Head of Cmc Portfolio Management

2 weeks ago

Vancouver, Canada AbCellera Full time

AbCellera is breaking the barriers of conventional antibody discovery to bring better medicines to patients, sooner. Our engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic with precision and speed. We are seeking a Head of CMC Portfolio Management to provide technical and strategic leadership for our portfolio of therapeutic antibody programs throughout their lifecycle.

In this role, based in beautiful Vancouver, Canada, you will be responsible for developing CMC strategies that are deeply integrated with our discovery, development, MSAT, manufacturing, quality and regulatory teams, as well as our partners, with the goal of producing better antibody therapeutics with precision and speed.

We're offering a generous compensation package including an equity stake in AbCellera success. Our future facility will be nestled in the heart of Vancouver, Canada - we'll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area

**We'd love to hear from you if you**
- Have a deep understanding of key CMC drug development activities throughout the life cycle of antibody products
- Have excellent communication and interpersonal skills, and enjoy working at the interface of multidisciplinary teams in a highly collaborative environment

**How you might spend your days**
- Devising and driving appropriate strategies to advance CMC drug development activities and lifecycle program management including acceleration mechanisms, risk identification and mitigation
- Considerations regarding science, program budgets, resources, and key tactical and regulatory strategies, and providing recommendations for program advancement
- Working closely with project managers to coordinate and monitor progress of key deliverables for the program lifecycle
- Interacting with partners and CDMOs to represent our Tech Ops team
- Prioritizing CMC activities across the portfolio, driving swift decision-making, and ensuring timely communications across AbCellera
- Managing and mentoring CMC technical leads, providing strategic leadership in the delivery of assets to meet portfolio priorities
- Engaging stakeholders within and outside Tech Ops to develop a long-term strategic view of product development needs to meet company objectives

**Required qualifications and experience**
- Master's (Science or MBA) or Ph.D. degree in biotechnology, chemical/biochemical engineering, or another relevant life-science discipline with a minimum of 15 years of industrial experience in antibody process development
- A track record of thinking innovatively, driving positive changes and fostering collaborative work environments
- Experience with end-to-end product development, manufacturing and supply management activities
- Experience working with both internal manufacturing organizations and external CDMOs is desirable
- Experience in authoring Module 3 CTD sections of IND filings and familiarity with regulatory standards and guidance documents for all phases of development
- Familiarity with regulatory requirements as it pertains to CMC activities for biologics (FDA, EMEA, ICH, etc)
- Experience authoring regulatory filings such as INDs, BLAs, IMPDs
- Experience with both monoclonal and bispecific therapeutic antibodies is highly desirable
- Proven track record building and leading teams in addition to successful professional development of team members

**What We Offer**

AbCellera's hiring range for this role is $146,000 - $183,000, annually, commensurate with your education and job-related knowledge, skills, and experience. We base our salary ranges on localized market data ensuring competitive compensation. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and 6% (non-match) RRSP contribution.

At AbCellera, we have a number of initiatives to support AbCellerites in maximizing their work-life synergy. You will have a $1,500 annual active lifestyle allowance, annual vacation and company-wide office closures (a real value to all), opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. Abundant team and social groups to build community and connections within AbCellera are a given.

**About AbCellera**

At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You'll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, comp

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