Generic Formulation & Technology Transfer Lead

Prescription Pharma Support; Indonesia; On-site; IDR 600,000,000 - 1,000,000,000; Full time

Job summary

Prescription Pharma Support in Jakarta, Indonesia, seeks a Generic Formulation & Technology Transfer Lead with 10-15 years in industrial generic R&D, specialized in advanced oral modified-release formulations and direct responsibility for technology transfer and scale-up.

You will oversee comparator characterization, optimization, BA/BE decisions, and commercial transfer, with exposure to ASEAN/ACTD and BPOM expectations; US FDA/EMA familiarity is advantageous.

Qualifications

• Minimum 10-15 years in industrial generic pharmaceutical R&D with at least five years in advanced oral modified-release formulation.
• Direct responsibility for technology transfer and scale-up.
• Direct experience supporting filings or approvals under ASEAN/ACTD and/or WHO pathways; BPOM familiarity advantageous.

Responsibilities

• Lead technology transfer and scale-up activities for generic formulations.
• Coordinate cross-functional teams and external partners to ensure timely transfer and regulatory readiness.
• Support filings or approvals in ASEAN/ACTD contexts and interactions with BPOM and other regulators.

Skills

Leadership

Cross-functional collaboration

Coaching

English proficiency

Regulatory knowledge

Job description

Position Title: Generic Formulation & Technology Transfer Lead

Location: Jakarta, Indonesia

Regulatory Focus: Indonesia BPOM, ASEAN/ACTD, applicable WHO guidance; USFDA/EMA familiarity advantageous

Experience: Minimum 10-15 years in industrial generic pharmaceutical R&D, including at least five years in advanced oral modified-release formulation, with direct responsibility for technology transfer and scale-up.

Demonstrated Results: Documented examples of generic products progressed through comparator characterization, optimization, registration/engineering batches, BA/BE decision-making and commercial transfer.

Regulatory Exposure: Direct experience supporting filings or approvals under ASEAN/ACTD and/or applicable WHO pathways; familiarity with BPOM and exposure to USFDA/EMA expectations are advantageous.

Leadership & Cultural Agility: Excellent professional English; ability to coach Indonesian technical teams, work with overseas partners and manage cross-functional decisions effectively.