Principal Scientist

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Bristol Myers Squibb

Principal Scientist

in

Jersey City

New Jersey

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 independently and collaboratively developing and scaling up innovative, safe and effective processes for the manufacture of chemical intermediates and drug substances and to build process understanding and expedite the progress of development programs.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

 A proven track record in process development with a demonstrated record of implementing creative solutions to overcome synthesis and manufacturing obstacles.

 Excellent laboratory skills and knowledge of organic synthesis. Proficient in the use and interpretation of NMR, HPLC, MS, IR, DSC, TGA, XRD, and automation.

 Ability to balance scientific, legal, and business needs as they relate to a given project.

 Ability to balance multiple projects at different levels, must be able to concomitantly work effectively in the lab and as a project manager.

 Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary team environment. Ability to work independently or in team environments under deadlines.

 Excellent verbal skills are essential, must be able to contextualize complex issues for colleagues in and outside of the department.

 Solid writing skills are critical, must be able to succinctly capture technical and project related information from diverse sources.

 Experience with CMC issues encountered in drug development.

 Familiarity with cGMP manufacturing and regulatory filings.

 Direct or indirect supervisory experience.

DUTIES AND RESPONSIBILITIES

 Serve as a key member of a dynamic, scientifically driven team dedicated to the discovery and development of elegant chemical syntheses and processes for active pharmaceutical compounds.

 Represent Drug Substance Development (DSD) on multidisciplinary Chemistry Manufacturing, and Controls (CMC) teams with direct scientific responsibility and oversight of DSD staff.

 Apply fundamental chemistry and engineering principles to solve challenges in synthesis and process development from bench through pilot plant manufacture.

 Develop and execute phase appropriate risk-based development and drug substance supply plans.

Manufacture development candidates for pre-IND studies.

 Manage technology transfers to and support manufacturing of GMP Drug Substance (DS) at Contract Research Organizations.

 Conduct DS related due diligence assessments for potential external collaborations.

 Serve as Celgene DSD representative on external collaborations.

 Remain current with required cGMP training and qualifications.

 Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements.

 Assist in the preparation of CMC regulatory documents.

 Evaluate and maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.

 Serve as a resource of scientific and technical expertise.

 Supervise scientists under a project specific matrix organization.

 Prepare technical reports, publications and oral presentations.

 Enhance the scientific and business capabilities of the department.

EDUCATION AND EXPERIENCE (As Applicable)

 Ph.D. in Organic Chemistry with 8 years relevant industrial experience.

 Experience in pharmaceutical development as it relates to route selection, process development, process understanding, salt selection, polymorphism, solubility, and stability testing.

 Extensive patent and academic journal publication record a plus.

WORKING CONDITIONS: (US Only) Work is performed both in a typical office and in a process development laboratory and/or a kilo lab for scale-up work. Some work is performed seated, but laboratory related work requires intermittent standing and walking for up to 40% 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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com