at Baxter Healthcare Corporation in Deerfield, Illinois, United States
Job Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.
Your Role at Baxter
This is where your work saves lives
Baxter's Pharmaceutical Segment is seeking an experienced senior toxicologist to support Baxter's Pharmaceuticals pipeline and portfolio. This individual will be required to have an in-depth knowledge of preclinical safety regulatory requirements as they relate to pharmaceutical product submissions to both domestic and international markets (i.e. FDA and ICH guidelines). This includes authorship of toxicological risk assessments as they relate to safety evaluation of leachables, impurities, and residual solvents. This role will also support initiation and monitoring of GLP impurity qualification and preclinical safety studies conducted at external contract research labs. This is an opportunity to become part of a highly matrixed multidisciplinary team that is responsible for ensuring the safety of both drugs and drug- device combinations.
What you'll be doing
This individual will be responsible for the following:
Author toxicological risk assessments of both API and drug formulation impurities/degradants as well as evaluation of container closure system extractables and leachables.
Support development of responses to address regulatory deficiencies, information requests, and complete response letters.
Author and review preclinical regulatory submission content, including CTDs and nonclinical overviews.
Aid in study design and monitor GLP safety studies for pharmaceutical impurity qualification, local tolerance assessment, and blood compatibility.
Provide support to manufacturing in change control initiatives and safety evaluation for field actions and batch dispositions as required.
In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance (ICH Q3A/B, Q3C, Q3D and M7), provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
Independently plan, implement and manage projects/programs that both span multiple subject areas and apply established methods, techniques or approaches.
Shares research outcomes, methodology and cycle-time reduction methods with team members and other divisional personnel.
What you'll bring
Degree in toxicology, or other related scientific field, with the following minimum previous experience working in the pharmaceutical industry in GLP/GMP environments:
MS degree and +15 years of experience or PhD with +10 years of experience
Must possess a working knowledge of toxicology and preclinical regulatory requirements as they relate to the development and registration of pharmaceuticals and/or an eagerness to learn and develop scientific competence beyond their current skills.
Ability to use in silico tools to support safety assessments.
Demonstrated technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions.
The individual must have demonstrated critical thinking skills and ability to adapt and learn new skills as needed.
Can effectively collaborate as part of a distributed team, including ability to work with individuals of diverse scientific and cultural backgrounds across multiple business units as well as with external partners/CROs.
Demonstrates flexibility and the ability to manage and coordinate multiple projects comfortably.
Demonstrated experience with GLP preclinical safety study execution and oversight is highly desired.
Toxicology Board Certification is desired (DABT or ERT)
Experience with safety and biocompatibility evaluation of medical devices and related regulatory guidance (USP, ISO 10993, EU MDR, etc) is... For full info follow application link.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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