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Director, Analytical Development CMC

Company: American Society for Biochemistry and Molecular Bi
Location: Cambridge
Posted on: January 13, 2021

Job Description:

American Society for Biochemistry and Molecular Biology Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron'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, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 trial. The Company is currently planning multiple Phase 3 trials with the potential to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) next year. In hematology, REBLOZYL-- (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States, Europe, and Canada for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn . What's in it for you? Acceleron is seeking a Director of Analytical Development CMC to provide strategic direction and drive the overall analytical strategy for various discovery and development programs, which includes identifying critical quality attributes and setting a phase appropriate control strategy. The Director Analytical Development fulfills a critical and highly visible role as a key strategist and team member in Acceleron's discovery & development teams, making substantial contributions to the company. S/he will also play a role in partnering with business development on due diligence of potential new assets. The role requires excellent leadership and networking capabilities to optimize the integration of internal domain expertise with external resources that include subject matter experts and CDMOs. What will you be doing?

  • Lead the development of a phase appropriate, analytical control strategy for biologics and small molecules including identification of the quality target product profile and critical quality attributes, justification of product specifications and establishment of test methods to enable product QC and batch release, extended characterization, formulation development, comparability assessments and stability programs.
  • Lead product characterization, and product attribute criticality assessments from candidate nomination through IND- and BLA-/NDA-enabling activities and ultimately commercial registration
  • Direct and oversee all analytical CMC activities for biologics, including both drug substance (DS) and drug product (DP), small molecules and other modalities as our pipeline grows.
  • Lead a team of scientists to execute and ensure that all CMC and discovery analytical deliverables are met for multiple projects, from clone selection and through IND/BLA filings.
  • Develop, optimize and validate analytical methods
  • Manage selection, method development, assay transfer, qualification and work carried out by contract research or manufacture organizations
  • Support drug substance and drug product impurity characterization and identification
  • Author and review CMC sections of regulatory submissions e.g. IND, BLA and supportive source documents such as technical reports and risk assessments
  • Lead and participate in cross-functional CMC program teams for biologics and small molecules. Represent CMC in company-wide program teams.
  • Manage day-to-day group activities including timeline, budget management and objective setting in a growing analytical development group
  • Assist in negotiation of third-party contracts including clinical and commercial supply agreements
  • Develop resource strategies, allocate budget, staff, tools and specialized support necessary for efficient operations
  • Lead and guide partner companies and external suppliers through collaborative, actionable and common goals and objectives enabling efficient, effective technical success and execution. Requirements What are we looking for?
    • A PhD in Biochemistry, Chemistry or a related life sciences field with a minimum of 15 years of experience in the biotechnology industry with at leadership experience and subject matter expertise in analytical development in a corporate drug development organization including several years' experience in biologics and small molecule drug development.
    • Extensive experience and demonstrated track record in biopharmaceutical development including but not limited to formulation development, drug product development, drug product process characterization and validation
    • Large molecule experience is required; experience with analytical techniques for small drug molecules including HPLC, LCMS, GS, UV/VIS, IR, PSA is desired
    • Knowledge of compendial (e.g. appearance, bioburden, particulate matter) and non-compendial test methods for batch release and stability studies such as HP-SEC, HP-IEX, CE-SDS, cIEF, binding ELISA and cell-based bioassay. Understanding of release methods to control process-related impurities such as residual host cell proteins, DNA and chromatography resin leachates. Experience with extended characterization methods for product structure elucidation including mass spectrometry, peptide mapping, glycan profiling, CD, DSC and AUC. Familiarity with in-use stability and container closure compatibility studies.
    • Exceptional oral and written communication skills to all employment levels, Board of Directors and external partners, suppliers and industry organizations
    • Proven experience in building a high performing analytical team. The ability to attract and recruit top talent, motivate and empower the team, delegate effectively, celebrate diversity within the team, and manage performance; viewed as a strong developer of others.
    • A leader who is self-reflective and leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement
    • A sought-after advisor, mentor, thinker - within and beyond the Quality arena; ability to lead and influence in a highly matrixes organization with complete transparency
    • Ability to navigate through ambiguity, rapid growth, and adapt to change How will you grow with us? This role will develop, inspire, lead and manage the Analytical CMC organization while transforming the supporting analytical methods and processes as Acceleron brings meaningful therapies to commercialization. This is an influential role who is well poised to grow as a leader more broadly in the organization as the development programs advance to commercialization. *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. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:
      • Location:
        Cambridge, Massachusetts, United States
      • Position Title: Director, Analytical Development CMC 11200 Rockville Pike, Suite 302Rockville, Maryland 20852(240) 283-6590

Keywords: American Society for Biochemistry and Molecular Bi, Cambridge , Director, Analytical Development CMC, Executive , Cambridge, Massachusetts

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