CSL Behring
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives.
Millions of people around the world are living with rare and serious medical conditions.
CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35
nations and 30,000 employees worldwide, CSL is inspired 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, CSL Plasma, CSL Seqirus and CSL Vifor.
CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Are you the next Director Testing & Verification? This position is located in Waltham MA.
It is a hybrid role.
You will report to the Senior Director Global Primary Packaging and Medical Devices.
You will be in a leadership position in the Primary Packaging and Medical Devices (PPMD) department within CSL R&D.
You will play an important role in the medical device and primary packaging development process, as we deliver specialized exploratory testing through design verification results.
The Testing & Verification Team is involved in device development projects from early stage and develop methods that can also support development, verification, through to commercial production Quality Control testing.
ResponsibilitiesMaintain combination product labs in Waltham, MA and Bern, Switzerland.
Plan, budget, procure, install, qualify, and maintain test equipment.
Manage test method development, including test method development, validation, transfer, and life cycle management for vials, transfer devices, e.
g.
, vial-to-vial transfer, syringes, needle-safety devices, autoinjectors, and on-body delivery systems.
Set direction, motivate, and cultivate engagement throughout Testing & Verification Team.
You will ensure that the skills of the team are up to date and aligned with the expectations and requirements of authorities and us.
Build new capabilities and technologies to support R&D pipeline.
Ensure compliance with current and emerging global legislation.
Will require interaction with critical partner groups such as Combination Product Quality, Regulatory Affairs, and diverse, multi-site groups, which may include technology transfer teams, external vendors, and other strategic suppliers.
Develop relationships with manufacturing, process development, Quality Control, and Quality Assurance to enable resolution to technical issues and improve.
Author or review technical documents for inclusion in DHFs and for regulatory submissions.
Support the laboratory operation such as sample inventory, equipment qualification, and maintenance.
QualificationsBachelor's degree in areas such as Engineering, Natural Sciences, Pharmacy, or other relevant area.
10
years of related experience in medical device development and testing within the medical device/pharmaceutical industry.
Expert knowledge of device standards, e.
g.
, ISO, ASTM, ANSI, and USP for testing and verification of primary container and combination products.
Track record working in a matrix environment; Influencing/building/promoting a culture of continuous improvement.
BENEFITSMedical, Dental Vision401KPaid time Off#LI-HybridOur BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
We are committed to the wellbeing of our employees and their loved ones.
CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
Our benefits are designed to support the needs of our employees at every stage of their life.
Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL BehringCSL 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.
We want CSL to reflect the world around usAs a global organization with employees in 35
countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!About the Company:
CSL Behring.
Estimated Salary: $20 to $28 per hour based on qualifications.
Millions of people around the world are living with rare and serious medical conditions.
CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35
nations and 30,000 employees worldwide, CSL is inspired 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, CSL Plasma, CSL Seqirus and CSL Vifor.
CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Are you the next Director Testing & Verification? This position is located in Waltham MA.
It is a hybrid role.
You will report to the Senior Director Global Primary Packaging and Medical Devices.
You will be in a leadership position in the Primary Packaging and Medical Devices (PPMD) department within CSL R&D.
You will play an important role in the medical device and primary packaging development process, as we deliver specialized exploratory testing through design verification results.
The Testing & Verification Team is involved in device development projects from early stage and develop methods that can also support development, verification, through to commercial production Quality Control testing.
ResponsibilitiesMaintain combination product labs in Waltham, MA and Bern, Switzerland.
Plan, budget, procure, install, qualify, and maintain test equipment.
Manage test method development, including test method development, validation, transfer, and life cycle management for vials, transfer devices, e.
g.
, vial-to-vial transfer, syringes, needle-safety devices, autoinjectors, and on-body delivery systems.
Set direction, motivate, and cultivate engagement throughout Testing & Verification Team.
You will ensure that the skills of the team are up to date and aligned with the expectations and requirements of authorities and us.
Build new capabilities and technologies to support R&D pipeline.
Ensure compliance with current and emerging global legislation.
Will require interaction with critical partner groups such as Combination Product Quality, Regulatory Affairs, and diverse, multi-site groups, which may include technology transfer teams, external vendors, and other strategic suppliers.
Develop relationships with manufacturing, process development, Quality Control, and Quality Assurance to enable resolution to technical issues and improve.
Author or review technical documents for inclusion in DHFs and for regulatory submissions.
Support the laboratory operation such as sample inventory, equipment qualification, and maintenance.
QualificationsBachelor's degree in areas such as Engineering, Natural Sciences, Pharmacy, or other relevant area.
10
years of related experience in medical device development and testing within the medical device/pharmaceutical industry.
Expert knowledge of device standards, e.
g.
, ISO, ASTM, ANSI, and USP for testing and verification of primary container and combination products.
Track record working in a matrix environment; Influencing/building/promoting a culture of continuous improvement.
BENEFITSMedical, Dental Vision401KPaid time Off#LI-HybridOur BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
We are committed to the wellbeing of our employees and their loved ones.
CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
Our benefits are designed to support the needs of our employees at every stage of their life.
Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL BehringCSL 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.
We want CSL to reflect the world around usAs a global organization with employees in 35
countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!About the Company:
CSL Behring.
Estimated Salary: $20 to $28 per hour based on qualifications.
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