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.
#J-18808-Ljbffr-
Senior Principal Scientist
4 weeks ago
Akron, Ohio, United States Bristol-Myers Squibb Full timeSenior Principal Scientist page is loaded Senior Principal Scientist Apply locations Summit West - NJ - US New Brunswick - NJ - US time type Full time posted on Posted 16 Days Ago job requisition id R Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is...
-
Senior Instrumentation Engineer
2 weeks ago
Akron, Ohio, United States Solvenow Inc. Full timeWe are seeking a Senior Instrumentation Engineer to contribute to our innovative projects at Solvenow Inc.The successful candidate will be responsible for:Acting as the principal engineer for both single and multi-discipline initiatives.Facilitating effective communication among project stakeholders, including team members, departments, suppliers, and...
-
Senior Instrumentation Engineer
2 weeks ago
Akron, Ohio, United States Solvenow Inc. Full timeWe are seeking a Senior Instrumentation Engineer to contribute to our innovative projects at Solvenow Inc.The ideal candidate will be responsible for:Acting as the principal engineer for both single and multi-discipline initiatives.Facilitating effective communication among project teams, various departments, suppliers, and clients.Creating detailed...
-
Senior Analytical Chemist
1 day ago
Akron, Ohio, United States FLEXSYS America Full timeJob TypeFull-timeDescriptionFLEXSYS America is a leading provider of rubber chemicals and innovative solutions, specializing in products such as insoluble sulfur, anti-degradants, and post-vulcanization stabilizers. Our mission is to deliver superior solutions for manufacturers in the tire and rubber industry, enhancing product performance, optimizing...
-
Akron, Ohio, United States Bristol Myers Squibb Full timeWorking with UsChallenging. 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...
-
Akron, Ohio, United States Akron Children's Hospital Full timeJob SummaryThe Senior Medical Technologist assists in the daily organization and oversight of work activities under general supervision of and in close cooperation with supervisor at Akron Children's Hospital.Key ResponsibilitiesPerform staff Medical Technologist duties, ensuring accuracy and efficiency in laboratory operations.Follow established procedures...
-
Principal Mechanical Engineer
1 week ago
Akron, Ohio, United States Jobot Full timeJob Title:Senior Mechanical EngineerCompany Overview:At Jobot, we pride ourselves on our diverse team of skilled engineers, architects, and designers dedicated to delivering exceptional results across various sectors. Our focus on client satisfaction drives our efficient project management approach.Why Join Our Team?We offer a dynamic work environment where...
-
Akron, Ohio, United States Synthomer Full timeJob SummaryWe are seeking a highly skilled and experienced Technical Service Leader to join our Adhesive Solutions team at Synthomer. As a Principal Application Scientist, you will play a key role in supporting our specialty customers and distributors, working closely with sales and account managers to develop and execute business strategies.Key...
-
Akron, Ohio, United States Bristol Myers Squibb Company Full timeWorking with UsChallenging. 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...
-
Senior Electrical Engineering Specialist
2 weeks ago
Akron, Ohio, United States Burns & McDonnell Full timePosition OverviewThe Principal Electrical Engineer will oversee and execute engineering projects focused on power system protection and control. These projects vary in scale and complexity, encompassing everything from minor upgrades to extensive transmission initiatives. This role plays a crucial part in shaping the future resilience, reliability, and...
-
Senior Med Tech: Flow Cytometry
5 hours ago
akron, United States Akron Children's Hospital Full timeSummary:The Senior Medical Technologist assists in the daily organization and oversight of work activities under general supervision of and in close cooperation with supervisor. Responsibilities:1. Performs staff Medical Technologist duties.2. Follow procedures for collecting and processing Biological specimens.3. Assists in the daily organization and...
-
Senior Med Tech: Flow Cytometry
3 weeks ago
AKRON, United States Akron Children's Hospital Full timeSummary:The Senior Medical Technologist assists in the daily organization and oversight of work activities under general supervision of and in close cooperation with supervisor. Responsibilities:1. Performs staff Medical Technologist duties.2. Follow procedures for collecting and processing Biological specimens.3. Assists in the daily organization and...
-
Senior Project Manager
3 months ago
Akron, United States LSI Industries, Inc. Full timeJob DescriptionJob DescriptionBuild your Career with an Industry LeaderHeadquartered in Cincinnati, LSI Industries (NASDAQ: LYTS) specializes in the creation of advanced lighting, graphics, and display solutions. The Company’s American-made products, which include lighting, print graphics, digital graphics, millwork, metal and refrigerated products, and...
-
Senior FP&A Analyst
2 months ago
Akron, United States Sequoia Financial Group Full timeSequoia Financial Group is a growing Registered Investment Advisor (RIA), headquartered in Northeast Ohio, offering financial planning and wealth management services. At Sequoia, we exist with a singular purpose: to enrich lives. Our values define how we behave and guide us through the pursuit of our purpose to enrich lives. At Sequoia, our core values are: ...
-
Senior Med Tech: Flow Cytometry
2 weeks ago
Akron, Ohio, 44308, Summit County, OH, United States Akron Children's Hospital Full timeSummary:The Senior Medical Technologist assists in the daily organization and oversight of work activities under general supervision of and in close cooperation with supervisor. Responsibilities:1. Performs staff Medical Technologist duties.2. Follow procedures for collecting and processing Biological specimens.3. Assists in the daily organization and...
-
Tax Intern
3 months ago
Akron, United States Apple Growth Partners Full timeJob DescriptionJob DescriptionDescription:Tax InternshipApple Growth Partners is a customer-focused, regional business advisory firm of Certified Public Accountants and industry experts serving growth-oriented, privately owned businesses for over 80 years. We are known as leaders in the development of our staff, and we pride ourselves on working with each...
-
Store Leader Sr., Getgo
3 months ago
Akron, United States GetGo Café + Market Full timeJob DescriptionJob SummaryThe Senior Store Leader is responsible for keeping the store team running like clockwork, because our customers' clocks are ticking. The Team Member in this role will coach, supervise, and lead the team. From the morning rush to the afternoon lunch crowds, you will make sure that each customer waiting for a fresh sandwich,...
