SCIENTIST
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.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Scientist serves as an integral part of the Analytical Strategy & Product Leadership team for approved and commercializing products within AS&T.
This organization is focused on creating and managing the analytical technical agenda from late stage development and validation (collaboratively with Analytical Development) through ROW and PAS filings, technical support for quality control labs around the world, assessment of method performance in the QC labs, life cycle management of specifications (methods and acceptance criteria), and responses to health authority questions on commercial products.
Duties/
Responsibilities:
Supports and assists with executing the technical agenda for the product.
Collaborates with analytical development leads, global quality product leads, technical project teams, and regulatory leads to assist with execution of the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, stability monitoring, and support of life cycle regulatory filings.
Assists with preparing analytical documents and sections in support of initial, ROW, and PAS filings.
Supports analytical methods change control as needed throughout the BMS network, TPM, and outside testing labs.
Method performance monitoring, including data gathering and analysis.
Supports analytical methods and analytical change control as needed throughout the BMS network, third party manufacturing and outside testing labs.
Supports optimization and improvement of analytical methods through trending & monitoring.
Supports statistical analysis in support of specification changes or implementation.
Supports the manufacture and testing of BMS Biologics by both internal and external resources.
Qualifications Specific Knowledge, Skills, Abilities, etc:
Recommended to have some data management system and data networks experience.
Expertise and experiences in biological analytical method data trending and/or statistical analysis.
Strong communication and leadership skills in a highly interactive environment.
Knowledge of biologics CMC regulations, cGMP requirements and regulatory filings.
Education/Experience/Licenses/Certifications:
A PhD or MS in Life Sciences, Chemistry, and/or Chemical Engineering or related disciplines with at least 0-2, 4-6 years of industrial experience in relevant fields, respectively.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1501133.
Estimated Salary: $20 to $28 per hour based on qualifications.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Scientist serves as an integral part of the Analytical Strategy & Product Leadership team for approved and commercializing products within AS&T.
This organization is focused on creating and managing the analytical technical agenda from late stage development and validation (collaboratively with Analytical Development) through ROW and PAS filings, technical support for quality control labs around the world, assessment of method performance in the QC labs, life cycle management of specifications (methods and acceptance criteria), and responses to health authority questions on commercial products.
Duties/
Responsibilities:
Supports and assists with executing the technical agenda for the product.
Collaborates with analytical development leads, global quality product leads, technical project teams, and regulatory leads to assist with execution of the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, stability monitoring, and support of life cycle regulatory filings.
Assists with preparing analytical documents and sections in support of initial, ROW, and PAS filings.
Supports analytical methods change control as needed throughout the BMS network, TPM, and outside testing labs.
Method performance monitoring, including data gathering and analysis.
Supports analytical methods and analytical change control as needed throughout the BMS network, third party manufacturing and outside testing labs.
Supports optimization and improvement of analytical methods through trending & monitoring.
Supports statistical analysis in support of specification changes or implementation.
Supports the manufacture and testing of BMS Biologics by both internal and external resources.
Qualifications Specific Knowledge, Skills, Abilities, etc:
Recommended to have some data management system and data networks experience.
Expertise and experiences in biological analytical method data trending and/or statistical analysis.
Strong communication and leadership skills in a highly interactive environment.
Knowledge of biologics CMC regulations, cGMP requirements and regulatory filings.
Education/Experience/Licenses/Certifications:
A PhD or MS in Life Sciences, Chemistry, and/or Chemical Engineering or related disciplines with at least 0-2, 4-6 years of industrial experience in relevant fields, respectively.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1501133.
Estimated Salary: $20 to $28 per hour based on qualifications.
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