Pfizer's Research and Development group is looking for a candidate to manage the analytical aspects of drug product development for PSSM, ensuring the delivery of new medicines from early design through global filing stages.
Requirements
- Extensive experience in analytical chemistry, including method development and validation, transfer of methods, filings and working with external vendors.
- Strong knowledge of regulatory requirements and guidelines for pharmaceutical development
- Technical proficiency in at least one area of analytical sciences such as chromatography, spectroscopy, dissolution etc.
- Excellent problem-solving skills
- Excellent working knowledge of Drug Product development and experience working as part of multi-disciplinary, cross-functional teams supporting development of sterile injectable products and other complex dosage forms.
- Strong supporter of technology, innovation and digitization.
Responsibilities
- Be responsible for the development of analytical strategies in order to develop and deliver drug product methods, controls/specifications and stability strategies ready for filings (IND/NDA etc).
- Be Accountable Manager for several projects at any one time, providing appropriate guidance and instruction to Analytical Project Leads.
- Technical proficiency in at least one area of analytical sciences such as chromatography, spectroscopy, dissolution etc.
- Effectively utilize SME’s both within and outside of ARD (e.g. SEG, Dissolution, PAT, modeling, digital).
- Be an effective member of the DPA Leadership Team that aims to collaborate effectively and manage resources as well as program risks.
- Engage in stakeholder communications to establish effective priorities for the group and project teams.
- Effectively represent the accomplishments and efforts of your teams and the group with both oral and written communication.
Other
- 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.
- Be able to thrive in a fast-paced matrixed environment.
- Work effectively with partner lines as needed to develop effective cross line deliverables.
- Be a vocal champion for innovation, incorporating new ways of working in order to improve efficiency and enable more digital & predictive tool use.
- Develop new leaders with effective training and mentoring of less experienced colleagues in the group.
- Be open and flexible in a changing business environment with an ability to pivot and adapt strategies easily.
- Be effective and supportive in the use of external vendors to manage timelines and deliverables.
- Be able to communicate and interact with colleagues and leadership at multiple levels. Be able to break down highly technical content into understandable and effective communications.
- Has attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required both laterally and vertically within the organization and representing Pfizer, ARD (API, GA, DSSE) outside of day-to-day responsibilities.
- Proven track record of leading and managing complex projects
- Approximately 10% travel is anticipated for a Groton based colleague
- Relocation support available
- Work Location Assignment: On Premise; minimum 4 days per week onsite.
- This position requires permanent work authorization in the United States.
