Anna M. Peck

Anna M. Peck Email and Phone Number

Senior Manager | Quality | Biotech | Pharma | CMC Strategy | Raw Materials | Early Phase | Clinical | Commercial @ ElevateBio
waltham, massachusetts, united states
Anna M. Peck's Location
Greater Boston, United States
About Anna M. Peck

Passionate Biopharma Leader Seeking Mid-Senior Level Leadership RoleGreetings! I am a results-driven professional with a background in the biotech and pharmaceutical industry, with experience working in both Technical Development and Quality, poised for a mid-senior level leadership role where I can leverage my expertise in supporting career development and contribute to the success of a dynamic CMC organization.Professional Journey:I bring a wealth of experience, having played a pivotal role at Moderna in the development of SPIKEVAX. As an employee from pre- to post-pandemic I was able to help move a product from IND filing to Emergency Use and then Commercial. This helped me develop skills in managing clinical programs in both early phase and late phase and see the impacts clinical strategy has on commercial products. My journey also includes valuable insights gained as a QC Chemist at other pharma companies such as Sandoz, CIL, and Akorn.Leadership and Mentorship:To me, leadership involves supporting and mentoring others to help them reach their full potential and, in turn, achieve excellence in their work. My leadership style is rooted in collaboration, empowerment, and a commitment to excellence.Key Strengths:Strategic Planning: Adept at developing and executing strategic initiatives.• developed a risk-based strategy for Raw material control.• Assuring a unified analytical strategy across multiple early-phase programs while maintaining compliance with various regulatory authorities like FDA, Swiss Medic, TGA, and EMA. • Also supported completion of various Change controls in eQMS.Ensure Quality: Managed training across multiple lab-based and administrative Quality Control teams.• Established and upheld a GMP-compliant environment through the formulation of role-based training programs, coupled with meticulous tracking of training completion to ensure adherence to regulatory standards and inspection readiness across multiple QC teams.• Created SOPs and completed the approval process in Veeva.Technical Proficiency: Strong foundation in QC chemistry, coupled with a keen understanding of biopharmaceutical processes which enables the creation of platform specifications. • Detailed investigations for OOS based on root cause analysis to enable efficient CAPAs.• Analyze data to ensure the creation of process-relevant specifications based on aligned CMC strategy. • Use AI to speed up brainstorming and simplify administrative tasksLet's connect! I am excited about bringing my skills and passion to a new leadership challenge.

Anna M. Peck's Current Company Details
ElevateBio

Elevatebio

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Senior Manager | Quality | Biotech | Pharma | CMC Strategy | Raw Materials | Early Phase | Clinical | Commercial
waltham, massachusetts, united states
Website:
elevate.bio
Employees:
123
Anna M. Peck Work Experience Details
  • Elevatebio
    Senior Manager Commercial Readiness, Quality
    Elevatebio Jul 2024 - Present
    Waltham, Massachusetts, United States
  • Moderna
    Manager, Quality Control, Raw Materials
    Moderna May 2022 - Dec 2023
    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.
  • Moderna
    Manager, Quality Control, Training
    Moderna Nov 2021 - May 2022
    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.
  • Moderna
    Principle Research Associate, Analytical Development
    Moderna Oct 2017 - Nov 2021
    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.
  • Cambridge Isotope Laboratories, Inc
    Quality Control Analyst
    Cambridge Isotope Laboratories, Inc Jan 2017 - Oct 2017
    Tewksbury, Massachusetts
    Quality control testing for enriched Urea and other products.
  • Akorn, Inc
    Chemist I
    Akorn, Inc Oct 2015 - Sep 2016
    • 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.
  • Akorn, Inc
    Qc Technician
    Akorn, Inc Jun 2015 - Sep 2016
    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.
  • Opx Biotechnologies, Inc.
    Senior Research Associate
    Opx Biotechnologies, Inc. Apr 2014 - Dec 2014
    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.
  • Opx Biotechnologies, Inc.
    Research Associate
    Opx Biotechnologies, Inc. Apr 2013 - Apr 2014
    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.
  • Opx Biotechnologies, Inc.
    Laboratory Research Assistant
    Opx Biotechnologies, Inc. Oct 2012 - Apr 2013
    Boulder, Co
  • Opx Biotechnologies, Inc.
    Lab Support Technician
    Opx Biotechnologies, Inc. Oct 2011 - Nov 2012
    Boulder, Co
    • Managed lab supplies and prepared media for use in several different groups.• Trained part time employees and maintained all glassware.
  • Sandoz
    Qc Chemist
    Sandoz Mar 2010 - Mar 2011
    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.
  • Physical Science Library, Cornell University
    Library Assistant At Circulation Desk
    Physical Science Library, Cornell University Sep 2008 - May 2009
    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.
  • Boyce Thompson Institute
    Research Assistant
    Boyce Thompson Institute May 2008 - Aug 2008
    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.
  • Cornell Dining, Cornell University
    Student Manager
    Cornell Dining, Cornell University Feb 2007 - May 2008
    Oversaw employee scheduling, hiring and promotions of part-time and student employees and the running of programs within the dining hall.
  • Cornell University
    Research Assistant
    Cornell University May 2007 - Aug 2007
    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.

Anna M. Peck Education Details

Frequently Asked Questions about Anna M. Peck

What company does Anna M. Peck work for?

Anna M. Peck works for Elevatebio

What is Anna M. Peck's role at the current company?

Anna M. Peck's current role is Senior Manager | Quality | Biotech | Pharma | CMC Strategy | Raw Materials | Early Phase | Clinical | Commercial.

What schools did Anna M. Peck attend?

Anna M. Peck attended Cornell University.

Who are Anna M. Peck's colleagues?

Anna M. Peck's colleagues are Kaya Cormier, Emily Sinclair, Jake Hodge, David Bourgeois, Bethany Walker, Do Kim, David Lewis, Csp, Sms.

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