Overview
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
Responsibilities
Position Summary:
This Principal Toxicologist position is with the B. Braun Pharmaceutical Research & Development department. The incumbent will support a portfolio of drugs, devices, and combination product development and global registration. This individual will apply expertise and in-depth applied knowledge of toxicology, biocompatibility, and related scientific knowledge to find innovative solutions to develop nonclinical regulatory strategies, solve technical challenges and move new product development from the innovation phase to commercial product realization (Para I-IV ANDA, PAS, 505b (1)/(2) NDA categories). The pharmaceutical portfolio includes: Injectable drugs & Premixes, Duplex® systems, parenteral nutrition, and Intravenous (IV) fluid replacement therapies.
The Principal Toxicologist will develop and author responses to regulatory agencies and will work with internal colleagues in nonclinical (toxicological) risk assessment, and work with external partners, scientific societies, and regulators globally. This is an opportunity to become part of a multidisciplinary team responsible for ensuring the safety of both drugs, medical device, and combination products.
Responsibilities: Essential Duties
- Independently authors and conducts qualitative or quantitative toxicological risk assessments to support of biological evaluation of drugs/impurities, medical device, and combination products.
- Independently develops and authors preclinical regulatory submission content for DHF files, US FDA, EU and other national or global submissions.
- Independently develops and authors responses to submission deficiencies/questions (e.g., ANDA, PAS, 505b (1)/(2) NDA categories and /or 510K, PMA, EU MDR).
- Aids in study design and monitoring of GLP safety and biocompatibility for drug impurities and container closure system/medical device, Extractable & Leachable studies for impurities, container material and medical device qualification.
- Provides support to manufacturing in change control initiatives and safety evaluation, as required.
- In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance (e.g., ISO 10993, ICH, OECD, FDA 21 CFR), provides experienced 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 plans, implements and leads projects/programs that both span multiple fields and apply established methods, techniques or approaches.
- Independently reviews literature and identifies relevant information to support product development and registration.
- Shares research outcomes, methodology and cycle-time reduction methods with team members and other divisional personnel.
The job function listed is not exhaustive and shall also include any responsibilities as signed by the supervisor from time to time.
General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself / herself and other person.
Expertise: Knowledge & Skills
- In-depth applied knowledge of USP < 87>, <88>, <1031>, <1663>, <1664>, ISO 10993-1, ISO 10993 -10, ISO 10993-17, ISO 10993-18 required.
- In-depth applied knowledge of ICH safety/quality/multidisciplinary guidelines (e.g. ICH S4, ICH M 3, ICH M7) and quality (e.g. ICH Q3A-Q3E) required.
- Must possess a working knowledge of toxicology and preclinical regulatory requirements as they relate to the development and registration of drugs and medical devices and an eagerness to learn and develop scientific competence beyond their current skills.
- Experience authoring Toxicological Risk Assessments and deriving Tolerable Intake values, permitted daily exposure, Margin of Safety and Analytical Evaluation Thresholds.
- Shown technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions.
- Ability to work independently and prioritize assignments to meet project schedules.
- Knowledge on the methodologies to conduct an in silico E&L/drug impurities toxicological assessment.
- Can effectively collaborate in a global team, including ability to work with individuals of diverse scientific and cultural backgrounds across multiple business units as well as with external partners/CROs.
#MSL
Target Based Range
$126,920 – $158,650
Qualifications
Expertise: Qualifications – Experience/Training/Education/Etc
Required:
- PhD in related science required, or an equivalent combination of Master’s degree and experience.
- 15+ years related experience required
- Applicable industry certification preferred.
Desired:
- N/A
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 40 pounds.
Additional Information
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Strength:
- Moderate work – Exerting up to 40 lbs. of force occasionally, and/or up to a negligible amount of force frequently, and/or a negligible amount of force constantly to move objects.
Lifting, Carrying, Pushing, Pulling and Reaching:
- Occasionally: Reaching upward and downward, Push/pull,
- Frequently: Standing, Sitting, Visual Acuity with or without corrective lenses
- Constantly: N/A
Activities:
- Occasionally: Reaching upward and downward, Push/pull, Walking, Talking
- Frequently: Standing, Sitting, Visual Acuity with or without corrective lenses, Hearing
- Constantly: N/A
Environmental Conditions:
- Occasionally: Work with chemicals in laboratory environment and wear personal protective equipment
- Frequently: N/A
- Constantly: N/A
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Noise Intensity: Moderate
- Occasionally: Production/manufacturing environment
- Frequently: N/A
- Constantly: Lab environment
What We Offer
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Notices
Equal Opportunity Employer Veterans/Disabled