Associate Director, Analytical Strategy
About this opportunity
CSL’s world-class R&D organisation continues to evolve as a biotechnology leader by advancing high-quality science and technology across five therapeutic areas being Immunoglobulins, Haematology, Cardiovascular & Renal, Transplant & Immunology and Vaccines that will make a meaningful difference to the lives of patients with rare and serious diseases.
CSL is now seeking two Associate Director level scientists to design and oversee analytical strategies that support product development and lifecycle management (LCM).
The Associate Director Analytical Strategy ensures the deployment of robust, compliant, and innovative analytical approaches across pre-clinical and clinical development as well as LCM for commercial products.
These are key senior scientific and strategic leadership roles supporting a diverse portfolio of recombinant protein and gene therapy products from early development, through licensure and ongoing commercial operations.
These positions have global reach and could be based at either of our sites in Bern, Marburg, King of Prussia, Waltham or Melbourne.
Key Responsibilities
Specific responsibilities for both these roles will include:
Developing global analytical strategies for assigned products aligned with program and corporate goals
Provide scientific and regulatory guidance for analytical plans across all product development and LCM phasesDrive innovation in analytical technologies, platforms, and workflows
Reviewing analytical study designs, reports, and regulatory documentation.
Oversee development, validation, characterisation and implementation of analytical methods.
Ensure high-quality data generation for product development and LCM programs.
Troubleshoot complex scientific and technical challenges.
Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, GMP) and interface with regulatory agencies, responding to health authority queries.
Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA)
Maintaining inspection readiness and quality standards.
Partnering with internal stakeholders across Manufacturing, Quality Control, Quality Assurance, Research and external partners such as CROs/CDMOs, academic collaborators and technology vendors.
Your Profile
PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience)
Typically, 8+ years in bioanalysis within biotech, pharma, or CRO/CDMO environments
Deep expertise in analytical development, product specification testing, characterisation, and data analysis.
Demonstrated knowledge of regulatory requirements and analytical validation standards.
Proven leadership and strategic program experience ideally in a global matrix environment.
Experience supporting regulatory submissions and health authority interactions.
Excellent communication skills including presenting complex information to non-scientific stakeholders.
Experience with gene therapy products desirable, but not essential
If you want to join a team that is working every day knowing that people’s lives depend on it, then apply now.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our 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 .
Job details
How this role compares
Computed from every other active BD&L & Strategic Planning role in our database, not just this employer's listings.
We currently track 129 comparable Associate Director BD&L & Strategic Planning roles across 41 biopharma companies.
Salary context
45 of 129 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 129 comparable roles
+ 19 more countries
Seniority mix
129 of 129 peers have a known seniority level
Therapeutic area mix
16 of 129 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.