Biomedical Engineer Scientist

Job Description

Job Description

Job Title: Biomedical Engineer Scientist
Shift: 8am - 5pm
Duration of Assignment: 12 months
We are seeking a skilled and hands-on Scientist or Engineer for a 12-month contract to develop dry-format, liquid-format, and high-throughput screening (HTS) products supporting drug discovery and drug development workflows. The contractor will be responsible for formulating, prototyping, characterizing, and scaling biochemical products across a range of formats, including tablets, mini-tablets, sachets, vials, and 24, 48, 96, and 384 well plates.
The scope of work encompasses biological buffers, biorelevant media, formulation excipients, stability-challenge reagents, LC-MS workflow reagents, biochemical screening matrices, and focused chemical libraries. The ideal candidate will bring a strong foundation in biomedical, biochemical, pharmaceutical, or chemical engineering sciences, combined with practical experience in formulation development, powder processing, tableting, automated solid and liquid dispensing, HTS plate preparation, analytical testing, moisture control, packaging, and stability studies.

Key Responsibilities:
Formulation & Product Development
Develop biochemical products in tablet, mini-tablet, sachet, vial, and HTS plate formats.
Formulate buffers, salts, sugars, amino acids, cofactors, excipients, stabilizers, stress reagents, quench reagents, and related biochemical materials.
Optimize powder flow, blend uniformity, compression parameters, tablet weight, hardness, friability, disintegration, dissolution, and reconstitution performance.
Support dry-plated reagents, liquid formulations, DMSO stocks, formulation-screening matrices, and focused chemical-library formats.

Equipment Operation & Process Development:
Operate or support tablet presses, powder blenders, solid and liquid dispensers, analytical balances, plate-handling equipment, and tablet-testing instruments.
Develop dry and liquid dispensing workflows for 24-, 48-, 96-, and 384-well plates.
Establish plate layouts, dispensing parameters, dose ranges, fill accuracy, precision, uniformity, and in-process controls.

Plate Qualification & Quality Control:
Qualify plate sealing, barcode identification, storage conditions, freeze-thaw exposure (where applicable), shipping, reconstitution, and end-use performance.
Evaluate cross-contamination, carryover, evaporation, edge effects, compound adsorption, solvent compatibility, and plate-to-plate reproducibility.

Analytical & Stability Testing:
Develop analytical methods using techniques such as UPLC/HPLC, LC-MS, UV-Vis, Karl Fischer moisture analysis, pH, conductivity, osmolality, dissolution, and tablet-performance testing.
Design and execute accelerated and real-time stability studies for tablets, dry plates, liquid plates, reagents, and final packaging configurations.
Assess bottles, vials, foil pouches, sachets, desiccants, plate seals, lids, and other moisture- or solvent-barrier packaging systems.

Troubleshooting:
Identify and resolve tableting, dispensing, and plating issues, including poor powder flow, sticking, segregation, content non-uniformity, precipitation, evaporation, carryover, and inconsistent well dosing.

Documentation & Collaboration:
Prepare product specifications, plate maps, batch records, dispensing instructions, analytical protocols, development reports, and manufacturing-transfer documentation.
Collaborate cross-functionally with R&D, Analytical, Manufacturing, Quality, EHS, Product Management, Automation, and internal technical teams.
Expected 12-Month Deliverables
Capability Assessment Evaluate current tableting, blending, dispensing, plating, analytical, stability, packaging, and data-management capabilities.
Standardized Workflows Establish development workflows for tablets, dry reagents, liquid reagents, and HTS plates.
Dispensing Qualification Qualify solid and liquid dispensing across relevant dose and volume ranges.
Product Prototyping Prototype two to three priority products in tablet, sachet, vial, or plate formats.
Performance Demonstration Demonstrate acceptable dose uniformity, plate uniformity, tablet performance, reconstitution, analytical quality, and stability.
Preliminary Specifications Establish preliminary specifications, plate maps, barcode and lot-tracking requirements, packaging recommendations, and stability plans.
Pilot Readiness Prepare at least one product candidate for pilot-scale manufacturing or customer evaluation.
Technical Roadmap Deliver a roadmap for scale-up, automation, manufacturing transfer, and future RUO, GLP-supporting, or GMP-grade development.

Required Qualifications
Education: PhD with relevant experience, or MS with substantial industrial experience, in Biomedical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Biochemistry, Chemistry, Materials Science, or a closely related field.
Hands-on experience in at least two of the following areas: dry formulation, tableting, powder processing, biochemical reagent development, automated dispensing, or HTS plate preparation.
Experience with 24-, 48-, 96-, or 384-well plate workflows, including solid or liquid dispensing, sealing, plate maps, storage, and quality control.
Solid understanding of powder properties, excipient functionality, solvent compatibility, moisture sensitivity, formulation stability, and packaging compatibility.
Demonstrated experience designing and documenting formulation, analytical, process-development, dispensing, or stability studies.
Ability to independently translate product concepts into structured experiments, prototypes, and transferable processes.

Preferred Qualifications
Experience with biological buffers, pharmaceutical excipients, dissolution media, LC-MS reagents, biochemical screening kits, formulation-screening plates, or chemical libraries.
Familiarity with automated solid or liquid dispensers, laboratory robotics, low-volume dispensing, DMSO solutions, dry-plated compounds, or plate sealing systems.
Proficiency with UPLC/HPLC, LC-MS, Karl Fischer analysis, dissolution testing, osmolality measurement, powder characterization, barcode tracking, LIMS, SDF/CSV file formats, or plate-data management systems.
Experience with Design of Experiments (DoE), Quality by Design (QbD), laboratory-to-pilot scale-up, technology transfer, RUO product development, GLP, GMP, or ICH stability principles.