Anna M. Peck Email & Phone Number

Waltham, Massachusetts, United States

Norwood, Massachusetts, United States

Managed Raw Material Qualification program which included tracking over 50 various materials used in Drug Substance and Drug Product process. Drove work across multiple departments to identify materials for testing, manage internal and external testing, author summary reports, and complete approval process for both material status and various program documents and SOPs. • Authored over 30 material-specific reports for initial qualification and annual requalification.• Authored and updated program documents including the Quality Master Plan for Raw Material Qualification to maintain appropriate phase appropriate Raw Material Control Strategy. • Managed work at External Testing labs for commercial Raw Materials, including Critical Raw Materials which included coordinating cross-functional communication with both internal and external entities. • Completed multiple Investigations for OOS and Deviations for Raw materials.• Designed and constructed presentation slides for Quality Management review to aid in overall CMC development. • Orchestrated the project mapping process for an AI tool, enhancing the efficiency of material evaluation for late-phase programs.

Norwood, Massachusetts, United States

Managed a small team to ensure onboarding and training underwent continuous improvement while working cross-functionally across all QC groups which includes analysts, managers, and various lab support teams. • Revamped the onboarding program to ensure new hires complete their first On-the-Job training within 30 days of hire, a significant improvement from previous timelines that exceeded 2 months. • Simplified bloated trained curriculum and made focused training for GMP practices in QC such as compliance and data integrity. • Created process to track and communicate completed training as well as upcoming critical training to both laboratory teams and quality management.• Ensured all training programs and materials adhered to regulatory requirements and maintained accurate training records for QC personnel.• Delegated an assortment of projects to direct reports.

Greater Boston Area

SPIKEVAX, (COVID19) support (Spring 2020-Fall 2021)Due to project needs, I engaged in multiple cross-functional projects.• Ran Storyboarding sessions for regulatory filing strategy.• Developed training for data verification as well as ran training across Technical Development after successfully training Analytical Development (>50 People).• Managed Data verification work for all Analytical Development regulatory documents and the technical documents that were used to support them. • Consolidated Analytical terminology to create an Analytical glossary which was approved by several groups within Technical Development as well as Quality. • Created an Onboarding checklist to support rapid growth within Analytical development.Raw Material Analytical Development Lead (Spring 2019-Fall-2021)• Developed and Documented Raw Material Qualification strategy.• Authored testing panels for non-compendial Raw materials.• Performed comparisons of Compendial monographs.• Established criteria and testing processes for raw material identification and disposition.• Approved Method validation protocols and reports from a technical perspective for Contract lab testing.• Managed and consolidated technical assessments for raw material deviations and investigations.Early Phase Program Manager ( Fall 2020-Fall 2021)• Managed Analytical development milestones for IND filing.• Trained Analytical Development Leads in early-phase strategy.• Authored relevant regulatory sections.• Reviewed release and stability data to develop specifications for drug substance and drug product.• Presented to Specification committee.Lab-based work: (Fall 2017-Spring 2019)• Ran various assays (HPLC-CAD, HPLC-UV, Beckman Coulter Counter, NTA, Encapsulation by UV) for in-process material, drug substance, and drug product to support development studies. • Authored Clinical In Use protocols and reports for vaccines and therapeutic products. • Performed Clinical In Use studies per protocols.

Tewksbury, Massachusetts

Quality control testing for enriched Urea and other products.

• Test raw materials and finished products in a GMP environment using various wet chemistry techniques.• Verify Research and Development methods to be run in Quality Control.• Run HPLC testing using Chromeleon software as well as processing and reporting of data.• Onboard and train new employees to our various methods and software such as Chromeleon, UV, and FTIR.• Manage and order lab inventory such as solid reagents, liquid reagents, and consumables.

Somerset, New Jersey

I work in a GMP environment doing quality testing on finished products and raw materials including various wet chemistry techniques and HPLC assays.

Bouder, Co

Run Das Gip and Applikon Fermentation systems as well as trouble shoot lab equipment such as YSIs, pH meters, and autoclaves. I also manage the rotating schedule for my group.

Boulder, Co

• Manage BioExpert and Das Gip software during each run as well as check optical density, glucose levels, and methanol levels for each of the 10-30 fermentation tanks. • Created different documents to track inoculation volume, glucose consumption rates, media formulation, and use and restocking of consumable inventory.

Boulder, Co

Boulder, Co

• Managed lab supplies and prepared media for use in several different groups.• Trained part time employees and maintained all glassware.

Worked in Test Specialist group in a GMP environment testing the quality of active pharmaceutical ingredients, excipients, and finished products. Most testing was done using USP methods with some EP. Worked mostly with wet chemistry as well as IR’s, UV’s, and Viscometers. Also took part in an FDA inspection.

Assisted Patrons in using library catalog, finding articles, and using other reference material as well as shelving books and scanning documents as well as directing them to the proper librarian when I could not assist them.

Worked in Frank Schroeder Lab on individual project which consisted of growing two mutant C. elegans strains to track the production of the dauer pheromone in the nematodes through differential analysis by 2-D NMR spectroscopy as well as organized the maintenance of 25 C. elegans strains and plates for heat stress experiments.

Oversaw employee scheduling, hiring and promotions of part-time and student employees and the running of programs within the dining hall.

Worked in Paul Weston’s Lab gathering data on the effects of Imidacloprid on Viburnum Leaf Beetles and Viburnum bushes through analysis of the beetle food consumption UV-VIS spectroscopy of treated leaves experiments. Also took care of specimens.