Senior Director, Analytical Development

Bluebird Bio, Inc. Cambridge , MA 02138

Posted 1 week ago

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel cell and gene therapy approaches. bluebird bio seeks an experienced professional to lead the Analytical Development organization and drive the strategy for our early- and late-stage clinical development programs. We are looking for an innovative, passionate scientist and leader with the breadth of experience and drive to implement the vision for this position.

The activities of Analytical Development include the development of novel methods with state-of-the-art techniques and approaches for the characterization and release of small molecules, oligonucleotides, lentiviral-based vectors and stem and immune cell-based therapies. You will lead all activities associated with development of biological, molecular, bioanalytical, and chemical characterization and release assays in support of early and late-phase clinical development of our novel products to ensure successful regulatory filings in the EU and US. In this role, you will collaborate across the broad organization, including Research, Process Development, Quality Control, Quality Assurance, and Regulatory Sciences.

There is great opportunity to lead and evolve this function to support a broad portfolio of therapies. We are interested in candidates with a proven track-record of technical excellence and product development and are looking for an authentic leader with a dedicated focus on developing organizations and growing future leaders. The successful candidate will integrate activities and perspectives across functions to deliver therapies that transform the lives of patients.

About the Role:

  • Develop and mentor a high-performing team of scientists with a vision of setting industry-leading scientific standards

  • Create and drive the scientific strategy for analytics as a long-term value driver

  • Lead a growing function that will require hands-on work to instruct and build the necessary skills within the group

  • Collaborate closely with Quality Control to optimize methods, set specifications, investigate out-of-specifications, and provide impact for change control in the GMP environment

  • Lead early and late stage analytical development method qualification and transfer

  • Participate in the characterization, attribute criticality assessment, and definition of the control strategy from candidate nomination through IND- and BLA-/MAA-enabling activities and ultimately commercial registration

  • Lead analytical comparability exercises during technical transfers and process improvements

  • Manage day-to-day group activities including timeline and budget management and objective setting and execution in a growing analytical development group

  • Collaborate with external CTO partners and assess opportunities for bringing work in-house

  • Review the design and execution of analytical scopes of work and protocols to satisfy FDA and ICH guidelines

  • Provide Subject Matter Expertise into the writing and review of regulatory submissions and take part in Agency interactions

  • Provide data analysis and review of method development, including stability-indicating methods and support the execution of stability studies

  • Represent analytics in cross-functional team meetings

  • Travel < />

About You:

  • A Ph.D. in engineering or life sciences, with 12+ years relevant industry experience

  • The ideal candidate will have an in-depth understanding and development-stage experience in biological potency method development, protein biochemistry and separation sciences

  • Experience with characterization and quantitative analysis of complex biological mixtures utilizing state-of-the-art techniques, including, but not limited to chromatography, electrophoresis, and gradient fractionation

  • Experience with cell-based assays desirable

  • In-depth understanding of quality control laboratory operations in a commercial setting a plus

  • Understanding of techniques for single cell analysis, cell phenotyping methods, and experience in cell or gene therapy

  • Familiarity with mass spectrometry, light scattering and flow cytometry is desirable

  • Experience in a GLP/GMP compliant environment

  • Independently motivated, detail-oriented and good problem solving with ability and experience to troubleshoot complex technical and scientific problems

  • Experience preparing technical documents for internal distribution or inclusion in regulatory filings

  • Strong ability to present data in a variety of team settings and actively participate in departmental meetings as well as cross-functional area project teams

  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations

  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders

  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities

  • Excellent oral and written communication skills

  • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals

  • A passion for addressing the critical unmet medical needs of patients

  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, andb yourself

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Senior Director, Analytical Development

Bluebird Bio, Inc.