Experience

ElevateBio

• United States
• Biotechnology Research
• 200 - 300 Employee

• Associate Director - Cell Therapy Manufacturing

  • Oct 2021 - Present

• Manufacturing Manager - Cell Therapy

  • Oct 2020 - Oct 2021



Lonza

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manufacturing Supervisor - Cell and Gene Therapy

  • Aug 2019 - Oct 2020

  Portsmouth, New Hampshire In this role I am accountable for overseeing a 10 person manufacturing team through the tech transfer of a novel Gene Therapy product through clinical readiness to clinical manufacturing at the Lonza Portsmouth Site. This role focuses heavily in clinical manufacturing readiness, supporting fast paced pre-clinical run timelines and working directly with the joint project team to accomplish customer requested goals.

• Aseptic Manufacturing Associate III - Cell & Gene Therapy

  • Jul 2018 - Aug 2019

  Portsmouth, New Hampshire In this role I am responsible for continuing to lead and participate in a multi customer product technical transfer into the Lonza Walkersville, MD site while continuing to meet objective timelines in a fast pace environment moving from non-GMP startup to GMP manufacturing, this includes: - Accountable for leading a technical transfer team consisting of 3-4 operators through the training and transfer of a novel Gene Therapy process into Lonza Walkersville, MD and Portsmouth, NH site.… Show more In this role I am responsible for continuing to lead and participate in a multi customer product technical transfer into the Lonza Walkersville, MD site while continuing to meet objective timelines in a fast pace environment moving from non-GMP startup to GMP manufacturing, this includes: - Accountable for leading a technical transfer team consisting of 3-4 operators through the training and transfer of a novel Gene Therapy process into Lonza Walkersville, MD and Portsmouth, NH site. As a team we develop BOMs, equipment purchase lists, author GMP documents, process descriptions, personnel load, etc. Worked with multiple new operators to develop basic to advanced processing skills including inoculation, 2D cell growth, non-viral transfection, cell morphology, formulation, cryopreservation, etc. Work directly with project management to achieve project milestones and drive operational success. - Continue to lead the Cell Therapy asset safety team lead which includes defining, tracking and performing job hazard analysis on different manufacturing operations to drive a zero incident safety culture. Work to identify safety concerns with the operators on the floor and provide safe solutions. - Participate in multiple CGT transfers within the asset providing oversight of technical operations including aseptic techniques, small scale to large scale processing, equipment operation and production run success.

• Aseptic Manufacturing Associate II - Cell & Gene Therapy

  • Jun 2017 - Jul 2018

  Portsmouth, NH In this role I was responsible for participating in a multi customer product technical transfer into the Lonza Portsmouth, NH site during a large scale multi-cleanroom suite reconstruction while continuing to meet objective timelines in a fast pace environment moving from non-GMP startup to GMP manufacturing, this includes: - Accountable for leading a technical transfer team consisting of 4-6 operators through the training and transfer of a novel Cell Therapy process into Lonza… Show more In this role I was responsible for participating in a multi customer product technical transfer into the Lonza Portsmouth, NH site during a large scale multi-cleanroom suite reconstruction while continuing to meet objective timelines in a fast pace environment moving from non-GMP startup to GMP manufacturing, this includes: - Accountable for leading a technical transfer team consisting of 4-6 operators through the training and transfer of a novel Cell Therapy process into Lonza Portsmouth, NH site. As a team we developed BOMs, equipment purchase lists, authored GMP documents, process descriptions, personnel load, etc. Manufacturing operations included 2D to 3D upstream growth platforms through the use of closed systems & bioreactors, final formation, harvest and cryopreservation.

• Aseptic Manufacturing Associate I - Cell & Gene Therapy

  • Jun 2016 - Jun 2017

  Portsmouth, NH In this role I was responsible for participating in a single customer product technical transfer into Lonza Portsmouth, NH site during an full scale cleanroom facility build out while striving to meet objective timelines in a fast pace environment moving from non-GMP startup to GMP manufacturing, this includes: - Authoring documents and developing quality systems for subjects including cleanroom gowning, biosafety cabinet processing & maintenance, cleanroom aseptic techniques, etc.… Show more In this role I was responsible for participating in a single customer product technical transfer into Lonza Portsmouth, NH site during an full scale cleanroom facility build out while striving to meet objective timelines in a fast pace environment moving from non-GMP startup to GMP manufacturing, this includes: - Authoring documents and developing quality systems for subjects including cleanroom gowning, biosafety cabinet processing & maintenance, cleanroom aseptic techniques, etc. Responsible for driving these quality systems to completion then delivering training to a cross functional operations team of ~60 personnel. - Performed upstream through downstream manufacturing operations on a mammalian-type cell scale up process. - Worked to become an SME on fill/finish activities within downstream processing during a filling operation producing ~70 vials per minute. - Lead the safety team for our Cell Therapy manufacturing asset which included defining, tracking and performing job hazard analysis on different manufacturing operations to drive a zero incident safety culture.

• Quality Control Associate

  • May 2015 - Jun 2016

  - Sampled various raw materials including WFI, soft waters, gas and steam. - Performed routine monitoring of HVAC systems through air viable, total particulate, settling and surface plate samples. - Performed critical monitoring of activities such as taking cells out of freeze, cell culture pooling and product bulk fill. - Executed aseptic qualifications on various groups for work in biosafety cabinets as well as VLFH. - Changed and edited various SOP documents in line with… Show more - Sampled various raw materials including WFI, soft waters, gas and steam. - Performed routine monitoring of HVAC systems through air viable, total particulate, settling and surface plate samples. - Performed critical monitoring of activities such as taking cells out of freeze, cell culture pooling and product bulk fill. - Executed aseptic qualifications on various groups for work in biosafety cabinets as well as VLFH. - Changed and edited various SOP documents in line with current GDP requirements. - Comply daily with GMP and GDP requirements in multiple aspects of the workplace. - Experienced in gowning and aseptic requirements in grade B, C, D cleanrooms.