CSL Behring Senior Toxicologist in King of Prussia, Pennsylvania
Senior ToxicologistUnited States of AmericaR-1027002012 CSL Behring L.L.C.
With operations in 35+ nations and 22,000 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 protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
As Senior toxicologist, this role is responsible for developing the toxicology strategy of assigned programs. The incumbent will be responsible for the design, adequate budgeting and monitoring of non-clinical safety studies conducted internally and externally both in a GLP and non-GLP environment.
Main Responsibilities and Accountabilities
Develop toxicology strategies and provide toxicological expert support to research and development projects.
Serve as function’s representative across activities in the area protein drug and gene therapy development.
Manage and coordinate internal and external toxicology studies as part of global teams.
Support the preparation of national and international regulatory submissions.
Take responsibility as preclinical project lead for selected research or development projects.
Oversee and manage toxicology programs along clinical development up to marketing.
Plan, monitor, analyze and report preclinical pharmacology and toxicology studies conducted internally or in collaboration with external contract research organizations (CROs) for selected projects.
Manage and prepare toxicological risk assessments to support drug development and manufacturing.
Actively collaborate with global, cross-continental project teams.
Prepare and review non-clinical documents as part of regulatory submissions and interactions.
Support the preclinical evaluation of external assets and in-licensing opportunities
Oversee a global team of functional experts and assigned budget
Support improvement initiatives to enhance efficiency and quality of the group's deliverables.
Maintain a high level of awareness of scientific developments and the competitive environment to assist on ongoing strategic re-evaluation of ongoing programs.
Actively establish and foster a high quality, global network with relevant experts internally and externally
Qualifications / experience
Advanced degree (PhD, PharmD, MS) in Life Sciences or closely related fields
Toxicology training, board certification preferred.
5+ years of experience as non-clinical toxicologist in a biotechnology, pharmaceutical or CRO setting.
Relevant experience in protein drug development.
Additional experience in development of gene therapies, RNA based therapies and/or small molecules of advantage
In depth knowledge of relevant regulatory guidelines.
Strong scientific background in at least one of the following therapeutic areas: hematology, immunology, transplantation, cardiovascular disease, pulmonology.
Good understanding of drug development process, strong knowledge of ICH/GLP
Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
Experience in working in cross-functional, multicultural and international teams.
Excellent communication and analytical skills. Experience in medical/regulatory writing preferable.
State/Province : Pennsylvania
City : King of Prussia
Street Address : 1020 First Avenue
Primary Location : CSL Behring King of Prussia
Full Time/Part Time : Full Time
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 click below.
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement