Scientist - Analytical Development

Summary:

BioPharma Consulting JAD Group is seeking a detail-orientedScientist - Analytical Development to join our expanding team. This role involves the development and validation of analytical methods for the characterization of biopharmaceuticals, including small molecules and biologics. The successful candidate will play a crucial role in ensuring the quality and reliability of our products through rigorous analytical assessments and will work closely with cross-functional teams to meet project objectives.

Key Responsibilities:

• Develop, qualify and transfer GC, HPLC, UPLC and mass spectrometry based assays of starting materials, raw materials, intermediates and excipients to suppliers, CMOs and QC.
• Identify impurity profiles and provide data to set impurity limits.
• Understand and apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development.
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Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust extracellular vesicle based biologic platform technology. The Company is committed to providing the latest clinical and scientific information through rigorous and thorough research. With deep knowledge and industry expertise in cellular and regenerative therapies, the company has brought to market a significant development in therapeutic biologics with the introduction of the highest quality production of extracellular vesicles.

Requirements

Some required skills for the Principal Scientist position:

• Top expert in biotechnology analytical method life cycle, with demonstrated success managing late-stage to commercial cell-based assay validation.
• Extensive knowledge of domestic and global regulatory requirements for late-stage and commercial analytical testing programs.
• Excellent...

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world.  Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.   

Why Choose Editas? 

At Editas Medicine, we’re a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine,...

We are looking for an experienced Senior Scientist in Analytical Development specializing in Radiopharmaceuticals to join our innovative team. In this role, you will lead the development and validation of analytical methods to support the characterization and quality control of radiopharmaceutical products.

Key Responsibilities:

• Design and develop robust analytical methods for the characterization of radiopharmaceuticals, including chromatography, mass spectrometry, and other relevant techniques.
• Oversee method validation and provide technical guidance to ensure compliance with regulatory requirements.
• Collaborate closely with cross-functional teams, including formulation, quality assurance, and regulatory affairs to support product development and release.
• Conduct complex data analysis and interpretation, presenting findings to stakeholders.
• Write and review regulatory documentation, including IND and NDA submissions.
...

Our Culture: Why work with us?

At Foghorn Therapeutics, we believe in “People First, Mission Always.”

We put “People First” because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics – demonstrated by our community speaking more than 22 languages and representing over 24 nationalities. We value our teammates as people, not just as employees – validated by our actions that let our people know that we care about them, their families, and their lives.

We say “Mission Always” because we know a relentless commitment to our mission will make a difference in the lives of others. We believe our success will come from evaluating the data to follow the science. We work hard to develop a new class of therapies that could improve the lives of over 2.5 million people with cancer.

Our culture is focused on...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

Editas is seeking an Associate Scientist to join our Analytical Development group. This person will work closely with teams across research & development to execute various biophysical methods for gene editing components and drug product...

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees.  Our US operations are US headquartered in Irvine, CA. Our 7 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and...