Sr. CMC Scientist/Engineer, Clinical Drug Product Manufacturing
The individual will be responsible for global clinical drug product manufacturing projects from initial technology transfer through preparation for commercialization. The individual will collaborate with clinical supply planning, process development subject matter experts, and external partners to meet clinical supply needs, and facilitate drug product manufacture, packaging and labeling operations - including scheduling, finances, document review, and maintenance of relevant quality systems.
The individual will be a key contact with our contract manufacturing partners, and will collaborate to improve business processes, evaluate metrics, and develop opportunities for continuous improvement. This includes maintaining productive relationships and communication with manufacturing partners as the BBI representative and contributing to processes for streamlining communication within our organization.
The individual will be responsible for conducting technology transfers, and supporting activities related to pilot scale experiments and engineering studies to ensure process robustness. As project lead, the individual must maintain project tools (schedules, timelines, plans, and trackers), proactively drive resolution of issues, and foster collaboration with our external partners.
The individual may also represent drug product manufacturing on cross-functional project teams, author and review drug product manufacturing sections of regulatory submissions, and contribute to internal operational and business process improvements.
• Manage clinical drug product manufacturing projects, including scheduling, finances, and document review/approval, and maintenance of relevant quality systems.
• Manage cross functional technology transfer for implementation of drug product processes at contract manufacturing facilities.
• Collaborate closely with other CMC team members, as well as Supply Chain, Quality, Regulatory, and Finance team members.
• Develop and maintain relationships with external partners.
• Represent drug product manufacturing on cross functional project teams.
• Provide person in plant oversight for critical drug product manufacture.
• Author and review drug product manufacturing sections of regulatory submissions.
• Minimum, BS degree in engineering, chemistry, biotechnology, or related science
• Minimum, 5-8 years of experience in development, operations and/or quality in pharmaceutical industry, CMC experience preferred.
• Knowledge of global ICH/GMP regulations and guidance.
• Experience within a project team (preferably involving external partners).
• Strong communication, presentation and analytical skills.
Boston Biomedical is an industry leader in the creation and development of next generation cancer theraputics. Our most advanced program involves inhibitors of cancer stem cell pathways. Cancer stem cells have been shown to contribute to both recurrence and metatasis. Because cancer stem cells are thought to be resistant to current chemotherapies, we believe that focusing on stemness pathways may hold promise for advancing cancer treatment. In addition to our advanced cancer stem cell pathway inhibitor program, we have several compounds, which include peptide vaccines and immune response modifiers, in preclinical and early clinical development.
Boston Biomedical is a fully integrated oncology drug research and development company with expertise in drug discovery, crystallography, medicinal chemistry, preclinical development, pharmacology, pharmaceutical development, CMC (chemistry, manufacturing and control), global clinical trials and regulatory affairs. Our scientists have established a track record of accomplishments in a short time, including the discovery and ongoing development of multiple compounds and programs.
As our compounds moved forward in development, we began building out our commercial operations group in 2013.
Boston Biomedical has created a unique corporate work environment. We aim to continue to leverage our innovation-driven culture, scientific leadership and drug development expertise to advance the development of novel cancer therapeutics for patients with cancer.
Sat, 13 May 2017 14:40:54 PDT