Engineer Upstream
Serves as a process technical lead and subject matter expert to large scale cell culture and harvest unit operations for the commercial manufacture of biopharmaceuticals at Devens.
This position offers the opportunity to provide strong and highly visible leadership of cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
The successful candidate will be key contributor to a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles, and delivering results within project timelines and will build and maintain effective collaborations with Manufacturing, Manufacturing Support, Quality Assurance, Analytical and Global Regulatory Sciences groups.
Strong communication and technical writing skills are required.
Expertise and experience in the design, control, and operation of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations are required.
Demonstrated skills in cross-functional partnerships, leading cross-functional teams and knowledge of regulatory and cGMP requirements are required.
o Provides technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls and preparation of regulatory filings.
o Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures.
o Leads process technology transfer, process validation and the preparation of CMC documentationfor regulatory filings for BMS Devens Large Scale Cell Culture facility.
o Leads cross functional team (Manufacturing, QA, QC, Regulatory, Supply Chain, etc) for process improvement implementations, new product start-ups or other process changes at BMS-LSCC facility.
o Evaluates process performance by comparing manufacturing data to historical data from other sites reports variances to management with recommendations for process enhancement.
o Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing upstream process o Participates in the preparation of regulatory filing documents and inspection readiness.
o Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Devens site.
Qualifications o B.
S.
, in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
Graduate education through M.
S.
or Ph.
D.
is desired.
o Minimum BS or equivalent with a minimum 6-8 years BMS/ relevant experience, MS or equivalent with minimum of 4-6 years BMS/ relevant experience, Ph.
D.
entry level in Scientific discipline with 0-2 years of relevant experience in upstream manufacturing technical support or upstream process development in the biopharmaceutical industry.
o Mastery of SOPs, cGMPs and the know how to work and manage within a regulatory environment.
o Proven experience in successful execution and management of process technical transfer.
o Experience in designing and executing process and equipment validation plans.
o Experience in the design, modification and optimization of biologics cell culture unit operations.
o Strong experience in investigating process deviations and developing issue resolving CAPAs.
o Proven project management skills that include leading cross functional teams and effectively balancing project assignments with other duties.
o Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
o 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.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502297.
Estimated Salary: $20 to $28 per hour based on qualifications.
This position offers the opportunity to provide strong and highly visible leadership of cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
The successful candidate will be key contributor to a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles, and delivering results within project timelines and will build and maintain effective collaborations with Manufacturing, Manufacturing Support, Quality Assurance, Analytical and Global Regulatory Sciences groups.
Strong communication and technical writing skills are required.
Expertise and experience in the design, control, and operation of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations are required.
Demonstrated skills in cross-functional partnerships, leading cross-functional teams and knowledge of regulatory and cGMP requirements are required.
o Provides technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls and preparation of regulatory filings.
o Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures.
o Leads process technology transfer, process validation and the preparation of CMC documentationfor regulatory filings for BMS Devens Large Scale Cell Culture facility.
o Leads cross functional team (Manufacturing, QA, QC, Regulatory, Supply Chain, etc) for process improvement implementations, new product start-ups or other process changes at BMS-LSCC facility.
o Evaluates process performance by comparing manufacturing data to historical data from other sites reports variances to management with recommendations for process enhancement.
o Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing upstream process o Participates in the preparation of regulatory filing documents and inspection readiness.
o Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Devens site.
Qualifications o B.
S.
, in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
Graduate education through M.
S.
or Ph.
D.
is desired.
o Minimum BS or equivalent with a minimum 6-8 years BMS/ relevant experience, MS or equivalent with minimum of 4-6 years BMS/ relevant experience, Ph.
D.
entry level in Scientific discipline with 0-2 years of relevant experience in upstream manufacturing technical support or upstream process development in the biopharmaceutical industry.
o Mastery of SOPs, cGMPs and the know how to work and manage within a regulatory environment.
o Proven experience in successful execution and management of process technical transfer.
o Experience in designing and executing process and equipment validation plans.
o Experience in the design, modification and optimization of biologics cell culture unit operations.
o Strong experience in investigating process deviations and developing issue resolving CAPAs.
o Proven project management skills that include leading cross functional teams and effectively balancing project assignments with other duties.
o Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
o 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.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502297.
Estimated Salary: $20 to $28 per hour based on qualifications.
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