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Formulation Scientist Resume Samples
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6-10 years of experience
Designed and executed formulation development, process development, process optimization, and stability protocols.
- Provided scale-up and tech transfer support to commercial manufacturing facilities through process validation and subsequent manufacturing activities.
- Authored module 3 CTD sections for 2 ANDA filings.
- Identified that dissolution variance leading to stage 2 testing correlated to tablet hardness and implemented proper control strategy prior to transferring to CMO.
- Identified root cause of blend non-homogeneity at CMO and implemented proper control strategies.
0-5 years of experience
Designed nutrient formulations based on customer specifications to meet label claim or target health concern.
- Worked closely with customers to ensure premix compatibility with their end product- assessing product processing conditions, shelf-life requirements, and application.
- Prepared prototype nutrient premixes with flavors and sweeteners to create finished product.
- Researched new ingredients and qualified alternate ingredient suppliers.
- Adjusted and approved production batch sheets before released to manufacturing.
- Generated test plans for finished premixes to establish minimum, target, and maximum specifications.
- Calculated reworks when nutrient analyses of finished product did not meet established limits.
0-5 years of experience
Oversaw process technology transfers between laboratories and external contract manufacturers for a sterile medical device.
- Directed contract laboratories to perform formulation development, process development, and manufacturing activities consistent with overall project timelines, quality and budget.
- Provided expertise and acted as a technical consultant within the company for product development, scale-up and manufacturing.
- Developed formulations and technologies for both parenteral drug products and medical devices in early and late stage development.
- Devised and performed lab scale experiments within internal lab facility.
- Authored reports and summaries of experimental findings and rationale for future work and recommendations including product interactions with glass vials, and high shear mixer scale up development.
- Authored sections of design history file, including design specification, verification and transfers for a medical device.
0-5 years of experience
Researched and studied the chemical properties of production materials, including polymers and film forming aids. Determined ways to strengthen or combine materials and developed new materials with new or specific properties for use in a variety of products and applications. Coated newly developed formulations on both extrusion and solvent castings machines.
- Planned laboratory experiments to confirm feasibility of processes and techniques used in the production of materials having special characteristics.
- Conferred with customers to determine how to tailor materials to their needs.
- Conducted research on the properties of materials and polymers to obtain information that could be used to develop new products or enhance existing ones.
- Devised testing methods to evaluate the effects of various conditions on particular materials.
- Determined ways to strengthen or combine materials or develop new materials with new or specific properties for use in a variety of products and applications.
- Recommended materials for reliable performance in various environments.
- Visited or communicated with suppliers of materials or users of products to gather specific information.
0-5 years of experience
Reviewed clinical research data and final reports, perform audits and provide written reports of findings write and review SOPs.
- Participated in creation/revision of SOPs related to clinical study activities.
- Oversaw the development of validation programs (IQ/OQ/PQ).
- Reviewed and approved Validation Protocols and Reports.
- Monitored tableting, blending, granulation, coating, analytical testing, and data analysis in the product and process optimization phases of the product development cycle.
- Recommended changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.
- Reviewed and monitored stability data on new and reformulated products.
- Performed Internal Quality Audits and provide support in handling audits by External Auditing Agencies.
0-5 years of experience
Managed project teams to finish an osmotic pump formulation development.
- Managed project teams to optimized process development and scale up a multiple-unit controlled release pellets formulation.
- Participated in evaluation and investigation of 2 controlled release process parameters optimization.
- Participated in evaluation and investigation of 1 ANDA formulations bioequivalence studies
0-5 years of experience
Planned and conducted feasibility and research activities for development of formulations and processes of nasal delivery products intended for their systemic actions. Formulations were carried through scale-up and transferred to production.
- Designed and developed different formulations for in vivo animal studies.
- Developed nasal formulations and prepared several batches under GLP and cGMP for preclinical and clinical studies.
- Reformulated a commercial nasal product which improved systemic absorption and patients’ compliance. Patent was awarded for the formulation.
- Initiated spray characterization studies of nasal sprays by use of Malvern Instruments for droplet size distribution and SprayVIEW
- Evaluated and recommended spray devices suitable for nasal spray formulations.
0-5 years of experience
Managed project teams to finish an osmotic pump tablet formulation development.
- Managed project teams to optimized process development and scale up a multiple-unit controlled release pellets formulation.
- Participated in evaluation and investigation of 2 controlled release process parameters optimization.
- Participated in evaluation and investigation of 1 ANDA formulations bioequivalence studies.
0-5 years of experience
Performed late stage formulation/process development for solid oral and sterile dosage forms.
- Applied QbD and PAT to formulation/process development.
- Prepared pilot scale batches of immediate release tablets.
- Developed optimal high shear wet granulation and fluid bed granulation processes.
- Characterized batches to identify formulation/process variables affecting product critical quality attributes.
- Evaluated parenteral formulation stability and excipient/container closure compatibility.
- Coordinated activities with various departments such as analytical, regulatory, quality control, API manufacturing.
0-5 years of experience
Responsible for the pharmaceutical formulation development work
- Analyzed pharmacokinetic data and formulations properties
- Characterized pharmaceutical components and drug substances prior to formulation
- Manufactured laboratory, pilot and production batches, conducted experiments, including experimental design, data collection/summary and interpretation
- Executed troubleshooting work in support of the manufacturing operations
0-5 years of experience
Managed and developed new generic formulations and process for solid dosage forms for immediate/sustained release tablets.
- Processed optimization and scale up for plain and film coated tablets.
- Promoted to manage the daily operation of Product Development department.
- Handled development of several generic products for ANDA submission.
- Optimized process for scale up batches.
- Improved existing product line.
- In charge of troubleshooting of commercial batches.
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Formulation Scientist
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
