Senior Manager / Associate Director, CMC Lead - Early Oncology
Technical Lead for Early Oncology clinical programs
Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches. bluebird bio seeks an outstanding CMC Sr Manager or Associate Director to act as a Technical Lead for early-stage oncology clinical programs. We seek candidates with proven ability to successfully integrate activities and perspectives across functions to develop and drive the CMC strategy for novel gene therapy programs, with the ultimate goal of delivering therapies that transform the lives of patients.
About the role:
- Partner with CMC Project Manager to co-lead CMC teams for multiple complex clinical programs to achieve product development and manufacturing goals
- Hold the technical expertise and set the vision for the projects integrating different perspectives from CMC team members (QC, analytics, process development, manufacturing, QA, regulatory, etc.)
- Proactively participate in setting CMC goals, vision and implementation strategy
- Anticipate obstacles and proactively lead risk planning/management activities for multiple contingencies to ensure successful CMC execution
- Build strong relationships with CMC team members to identify and address challenging issues in product development and manufacturing and develop CMC strategy
- Coach new CMC team members to develop future leaders
- Clearly communicate and ensure buy-in with CMC vision, strategy and tactics
- Represent CMC at program team meetings to ensure alignment with CMC timelines, milestones and budget
- Effectively communicate with internal and external team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with the various CMC projects, as well as ensure CMC teams are aware of current integrated program timelines
- Assist in establishment of development processes for early stage programs
- Participate in submissions to and interactions with health authorities. May include authoring and reviewing documents, participating if teleconference and fact to face meetings
- PhD in biological sciences, chemical engineering, or related field with 6+ years or MSc/BSc with 8-10+ years of relevant biopharmaceutical industry experience.
- Technical understanding and experience in biopharmaceutical development and cGMP manufacturing practices
- Previous early phase (pre-clinical to Phase I) experience in process and/or analytical development and manufacturing of cell & gene therapy is preferred.
- Prefer 2+ years of CMC project lead at a fast-paced, innovative biotech/pharma company. Early-phase CMC experience preferred.
- Knowledge and understanding of pharmaceutical development for oncology targets and working knowledge of key interface functions
- Track record of driving preclinical and/or early clinical programs through CMC successful execution, oncology experience preferred
- Strong scientific and technical mastery including superior technical writing and presentation skills
- Experience authoring and reviewing relevant regulatory documents, including INDs, and understanding of current regulatory guidelines
- Proven ability to distill complex plans across multiple programs into an intuitive, simple and clear communication to facilitate prioritization and resourcing
- Strong interpersonal and leadership skills with the ability to motivate others, influence without authority, and negotiate conflict situations
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Independently motivated, detail oriented and great problem solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Excellent communication skills and ability to influence stakeholders and leaders across multiple functions.
- A passion for addressing the critical unmet medical needs of patients
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself