therapeutics including, chromatographic separation/fractionation of proteins and other methods of protein purification, formulation activities and associated analytics (in-process, characterization and GMP release methods), from bench-scale to clinical manufacturing scale
  • Understanding of the regulatory requirements and compliance standards (FDA, EMA, JP, TGA) associated with GMP production of proteins for clinical development programs, process validation & characterisation required for BLA applications.

Responsibilities

  • Key point of contact and Management of strategic partners for Contract Analytical Services including forecasting, reporting and oversight of budgets.
  • Management of Biopharmaceutical Pharmaceutical Product Development (BPD, Recombinant) Analytical Outsourcing and Tech Transfer Strategy
  • Executing Analytical strategic plans for BPD projects (Recombinants).
  • Leading Tech Transfer of BPD analytical activities projects internally and externally
  • Ensuring project requirements, both internal and external stakeholders are met with respect to quality, cost and timelines.
  • Participate in due diligence activities for New Product Opportunities
  • Utilise insights from the product development pathway and global biopharmaceutical trends to guide R&D policy, support preparation of regulator packages and identify new opportunities for cost savings and process efficiencies.

FAQs

What is the job title for this position?

The job title is Associate Director/ Head of Analytical TT Strategy Recombinant (m/f/x).

What division is this position part of?

This position is part of the Biopharmaceutical Product Development (BPD) division.

Where will this role be primarily based?

The role will primarily support the Marburg and Melbourne BPD Recombinant early and late clinical phase portfolio.

What experience is required for this position?

A minimum of 10 years of hands-on experience in Analytical Development and related process development activities is required.

What qualifications are necessary to apply for this position?

A post-graduate qualification in a relevant branch of Chemistry or Biological Science is necessary.

What are the key responsibilities of the Head of Analytical TT Strategy?

Key responsibilities include managing strategic partners for Contract Analytical Services, overseeing Analytical Outsourcing and Tech Transfer Strategy, executing analytical strategic plans, and ensuring project requirements are met in terms of quality, cost, and timelines.

What kind of knowledge should candidates have regarding regulatory requirements?

Candidates should have an understanding of regulatory requirements and compliance standards (FDA, EMA, JP, TGA) associated with GMP production of proteins for clinical development programs.

What benefits are offered to employees in this position?

Benefits include excellent income potential, extended benefits, up to two additional leave days for personal wellbeing, family services, and hybrid working models.

Is there support for employees' personal well-being?

Yes, we offer services such as psychological support, legal advice, and family care services.

How can candidates apply for this position?

Candidates should apply online with a cover letter, CV, certifications, and salary expectation.

What is the mission of CSL Behring?

CSL Behring is dedicated to developing and delivering high-quality medicines for people with rare and serious diseases, impacting lives in more than 100 countries.

How does CSL Behring view diversity and inclusion?

CSL Behring embraces diversity and inclusion and aims to reflect the world around us within the organization.

Science & Healthcare
Industry
10,001+
Employees
1916
Founded Year

Mission & Purpose

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.