03 nov
|
Laboratorio Pablo Cassara
|
Buenos Aires
03 nov
Laboratorio Pablo Cassara
Buenos Aires
Laboratorio Cassará is driving a strategic general biopharmaceutical project and seeks to bring on a Technology Transfer Project Manager to lead the US market entry of a recombinant protein developed and produced in Argentina.
The product completed Phase II patient enrollment during October 2026 and holds Fast Track Designation from the FDA for the indication of Amyotrophic Lateral Sclerosis (ALS).
It represents a key opportunity for biopharmaceutical professionals looking to lead an end-to-end technology transfer, coordinating complex operations alongside international partners.
About the Role: The position seeks a leader to manage the end-to-end transfer of the manufacturing processes for the Drug Substance (DS) and Drug Product (DP) of a recombinant protein from Argentina to external Contract Development and Manufacturing Organizations (CDMOs).
The program is in an advanced development stage. This role will drive the transfer through engineering runs, GMP batches, and Process Performance Qualification (PPQ), generating the technical and data package necessary for future regulatory submissions (BLA/MAA). The ideal candidate combines a deep understanding of pharmaceutical biotechnological production processes at an industrial scale with the leadership capabilities to manage external partners and a multidisciplinary team.
Mandatory Requirements:
- Bachelor’s degree in Biotechnology, Biochemistry, Chemical or Bioprocess Engineering, Pharmacy, or another related scientific or engineering field.
- Over 10 years of proven track record in the biopharmaceutical industry working in biological process development, MSAT, production, or technology transfer.
- Proven practical experience in recombinant protein manufacturing processes within a GMP environment.
- Experience leading technology transfers to or from CDMOs/CMOs.
- Solid knowledge of GMP regulations, ICH guidelines (Q5, Q7, Q8, Q9, Q10, Q11), and process validation principles.
- Fluent level of English (oral and written).
- Availability for frequent international travel, including extended stays during critical campaigns at the CDMOs.
Preferred Requirements:
- Direct experience working with the recombinant interleukin-2 process.
- Postgraduate education, such as a Master’s or Ph.D., in a relevant scientific area.
- Experience in late-stage programs, PPQ, and regulatory submissions (BLA/MAA).
- Experience in aseptic processing and fill/finish of biological products.
- Experience in people management and formal project management certifications, such as PMP.
Terms of Employment:
- We offer excellent employment conditions and benefits.
- The project assignment will have a duration of 18 months from the start date.
- International travel and accommodation expenses will be covered according to current company policies.
- Location: Buenos Aires, Argentina, with frequent international travel to CDMO plants.
If you meet the profile and are looking for a global-scale challenge, we invite you to send your updated CV https://forms.gle/99xHDjazenniz8Tc7
📌 Technology Transfer Project Manager (Buenos Aires)
🏢 Laboratorio Pablo Cassara
📍 Buenos Aires