Senior Scientist: Formulation & Process Development (Onsite)

Yoh Services LLC; Rosenberg (TX); On-site; USD 105,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

HSA

Life & disability insurance

401K retirement plan

Direct payroll

Referral bonuses

Training opportunities

Job summary

Yoh Life Sciences in Rosenberg, TX, is seeking a Senior Scientist in Pharmaceutical Formulation & Process Development for direct-hire. The role is fully onsite and stresses hands-on lab leadership, QbD/DOE-driven development, and cross-functional collaboration to advance dosage forms from lab to manufacturing.

The candidate will design and execute formulation and process studies, optimize drug-product formulations, and transfer technology to manufacturing while supporting regulatory and quality

Qualifications

• PhD required in Pharmaceutical Sciences, Pharmaceutics, Pharmaceutical Engineering, Chemical Engineering, or a closely related scientific or engineering discipline.
• Minimum of seven years of relevant pharmaceutical-industry development experience required.
• Demonstrated hands‑on experience in pharmaceutical formulation development and process development required.
• Demonstrated experience taking pharmaceutical products or processes from laboratory development through scale-up, pilot, engineering, GMP manufacturing, and/or commercialization.
• Strong experience with pharmaceutical process optimization, process characterization, troubleshooting, and technology transfer.
• Advanced knowledge of QbD, DOE, CQAs, CMAs, CPPs, process robustness, and pharmaceutical manufacturing principles.
• Experience with oral dosage forms, oral liquids, liquid formulations, semi-solids, and/or suppository/pessary products preferred.
• Experience supporting ANDA, NDA, 505(b)(2), 510(k), cosmetic, or other regulated product-development programs preferred.
• Experience with engineering batches, registration batches, validation/PPQ activities, or commercial manufacturing support preferred.
• CDMO or other fast‑paced, multi-project pharmaceutical-development experience is highly desirable.
• Strong experimental-design, data-analysis, troubleshooting, and root-cause-analysis capabilities.
• Ability to independently execute complex technical assignments and translate laboratory findings into practical manufacturing recommendations.
• Strong scientific judgment, technical writing, documentation, and communication skills.
• Ability to effectively manage multiple development programs and collaborate across technical and business functions.

Responsibilities

• Design and personally execute pharmaceutical formulation and process-development experiments.
• Develop and optimize finished drug-product formulations and manufacturing processes.
• Evaluate API and excipient properties, compatibility, formulation robustness, and product performance.
• Design scientifically sound experimental plans based on product objectives and development risks.
• Generate, analyze, and interpret experimental data and recommend scientifically justified next steps.
• Apply Quality by Design (QbD) and Design of Experiments (DOE) principles to formulation and process development.
• Identify and evaluate Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs), and Critical Process Parameters (CPPs).
• Perform process optimization, characterization, scale-up, and technology-transfer activities.
• Translate laboratory processes into robust pilot-scale and commercial manufacturing processes.
• Evaluate manufacturing variables including mixing, shear, homogenization, temperature, order of addition, processing time, hold time, transfer, and filling parameters.
• Troubleshoot formulation, process, scale-up, and manufacturing issues through experimentation and root-cause analysis.
• Provide hands‑on technical support during pilot, engineering, scale-up, registration, validation, technology-transfer, and manufacturing activities.
• Support investigations involving process deviations, product-performance issues, and manufacturing challenges.
• Collaborate cross-functionally with Manufacturing, Engineering, Analytical Development, Quality, Regulatory Affairs, and Project Management.
• Prepare and maintain laboratory notebooks, protocols, batch documentation, experimental records, technical reports, and development summaries.
• Operate appropriate laboratory and pilot-scale pharmaceutical processing equipment.
• Support technical-transfer documentation and manufacturing implementation.
• Serve as a senior technical resource and mentor scientists and laboratory technicians without formal personnel-management responsibility.
• Manage multiple technical assignments while maintaining ownership of quality, documentation, and timelines.
• Perform other duties as assigned.

Skills

Formulation development

Process development

DOE

QbD

Tech writing

Cross-functional collaboration

Education

PhD in Pharmaceutical Sciences

Job description

Yoh Life Sciences in Rosenberg, TX, is seeking a Senior Scientist in Pharmaceutical Formulation & Process Development for direct-hire. The role is fully onsite and stresses hands-on lab leadership, QbD/DOE-driven development, and cross-functional collaboration to advance dosage forms from lab to manufacturing.

The candidate will design and execute formulation and process studies, optimize drug-product formulations, and transfer technology to manufacturing while supporting regulatory and quality