Director, Genomics Operations
Burlington, MA, USA
Company Overview: ProtaGene is a world-leading analytic CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and Quality system driven analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021, GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were integrated into our platforms and service offerings, establishing ProtaGene. The organization operates over four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.
Candidate Role: ProtaGene is seeking an experienced and dynamic leader to join the Genomics team in a fast pace, high growth global CRO in the biologics and cell and gene therapy industry. This is a unique opportunity to join a quickly growing team undergoing expansion and to play a key role in leading next stage growth. This position will report to the US Site Head of the US Lab in Burlington, MA USA with a strong dotted line to the Senior Director Genomics in Heidelberg, Germany.
- Provide strategic and tactical leadership to the Genomics scientists and lab team supporting ‘Integration Site Analysis’, ‘BioDistribution’ and ‘Shedding Studies’ in a GLP and GCP quality environment.
- Provide scientific guidance and oversight in the design of project objectives and deliverables.
- Guide scientific exchanges with clients in complex scientific projects.
- Collaborate with Business Development, Marketing and Sales to help shape and develop future opportunities with clients with a focus on ProtaGene’s genomics analytical services.
- Collaborate across internal teams and stakeholders to support on-going technology and process harmonization between different sites (US and Germany).
- Provide guidance, direction and strategies for the implantation and maintenance of GCP/GLP compliance, to ensure the quality and reliability of the work.
- Provide thoughtful leadership in identifying key areas of opportunity and risks as well as the implementation of solutions.
- Manage the design and transfer of qualified methods into validated environments.
- Represent the company in national and international scientific conferences and meetings.
- Successfully completed advanced research in the life sciences field (e.g., genomics, virology, molecular medicine). Ph.D. preferred with at least 5+ years of relevant experience or MS degree with 10+ years of relevant experience.
- Broad knowledge of the analytical environment for safety testing in the Cell & Gene Therapy space, with a primary focus on nucleic acid analysis methods (e.g., NGS, qPCR, ddPCR).
- Industry experience and/or previous work in a GLP/GCP compliant environment is highly desirable.
- Basic understanding of NGS data analysis related challenges and bioinformatics is a plus.
- Proven ability to deliver projects to objectives and timelines, while managing client and partner processes, people, and relationships at the highest levels of excellence.
- The ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple projects.
- Highly detail-oriented, self-motivated and results driven.
- Approach to excellence in every aspect of the role.
- Excellent verbal and written communication skills.
- Exceptional relationship management skills and the ability to develop connections with people of all types of backgrounds.
- Experience in attracting, developing, and managing talent.
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