Abbott Exclusively Hiring For the Post of Principal Scientist – NonClinical Safety
With over 14,000 employees For over 100 years, Abbott in India has endeavoured to be closer to our consumers. This is why Abbott invested in manufacturing plants for its biggest businesses—nutritional products and pharmaceuticals. Abbott Nutrition’s first green-field plant in India will be operational later this year. And our pharmaceuticals business fulfills most of its product requirements in India through two local plants—Baddi in Himachal Pradesh and Verna in Goa.
JOB DESCRIPTION :
- Represent nonclinical safety in EPD Development, responsible for scientific content and compliance with relevant guidelines of nonclinical safety contributions to EPD Development projects, regulatory submissions and authority interactions.
CORE JOB RESPONSIBILITIES:
- Provide scientific support to further development of established products in the area of nonclinical safety.
- Represent Preclinical in project teams and workstreams as needed.
- Give scientific advice to project teams, development workstreams, Regulatory function colleagues, and EPD Development management.
- Provide expert statements to authorities on nonclinical aspects of established products.
- Prepare/update nonclinical part of regulatory documents (e.g. dossiers, IBs, SPC) for established products.
- Propose, initiate, monitor and report nonclinical safety studies of established products.
- Participate in scientific peer review of Preclinical team output.
- Risk assessments regarding impurities and extraneous matters in established pharmaceuticals as well as products from other Abbott divisions
- Represent nonclinical safety and provide scientific advice and support to Pharmacovigilance, SMA, DPD and Regulatory Affairs
- Coach and supervise other scientists in the Nonclinical Safety group of EPD Preclinical, initiate and steer regular team meetings, ensure scientific peer review of team output.
POSITION ACCOUNTABILITY / SCOPE:
- Reports to Director Preclinical Development
- Represents Abbott/EPD in interactions with regulatory authorities
- Represents EPD Preclinical in interactions with many functions in EPD
- Ensures adequate and timely preclinical support for all EPD established products
- High responsibility for patient and employee safety
- Major impact on “recall” decisions of already delivered batches in case of impurities/extraneous matter.
MINIMUM EXPERIENCE / REQUIREMENTS
- Broad expertise and >5 years experience in preclinical R&D, experience in interactions with regulatory authorities, high level of ethical autonomy, proven ability to supervise/coach teams of scientists
- Ph.D. (or equivalent) in a relevant area of Life Sciences and proven scientific expertise in all areas of nonclinical safety.