Senior Scientist, Analytical R&D- Dissolution
Lake Forest, IL
Job posting number: #7107629 (Ref:4856766)
Posted: August 9, 2022
Application Deadline: Open Until Filled
Job DescriptionWhy Patients Need You
Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
What You Will Achieve
The successful candidate will have a strong track record in chemistry, formulation science, pharmaceutical sciences, or analytical chemistry, and will support the development of Pfizer’s Pharmaceutical Sciences Small Molecule portfolio through the development and application of dissolution and advanced in-vitro methods for the prediction of clinical performance and ultimately to steer formulation development.
They will work with cross-functional development teams collaborating with analytical chemists, and formulation scientists from across Pfizer’s global organization, applying their knowledge of dissolution science, advanced in-vitro tools, and the relevant regulatory requirements to the development of Pfizer’s solid oral drug product development portfolio. The colleague will have the ability to learn new techniques and develop new approaches in the pursuit of in-vitro prediction of clinical performance and work with other subject matter experts to solve complex problems. It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Working closely with drug product development teams develop and validate dissolution methods which are compliant with contemporary global regulatory requirements for Pfizer’s portfolio of solid oral products.
Employ dissolution and advanced in-vitro tools to inform the development of novel, innovative, breakthrough medicines in clinical development, including treatments for Covid-19, rare infectious disease, cancer and other life-threatening conditions.
Effectively collaborate with project team members, including presenting data at project team meetings, critically reviewing experimental data, and be actively involved in solving technical challenges that arise during pharmaceutical development.
Team interaction is critical, and the colleague must be able to collaborate with and mentor peers as well as effectively interact with leaders as part of a multi-disciplinary team, thriving in a fast-paced environment.
May represent the analytical department on global, cross-functional project teams and initiatives.
May author internal and external publications and relevant sections of CMC regulatory documentation, e.g. IND, IMPD, CTDs.
Provide technical coaching/mentoring to colleagues within project teams and the wider department.
Provide presentations, training, and advice to others to share learnings and promote increased scientific and technical understanding of dissolution and biorelevant methods.
Be a positive advocate for new technology, process improvements and for the application of computational tools and digital design approaches.
Maintain written records of experimental work in accordance with GLP/GMP and departmental philosophies.
Skills and Experience
Sound knowledge of dissolution development and related regulatory considerations.
A team orientated person with experience in a laboratory environment in the pharmaceutical industry is highly desirable.
Excellent communication skills are essential for this highly interactive position.
Excellent team collaboration and organizational skills are also essential.
A rational approach to problem solving with strong attention to detail and a desire to learn and grow their skills is essential.
A good appreciation of small molecule pharmaceutical development and an ability to apply scientific technical skills and knowledge to projects independently and proactively.
Experience in contributing to the authoring external technical publications and/or CMC regulatory submissions is desirable.
High level of practical competence with good laboratory safety awareness is expected.
Knowledgeable in the use of computational, modelling and simulation tools would be beneficial.
Masters degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry or a related discipline with 4+ years of experience in the pharmaceutical industry in a relevant role.
PhD degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field, ideally with at least 1 year of experience in the pharmaceutical industry in a relevant role.
Experience of working in a cGMP environment.
Experience of working in a people leadership role.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some limited travel to other Pfizer locations can be expected and the colleague will need to work with colleagues globally mainly in an on-line manner
Work Location Assignment: On Premise
Relocation Assistance Available
Eligible for Employee Referral Bonus
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.