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Scientist/Senior Scientist, Drug Product Formulation And Process Development

Expired Job

Acceleron Pharma Cambridge , MA 02138

Posted 4 months ago

Who are we?

Acceleron is a Cambridge-based, clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchise with two distinct Myostatin

  • agents, ACE-083 and ACE-2494, and a pulmonary program with sotatercept in pulmonary arterial hypertension.

What's in it for you?

Within the Technical Operations Organization, our Drug Product-Technical Development team is seeking a highly knowledgeable and motivated protein scientist to lead process development efforts on late stage IgG1-FC fusion protein projects. This scientist will provide scientific, technical and strategic support to liquid and lyophilized product development interfacing with Discovery, Development and CMOs.

Reporting to the Director/Sr. Director of Drug Product Development, you will collaborate extensively with formulation, drug substance development and manufacturing groups in developing late stage processes and technology transfer activities. You will also focus on solid state characterization methods for lyophilized products.

What will you do?

  • Develop robust drug product process (both liquid & Lyo) for Ph2/Ph3/Commercial application

  • Design smart-lyo approaches to predict and map bench scale lyo process to large scale manufacturing at CMOs

  • Understand and implement new technologies for drug product development

  • Utilize key solid state characterization tools both in-house and at CROs to develop predictable lyo cycles contributing to cycle time reduction

  • Develop container closure systems and design IFUs for Ph3 and commercial dosage forms meeting clinical and commercial demands

  • Contribute to formulation development of early stage developmental programs and represent drug product on CMC teams and Product Development Committees

  • Build and maintain strong working relationships with drug substance & drug product manufacturing and Technical Development teams

  • Contribute to regulatory filings including IND and BLA; assist in answering questions from regulatory agencies as needed

What are we looking for?

  • Doctorate degree and minimum of 3 years of biotech industry experience or bachelor's degree and minimum of 10 years of biotech industry experience

  • Expertise in fill-finish operations and ICH guidelines knowledgebase required

  • Experience in device development such as pre-filled syringe, cartridges, and pens is desirable

  • Experience in publishing original research in peer-reviewed journals and making external presentations is a plus

  • Hands-on experience on lab scale freeze dry units and cycle programming

  • Strong interpersonal skills with experience working with cross-functional teams in matrix environment and ability to work collaboratively with others across functions and levels

How will you grow with us?

This role offers the right candidate an exceptional opportunity to help drive highly critical projects for a rapidly expanding organization. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. This will be a time of dynamic growth, requiring timely, strategic, and innovative approaches and initiatives. If you're seeking to make valuable contributions and develop professionally within a collaborative, fun and fast-paced environment, apply today.

  • In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.
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Scientist/Senior Scientist, Drug Product Formulation And Process Development

Expired Job

Acceleron Pharma