Manager, Cell Manufacturing Process Development

With operations in 35 nations and 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus.

CSL Behring is a global leader in the biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

The Manager, Process Development, is responsible for developing Gene Therapy treatments for rare diseases as part of Biopharmaceutical Product Development at CSL. This position will report to the Director of Cell Manufacturing and will lead a team of scientists in designing and optimizing clinical-scale manufacturing processes for CSL’s ex-vivo hematopoietic stem cell (HSC) gene therapy pipeline. This position is a key role within CSL’s  global gene therapy network and will work closely with Manufacturing, Quality Assurance, CMC, Clinical, BioAnalytics, Vector Development and Tech transfer to establish cell manufacturing processes for all stages of clinical development. The successful applicant will be a highly motivated, innovative, organized individual with expert knowledge of clinical manufacturing of cell therapies to cGMP standards.

This is a unique opportunity to contribute to the development of highly innovative, next generation therapeutics with the potential to positively impact the lives of patients with serious diseases.

Responsibilities:

• Leads process design, development and optimization for cGMP compliant manufacture of autologous cellular products
• Manages Process Development team, including project planning to timelines, deliverables and budget, resource management and training, maintaining safe laboratory environment and work practices.
• Establishes relationships with internal and external stakeholders including Manufacturing, BioAnalytics, Quality, Facilities, Tech Transfer, CMC, external suppliers and service vendors
• Identifies new opportunities for innovation and lead external collaborations and technology evaluation
• Authors and reviews manufacturing SOPs, forms and batch records.
• Supports technical transfer of manufacturing processes from PD environment to GMP 
• Critically analyzes experimental results. Prepares written reports and presents data at internal and external meetings.
• Liaises with QA to establish and implement quality systems in cellular manufacturing and process development ensuring stage-appropriate GSP/GMP compliance.

Qualifications:
• Postgraduate degree (MSc or PhD) in molecular biology, microbiology, immunology, genetics,  biochemistry, or related field.
• Minimum of 5 years' relevant industry experience and / or equivalent experience in a relevant academic environment.
• Extensive experience in manufacturing of primary human cells and process development for clinical trials.

• Strong knowledge of GMP regulations and best practices for cGMP manufacturing of Gene Therapy products

• Excellent problem solving & critical thinking skills

• Excellent organizational and planning skills

• Experience managing a team of scientists
• Excellent communication skills

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.