Qualifications:
· 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