Senior/Staff Analyst, Quality Control at Acceleron Pharma
Cambridge, MA, US
Acceleron is a 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 superfamily 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 program with ACE-083, a locally-acting Myostatin+ agent in Phase 2 development in facioscapulohumeral muscular dystrophy and Charcot-Marie-Tooth disease and is conducting a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.

What’s in it for you?

In this role, you will work collaboratively with the entire QC team to assist with various projects supporting the manufacturing, testing, release and distribution of our drug candidates. You will also interface with cross-functional departments in support of this Quality Control function. We are looking for an energized and interested learner with experience performing ELISA and cell-based assays in a biotechnology/pharma setting to join our team.

What will you be doing?
  • Bioassays: Reporter Gene Assay (RGA) based and ELISA based Potency assays, Protein A and CHO Protein ELISA assays
  • Microbiological testing (Endotoxin and Bioburden) and analytical assays to test bulk and final products for release testing and stability studies
  • Method transfer of assays between internal laboratories and contract manufacturing organizations (CMOs)
  • Effectively communicate results through written documentation and oral presentations to multidisciplinary teams
  • Understand project timelines and deliverables and coordinate projects both within and outside of QC
  • Demonstrate initiative to perform routine QC responsibilities such as sample coordination, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents as needed
  • Compile data and prepare graphs for documentation of test procedures and preparation of reports
  • Use scientific expertise to provide assistance for troubleshooting, laboratory investigations and problem resolution with minimal supervision
  • Author relevant CMC sections for regulatory filings and for responses to regulatory agency comments /recommendations
  • Assist in the writing, reviewing and editing of standard operating procedures and protocols, deviations and investigations
 What are we looking for?
  • B.S. or M.S. in life sciences or other biologics-related discipline required
  • Minimum 7 years of relevant work experience within the Biotechnology field and a GMP Quality Control laboratory
  • Experience with ELISA and Mammalian cell culture-based assays, Protein A and CHO Protein ELISA assays.
  • Excellent aseptic technique
  • Experience with microbiological testing (Endotoxin and Bioburden) and analytical assays necessary in testing bulk and final products for release testing and stability studies are desired
  • Ability to independently design, execute, and report results of experiments in a timely fashion
  • Creative problem-solving ability and motivation to continually improve processes
  • Strong organizational, communication, presentation, and writing skills
  • Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal and external personnel and various levels of management
  • Ability to work independently, have strong organizational skills, and be detail oriented
  • Enthusiastic with a high level of integrity and attention to detail
How will you grow with us?

In this role you will have the opportunity to increase your QC expertise and expand your role as Acceleron brings novel molecules from clinical development to commercialization.  As a valued member of the team, you will have the opportunity to bring your innovative ideas to the team as well as the opportunity to learn new skills through collaboration on various projects, including participating in tech transfer activities. Acceleron’s active pipeline and fast-paced environment will keep you motivated and challenged to develop and grow your skills through direct, hands-on experience.  Help us in our mission to transform patients’ lives and join our team!  
*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.