Director Analytical Chemistry
PfizerAbout the role
ROLE SUMMARY:
The Active Pharmaceutical Ingredient (API) Analytics group is working diligently to bring new cutting-edge medicines to patients around the world. Our team members use the latest science and technology to characterize and develop new drug candidates from the early phases of development through to commercial launch.
As a Director in our group, you will lead a team of analytical scientists to assess the chemical and physical properties of Pfizer’s newest drug candidates and evaluate their suitability for progression into clinical studies and ultimately to commercialization. You will have a strong passion for developing early career scientists and be skilled at guiding them to solve difficult technical problems. You will also be constantly looking for ways to improve the speed and efficiency of scientific and business processes used in the development of Pfizer medicines.
A deep knowledge of pharmaceutical development, analytical measurements, control strategies, formulation & process development, as well as relevant computational skills are desirable for this leadership position. In addition, experience of working successfully as part of a multidisciplinary organization is vital for your success. You will be responsible for the continuous enhancement of technical skills, scientific knowledge, and personal growth of colleagues. You will also have the opportunity to grow your skills as a people leader and your influence within global analytical research and development at Pfizer.
The successful candidate will have a proven track record in pharmaceutical development and extensive experience in regulatory filing requirements and strategies, as well as being comfortable leading multiple teams inside and outside the Pfizer network to meet milestones and deliverables. An ability to respond well to change, thrive in a dynamic environment, support and champion technology and innovation are also needed to thrive in this role.
As a Director in the API Analytics team, you will work in an environment where you will:
-Lead a team of analytical chemists with responsibilities for the progression of analytical methodology throughout all stages of development.
-Coach and develop analytical chemists to drive towards mastery, to ensure your team is appropriately supported, and to develop meaningful growth plans.
-Partner with Chemical Research and Development to successfully deliver new medicines.
-Define and drive the control strategy in partnership with Chemical Research and Development, and other CMC associated functions (Formulation Development, Clinical and Commercial Supply Chains, Nonclinical and Clinical Development, Quality Assurance, Regulatory Affairs, Pfizer Global Supply for Commercial Manufacturing)
- Have overall accountability 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
-- Plan, track, drive all project related analytical activities and expenditures.
- Drive the decision-making process in a multidisciplinary matrix organization.
- Be a leader across Analytical Research and Development (ARD) and contribute to departmental operational and strategic teams.
- Ensure fit for purpose and robust analytical deliverables with respect to the project timelines and costs.
As an API Analytics Director you will contribute with the following activities:
- Being accountable for the analytical development strategy and contribute to the high-level milestone plan (CMC Plan) in alignment with the overall ARD development strategy
- Defining the timelines, budget and resources and to coordinate all analytical activities to meet the overall project timelines and deliverables
- Fostering effective collaboration with the other lines in order to ensure high-quality fit-for-purpose analytical deliverables.
- Monitoring progress against project plans and report progress updates to co-development project team and governance bodies.
- Ensuring effective communication with all other involved CMC and associated functions as well as with external partners
- Participating in continuous improvement initiatives as required to ensure best in class project management
- Being a champion for novel ways of working, including digital efforts, modeling, simulation and integrated online efforts.
QUALIFICATIONS
- PhD in Analytical Chemistry, Organic Chemistry, Chemical Engineering, or related discipline with 10+ 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 25+ years relevant pharmaceutical industry experience.
- Extensive practical experience working within cross-discipl
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