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Principal Scientist, Analytical CMC Strategy

Employer
Bristol Myers Squibb Company
Location
Devens, Massachusetts
Start date
Apr 10, 2024

Job Details

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. Read more: careers.bms.com/working-with-us .

Position Summary

The Principal Scientist will serve as the point of contact for BMS on the technical leadership for a multitude of products or major brands (Biologics) for the Global Quality Analytical Science & Technology organization. This role requires matrix leadership of scientists supporting commercialized and late-stage biopharmaceutical products with a focus on establishing the analytical CMC strategy, enabling regulatory filings, providing technical partnership for quality control laboratories around the world, managing the life cycle of specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products.

The Principal Scientist will also be responsible for implementing strategic initiatives that will develop and integrate best practices across brands, Analytical Sciences, and the wider Global Product Development and Supply. GPS. These initiatives may include leading, managing complex Health Authority communications, and providing robust Health Authority Strategies with high probability of success across the portfolio of biological brands.

Key Responsibilities:
  • Accountability for strategy and execution of analytical activities (method validation / specification setting / reference standard strategy / analytical comparability) required to advance late-stage programs and manage the analytical lifecycle of commercial programs.
  • The Principal Scientist will be responsible for leading effective matrix analytical support during all Biological License Applications (BLA), Marketing Authorization Applications (MAA), Rest of World (ROW) & Post Approval Submissions (PAS) filing preparation and review, including responses to HA queries.
  • Work with Analytical Development in supporting the responses to Follow Up Measures (FUMs) and Post Marketing Commitments (PMCs).
  • This person serves as the analytical Single Point of Contact for a commercial brand(s) and is responsible for the delivery of the analytical brand Book of Work.
  • Lead a network-based Analytical Sub-Team accountable for driving the execution of the analytical control strategy and associated Book of Work for a commercial brand(s).
  • Create and maintain effective partnerships with stakeholders from Analytical Development, Manufacturing Sciences and Technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.
  • Lead the effort to implement effective control strategy, analytical method, and specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs.
  • Serve as analytical product expert during Health Authority inspections.
  • Provide strong technical leadership to Quality Control teams during complex method troubleshooting / investigations / tech transfers / method validations.
  • Responsible for leading and managing the analytical development and support of the analytical quality control strategies during late stage and post approval (commercialization) phases .
  • Provide mentorship to junior Analytical CMC Strategy team members.
  • Lead and/or contribute to continuous improvement initiatives and actively engage in knowledge management within the Analytical CMC Strategy team.
Key Requirements:
  • A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 4, 6 or 10 years of biologics experience within analytical CMC / relevant field, respectively.
  • Demonstrated successful leadership of cross-functional teams, stakeholder management, and ability to ensure progress of complex projects under defined timelines.
  • Possess extensive practical knowledge and experience in the application and execution of key analytical CMC activities in the commercial environment, including but not limited to:
    • Preparation, review, and lifecycle management of Biological License Applications (BLA), Marketing Authorization Applications (MAA), Rest of World (ROW), and Post Approval Submissions (PAS).
    • Proficient handling of Health Authority Information Requests (IRs) and effective management of Follow Up Measures (FUMs) and Post Marketing Commitments (PMCs).
    • Method/specification lifecycle and associated change control (Extensive change control experience required).
  • Proven expertise in conducting and overseeing analytical comparability assessments, ensuring robust evaluation of critical quality attributes and method performance across different manufacturing processes or product lots.
  • Substantial practical experience in leading and managing analytically related complex Health Authority communications and providing commercial analytical strategies with high probability of technical and regulatory success.
  • Requires advanced knowledge of the relevant principles and concepts of analytical CMC (JOS / analytical procedures / method validation / analytical comparability / reference standard strategy) and associated GMPs.
  • Proven track record in independently authoring complex technical CMC documents (Justification of Specification / Analytical Comparability Risk Assessments, Protocols & Reports / Method Summaries, Method validation gap assessments etc.)
  • Significant industry experience in independently writing formal reports/documents, technical presentations, articles for publication and scientific publications or patents.
  • Demonstrates ability to analyze and interpret data to draw appropriate conclusions, identify problems/gaps, and recommend potential next steps or solutions to ensure good scientific, compliance and regulatory outcomes.
  • In depth knowledge of common analytical techniques used in the bio-pharmaceutical industry such as iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS etc., including method qualification/validation, method development and/or method transfer.
  • In depth knowledge of FDA and international regulatory guidelines and standards as well as extensive experience with supporting Health Authority inspections.
#LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
US

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