The opportunity
The person hired for this position will need to sit out of our West Chester, PA site 5 days a week
Leads and coordinates all aspects multiple diverse pharmaceutical R&D projects/programs with respect to the Characterization and Bioassay for Innovative Biologics Development. Utilizes expertise and leadership skills to direct staff and resolve issues to ensure project goals and timelines are met. Drive innovative/creative culture in delivering business results. Willingness to challenge boundaries. Excellent organization and problem solving skills. Engage, coach, mentor and empower others to reach their full potential.
How you’ll spend your day
Within Biologics CMC’s Analytical Development Team, oversee the Characterization and Potency sub functions consisting of approximately 22 scientists ranging from advanced degrees and experience to new bachelor scientists, responsible for product characterization, including functional ( Potency and Binding) assay development and Mass Spectrometry (MS) analyses techniques for candidate programs. Responsible for leading and managing a aspects of bioassay and MS assay development, assay qualification (leading to validation) and sample analysis activities.
Responsibilities include being an active member of the AD leadership team, assist in tracking, managing, and to provide oversight of biologics drug development, strategy, compliance and regulatory submission practices, as well as some FTE and budget resourcing. Lead and be a part of the Analytical Development leadership team, to assist in planning, coordinating and leading the activities of product characterization and potency functional assays for innovative (and biosimilar) drugs (as needed), according to ICHQ6. Collaborate with project teams on assays and planning relevant to long term objectives and concerns. Communicate with inter-organizational teams concerning projects, operational decisions and scheduling requirements.
Monitor completion of tasks and projects according to agreed and accepted milestones. Collaborate on patent applications and manuscripts of publications. Assist in developing budgets for CAPEX, labor and contracts. Provide oversight and authorship (where necessary) for regulatory fillings and support oversight for any CRO activities, (outside of our internal development activities)
Quality management & Personnel:
Ensures the following for self and direct reports:
Establishment and implementation of SOP’s relating to development space lab testing.
Ensure test methods comply with relevant (phase appropriate) regulatory guidelines
Ensure correct, accurate, precise and verified results are reported
Responsible for supervision, training and management of lab staff.
Responsible for evaluations of performance, promotions and qualifications of potential new hires.
