PROCESS ENGINEER
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.
Responsibilities:
Provides technical expertise for investigation and resolution of downstream process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls and preparation of regulatory filings.
Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures.
Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for BMS Devens Large Scale Cell Culture facility.
Leads cross functional teams for process improvements, new product start-ups at BMS-LSCC facility.
Evaluates process performance by comparing manufacturing data to historical data from other sites; reports variances to management with recommendations for process enhancement.
Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing downstream process Participates in the preparation of regulatory filing documents and inspection readiness.
Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Devens site.
Qualifications Minimum BS in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent with a minimum 6-8 years BMS/ relevant experience OR MS or equivalent with minimum of 4-6 years BMS/ relevant experience OR Ph.
D.
entry level in Scientific discipline with 0-2 years of relevant experience in downstream manufacturing technical support or downstream process development in the biopharmaceutical industry.
Mastery of cGMPs and the know how to work and manage within a regulatory environment.
Proven experience in successful execution and management of process technical transfer.
Experience in designing and executing process and equipment validation plans.
Experience in the design, modification and optimization of biologics purification unit operations.
Strong experience in investigating process deviations and developing issue resolving CAPAs.
Proven project management skills that include leading cross functional teams and effectively balancing project assignments with other duties.
Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
Excellent verbal & written communications skills.
Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
Strong communication and technical writing skills are required.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502174.
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.
Responsibilities:
Provides technical expertise for investigation and resolution of downstream process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls and preparation of regulatory filings.
Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures.
Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for BMS Devens Large Scale Cell Culture facility.
Leads cross functional teams for process improvements, new product start-ups at BMS-LSCC facility.
Evaluates process performance by comparing manufacturing data to historical data from other sites; reports variances to management with recommendations for process enhancement.
Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing downstream process Participates in the preparation of regulatory filing documents and inspection readiness.
Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Devens site.
Qualifications Minimum BS in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent with a minimum 6-8 years BMS/ relevant experience OR MS or equivalent with minimum of 4-6 years BMS/ relevant experience OR Ph.
D.
entry level in Scientific discipline with 0-2 years of relevant experience in downstream manufacturing technical support or downstream process development in the biopharmaceutical industry.
Mastery of cGMPs and the know how to work and manage within a regulatory environment.
Proven experience in successful execution and management of process technical transfer.
Experience in designing and executing process and equipment validation plans.
Experience in the design, modification and optimization of biologics purification unit operations.
Strong experience in investigating process deviations and developing issue resolving CAPAs.
Proven project management skills that include leading cross functional teams and effectively balancing project assignments with other duties.
Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
Excellent verbal & written communications skills.
Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
Strong communication and technical writing skills are required.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502174.
Estimated Salary: $20 to $28 per hour based on qualifications.
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