Reference Standards and Critical Reagents 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 primary role is to support coordination, draft protocols, and review reports for qualification activities of reference standards and critical reagents throughout the global BMS biologics testing network.
The candidate will leverage technical and analytical skills (including cell-based bioassay, physicochemical characterization techniques, and binding) to support protocol troubleshooting for commercial biologics programs.
The RS&CR team in AST is committed to supporting our global biologics QC network with reliability, integrity, active engagement, and cross functional collaboration.
Must embrace collaboration with partners, customers, and team members, while operating with integrity, as well as seeking and participating in the continuous improvement of systems and culture.
Duties/
Responsibilities:
Ensures adequate supply of standards and reagents are available as needed through the BMS global network.
Ensures that customers receive required reagents, to ensure continuous testing capabilities of the customers.
Authors SOPs and technical documents associated with the reference standard and critical reagent program.
Performs routine data review and verification.
Tracks accurate records of the current inventory and qualification status of all reference standards and critical reagents used within the BMS global network and anticipates need to ensure seamless operations.
Participates and presents in team meetings to provide support and troubleshooting for protocols.
Works according to GMP requirements and HA expectations Qualifications
Qualifications:
BS in Biological Sciences, Chemistry or related discipline with at least 8 years of combined academic/industry laboratory experience OR an MS in Biological Sciences, Chemistry or related discipline with at least 4 years of combined academic/industry laboratory experience OR a PhD in Biological Sciences, Chemistry or related discipline with at least 2 years of combined academic/industry laboratory experience.
Candidates having prior experience with iCIEF/IEF, HPLC, peptide mapping, sialic acid analysis, and/or BIAcore, are strongly preferred.
Must have experience with qualification of biologics reference standards.
Candidates having prior experience with iCIEF, HPLC, peptide mapping, sialic acid analysis, cell-based bioassay, and BIAcore, are desirable.
Must have previous hands-on project management experience Must have experience with GMP regulations and have demonstrated ability to follow SOPs, general scientific methods, and protocols, and support drafting technical documents and reports.
Must demonstrate skills in teamwork, strong organizational skills with ability to multi-task, strong computer competency, effective written and verbal communications, and has hands-on laboratory experience.
The individual must be detail-oriented and able to quickly apply new skills.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502504.
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 primary role is to support coordination, draft protocols, and review reports for qualification activities of reference standards and critical reagents throughout the global BMS biologics testing network.
The candidate will leverage technical and analytical skills (including cell-based bioassay, physicochemical characterization techniques, and binding) to support protocol troubleshooting for commercial biologics programs.
The RS&CR team in AST is committed to supporting our global biologics QC network with reliability, integrity, active engagement, and cross functional collaboration.
Must embrace collaboration with partners, customers, and team members, while operating with integrity, as well as seeking and participating in the continuous improvement of systems and culture.
Duties/
Responsibilities:
Ensures adequate supply of standards and reagents are available as needed through the BMS global network.
Ensures that customers receive required reagents, to ensure continuous testing capabilities of the customers.
Authors SOPs and technical documents associated with the reference standard and critical reagent program.
Performs routine data review and verification.
Tracks accurate records of the current inventory and qualification status of all reference standards and critical reagents used within the BMS global network and anticipates need to ensure seamless operations.
Participates and presents in team meetings to provide support and troubleshooting for protocols.
Works according to GMP requirements and HA expectations Qualifications
Qualifications:
BS in Biological Sciences, Chemistry or related discipline with at least 8 years of combined academic/industry laboratory experience OR an MS in Biological Sciences, Chemistry or related discipline with at least 4 years of combined academic/industry laboratory experience OR a PhD in Biological Sciences, Chemistry or related discipline with at least 2 years of combined academic/industry laboratory experience.
Candidates having prior experience with iCIEF/IEF, HPLC, peptide mapping, sialic acid analysis, and/or BIAcore, are strongly preferred.
Must have experience with qualification of biologics reference standards.
Candidates having prior experience with iCIEF, HPLC, peptide mapping, sialic acid analysis, cell-based bioassay, and BIAcore, are desirable.
Must have previous hands-on project management experience Must have experience with GMP regulations and have demonstrated ability to follow SOPs, general scientific methods, and protocols, and support drafting technical documents and reports.
Must demonstrate skills in teamwork, strong organizational skills with ability to multi-task, strong computer competency, effective written and verbal communications, and has hands-on laboratory experience.
The individual must be detail-oriented and able to quickly apply new skills.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502504.
Estimated Salary: $20 to $28 per hour based on qualifications.
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