Director External Partnerships & Technology Transfer at CSL USA

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

24 Aug, 26

Salary

0.0

Posted On

26 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CDMO Partnering, Technology Transfer, Manufacturing Science & Technology, Gene Therapy, Recombinant Protein Production, Strategic Partnering, Alliance Management, Stakeholder Management, AAV Vector Development, Monoclonal Antibody Manufacturing, CMC Science, Vendor Selection, Technical Dossier Writing, Process Development, Method Transfer, Conflict Management

Industry

Biotechnology Research

Description

Director of External Partnerships & Technology Transfer Position Description Summary The Director of External Partnerships & Technology Transfer is responsible for establishing and maintaining effective external relationships for the manufacture of gene therapy and recombinant products. The incumbent will work with key CSL functions in selection of external partners that support gene therapy and recombinant team goals to accelerate development and commercialization of products within the assigned portfolio. Key accountabilities include vendor selection, technology transfer, technical dossier writing and ongoing technical support for routine operations at contract development & manufacturing organizations (CDMOs). Main Responsibilities & Accountabilities Identifies external partnering needs for the gene therapy and recombinant portfolio, supports Network Strategy make vs buy decisions, associated due diligence activities and vendor selection Supports drafting of agreements with external partners e.g. technical service agreements (TSA) product agreements, statements of work (SOW) and direct supply & commercialisation agreements (DCSA) Responsible for process and analytical technology transfer oversight between sending and receiving units through to registration Provides technical SMEs, including person-in-plant (PIP), for process/analytical development, manufacturing and QC testing at CDMOs through technology transfer into and during routine commercial operations Maintains business relationships through development and tech transfer stages transitioning responsibility to CMO Operations post PPQ/registration. Ensures that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained Ensures key process and asset attributes relevant to reducing variability are tracked, increasing performance of the process and visualizing in reporting Evaluates long-term trends, maintains log of loss drivers (e.g. performance, availability and quality losses), identifies improvement levers, and identifies, prioritizes and plans robustness and continuous improvement initiatives Maintains capability in CMC Science that interprets developments in CMC guidance, applies relevant standards to CSL projects and diligence activities, ensuring CSL manufacturing processes meet Health Authority expectations Qualifications and Experience Requirements Education BSc, MSc or PhD in Life Sciences, Biomedical Sciences, Pharmacy, Biotechnology, Process Engineering or related field required. Experience 10–15+ years experience in process development, method transfer, manufacturing science & technology Expertise in adeno-associated viral (AAV) vector gene therapy and recombinant/monoclonal antibody development and manufacturing Strong communication and conflict management skills to influence project professionals and stakeholders, including non‐specialists, at all levels in the organization Demonstrated experience in managing, organizing, developing and deploying best practice frameworks, processes, tools and templates in a technical operations context, in alignment with Enterprise standards Experience working within a global matrix organization Involvement in cross-functional, multicultural and international teams Core Competencies Technical leadership CDMO partnering and technology transfer Manufacturing Science & Technology Gene therapy and recombinant protein production Strategic partnering and external innovation Alliance and stakeholder management Leadership and cross-functional influence 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. 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 click here. CSL Global Privacy Notice for Job Applicants and Candidates

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Responsibilities

Responsible for establishing external partnerships and overseeing technology transfer for the manufacture of gene therapy and recombinant products. This includes vendor selection, drafting technical agreements, and providing technical SME support at CDMOs to accelerate product commercialization.