Dei BioPharma Ltd
Announcement Number: DB/05/2025/RD01
Position Title: Formulation Development Specialist
(Number of positions: 04)
Opening Period: 05/05/2025 – 05/12/2025
Series/Grade: L (5)
Salary: Competitive
Who May Apply: All Interested Applicants
Duration Appointment: Indefinite, subject to successful completion of probationary period
Supervisory Position: None
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 (GMP). 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:
1. Design and develop new pharmaceutical formulations with focus on bioavailability, stability, and manufacturability.
2. Conduct pre-formulation and compatibility studies for APis and excipients.
3. Execute laboratory-scale and pilot-scale trials and evaluate process parameters for scale-up.
4. Prepare development reports, formulation compositions, batch manufacturing records (BMRs) and technology transfer documents.
5. Evaluate and interpret data from dissolution, assay and stability studies in line with ICH Q8-Q10 guidelines.
6. Support the selection and qualification of excipients, packaging systems and equipment for product development.
7. Troubleshoot formulation-related issues during development, scale-up and commercial production.
8. Collaborate with Regulatory Affairs for dossier preparation, especially CTD Module 3 (P.2, P.3, P.5).
9. Participate in risk assessment, design of experiments (DoE) and quality-by-design (QbD) initiatives.
10. Ensure documentation and practices comply with GMP, 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:
1. Minimum of 4-6 years of hands-on experience in pharmaceutical formulation development in an R&D or tech-transfer role.
2. Proficient in formulation techniques for tablets, capsules, suspensions, syrups, gels and other dosage forms.
3. Sound knowledge of QD principles, DoE tools and ICH guidelines (Q1-Q10).
4. Demonstrated experience with scale-up, optimization, and technical documentation.
5. Familiarity with GMP requirements and regulatory documentation for product registration.
6. Strong problem-solving, project management, and cross-functional communication skills.
All applicants under consideration will be required to pass medical and security certifications.
EQUAL OPPORTUNITY EMPLOYER: Dei BioPharma Ltd, provides equal opportunity and fair and equitable treatment in employment to all people without regard to race, color, religion, sex, national origin, age, disability, political affiliation or marital status.
HOW TO APPLY:
All interested candidates who meet the required qualifications and experience are invited to submit their CVs, Cover Letter & Academic documents (addressed to the Human Resources Manager)
All Application documents should be merged as one document in PDF or DOC / DOCX, which should not exceed 10MB
Applications should be sent by email to recruitment@deibiopharma. com with the JOB TITLE IN THE SUBJECT LINE
Should you not hear from us within twenty one (21) days from the closing date of this advertisement, you may consider your application to be unsuccessful
Deadline: 12th May 2025 by 5:00PM
