Design, develop and perform forced degradation stability studies using West’s container systems.
Perform feasibility assessments for novel drug formulation – delivery device combinations and advance their applications in the Cell & Gene Therapy industry.
Evaluate new drug formulation proposals for biologic products and advanced therapies.
Support engineering teams in the design and development of new drug delivery solutions that support client needs
Manage and contribute to complex research projects across several technologies and a variety of project formats, from short-term student internships, through to feasibility projects and long-term collaborations.
Collaborate and gain commitment with stakeholders internally within West as well as externally with research partners (postdocs, professors and clinicians) as needed to achieve project objectives.
Analyze and evaluate experimental results to make well-reasoned strategic recommendations that are to be disseminated internally to inform future research and development decisions at West.
Actively seek out new and emerging technologies and therapies, track publications, identify and highlight active academics and keep our organization informed of research and industry developments.
Provide subject matter expertise across the organization in the field of applied research in drug formulations development.
Capture project outputs in appropriate format including: technical reports, presentation slides, research posters, invention disclosures or as project requires.
Attend select targeted scientific and research conferences to learn and present out research findings with intention of increasing West scientific reputation in novel fields.
Basic Qualifications
life sciences, pharmaceutical sciences, bioengineering or equivalent scientific discipline.
Experience: 5-8 years of experience, can include time spent either in industry or graduate school.
Hands-on experience of biologics product development including formulation and fill/finish development and/or cryobiology.
Preferred Knowledge, Skills and Abilities
Education: PhD in life sciences, pharmaceutical sciences, bioengineering or equivalent scientific discipline.
Knowledge in apoptosis and necrosis pathways, coupled with experience in cryopreservation is highly desirable.
Demonstrated ability to lead complex research projects, can either be shown in relevant industry projects or via strong collaborative postgraduate research.
Strong interpersonal skills to generate, maintain and grow research relationships and gain commitment from all internal and external stakeholders across research projects.
Excellent written and verbal communication and ability to articulately disseminate scientific research to a variety of different audiences, from expert through to non-technical.
Scientific knowledge in material science and drug formulation design
Scientific publication track record and/or conference proceedings in a chosen field of expertise.
Understanding of regulated manufacturing environments, i.e. aseptic and GMP production.
Experience and ability to draft drug product sections of INDs, IMPDs, NDAs and MAAs.
Working knowledge related to manufacturing or process development experience in biotech industry
Maintain the ability to work well with others in a variety of situations.
Able to multi-task, work under time constraints, problem solve, and prioritize.
Travel Requirements
Must be able to travel domestically or internationally up to 10% of the time.
Physical & Mental Requirements:
Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
Must be able to communicate effectively, speak in front of groups, express & exchange ideas and understand direction.
Maintain the ability to work well with others in a variety of situations.
Able to multi-task, work under time constraints, problem solve, and prioritize.
Able to learn and apply new information or new skills.