Scientist-Downstream SME
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/Engineer is knowledgeable and proficient in downstream purification processes for biologics.
Duties/
Responsibilities:
Responsible for process fit, technical transfers, process validation, maintenance and continuous improvement of process performance at third party manufacturing and other internal manufacturing facilities.
Maintain strong working relationship with third party entity.
Develop and maintain keen technical familiarity with process and process equipment, process optimization, and technical problem solving.
Prepare, produce, and/or review GMP document, regulatory documents and other technical reports.
Monitor process parameters and process performance, evaluate any excursion out of history trend.
Initiate, conduct or lead investigation into any process excursion and quality events.
Align and maintain collaborative partnership with internal BMS functions such as Process Sciences, Manufacturing Science and Technology, Analytical Development and Testing, QA, QC, and facilities engineering.
Independently lead cross functional project team to drive complex process improvement or to enable or enhance organizational capabilities Qualifications PhD in protein chemistry, biochemistry, biochemical engineering or other related discipline with 2
years of relevant experience OR MS with 6
years of experience OR BS with 8
years of experienceDirect experience with cGMP protein therapeutic manufacturingScale-up experience in downstream purification process of biologics.
High skill level in process development, process scale-up, technical transfers, process troubleshooting, and continuous improvement Working knowledge of regulatory and compliance requirements for biologics Technical writing, computer, and written and verbal communication skills Ability to work effectively as a member of larger cross functional team Must be willing and able to wear necessary personal protective equipment (PPE).
This role will observe operations that are involved with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics.
Powdered materials and high temperature liquids and solids are also handled.
Travel up to 20% of the time.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502024.
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/Engineer is knowledgeable and proficient in downstream purification processes for biologics.
Duties/
Responsibilities:
Responsible for process fit, technical transfers, process validation, maintenance and continuous improvement of process performance at third party manufacturing and other internal manufacturing facilities.
Maintain strong working relationship with third party entity.
Develop and maintain keen technical familiarity with process and process equipment, process optimization, and technical problem solving.
Prepare, produce, and/or review GMP document, regulatory documents and other technical reports.
Monitor process parameters and process performance, evaluate any excursion out of history trend.
Initiate, conduct or lead investigation into any process excursion and quality events.
Align and maintain collaborative partnership with internal BMS functions such as Process Sciences, Manufacturing Science and Technology, Analytical Development and Testing, QA, QC, and facilities engineering.
Independently lead cross functional project team to drive complex process improvement or to enable or enhance organizational capabilities Qualifications PhD in protein chemistry, biochemistry, biochemical engineering or other related discipline with 2
years of relevant experience OR MS with 6
years of experience OR BS with 8
years of experienceDirect experience with cGMP protein therapeutic manufacturingScale-up experience in downstream purification process of biologics.
High skill level in process development, process scale-up, technical transfers, process troubleshooting, and continuous improvement Working knowledge of regulatory and compliance requirements for biologics Technical writing, computer, and written and verbal communication skills Ability to work effectively as a member of larger cross functional team Must be willing and able to wear necessary personal protective equipment (PPE).
This role will observe operations that are involved with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics.
Powdered materials and high temperature liquids and solids are also handled.
Travel up to 20% of the time.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502024.
Estimated Salary: $20 to $28 per hour based on qualifications.
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