Drug Dev and Preclinical Studies
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
PURPOSE AND SCOPE OF POSITION:
The Principal Scientist is responsible for the development and validation of analytical methodology for the characterization of our products and processes, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development.Support for drug candidates across all stages of development and, as needed, within our commercial product portfolio will be required.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug product development
- Mastery of chemistry with extensive expertise in measurement science.
- Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables).
- Knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR.
- Strong statistical knowledge and capabilities.
- Understands drug development and works to build CMC dossier for regulatory submissions as an author/reviewer.
- Advanced skills in DOE, Lean and/or Six Sigma.
- Familiar with modern laboratory equipment and automation.
- Understands and applies Quality by Design principles when required
- Advanced skills in PAT and chemometrics.
DUTIES AND RESPONSIBILITIES
- Support drug substance process development including characterization of starting materials, intermediates, and final API.
- Support drug product formulation and process development including characterization of the process and finished product.
- Develop, optimize and validate analytical methods.
- Support drug substance and drug product impurity characterization and identification.
- Qualify/transfer analytical methodology to quality control and contract laboratories.
- Provide leadership and supervision to scientific staff.
- Develop, coach and mentor others.
- Serve on and lead departmental, interdepartmental and project teams.
- Report and discuss analytical results and conclusions both orally and in writing.
- Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
- Represent the company in discussions with regulatory authorities and alliance partners
- Review analytical data for completeness and correctness.
- Complies with Environmental Health and Safety Requirements.
- Ensure that all facilities, equipment and personnel are and remain in compliance with cGLP / cGMP, FDA and EMA requirements, appropriate SOPs and corporate policies.
- Contributes to the ownership and advancement of lab instrumentation, work processes, and procedures
EDUCATION AND EXPERIENCE (As Applicable)
Completed BS and minimum of 12 years; MS minimum of 10 years; or Ph.D. and minimum of 8 years in Chemistry (or relevant discipline) with pharmaceutical experience.
WORKING CONDITIONS: (US Only)
Work is performed both in a typical office and in an analtyical development laboratory. Some work is performed seated, but laboratory related work requires intermittent standing and walking for up to 70% of the time. Laboratory work involves working around potentially hazardous materials (solvents, reagents, developmental drug substances and synthesis intermediates). Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
DEFINITIONS AND ABBREVIATIONS (As Applicable)
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.