Current jobs related to Senior Principal Scientist, Analytical CMC Strategy - Devens - Bristol Myers Squibb Company

  • Senior Analytical Scientist

    1 week ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    About the RoleBristol Myers Squibb is seeking a highly skilled Principal Scientist to join our Process Analytics team. As a key member of our team, you will be responsible for leading analytical characterization of protein biologics, including extended characterization and impurity testing.Key ResponsibilitiesDevelop and implement analytical methods for...

  • Senior Analytical Scientist

    7 days ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    About the RoleBristol Myers Squibb is seeking a highly skilled Principal Scientist to join our Process Analytics team. As a key member of our team, you will be responsible for leading analytical characterization of protein biologics, including extended characterization and impurity testing.Key ResponsibilitiesDevelop and implement analytical methods for...

  • Lead Scientist in Process Analytics

    4 weeks ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    Join Our TeamAt Bristol Myers Squibb, we offer a unique opportunity to engage in work that is both challenging and impactful. Our environment fosters innovation and collaboration, allowing you to contribute to meaningful advancements in patient care.About the RoleThe Principal Scientist in Process Analytics will play a crucial role in our Biologics Drug...

  • Analytical Scientist

    2 months ago

    Devens, United States Veranova L P Full time

    Job DescriptionJob DescriptionCompany DescriptionVeranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.Job DescriptionResponsible...

  • Scientist - Boundary Particle Transport

    4 weeks ago

    Devens, United States Commonwealth Fusion Systems Full time

    Commonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy.CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact fusion power plants that can be constructed faster and at lower cost. Our mission...

  • Principal Safety Risk Engineer

    2 days ago

    Fort Devens, United States Commonwealth Fusion Systems Full time

    Job Title: Principal Safety Risk EngineerCommonwealth Fusion Systems (CFS) is a leading innovator in the field of fusion energy. We are seeking a highly skilled Principal Safety Risk Engineer to join our team.About the RoleThe successful candidate will be responsible for leading the development and implementation of safety risk management strategies for our...

  • Senior Manager, Emerging Capabilities

    1 week ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    About the RoleBristol Myers Squibb is seeking a highly skilled Senior Manager to join our GPS-BIA organization. As a key member of our team, you will be responsible for building and implementing strategic capabilities that drive business growth and innovation.Key ResponsibilitiesDevelop and implement analytical solutions to drive business...

  • Principal Chemical Engineer

    1 week ago

    Devens, United States Commonwealth Fusion Systems Full time

    Commonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy.CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact fusion power plants that can be constructed faster and at lower cost. Our mission...

  • Principal Program Manager

    2 months ago

    Devens, United States VulcanForms Full time

    Job DescriptionJob DescriptionSalary: About us VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser additive metal manufacturing (AM) solution and...

  • Principal Program Manager

    2 weeks ago

    Devens, United States VulcanForms Full time

    Job DescriptionJob DescriptionSalary: About us VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser additive metal manufacturing (AM) solution and...

  • Senior Reachback Intelligence Analyst

    2 weeks ago

    Devens, Massachusetts, United States Prescient Edge Full time

    Job Title: Senior Reachback Intelligence AnalystJob Summary:Prescient Edge is seeking a Senior Reachback Intelligence Analyst to support a federal government client. As a Senior Reachback Intelligence Analyst, you will be responsible for providing expert-level analytical support to senior leadership at the O6 level. You will also be responsible for mentoring...

  • Statistician

    2 weeks ago

    Devens, United States Aequor Technologies LLC Full time

    Top 3 Must Have's to be considered for this role: 2+years of statistical analysis experience in Biopharma or Phd ICH guidelines Stability Data, Specification Job Description: CMC Statistician Client Hybrid role, Devens OR New Brunswick site Work Schedule: Mon - Fri, Business hours This position is responsible for providing statistical analysis to service...

  • Senior Counter Intelligence Analyst

    1 week ago

    Devens, Massachusetts, United States SOSi Full time

    Job Title: Senior Counter Intelligence AnalystSOSi is seeking a highly skilled Senior Counter Intelligence Analyst to provide analysis support to an intelligence analytical team in the USCENTCOM AOR.Key Responsibilities:Analyze All-source reporting to identify individuals of CI concern and proactively identify insider threats.Establish, maintain, and improve...

  • Senior Counter Intelligence Analyst

    8 hours ago

    Devens, Massachusetts, United States SOSi Full time

    Job Title: Senior Counter Intelligence AnalystSOSi is seeking a highly skilled Senior Counter Intelligence Analyst to provide analysis support to an intelligence analytical team in the USCENTCOM AOR. The successful candidate will have a strong background in counter intelligence and experience working with military and DoD civilian analysts.Key...

  • Senior Director, Manufacturing Operations

    1 week ago

    Devens, Massachusetts, United States Bristol Myers Squibb Full time

    About the RoleThe Senior Director, Manufacturing Operations will provide leadership and direction to the 24/7 GMP Maintenance team supporting the Devens Site Biologics Manufacturing Operations. The primary responsibility of this role is the management of the GMP Maintenance team within the Devens Site Engineering Department.Key Responsibilities:Member of the...

  • Principal Engineer Process Safety Management

    2 days ago

    Fort Devens, United States Commonwealth Fusion Systems Full time

    Job Title: Principal Engineer, Process Safety ManagementCommonwealth Fusion Systems (CFS) is a leading innovator in the field of fusion energy, and we are seeking a highly skilled Principal Engineer, Process Safety Management to join our team.About the RoleWe are looking for a seasoned professional with expertise in process safety management, risk...

  • Senior Counterintelligence Analyst

    17 hours ago

    Devens, Massachusetts, United States JCTM Full time

    Job Title: Reach Back Senior Counterintelligence AnalystLocation: Devens, MassachusettsThe Challenge:In today's rapidly evolving global landscape, understanding and analyzing intelligence at both the tactical and operational levels is crucial for informed decision-making. As a Reach Back Senior Counterintelligence Analyst with JCTM, you will provide critical...

  • Senior Application Support Engineer

    2 weeks ago

    Devens, Massachusetts, United States VetJobs Full time

    About the RoleWe are seeking a highly skilled Senior Application Support Engineer to join our team at VetJobs. As a key member of our Application Support Team, you will be responsible for providing high-quality technical support to our site users, ensuring the smooth operation of our Manufacturing Execution System.Key ResponsibilitiesWork closely with a...

  • Data Engineer

    3 weeks ago

    Devens, United States Omni Inclusive Full time

    We are seeking a talented and highly motivated data engineer to join the Quantitative Sciences & Digital Transformation group within the Portfolio Integration & Business Operations organization. The candidate will work closely with data scientists, statisticians, Biologics Development (Client) scientists, and IT partners to develop and implement data...

  • Senior Financial Analyst

    18 hours ago

    Devens, Massachusetts, United States VulcanForms Full time

    Job OverviewVulcanForms is seeking a highly skilled Senior Financial Analyst to join our team in Devens, MA. As a key member of our Finance organization, you will play a critical role in driving business growth and success.Key ResponsibilitiesCollaborate with Finance leadership to develop and implement financial processes and procedures that drive...

Senior Principal Scientist, Analytical CMC Strategy

4 months ago

Devens, United States Bristol Myers Squibb Company Full time

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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 Senior Principal Scientist will serve as the point of a 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 Senior 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 Senior 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 accountable for leading the delivery of the analytical Book of Work.

Strategically 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.

Design and 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 5, 8 or 12 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.

Requires extensive in-depth knowledge in the application and execution of key analytical CMC activities in the commercial environment including but not limited to:

Biological License Applications (BLA), Marketing Authorization Applications (MAA), Rest of World (ROW) & Post Approval Submissions (PAS) filing preparation & review

Health Authority Information Requests (IRs)

Follow Up Measures (FUMs) and Post Marketing Commitments (PMCs)

Method/specification lifecycle and associated change control

Extensive 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 highly 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.)

Extensive 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 doesnt 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.