Lead Analytical Scientist

2 weeks ago


New Brunswick, New Jersey, United States Bristol-Myers Squibb Full time
About Us:
At Bristol Myers Squibb, we believe in the power of innovation to transform lives. Our work is not just a job; it is a commitment to making a meaningful impact in the world of healthcare.

Every day, our teams engage in fascinating projects that span from enhancing production processes to pioneering advancements in cell therapy. This is where your work can change the lives of patients and elevate your career.

We offer unique opportunities for growth and development, working alongside diverse, high-performing teams.

Position Overview:


The Lead Analytical Scientist will take on the role of CMC analytical lead (CMC-AL) for drug candidates at various stages of development, as well as within our commercial product portfolio.

As a vital member of a cross-functional CMC team, you will be instrumental in shaping analytical strategies related to CMC.

By collaborating with multiple functional areas, you will identify critical quality attributes for both drug substances and products, establishing necessary controls and testing protocols to ensure the delivery of high-quality products.


Key Responsibilities:


In this role, you will primarily function as an individual contributor while also leading a matrix team of analytical scientists. You will be a core member of the CMC team, working closely with Analytical Leads, Drug Substance and Drug Product Leads, Quality Lead, and Regulatory Lead to develop and implement analytical strategies that uphold product quality.

You will be responsible for understanding product critical quality attributes and establishing methods, specifications, and analytical control strategies throughout product development.
Participate in a cross-functional team focused on analytical CMC strategy development.
Review and communicate analytical results and conclusions effectively, both orally and in writing.

Prepare, review, and approve reports that serve as source documents for regulatory submissions, while also supporting the generation of responses to inquiries from regulatory authorities.

Provide leadership and mentorship to scientific staff, fostering the development of others in a matrix environment.

Qualifications:

Essential:
A completed BS with 12-15 years of experience; MS with 9-12 years; or Ph.D. with 6-8 years in Chemistry or a related field, particularly within the pharmaceutical industry.
A proven track record of scientific achievement, including laboratory experimentation, publications, and presentations.
Knowledge of risk assessment writing/approval and familiarity with GMP and GLP requirements for drug product development.

Proficiency in synthetic chemistry, drug substance processing, formulation development, and pharmaceutical processing, with a comprehensive understanding of pharmaceutical sciences related to drug product development.

Expertise in measurement science and extensive experience in developing and performing analytical tests for various drug substances and products (including solid oral dosage forms, topicals, and parenterals).

In-depth knowledge of dissolution method development and testing, as well as biopharmaceutical assessment.

Strong understanding of method development, validation, and technology transfer.
Well-versed in ICH and country-specific requirements to support analytical control strategies.
Experience managing external manufacturing and testing laboratories as needed for product development.
Comprehension of drug development processes and the ability to contribute to the CMC dossier for regulatory submissions as an author/reviewer.
Experience in the global commercialization of small molecule drug products, particularly with recent approvals in major markets.

The ideal candidate will have a history of successful drug approvals as an analytical expert in both drug substance and drug product analytical development.


Preferred Attributes:

Exceptional verbal and written communication skills, with strong interpersonal abilities as a team member and leader in an environment that values initiative, collaboration, and accountability.

Familiarity with modern laboratory equipment and automation.
Understanding and application of Quality by Design principles when necessary.
Experience leading matrix teams.

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