4 Formulation Development Specialist
2025-05-09T08:20:17+00:00
Dei BioPharma
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https://deibiopharma.com/
FULL_TIME
Matugga
Uganda
00256
Uganda
Healthcare
Healthcare
2025-05-12T17:00:00+00:00
Uganda
8
Job Summary:
The Formulation Development Specialist is responsible for designing, developing, optimizing, and scaling up pharmaceutical formulations including oral solids, liquids, semi-solids, and innovative delivery systems. The role involves pre-formulation studies, excipient compatibility testing, prototype development, stability evaluation and technology transfer to manufacturing. The specialist ensures compliance with regulatory expectations, ICH guidelines, and current Good Manufacturing Practices (cGMP). This position requires collaboration with cross-functional teams such as analytical development, quality assurance, regulatory affairs, and production to deliver robust and reproducible formulations. The ideal candidate should have a strong background in pharmaceutics and proven experience in formulation design, scale-up and documentation aligned to product development lifecycles.
Key Duties and Responsibilities:
- Design and develop new pharmaceutical formulations with focus on bioavailability, stability, and manufacturability.
- Conduct pre-formulation and compatibility studies for APIs and excipients.
- Execute laboratory-scale and pilot-scale trials and evaluate process parameters for scale-up.
- Prepare development reports, formulation compositions, batch manufacturing records (BMRs) and technology transfer documents.
- Evaluate and interpret data from dissolution, assay and stability studies in line with ICH Q8–Q10 guidelines.
- Support the selection and qualification of excipients, packaging systems and equipment for product development.
- Troubleshoot formulation-related issues during development, scale-up and commercial production.
- Collaborate with Regulatory Affairs for dossier preparation, especially CTD Module 3 (P.2, P.3, P.5).
- Participate in risk assessment, design of experiments (DoE) and quality-by-design (QbD) initiatives.
- Ensure documentation and practices comply with cGMP, GLP and regulatory requirements.
Academic Qualifications:
Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or Industrial Chemistry. A Master’s degree or postgraduate diploma in Pharmaceutics or Drug Development is a strong advantage.
Experience and Competencies:
- Minimum of 4–6 years of hands-on experience in pharmaceutical formulation development in an R&D or tech-transfer role.
- Proficient in formulation techniques for tablets, capsules, suspensions, syrups, gels and other dosage forms.
- Sound knowledge of QbD principles, DoE tools and ICH guidelines (Q1–Q10).
- Demonstrated experience with scale-up, optimization, and technical documentation.
- Familiarity with GMP requirements and regulatory documentation for product registration.
- Strong problem-solving, project management, and cross-functional communication skills
Design and develop new pharmaceutical formulations with focus on bioavailability, stability, and manufacturability. Conduct pre-formulation and compatibility studies for APIs and excipients. Execute laboratory-scale and pilot-scale trials and evaluate process parameters for scale-up. Prepare development reports, formulation compositions, batch manufacturing records (BMRs) and technology transfer documents. Evaluate and interpret data from dissolution, assay and stability studies in line with ICH Q8–Q10 guidelines. Support the selection and qualification of excipients, packaging systems and equipment for product development. Troubleshoot formulation-related issues during development, scale-up and commercial production. Collaborate with Regulatory Affairs for dossier preparation, especially CTD Module 3 (P.2, P.3, P.5). Participate in risk assessment, design of experiments (DoE) and quality-by-design (QbD) initiatives. Ensure documentation and practices comply with cGMP, GLP and regulatory requirements.
Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or Industrial Chemistry. A Master’s degree or postgraduate diploma in Pharmaceutics or Drug Development is a strong advantage. Experience and Competencies: Minimum of 4–6 years of hands-on experience in pharmaceutical formulation development in an R&D or tech-transfer role. Proficient in formulation techniques for tablets, capsules, suspensions, syrups, gels and other dosage forms. Sound knowledge of QbD principles, DoE tools and ICH guidelines (Q1–Q10). Demonstrated experience with scale-up, optimization, and technical documentation. Familiarity with GMP requirements and regulatory documentation for product registration. Strong problem-solving, project management, and cross-functional communication skills
JOB-681dbac1217ed
Vacancy title:
4 Formulation Development Specialist
[Type: FULL_TIME, Industry: Healthcare, Category: Healthcare]
Jobs at:
Dei BioPharma
Deadline of this Job:
Monday, May 12 2025
Duty Station:
Matugga | Uganda | Uganda
Summary
Date Posted: Friday, May 9 2025, Base Salary: Not Disclosed
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JOB DETAILS:
Job Summary:
The Formulation Development Specialist is responsible for designing, developing, optimizing, and scaling up pharmaceutical formulations including oral solids, liquids, semi-solids, and innovative delivery systems. The role involves pre-formulation studies, excipient compatibility testing, prototype development, stability evaluation and technology transfer to manufacturing. The specialist ensures compliance with regulatory expectations, ICH guidelines, and current Good Manufacturing Practices (cGMP). This position requires collaboration with cross-functional teams such as analytical development, quality assurance, regulatory affairs, and production to deliver robust and reproducible formulations. The ideal candidate should have a strong background in pharmaceutics and proven experience in formulation design, scale-up and documentation aligned to product development lifecycles.
Key Duties and Responsibilities:
- Design and develop new pharmaceutical formulations with focus on bioavailability, stability, and manufacturability.
- Conduct pre-formulation and compatibility studies for APIs and excipients.
- Execute laboratory-scale and pilot-scale trials and evaluate process parameters for scale-up.
- Prepare development reports, formulation compositions, batch manufacturing records (BMRs) and technology transfer documents.
- Evaluate and interpret data from dissolution, assay and stability studies in line with ICH Q8–Q10 guidelines.
- Support the selection and qualification of excipients, packaging systems and equipment for product development.
- Troubleshoot formulation-related issues during development, scale-up and commercial production.
- Collaborate with Regulatory Affairs for dossier preparation, especially CTD Module 3 (P.2, P.3, P.5).
- Participate in risk assessment, design of experiments (DoE) and quality-by-design (QbD) initiatives.
- Ensure documentation and practices comply with cGMP, GLP and regulatory requirements.
Academic Qualifications:
Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or Industrial Chemistry. A Master’s degree or postgraduate diploma in Pharmaceutics or Drug Development is a strong advantage.
Experience and Competencies:
- Minimum of 4–6 years of hands-on experience in pharmaceutical formulation development in an R&D or tech-transfer role.
- Proficient in formulation techniques for tablets, capsules, suspensions, syrups, gels and other dosage forms.
- Sound knowledge of QbD principles, DoE tools and ICH guidelines (Q1–Q10).
- Demonstrated experience with scale-up, optimization, and technical documentation.
- Familiarity with GMP requirements and regulatory documentation for product registration.
- Strong problem-solving, project management, and cross-functional communication skills
Work Hours: 8
Experience in Months: 48
Level of Education: bachelor degree
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