Formulation Specialist

Job Opportunity: Formulation Specialist / Formulation Supervisor

Location: Baghdad Altaji, Iraq

Department: Research & Development – Formulation

Industry: Pharmaceutical Industry

Company: Alalamyah Pharma

Alalamyah Pharma is seeking an experienced and highly motivated Formulation Specialist / Formulation Supervisor to join our R&D team. The ideal candidate will have strong expertise in both sterile and non-sterile pharmaceutical formulation development, with the ability to lead development activities, manage documentation, and support scale-up, technology transfer, and validation processes.

Experience Required

6 to 20 years of experience in pharmaceutical R&D / formulation

Experience in both sterile and non-sterile dosage forms is required

Key Responsibilities

Review and approve complete documentation for assigned products, including PDR, MFR, MPR, and BMR, in coordination with the QA Department.

Oversee formulation development activities and allocate/prioritize products to meet target throughput.

Approve formulation strategies, final formula selection, and packaging material selection.

Coach and support the formulation team while identifying and defining key development areas.

Monitor and review all experimental data, product records, and instrument logbooks.

Coordinate with the Analytical R&D section for trial submissions, validation requirements, and result follow-up.

Plan and coordinate with the Production Department for scale-up and pilot batches.

Design and support troubleshooting activities during scale-up and pilot batches.

Plan technology transfer and validation activities for first commercial batches in coordination with Production and QA.

Review all documentation in line with ALCOA+ requirements and ensure immediate closure of documentation gaps.

Prepare weekly reports for the R&D Manager on achievements, progress, and future plans.

Define and execute monthly and annual R&D plans, portfolio development, and strategy.

Set departmental KPIs in coordination with the HR Department.

Oversee section activities and performance through section heads.

Organize the R&D development framework across sections and resolve bottlenecks to ensure smooth workflow.

Ensure development strategies are scientifically sound, practical, and manufacturable.

Approve key development decisions, plans, and strategies.

Ensure systematic risk management through definition of CQA / CPP in coordination with the QA Department.

Ensure suitability of analytical methods and transferability to commercial batch release.

Ensure method development and validation strategies are scientifically sound and compliant with quality requirements.

Ensure the stability program is properly designed, executed, and trended to support timely regulatory submission.

Lead departmental readiness for internal and external audits and ensure timely closure of audit observations.

Serve as the primary R&D interface with QA, QC, Production, Engineering, Supply Chain, and Regulatory departments.

Build department capability through training, mentoring, and succession planning.

Suspend R&D activities when significant quality or data integrity risks are identified and initiate investigation/CAPA through the QMS.

Report directly to the Site Director / Upper Management.

Qualifications

Bachelor’s degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific field.

Strong technical background in pharmaceutical formulation and development.

Excellent leadership, communication, and organizational skills.

Strong knowledge of GMP, ALCOA+, validation, technology transfer, and regulatory requirements.

Ability to work collaboratively across departments and lead under pressure.