Senior Principal Scientist
3 weeks ago
Apply locations Summit West - NJ - US New Brunswick - NJ - US time type Full time posted on Posted 16 Days Ago job requisition id R1582246
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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 with the resources to pursue their goals, both at work and in their personal lives.
Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients’ lives while developing professionally to achieve your own career goals.
Position Summary:
The Senior Principal Scientist will be a CMC analytical lead (CMC-AL) for drug candidates across all stages of development and, as needed, within our commercial product portfolio. They will serve as a member of a cross functional CMC team responsible for analytical related CMC strategy development. Collaborating with various functional areas, they will identify drug substance and drug product critical quality attributes and establish controls and testing to deliver quality products.
They will drive analytical controls adhering to ICH guidelines and Health Authority requirements. The Senior Principal Scientist will have a direct impact on the division and also influence in the broader BMS community.
Role & Responsibilities:
- Understanding of product critical quality attributes and establish methods, specifications, analytical control strategies for product development.
- Serve on a cross functional team responsible for analytical related CMC strategy development.
- Review and discuss analytical results and conclusions both orally and in writing.
- Author/ review/approve reports as source documents for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
- Provide leadership and mentoring to scientific staff. Develop, coach and mentor others in matrix environment.
Desired Experience:
Required:
- Completed BS and 12-15 years; MS and 9-12 years; or Ph.D. and 6-8 years of experience in Chemistry (or relevant discipline) with pharmaceutical experience.
- A demonstrated record of scientific accomplishment, laboratory experimentation, publications, and presentations.
- Understands writing/approval of risk assessments and understands both GMP and GLP requirements for drug product development.
- 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, topicals, parental etc.).
- Knowledge of dissolution method development and testing, and biopharmaceutical assessment.
- In-depth knowledge on method development, validation, and tech transfer.
- Well versed in ICH and country specific requirements to support analytical control strategy.
- Experience in managing external manufacturing and testing laboratories as required for the product.
- Understands drug development and works to build CMC dossier for regulatory submissions as an author/reviewer.
- Experience in worldwide commercialization of small molecule drug products, with recent approvals in major markets. The ideal candidate would have a history of drug approvals as an analytical expert in both drug substance and drug product analytical development.
Ideal Candidates Would Also Have:
- Exceptional verbal and written communication skills and interpersonal skills as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
- Familiar with modern laboratory equipment and automation.
- Understands and applies Quality by Design principles when required.
- Experience leading Matrix teams.
Why You Should Apply
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
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