This is a senior-level, hands-on individual contributor position focused on pharmaceutical formulation and process development, experimental execution, scale-up, troubleshooting, and technology transfer. The ideal candidate will bring significant pharmaceutical-industry experience and the ability to personally translate product-development objectives into scientifically sound experiments, robust manufacturing processes, and successful scale-up and technology-transfer activities.
Title: Senior Scientist – Pharmaceutical Formulation & Process Development
Employment Type: Direct Hire
Salary:$105,000–$120,000/year
Location: Rosenberg, TX – Greater Houston
Schedule: Monday–Friday, approximately 8:00 a.m.–5:00 p.m.
Work Arrangement: Fully onsite
Limited relocation assistance may be available in the form of a sign-on bonus for qualified candidates.
Position Summary
Working under the direction of the Director of Research and Development, the Senior Scientist will personally design and execute formulation and process-development studies from laboratory scale through pilot, engineering, technology-transfer, and manufacturing activities.
The position requires a strong and consistent presence in the laboratory and pilot-plant environment. This is not a people-management or primarily administrative role. The Senior Scientist is expected to remain technically hands-on while serving as a senior scientific resource to other members of the R&D organization.
The role may support pharmaceutical finished-dosage-form programs including oral products, liquids, semi-solids, and suppository/pessary products, as applicable, across cosmetic, 510(k), ANDA, NDA, and other development programs.
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.
- 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.
#IND-SPG
Estimated Min Rate: $105000.00
Estimated Max Rate: $120000.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
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