Director of Biology

Major Duties/Responsibilities

· Lead drug product formulation and formulation process development in a GMP, CDMO network.

· Lead process scale up and characterization studies required to support drug product and formulation development life-cycle management.

· Lead Drug Product PPQ.

· Lead internal and external formulation development for injectable drug products and ultimate technical transfer(s), as applicable, of the manufacturing process to commercial manufacturing site(s).

· Partner with key stakeholders and work collaboratively with cross-functional CMC, quality, regulatory, project management, legal, supply chain, and other functions to meet company goals.

· Author applicable drug product sections in IND and BLA filings.

· Establish applicable technical procedures and business process flows to support drug product life-cycle management.

Requirements

• Masters degree...

Luminary Group is seeking a highly skilled and experienced Senior Director of Computational Biology to lead our client's efforts in leveraging computational techniques to extract valuable insights from biological and clinical data. As the Senior Director of Computational Biology, you will play a key role in driving innovation and advancing the field of computational biology within the healthcare industry.

Responsibilities:

• Lead and manage a team of computational biologists and bioinformaticians, providing guidance, mentorship, and performance evaluations.
• Define and execute the computational biology strategy and roadmap, aligning with the company's overall goals and objectives.
• Collaborate with cross-functional teams to identify research questions and develop computational approaches to address them using biological and clinical data.
• Oversee the development and implementation of computational workflows and algorithms for the analysis...

About Us

Serna Bio is building the world’s first map of the druggable transcriptome, systematically opening up the universe of RNA biology to small-molecule drug modulation. Using our Discovery Platform, we are tackling the classically intractable targets, with an initial focus on Oncology and Rare Disease.

The current toolkit for developing drugs is focused almost entirely on protein targets. However, 85% of the approximate 3 billion base pairs in the human genome encodes for RNA but not protein. Our platform enables a novel approach to understanding RNA structure, function and binding sites in order to develop a new class of drugs. Targeting RNA in this way enables us to explore therapeutics for the many diseases with no known treatments.

Our mission is to develop a new class of drugs that will impact patient lives. We are a globally distributed, remote-first team headquartered in the United States. We are curious, nimble, breaking new ground and growing...