Director, Drug Product Analytical Research and Development
Pfizer
- Groton, CT
- Permanent
- Full-time
- Have overall responsibility for the project management of the analytical activities and associated strategy in the field of Chemistry, Manufacturing and Controls (CMC) Development for defined therapeutic development projects
- Define and drive the analytical development strategy in full alignment with the other CMC and associated functions (Drug Product Design, Clinical and Commercial Supply Chains, Nonclinical and Clinical Development, Quality Assurance, Regulatory Affairs, Pfizer Global Supply for Commercial Manufacturing)
- Plan, track, drive all project related analytical activities and expenditures.
- Be empowered to drive the decision-making process in a multidisciplinary matrix organization.
- Ensure fit for purpose and robust analytical deliverables with respect to the project timelines and costs.
- To define the analytical development strategy and contribute to the high-level milestone plan (CMC Plan) in alignment with the overall ARD development strategy
- To define the timelines, budget and resources and to coordinate all analytical activities to meet the overall project timelines and deliverables
- To foster efficient collaboration with the other lines in order to ensure high-quality fit-for-purpose analytical deliverables.
- To monitor progress against project plan and report progress updates to co-development project team and governance bodies.
- To establish and track project budget for internal and external activities
- To update the CMC plan with respect to analytical activities on a regular agreed basis in line with updated development plan and strategies.
- To prioritize the analytical activities effectively (in collaboration with Pharmaceutical Sciences Team Leads and other lines) according to project timelines and resources constrains.
- To ensure effective communication with all other involved CMC and associated functions as well as with external partners
- To initiate risk assessments and development of risk mitigation strategies regarding analytical activities
- To participate in improvement initiatives as required to ensure best in class project management
- To champion novel ways of working, including digital efforts, modeling, simulation and integrated online efforts.
- PhD in Analytical Chemistry, Chemical Engineering, or related discipline with 15+ years relevant experience in small molecule drug substance / drug product development, or BS/MS in Analytical Chemistry, Chemical Engineering, or related discipline with a minimum of 20+ years relevant pharmaceutical industry experience.
- Extensive practical experience working within cross-disciplinary project teams and achieving results in a matrix environment.
- Experience in actively developing and advancing scientific initiatives and external collaborations.
- Proven track record of mentoring and coaching early and mid-career scientists.
- A passion for leadership and the ability to guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Excellent organizational and communication (oral and written) skills.
- Ability to work independently, as well as thrive as part of a team. Interchange roles imperceptibly.
- Possess a passion for coaching and mentoring a new generation of leaders and scientists.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Occasional travel may be required for in-person meetings, conferences, or project support. Less than 10% travel is anticipated for this role.
- Last Date to Apply for Job: March 31, 2024
- Eligible for Employee Referral
- Eligible for Relocation Package
- Work Location: Groton, CT