· PhD in immunology, cell biology, molecular biology or equivalent field with preferred working experience in GCT area.
· Minimum of 8-10 years directly related experience in biopharmaceutical development.
· Strong technical knowledge of viral assay development. Strong history of rigorous science applied to drive technical accomplishments.
· Knowledge in analytical method validation and global regulatory filing requirements.
· Demonstrated leadership capabilities to develop a high performing team, drive change and influence internal and external stakeholders.
· The ideal candidate will have an in-depth understanding and development-stage experience in biological potency method development, protein biochemistry and viral based products.
· Experience with characterization and quantitative analysis of complex biological mixtures utilizing state-of-the-art techniques, including, but not limited to sequencing, qPCR, and NextGen.
· Experience with cell-based and replication competent assays desirable.
· In-depth understanding of quality control laboratory operations in a commercial set up.
· Independently motivated, detail-oriented and good problem solving with ability and experience to troubleshoot complex technical and scientific problems.
· Strong ability to present data in a variety of team settings and actively participate in departmental meetings as well as cross-functional area project teams.
· Strong interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations.
· Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
· Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
· Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals.
Education and Experience:
· Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent and relevant combination of education, training, & experience.
· 5+ years of management responsibility
· Proven leadership skills
Knowledge, Skills and Abilities:
· Thorough knowledge of GMP or GLP
· In-depth knowledge of clinical laboratory science, ICH guidelines, FDA regulations concerning clinical labs processes in drug development process, method development, method validation, R&D, sample production and/or data processing
· Strong leadership skills including budgeting, forecasting and fiscal management
· Project and time management skills
· Excellent communication/interpersonal skills including presentation skills
· Demonstrated strategic planning skills
· In-depth global and cultural awareness
· Strong organizational agility and demonstrated drive for results
· Excellent coaching and mentoring skills