(908) 555-0139 ◇ Bridgewater, NJ
meera.sundaram@example.com ◇ linkedin.com/in/meera-sundaram ◇ meerasundaram.com
Pharmaceutical scientist with 8 years in formulation development and drug product manufacturing, currently a senior scientist leading oral solid dosage formulation for a mid-size pharmaceutical company with 12 marketed products. Led formulation for 3 products through regulatory approval including a modified-release tablet now generating $180M a year, cut development timelines 30% through a quality-by-design platform, and holds a 0 critical observation record across 6 regulatory inspections. Manages a lab team of 6 and about $2.4M in annual development budget. Develops medicines that can be made the same way 10 million times, because a formulation that only works once is an experiment, not a product.
Dissertation on modified-release matrix systems for poorly soluble compounds. Coursework in Pharmaceutics, Biopharmaceutics, Solid State Chemistry, and Statistical Design of Experiments.
Coursework in Pharmaceutical Chemistry, Pharmacology, Dosage Form Design, and Pharmaceutical Analysis. Also completed a quality-by-design certification in 2019.
- Lead oral solid dosage formulation for a pharmaceutical company with 12 marketed products and 8 development programmes, managing a lab team of 6 and a $2.4M annual development budget.
- Led formulation for 3 products through regulatory approval including a modified-release tablet now generating $180M a year, with 0 major deficiencies in chemistry, manufacturing, and controls sections across 3 submissions.
- Cut development timelines 30% through a quality-by-design platform with standardised design of experiments, and hold a 0 critical observation record across 6 regulatory inspections.
- Developed formulations for 5 generic and 2 new chemical entity programmes over 3.75 years, with 4 reaching commercial manufacture.
- Led technology transfer of 3 products to 2 contract manufacturers with first-batch success on all 3 and 0 batch failures in the first year.
- Resolved a dissolution failure on a marketed product through root cause analysis on 12 batches, avoiding a recall and about $9M in lost sales.
- Published 6 peer-reviewed papers on modified-release systems and presented at 4 conferences during doctoral research.
- Completed a 6-month industry internship developing 2 prototype formulations that entered the company pipeline.
- Received a full-time offer at the end of the 6-month internship based on the prototype formulations.
Modified-Release Tablet Development. Led formulation development for a modified-release tablet from pre-formulation through approval over 3.5 years, screening 40 prototype formulations, running a 6-factor design of experiments on the matrix system, and authoring the chemistry, manufacturing, and controls sections, which was approved with 0 major deficiencies and now generates $180M a year with 0 batch rejections across 90 commercial batches.
Quality-by-Design Platform. Built a formulation development platform with standardised risk assessments, a library of 12 design of experiments templates, a design space documentation standard, and training for 14 scientists, which cut development timelines 30%, cut late-stage formulation changes 70%, and was cited as a strength in 2 regulatory reviews.
Dissolution Failure Investigation. Led a root cause investigation at a previous employer into dissolution failures on a marketed product, analysing 12 batches with solid state characterisation and a supplier audit that identified an excipient particle size shift, and implemented a specification and process control, which avoided a recall, restored supply in 6 weeks, and protected about $9M in annual sales.
- Member of a pharmaceutical scientists association, presenting at the annual meeting in 2022 and 2024.
- Peer reviewer for 2 pharmaceutical science journals, reviewing about 8 manuscripts a year.
- Volunteer mentor for a women in science programme, coaching about 4 graduate students a year.
- Lead a formulation lab team of 6 scientists with project assignment, reviews, and development, with 2 promotions in 3 years.
- Represent formulation development on 4 cross-functional programme teams and present to the research and development leadership team quarterly.
- Trained 14 scientists on the quality-by-design platform and serve as the formulation subject matter expert during regulatory inspections.

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