Associate Analytical Scientist, Raw Materials & Compendial Testing - Bristol Myers Squibb
New Brunswick, NJ
About the Job
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 .
Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.
Position Summary
V ersatile, Pharmaceutical Product Development GxP laboratory seeks a pro-active, hard-working, and results-focused analyst to bring world class Biologics and Pharma (small molecule) drugs to market. This Associate Scientist position consists of primarily on-site, lab-based responsibilities supporting multiple programs across the portfolio. The position will flex between analytical testing of Biologics clinical DS and DP, with a concentration in compendia testing, and release testing of Pharma clinical DP, DS, intermediates, excipients, and raw materials. The role requires a strong ability to manage time and multiple responsibilities with an emphasis on working in compliance with GMP laboratory requirements. This position is located at the BMS New Brunswick (NBR) site in New Brunswick, NJ, reporting directly to lab management within the Analytical Strategy & Operations Biologics GxP - Raw Materials Center of Excellence.
Role & Responsibilities
Essential duties and responsibilities include, but are not limited to, the following:
+ Independently perform analytical testing including identification by FTIR and Raman spectroscopy, protein concentration by UV/Vis spectroscopy (A280), protein identification by ELISA, pH, osmolality, visual analysis tests, and general wet chemistry techniques.
+ Additional duties include qualification testing of reference standards and specification setting support of clinical drug products, raw materials, and excipients. This work supports clinical release and stability testing of drug substances, drug products, intermediates, excipients, and raw materials.
+ Independently execute analytical method qualification/validation and transfers to internal and/or external QC laboratories, carefully adhering to approved protocols (as applicable).
+ Identify and implement improvements in lab operations, notably with regards to compliance and data reporting.
+ Demonstrate practical knowledge of working within a GMP laboratory environment in full compliance of all required regulations, corporate policies, and site procedures.
+ Review laboratory notebooks and testing results to assure technical merit, accuracy, and completeness.
+ Author clear and complete analytical testing documents (methods, protocols, reports), and contribute to design of experiments (as applicable).
+ Support shared accountabilities for upkeep of laboratory instrument reference standards as well as general instrument maintenance and service calls. Adhere to company, site, and local laboratory safety requirements.
+ Proactively provide clear, timely communication of potential issues to management.
Experience & Qualifications
+ B.S. or equivalent with a degree in Analytical Chemistry, Chemistry, Biochemistry or related field and 1-2 years of analytical laboratory experience is preferred, in a GMP environment is a plus.
+ A demonstrated ability to learn quickly and retain skills is critical for this role as a wide range of analytical testing in multiple laboratories is a core responsibility.
+ Experience with understanding and executing various analytical test methods and techniques is a plus, as is an awareness for improvements to lab operations.
+ The candidate must have good written communication skills, particularly with respect to documentation of laboratory generated data and results.
+ The candidate must be able to contribute to the development of analytical methods, qualification/validation protocols and technical reports.
+ Ability to comply with all applicable SOPs, internal requirements and external regulations is a must. Ability to learn and understand cGMP/GLP and GDPs practices and EHS requirements is essential.
+ Experience using Electronic Laboratory Notebook (ELN) applications, Laboratory Information Systems (LIMS), and common Microsoft Office applications is preferred. Familiarity with electronic documentation management systems (eDMS) for routing documents (SOPs, protocols, reports, technical documents, etc.) is a plus.
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/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585241
Updated: 2024-09-20 04:55:50.817 UTC
Location: New Brunswick-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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 .
Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.
Position Summary
V ersatile, Pharmaceutical Product Development GxP laboratory seeks a pro-active, hard-working, and results-focused analyst to bring world class Biologics and Pharma (small molecule) drugs to market. This Associate Scientist position consists of primarily on-site, lab-based responsibilities supporting multiple programs across the portfolio. The position will flex between analytical testing of Biologics clinical DS and DP, with a concentration in compendia testing, and release testing of Pharma clinical DP, DS, intermediates, excipients, and raw materials. The role requires a strong ability to manage time and multiple responsibilities with an emphasis on working in compliance with GMP laboratory requirements. This position is located at the BMS New Brunswick (NBR) site in New Brunswick, NJ, reporting directly to lab management within the Analytical Strategy & Operations Biologics GxP - Raw Materials Center of Excellence.
Role & Responsibilities
Essential duties and responsibilities include, but are not limited to, the following:
+ Independently perform analytical testing including identification by FTIR and Raman spectroscopy, protein concentration by UV/Vis spectroscopy (A280), protein identification by ELISA, pH, osmolality, visual analysis tests, and general wet chemistry techniques.
+ Additional duties include qualification testing of reference standards and specification setting support of clinical drug products, raw materials, and excipients. This work supports clinical release and stability testing of drug substances, drug products, intermediates, excipients, and raw materials.
+ Independently execute analytical method qualification/validation and transfers to internal and/or external QC laboratories, carefully adhering to approved protocols (as applicable).
+ Identify and implement improvements in lab operations, notably with regards to compliance and data reporting.
+ Demonstrate practical knowledge of working within a GMP laboratory environment in full compliance of all required regulations, corporate policies, and site procedures.
+ Review laboratory notebooks and testing results to assure technical merit, accuracy, and completeness.
+ Author clear and complete analytical testing documents (methods, protocols, reports), and contribute to design of experiments (as applicable).
+ Support shared accountabilities for upkeep of laboratory instrument reference standards as well as general instrument maintenance and service calls. Adhere to company, site, and local laboratory safety requirements.
+ Proactively provide clear, timely communication of potential issues to management.
Experience & Qualifications
+ B.S. or equivalent with a degree in Analytical Chemistry, Chemistry, Biochemistry or related field and 1-2 years of analytical laboratory experience is preferred, in a GMP environment is a plus.
+ A demonstrated ability to learn quickly and retain skills is critical for this role as a wide range of analytical testing in multiple laboratories is a core responsibility.
+ Experience with understanding and executing various analytical test methods and techniques is a plus, as is an awareness for improvements to lab operations.
+ The candidate must have good written communication skills, particularly with respect to documentation of laboratory generated data and results.
+ The candidate must be able to contribute to the development of analytical methods, qualification/validation protocols and technical reports.
+ Ability to comply with all applicable SOPs, internal requirements and external regulations is a must. Ability to learn and understand cGMP/GLP and GDPs practices and EHS requirements is essential.
+ Experience using Electronic Laboratory Notebook (ELN) applications, Laboratory Information Systems (LIMS), and common Microsoft Office applications is preferred. Familiarity with electronic documentation management systems (eDMS) for routing documents (SOPs, protocols, reports, technical documents, etc.) is a plus.
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/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585241
Updated: 2024-09-20 04:55:50.817 UTC
Location: New Brunswick-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb
