Brittany Norman Email and Phone Number
Senior Process Engineer II - Viral Vector Global MSAT at Bristol Myers Squibb at
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Bristol Myers Squibb
Brittany Norman's Location
Lynnwood, Washington, United States, United States
Brittany Norman's Contact Details
Brittany Norman work email
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Brittany Norman personal email
n/a
About Brittany Norman
Experienced Process Engineer with a demonstrated history of working in the pharmaceuticals industry. Skilled in cGMP, Aseptic Processing, Communication, and Teamwork. Experience supporting Technology Transfer Activities and Process Performance Qualifications (PPQ). Experience working with and supporting Contract Manufacturing Organizations (CMOs) virtually and in person.
Brittany Norman's Current Company Details
Bristol Myers Squibb
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Senior Process Engineer II - Viral Vector Global MSAT at Bristol Myers Squibb
Brittany Norman Work Experience Details
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Senior Process Engineer Ii - Viral Vector Global MsatBristol Myers Squibb Apr 2022 - PresentLawrence Township, Nj, Us• Supported and/or co-led four Technology Transfers and Process Performance Qualifications (PPQ) at a CMO and an internal manufacturing site.• Authors and reviews data packages and regulatory filings to support regulatory commitments.• Coordinated and implemented process changes to increase the run rate at a CMO.• Develops and owns multiple change controls to ensure adherent lentiviral vector supply continuity.• Coordinates distribution of action items between MSAT commercial support team members to ensure success of the team and individuals.• Authors and reviews technical assessments in support of deviation investigations and change controls.• Developed and implemented deviation management tools used cross-functionally and at the CMO.
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Process Engineer I - Viral Vector Global MsatBristol Myers Squibb Jun 2021 - Apr 2022Lawrence Township, Nj, Us• Develops and owns change controls to ensure adherent lentiviral vector supply continuity and for continuous improvement.• Coordinates distribution of action items between MSAT commercial support team members to ensure success of the team and individuals.• Authors and reviews technical assessment in support of deviation investigations and change controls.• Developed and implemented deviation management tools used cross-functionally and at the CMO.• Participated in the Kaizen Process and Process Mapping for deviation reduction, increasing run rate at CMO’s, overall process optimizations, and to outsource buffer production.
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Manufacturing Compliance Specialist IiiBristol Myers Squibb Oct 2019 - Jun 2021Lawrence Township, Nj, Us• Managed creation and revision of Commercial Master Batch Records under urgent timelines in support of multiple PLI pre-inspection requests for the commercial launch of a CAR-T immunotherapy in the US, Japan, Canada, and Switzerland.• Owned and implemented actions in response to PLI observations to achieve licensure.• Experience leading and working on cross-functional teams to develop and implement process improvements through change controls and corrective actions & preventative actions (CAPAs).• Experience representing Manufacturing at L2 and L3 Governance Teams.• Utilizing advanced technical writing skills to initiate, investigate, and perform root cause analyses for minor, major, and critical process deviations.• Revising Master Batch Records (MBRs) and Standard Operating Procedures (SOPs) to close identified gaps in procedures.
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Manufacturing Compliance Specialist IiBristol Myers Squibb Sep 2018 - Sep 2019Lawrence Township, Nj, Us• Managed creation and revision of Commercial Master Batch Records under urgent timelines in support of multiple PLI pre-inspection requests for the commercial launch of a CAR-T immunotherapy in the US, Japan, Canada, and Switzerland.• Owned and implemented actions in response to PLI observations to achieve licensure.• Experience leading and working on cross-functional teams to develop and implement process improvements through change controls and corrective actions & preventative actions (CAPAs).• Experience representing Manufacturing at L2 and L3 Governance Teams.• Utilizing advanced technical writing skills to initiate, investigate, and perform root cause analyses for minor, major, and critical process deviations.• Revising Master Batch Records (MBRs) and Standard Operating Procedures (SOPs) to close identified gaps in procedures.
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Manufacturing Associate IiBristol Myers Squibb Feb 2018 - Sep 2018Lawrence Township, Nj, Us• Experience leading and working on cross functional teams to develop, implement, and document process improvements through change controls.• Utilizing advanced technical writing skills to initiate, investigate, and perform root cause analyses for minor and major process deviations.• Qualified trainer on all manufacturing operations and reviewing of Master Batch Records (MBR).• Revising Standard Operating Procedures (SOP) to close identified gaps in procedures.• Update and inform shift on process impacting changes and procedures.• Utilized aseptic techniques in an ISO5 BSC (Biological Safety Cabinet) to manipulate cellular material per SOP and MBR. • Perform maintenance activities on equipment per procedure.• Operate Bio Processing Equipment to formulate patient specific drug product including: Sepax, CliniMACS, Controlled Rate Freezers, Xuri Bioreactors, Class I/II BSC.
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Manufacturing Associate IBristol Myers Squibb Dec 2016 - Feb 2018Lawrence Township, Nj, Us• Utilized aseptic techniques in an ISO5 BSC (Biological Safety Cabinet) to manipulate cellular material per SOP and MBR. • Utilized technical writing skills to initiate, investigate, and perform root cause analyses for minor process deviations.• Operated Bio Processing Equipment to formulate patient specific drug product including but not limited to: Sepax, CliniMACS, Controlled Rate Freezers, Xuri Bioreactors, and Class I/II BSC.• Performed preventative maintenance activities on equipment per procedure.
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Laboratory Teaching AssistantSeattle Pacific University Sep 2015 - Dec 2016Seattle, Wa, Us• Prepared solutions and materials for lab classes• Assisted professors and faculty members with lab sections and grade lab reports -
Undergraduate Research AssistantSeattle Pacific University Sep 2015 - Jul 2016Seattle, Wa, Us• Quantified levels of nitrite in store-bought bacon• Actively troubleshoot issues and designed reports to communicate results• Helped develop necessary procedures to ensure better efficiency and accuracy
Brittany Norman Skills
Problem Solving
Communication
Close Attention To Detail
Team Leadership
Teamwork
Positive Team Player
Organization And Prioritization Skills
Aseptic Processing
Gmp
Deviation Management
Gdp
Reliable
Trustworthy
Brittany Norman Education Details
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Seattle Pacific UniversityChemistry
Frequently Asked Questions about Brittany Norman
What company does Brittany Norman work for?
Brittany Norman works for Bristol Myers Squibb
What is Brittany Norman's role at the current company?
Brittany Norman's current role is Senior Process Engineer II - Viral Vector Global MSAT at Bristol Myers Squibb.
What is Brittany Norman's email address?
Brittany Norman's email address is br****@****ics.com
What schools did Brittany Norman attend?
Brittany Norman attended Seattle Pacific University.
What are some of Brittany Norman's interests?
Brittany Norman has interest in Science And Technology, Children, Chemistry Dance Arts Reading, Health.
What skills is Brittany Norman known for?
Brittany Norman has skills like Problem Solving, Communication, Close Attention To Detail, Team Leadership, Teamwork, Positive Team Player, Organization And Prioritization Skills, Aseptic Processing, Gmp, Deviation Management, Gdp, Reliable.
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