Experience

Viridian Therapeutics, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Quality Operations Manager

  • Nov 2022 - Present

  Waltham, Massachusetts, United States



Repertoire Immune Medicines

• United States
• Biotechnology Research
• 1 - 100 Employee

• Sr. Quality Operations Manager

  • Mar 2022 - Nov 2022

  Cambridge, Massachusetts, United States

• Quality Operations Manager

  • Sep 2020 - Mar 2022

  Cambridge, Massachusetts, United States • Quality oversight for GMP manufacturing from raw materials through product shipment to clinical sites • Batch disposition for patient manufacturing: o Review of CMO manufacturing batch records, QC test methods, and EM data o Review of CMO deviations related to batch release, approval of major and critical deviations o Generation of final CoA and disposition memo • Perform vendor qualification activities including audits (on-site and remote), audit report generation, review and… Show more • Quality oversight for GMP manufacturing from raw materials through product shipment to clinical sites • Batch disposition for patient manufacturing: o Review of CMO manufacturing batch records, QC test methods, and EM data o Review of CMO deviations related to batch release, approval of major and critical deviations o Generation of final CoA and disposition memo • Perform vendor qualification activities including audits (on-site and remote), audit report generation, review and drafting of Quality Agreements, management of AVL • Support Trackwise Digital implementation o Configuration of the following modules: Document Management System, Training Management System, Quality Management System (Deviation, CAPA, Change Control, Audits), Supplier Quality Management System (Vendors, SCARs) o Incorporation of ComplianceWire e-learning modules within Trackwise TMS o Review and approval of validation protocols, URS/FS • Quality review and closure of deviation, CAPAs, change controls, and OOS. • Management of manual trackers for master controlled documents, QMS, training, disposition • Lead Quality Management Reviews, Material Review Board • Development and/or review of policies to support GMP operations including Quality Manual, Stability Policy, Specification Policy, Quality Roles & Responsibilities • Documentation Control activities (paper-based) – manage workflow for new, revised and obsolete controlled documents including SOPs, work instructions, protocols, reports, policies. • Support review of IND amendment submissions



EyePoint Pharmaceuticals

• United States
• Biotechnology Research
• 1 - 100 Employee

• Quality Assurance Associate II

  • Jun 2019 - Sep 2020

  Watertown, Massachusetts, United States • Perform review and approval of batch related documentation (in-process and finished goods batch records, QC testing method packets, external testing results, CoAs, inventory accountability) as part of lot disposition • Perform review of CMO batch records and CoA to support lot disposition. • Quality review and closure of Quality System activities such as deviations, CAPAs, change controls, MER, OOS, OOT, and EAR. • Tracking of QMS logs… Show more • Perform review and approval of batch related documentation (in-process and finished goods batch records, QC testing method packets, external testing results, CoAs, inventory accountability) as part of lot disposition • Perform review of CMO batch records and CoA to support lot disposition. • Quality review and closure of Quality System activities such as deviations, CAPAs, change controls, MER, OOS, OOT, and EAR. • Tracking of QMS logs, documentation system, training • Support implementation of Quality System improvements • Responsible for day-to-day Quality Operations support including line clearance, cleaning verification, in-process and final product inspections, AQL • Responsible for raw material review, approval and release • Provide support for regulatory inspection and internal audits including support of War Room and preparation of document requests and review of response letters • Oversight of training for employees (electronic and paper-based) – uploading content and creating courses in SABA Lab Management Software (LMS) System and issuing training forms. • Documentation Control activities – manage workflow for new, revised and obsolete controlled documents including SOPs, test methods, raw material specifications, protocols and reports. Issuance of batch records, test methods, and protocols. On-site scanning and archival of executed GMP documents. • Work with cross-functional groups to ensure proper support and systems to achieve compliance when performing daily functions. Show less



Brammer Bio

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Specialist, Quality Control

  • Oct 2018 - Jun 2019

  Cambridge, MA • Manage external contract testing for five+ client projects, including release and in-process testing of engineering and GMP production lots of drug substance, drug product, master and working cell banks. Also includes protocol studies such as buffer and media hold studies for media expiry extension o Develop internal sampling plans utilizing USP and FDA regulatory guidance, create product specifications, obtain quotes from contract testing… Show more • Manage external contract testing for five+ client projects, including release and in-process testing of engineering and GMP production lots of drug substance, drug product, master and working cell banks. Also includes protocol studies such as buffer and media hold studies for media expiry extension o Develop internal sampling plans utilizing USP and FDA regulatory guidance, create product specifications, obtain quotes from contract testing labs (CTLs), complete test submission/hazard/questionnaire forms, and coordinate shipments with Supply Chain o Weekly client-interface and CTL meetings o Manage tracker/schedule of testing status for each project o Review method development, validation protocols, and data reports o Assays outsourced include host cell identity, extractable volume, adventitious viruses, qPCR assays, sterility, bioburden, endotoxin, mass spectrometry, mycoplasma, mycobacteria • Author change controls and performed impact assessments. Initiate deviations, CAPAs and perform investigations using 6M root cause analysis, and developed hypothesis testing protocols to evaluate for OOS results • Develop raw material specifications for compendial and non-compendial materials, with knowledge of USP-NF/EP monographs • Work with other departments to establish MSA/CDAs with CTLs

• Specialist, Quality Control

  • May 2018 - Oct 2018

  Cambridge, MA • Manage external contract testing for multiple client projects including release and characterization testing for master/working cell and viral banks of adherent and suspension human (HeLa, HEK293, HEK293F), primate (vero), murine (BHK), and insect (Sf9) cell lines o Includes developing sampling plans, product specifications, coordination with CTLs, submission of testing forms o Assays include mycoplasma, spiroplasma, TEM… Show more • Manage external contract testing for multiple client projects including release and characterization testing for master/working cell and viral banks of adherent and suspension human (HeLa, HEK293, HEK293F), primate (vero), murine (BHK), and insect (Sf9) cell lines o Includes developing sampling plans, product specifications, coordination with CTLs, submission of testing forms o Assays include mycoplasma, spiroplasma, TEM, F-PERT/Q-PERT, human/simian virus panels, co-cultivation for retrovirus detection, in vitro and in vivo adventitious agents • Review method feasibility/development and validation of ID tests for non-compendial raw materials: media and buffers • Quality Systems – change controls, deviations, CAPAs

• QC Technical Writer

  • Apr 2017 - May 2018

  Cambridge, MA • Process documents for QC via manual and electronic (EtQ) systems – SOPs, work instructions, forms, raw material specifications, release specifications, test records for cell viability/cell growth • Ensure procedures, polices and documentation meet Brammer Bio and cGMP regulatory standards • Developed site Vi-Cell Assay Qualification from bridged study and created Sample Suitability addendum protocols for different cell lines per client • Interim outsource… Show more • Process documents for QC via manual and electronic (EtQ) systems – SOPs, work instructions, forms, raw material specifications, release specifications, test records for cell viability/cell growth • Ensure procedures, polices and documentation meet Brammer Bio and cGMP regulatory standards • Developed site Vi-Cell Assay Qualification from bridged study and created Sample Suitability addendum protocols for different cell lines per client • Interim outsource manager from Jan to Jun 2018 - planned and coordinated release testing of 8+ cell banks for multiple client projects at CTLs, and for 30+ raw materials • Responsible for planned variances, deviations, and change controls associated with raw materials, cell banking, test record execution, and outsource testing



Things Remembered

• United States
• Retail
• 700 & Above Employee

• Engraver

  • Apr 2007 - Jul 2017

  Warwick, Rhode Island Interim manager – manager on duty, allocating tasks, communicating store goals and key events to other employees, checking emails and company newsletter/updates, and resolving any customer and production issues Weekly/monthly machine maintenance including resetting laser, cleaning machine components, and checking inventory on workholders, engraving cutters, and machine parts Production lead - train new employees on engraving and production skills, communicate production times with… Show more Interim manager – manager on duty, allocating tasks, communicating store goals and key events to other employees, checking emails and company newsletter/updates, and resolving any customer and production issues Weekly/monthly machine maintenance including resetting laser, cleaning machine components, and checking inventory on workholders, engraving cutters, and machine parts Production lead - train new employees on engraving and production skills, communicate production times with the manager on sales floor Main engraver during busy seasons, usually running two or three machines simultaneously Show less