Bioanalytical Project Manager Jobs in Lexington, MA

This Director role sits at the heart of Integrated Bioanalysis, driving end-to-end bioanalytical strategies that shape the future of our Oncology portfolio. The position leads the design and implementation of robust approaches for PK, immunogenicity and biomarker endpoints, ensuring assays are developed, validated and applied in line with their context of use. Working closely with internal laboratories and external CRO partners, the role provides scientific oversight across multiple modalities and stages of development. Acting as IBA project lead on selected programs, this Director partners with cross-functional teams to align on strategy, manage expectations and deliver high-quality data that informs key decisions. The role offers the chance to influence a diverse pipeline, contribute to departmental strategy and help advance life-changing medicines for patients with cancer.

Accountabilities

Based at one of our US research hubs in Gaithersburg, MD or Boston, MA, this Director leads integrated bioanalytical strategy and delivery for selected Oncology programs. The role partners with TA leads and stakeholders across Clinical Pharmacology and Safety Sciences, Translational Medicine, Research and Clinical Development to ensure timely, fit-for-purpose bioanalytical support. Key responsibilities include defining and driving bioanalytical plans for complex modalities such as ADCs, radio-conjugates, T cell engagers, biologics, cell therapies and small molecules, while maintaining strong scientific oversight of internal and external laboratory execution. The Director will engage with CROs on assay transfer, validation and study conduct, interpret complex datasets and communicate clear conclusions to project teams. A critical part of the role is interaction with global Health Authorities: contributing to regulatory submissions, addressing questions and mitigating risk across geographies. As a recognized Subject Matter Expert, the Director will represent IBA at internal and external forums, publish scientific work and help shape strategic initiatives that strengthen the group's position as a trusted scientific partner. The role also involves encouraging collaboration across matrixed teams, promoting knowledge exchange and ensuring resources are prioritized effectively across multiple concurrent projects. Ready to influence strategy while staying close to the science?

Essential Skills/Experience

• Master's in immunology, molecular biology, or related studies with minimum of 10+ years relevant experience
• PhD in immunology, molecular biology, or related studies with minimum of 7+ years relevant experience in Biopharmaceutical industry. Experienced in serving as a project representative, worked with team members, experienced in drug development process and regulatory filings.
• Confirmed experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK (CK), PD and immunogenicity assessments (humoral and cellular).
• Experienced in regulated bioanalysis, in-depth knowledge of complex biologics and/or bioanalysis of ADCs and related modalities
• Experienced as a bioanalytical lead in diverse project teams, defining, leading, and implementing robust bioanalytical strategy to advance the portfolio.
• Collaborated with team members, providing solutions to challenges and mitigating risk.
• Skilled scientist able to discern the advantages of a range of analytical techniques such as Ligand binding assays, LC-MS, molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays.
• Experienced in assay transfer, scientific quality, and study conduct at CRO partners, data analysis and interpretation, delivery of preclinical and clinical data to project teams.
• Deep understanding of global regulatory expectations and guidance in relevant areas
• Contributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies.
• Interpretation of integrated and complicated datasets
• Ability to prioritise multiple projects and / or tasks concurrently in a fast-paced environment, ability to prioritize and manage resources.
• Background in pharmaceutical clinical trial research
• Validated publication and presentation record
• Outstanding verbal and written communication skills!

Desirable Skills/Experience

• T cell engagers, monoclonal Abs, ADCs, other biologics and or small molecule experience is desired.
• Strong scientific background in immunology, ability to support drug programs across multiple therapeutic areas, working knowledge of flow cytometry.
• Experienced in partnering with operational functions within bioanalysis, clinical operations, external CROs to develop efficient processes for bioanalytical execution.

The annual base pay for this position ranges from $175,498.40 - $263,247.60. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the When we put unexpected teams in the same room, we ignite bold thinking with the power to Inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our outstanding and bold world.

AstraZeneca offers an environment where science leads the way: curiosity is encouraged, bold ideas are tested and investment backs innovation at scale. Teams work with high-quality molecules across all stages of development, collaborating with leading academic centres and external partners to tackle some of the hardest-to-treat cancers. Colleagues are empowered to ask challenging questions, take smart risks and see their work translated into new medicines that reach patients worldwide. With a strong track record of delivering new Oncology medicines and a commitment to sustained R&D investment, this is a place to build a meaningful career while helping transform cancer care!

If this opportunity matches your skills and ambition, apply now to join us and help shape the next generation of Oncology therapies.

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