Overview
Work History
Timeline
Sonia Singh

Sonia Singh

Belmont,MA

Overview

17
17
years of professional experience

Work History

Senior Manager, CMC, Drug Product

Xenon Pharmaceuticals Inc.
Burnaby, Canada
05.2024 - 01.2025
  • Technical oversight of drug product manufacturing operations of XEN1101 (Azetukalner) at external manufacturing site (CMO)
  • Project Manager for XEN1101 (Azetukalner) responsible for setting agenda for weekly meetings with CMO, facilitating weekly joint meetings with CMO and internal team (Quality, QC, Supply Chain, Manufacturing and Finance), maintained manufacturing timelines and activities (for clinical and registration lots), assessed and mitigated potential risks to manufacturing plan
  • Support the process development and optimization of XEN1101 (Azetukalner) drug product currently in Phase 3 development
  • Manage pre-commercial manufacturing activities for XEN1101 drug product (registration batch manufacture, FMEA, process risk assessment, process improvement, and scale-up)
  • Technical review of development protocols and reports, data tracking and trending
  • Support clinical (CTM) batch manufacture at external manufacturing site
  • Responsible for technical review and updates to Master Batch records and responsible for technical review of release records
  • Liaise with external partners and internal stakeholders such as Quality, Quality Control, and Supply Chain/Logistics to ensure manufacturing for XEN1101 drug product were executed according to cGMP
  • Technical operations lead on manufacturing deviations and investigations
  • Partnered closely with Quality to ensure on-time batch release

Senior Manager, Pharmaceutical Development, Drug Product

Ipsen Pharmaceuticals
Cambridge, USA
03.2023 - 05.2024
  • Member of pharmaceutical development team supporting multiple, legacy clinical programs
  • Supported the internal transfer of Bylvay drug product manufacturing from Albireo technical operations to Ipsen technical services after merge, ensuring no risk to commercial supply
  • Led formulation development and process optimization of small-molecule candidates in early-stage development at qualified CDMOs
  • Attended GMP manufacturing campaigns

Senior Manager, Commercial Drug Product Manufacturing

Albireo Pharma
Boston, USA
02.2022 - 03.2023
  • Technical oversight of commercial drug product manufacturing operations of Bylvay (Odevixibat) at external manufacturing site (CMO)
  • Supported forward demand projection of drug products, identifies potential supply risks, and supports developing/implementing timely backup
  • Managed commercial forecast at qualified CMOs to assure adherence to the agreed supply plan
  • Led backup drug product supplier identification and qualification, based on supply risk assessments
  • Authored RFIs and RFPs, reviewed responses and documented vendor selection recommendation after comparative assessment of strengths and weaknesses
  • Collaborated with CMO and/or Pharmaceutical Development to assess potential drug product process improvements prior to implementation
  • Led and managed change implementation, under corporate change control system

Senior Manager, Technical Operations, Drug Product Development

Dicerna Pharmaceuticals
Cambridge, USA
10.2018 - 01.2022
  • Managed aseptic fill-finish of multiple early to late-stage clinical siRNA programs at external drug product manufacturing sites both domestic and international
  • Technical review of drug product batch production records, review and resolution of manufacturing deviations and investigations
  • Work across multiple departments (Quality, QC, Supply chain and logistics) to ensure the timely production and release of clinical trial material
  • SME review of Master Service Agreements, Quality Agreements, and RFPs
  • Support the selection and development of a combination product (Pre-Filled Syringe) for a Phase III candidate (Nedosiran)
  • Support drug product validation activities for Nedosiran including registration stability lots for both vials and pre-filled syringes, review of validation protocols and reports and process evaluation batches vials and PFS
  • Managed the successful execution of process performance qualification (PPQ) batches for Nedosiran vials and pre-filled syringes at CMO
  • Support Nedosiran NDA (Module 3 Drug Product)
  • Primary technical contact for all drug product manufacturing and Person in plant during production
  • SME for new drug product site selection, responsible for all technical transfer activities between sites

Senior Manager, Supply Chain Operations

Lyndra
Watertown, USA
05.2018 - 10.2018

Senior Manager, External Manufacturing Assembly, Label and Packaging

Biogen
Cambridge, USA
04.2017 - 07.2017

Senior Manager, Commercial Supply and Manufacturing Operations

Takeda Pharmaceuticals International Co.
Cambridge, USA
04.2013 - 03.2017
  • Supports routine commercial manufacture of sterile injectable (antibody-drug conjugate) and solid oral dose products at both domestic and international CMOs
  • Maintained operational and business activities with drug product manufacturing and packaging sites including vendor management, logistics and planning
  • Collaborates with internal and external QA, QC, RA and technical operations groups to ensure drug product manufacture and finished goods release timelines
  • Working with matrix teams including quality, external vendors and alliance partners to initiate and facilitate to closure relevant manufacturing investigations, deviations and change controls
  • Launch team member for oral oncology programs collaborating with commercial marketing and operations group for strategy on US/Global commercial image, packaging and labeling
  • Packaging validation team leader responsible for determining validation strategy and execution for a solid oral (capsule) oncology product
  • Responsible for generating RFPs, commercial packaging site selection, validation timelines, requisitions/POs/invoices
  • Authoring manufacturing section of new drug application (NDA)
  • Successfully led team in completion of packaging validation for Nilaro (ixazomib citrate) for US launch six months ahead of initial launch timeline
  • Responsible for working with external partners on commercial pack design, child-resistant testing and process qualification and validation
  • Successfully completed packaging validation for Ninlaro (ixazomib citrate) for EUCAN and emerging markets
  • Manages the production of Ninlaro (ixazomib citrate) drug product and finished goods across all global markets including primary packaging for Japan

Research Investigator, Small Molecule Formulation Development

Millennium Pharmaceuticals, The Takeda Oncology Company
Cambridge, USA
07.2009 - 04.2013
  • Technical Expertise
  • Oral solid and lipid-based formulation development of potent small molecules for oncology
  • Utilized solids formulations unit operations: high shear wet granulation, fluid bed dryer, spray dryer, tablet press, encapsulation, roller compactor, co-mill, and coater
  • Managed physical testing equipment: hardness tester, friability tester, disintegration tester, shear cell tester, BET, laser diffraction particle size tester, and SEM
  • Formulated experimental design and statistical analysis

Pharmaceutical Development, Senior Research Associate

TransTech Pharma
High Point, USA
03.2008 - 06.2009
  • Preparation of lab scale batches of prototype liquid and solid capsule formulations of novel small molecule drug candidates
  • Familiar with the use of various methodologies including wet granulation, spray drying, and nano-milling
  • Analytical support for Phase 1 and Phase 2 clinical formulations including dissolution, dissolution method development, and stability testing of formulations as well as drug substances
  • Development of analytical methods for small molecule discovery candidates as well as prototype formulations
  • Transferring formulation and manufacturing technology to contract research facilities (CRO)
  • Collaborating with CRO’s for analytical as well as formulation method validation

Timeline

Senior Manager, CMC, Drug Product - Xenon Pharmaceuticals Inc.
05.2024 - 01.2025
Senior Manager, Pharmaceutical Development, Drug Product - Ipsen Pharmaceuticals
03.2023 - 05.2024
Senior Manager, Commercial Drug Product Manufacturing - Albireo Pharma
02.2022 - 03.2023
Senior Manager, Technical Operations, Drug Product Development - Dicerna Pharmaceuticals
10.2018 - 01.2022
Senior Manager, Supply Chain Operations - Lyndra
05.2018 - 10.2018
Senior Manager, External Manufacturing Assembly, Label and Packaging - Biogen
04.2017 - 07.2017
Senior Manager, Commercial Supply and Manufacturing Operations - Takeda Pharmaceuticals International Co.
04.2013 - 03.2017
Research Investigator, Small Molecule Formulation Development - Millennium Pharmaceuticals, The Takeda Oncology Company
07.2009 - 04.2013
Pharmaceutical Development, Senior Research Associate - TransTech Pharma
03.2008 - 06.2009

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Sonia Singh