Director, Primary Packaging
CSL Behring
Waltham, MA
The Opportunity:
This role is a leadership position in the Drug Delivery Systems and Packaging (DDSP) department within CSL TechOps.
The ideal candidate has a solid track record in pharmaceutical primary packaging development with hands-on experience in technical review and trade-off discussions.
You are passionate in both making the right product that meets the needs of the patients as well as making the product right with the needed technical rigor ensuring high quality products.
The ideal candidate will be instrumental in primary packaging development through delivery by establishing and evolving best-in-class practices and procedures.
You will contribute to in-depth technical discussions as well as effectively communicate technical dilemmas to senior leadership.
The Role:
Set and drive best practices within DDSP for primary packaging development.
Collaborate with key stakeholders in CSL to evaluate new device technologies to meet pipeline needs.
Lead primary packaging engineers and scientists to effectively handle commercial biological/drug-device combination product development.
Guide integration of primary packaging system development with CMC, device development, and Verification and Testing workstreams to influence and enable CSL clinical asset development strategy.
Ensure container closure system control strategy and test methods are appropriately developed and qualified to inform design decision-making and enable control of device/containers/packaging performance.
Provide input on behalf of DDSP on aseptic filling processes and controls to CMC as well as external CMOs.
Create and maintain standard operating procedures, work instructions, and templates for DDSP to use in the development of primary packaging.
Work closely with Business Units, Affiliates, and Manufacturing to ensure the appropriate qualification of primary packaging and the successful tech transfer to manufacturing sites to enable commercial strategies.
Provide in-depth technical advice and guidance beyond DDSP department. Work with CMC, Operations, and QC lab organizations to assess projects for design and process risks and use resources to mitigate those risks before they affect the project delivery timeline.
Identify and develop talent to meet DDSP business requirements. Plus develop robust succession plans that provide career opportunities for individuals while supporting business resiliency.
Provide Primary Packaging budget input for projects.
Author and or review technical documents for regulatory submissions and responses to regulatory agency questions on combination products.
Ensure that material science translates into flawless industrial performance by providing mathematical rigor and statistics to move beyond “trial and error” utilizing six sigma principles.
Skills & Experience:
10+ years of experience in pharmaceutical primary packaging development with hands-on experience in technical review and trade-off discussions.
Extensive experience within pharmaceutical production, especially aseptic filling and visual inspection.
Deep knowledge of material properties (e.g., rigid plastics, glass, films), sterilization/ filling methods, and simulation software.
Proven ability to develop strategies and lead improvement projects.
Excellent communication skills and a track record working in a matrix environment; Influencing/building/promoting a culture of continuous improvement.
Strong leadership through a partnership and engagement approach with manufacturing for advancing quality outcomes and operational excellence.
Previous experience with health authority interactions
Intellectual property development experience
Certified six sigma black belt.
Ability to travel internationally for primary packaging design and development projects up to 20%.
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.