Temporary Consultant : Senior/ Director, Drug Product Development - 3 month contract

Company Background

GondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Portal Therapeutics is an early clinical stage biotechnology company, and the most advanced program in GondolaBio’s portfolio. Portal is developing a novel potential best-in-class therapy for erythropoietic protoporphyria, a severe genetic disease of the blood which results in extreme sensitivity to sunlight and liver damage.

Who You Are

This position is responsible for formulation development and drug product manufacturing activities of new and existing products at external Contract Manufacturing Organizations (CMOs). Activities include but not limited to formulation and process design, scale up, technology transfer, process validation, and interpretation of data of varying complexity. In this cross functional role, he/she works directly with Analytical Development, Process Chemistry, Supply Chain, Quality and Regulatory teams at GondolaBio . Position reports directly to VP, CMC. The ideal candidate for this position would be an individual with a growth mindset who is looking for high impact contribution and the opportunity to learn and expands beyond his/her current knowledge and skills.

Responsibilities

• Act as the formulation subject matter expert and manage external Lipid Deposits formulation development activities to support advancing GondolaBio product candidates in clinical studies and potential commercial launch activities.
• Support technology transfer for manufacturing of clinical supplies from CMO to CMO to support scale up and late-stage development activities.
• Develop, review, and approve technical reports and controlled GMP documentation such as manufacturing batch records.
• Oversee efforts and works closely with CMOs, Quality, Supply Chain, Regulatory CMC, and Analytical teams to ensure operational excellence and GMP compliance during manufacturing and timely release of drug product for clinical use.
• Provide technical support for change controls, process deviations, root cause identification and CAPA implementation associated with manufacturing deviations and quality events in a collaborative manner with Quality Assurance (QA).
• Develop phase-appropriate pharmaceutical project plans and manage successful execution of these plans consistent with corporate timelines and compliant with cGMP/regulatory requirements and expectations.
• Interpret complex data and make recommendation on formulation development directions.
• Maintain awareness of state-of-the-art manufacturing practices. Keep up with the latest regulatory and cGMP guidance.
• Sources relevant scientific literature within field.
• Displays greater ability to productively disseminate ideas across disciplines.
• Develop and maintain strong relationships with CMOs and participate in periodic business and technical review meetings with relevant CMOs.

Education, Experience & Skills Requirements

• MS or PhD degree in Pharmaceutical Sciences, Pharm D., Chemical Engineering or related life sciences discipline.
• At least 8-10 years of hands-on experience in small-molecule pharmaceutical product development and commercialization. 6-8 years’ experience with Ph.D.
• Strong technical background in developing and scaling up Lipid Deposit formulations is required. Hands on experience with tableting, encapsulation, wet granulation and roller compaction are desirable. Pediatric formulation experience is a plus.
• Thorough knowledge of cGMP, regulatory requirements, and approaches for implementation of Quality by design (QbD) principles, Design of Experiments (DoE) in DP development, process validation.
• Ability to work successfully in a team/matrix environment and independently, as required.
• Pragmatic, solution-oriented thinker with excellent verbal and written communication, and strong interpersonal and organizational skills.
• Fluency with standard computer software packages (MS Word, Excel, PowerPoint) and statistical tools.
• Ability to travel as needed (about 10%) to support critical manufacturing campaigns, among other activities

The expected hourly rate for this position is $150.00 to $200.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.