Senior Science Leader in Pharmaceutical Development
At AbbVie, we are dedicated to pushing the boundaries of science and innovation to improve life quality globally. As part of our vibrant team, you will help transform possibilities in neurological and psychiatric care into realities.
As a Senior Science Leader in Pharmaceutical Development, you will independently manage programs of various complexity utilizing a matrix approach. You will lead Chemistry, Manufacturing and Controls (CMC) teams and Product Presentation and Device Strategy Teams (PPDST) of functional representatives from various departments and divisions for projects involving external collaboration partners per Pipeline Commercialization Model (PCM).
In this role, you will be accountable for creating a CMC strategy and development plan that aligns with the overarching asset strategy to effectively advance to the next key milestone and deliver a differentiated product.
You will serve as the spokesperson for all CMC functions and ensure information flow among Asset Strategy Teams (AST) and various line functions and stakeholders.
You will partner with key collaborators, including Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME and Commercial organizations.
Key responsibilities include:
* Representing all CMC areas on the AST, serving as spokesperson for the CMC project team, and ensuring information flow among the AST and all line functions.
* Ensuring high-quality science, technology, deliverables, and certifying compliance with global regulatory and quality requirements.
* Participating in meetings with Regulatory Authorities, responding to regulatory queries, and participating in communications and meetings with regulatory agencies.
* Taking accountability for creating CMC development plans, including timelines, risks, and mitigations, in collaboration with line functions and AST.
* Leading PPDST and/or CMC development teams for assigned projects: scheduling meetings, developing agendas, issuing highlights, identifying risks, and developing mitigation plans with technical functions.
* Conducting periodic reviews to ensure that phase transition criteria are met in the most efficient and resource-effective manner.
Additional responsibilities include reviewing contracts with Third Party Manufacturers and consultants, developing budget needs in collaboration with AST, obtaining resources from functional areas, staying within approved funding, driving legal and financial aspects of outsourcing, contracts, and statements of work (SOW), demonstrating excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders, demonstrating strong negotiating, influencing, and leadership skills, leading teams and partner interactions for new due diligence in-licensing opportunities, and successfully transitioning leadership for programs where development is internalized.
Required Skills and Qualifications
This is how you can make a difference:
* Bachelor's Degree with at least 10 years of experience in a variety of relevant functions required; Master's Degree with at least 8 years of relevant experience required; or PhD with at least 6 years of relevant experience required.
* 2-6 years of working experience required in the same/similar role or in related CMC function.
* Must possess excellent scientific writing and verbal communication skills.
* Must have a good working knowledge of regulatory requirements and familiarity with relevant scientific instrumentation and techniques.
* Good knowledge of pharmaceutical drug development process.
* Must have CMC interdisciplinary experience and expertise.
* Possess negotiating, influencing, leadership skills.
* Creative in implementing entrepreneurial thinking and making smart business decisions.
* Ensure high level of morale and collaboration in cross-functional teams to maximize team impact and output.
Benefits
At AbbVie, your individual contributions count - help us move mountains together. Be a part of our success, grow with us, and accomplish more than you could have imagined.
We look forward to receiving your application. All you need is a complete CV - we will discuss everything else with you in person.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community.
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We take our impact on the environment and our communities seriously, and therefore focus on giving something back on a regular basis.
We are committed to equality, equity, diversity, and inclusion (EED&I) - a commitment that is fundamental to us.
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