Pfizer Sr. Principal Scientist, Analytical & Viral Assay Development in San Diego, California
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
This candidate is expected to provide technical leadership and supervision to a group of scientists responsible for providing analytical support for early phase vaccine programs. This group is responsible for the development of traditional analytical techniques, antibody based bioassays, method qualification, assay transfer and in-process support. The candidate will develop assay control strategies, prioritize group activities within a program team setting, and manage the overall resources of this group. The candidate will represent the vaccine analytical group on cross functional and cross departmental teams.
• Manage a group of scientists (supervise up to 10 colleagues) within the Analytical Development group within Vaccine Research and Development, which has a focus on supporting the analytical and antibody-based bioassay development and analysis of various antigens (including viruses, proteins, and conjugates) used in vaccines under development.
• Review design and oversee development, qualification and transfer of assays for testing/characterization of intermediate, in-process, DS, formulated or final fill vaccine samples Primary methodologies include separation-based techniques, mass spectrometry, and antibody-based bioassay-based techniques.
• Collaborate as necessary with appropriate leaders/scientists within Vaccines and across other departments.
• Plan, coordinate and support resources to ensure the timely execution of the analysis of intermediate, in-process, formulated, or final fill vaccine samples for samples used in support of planned Toxicology studies.
• Supervise assigned staff including setting objectives, performance management, and career development. Ensure that the staff has received appropriate training and that the training is current. Provide work assignments to direct reports on a regular basis. Manage and assist reporting scientists in the prioritization of method development and analysis efforts. Identify appropriate scientific meetings/training workshops for direct reports.
• Write and review technical documents to support assay development, qualification, and transfer.
• Closely work with management to define long term strategies for Analytical and Formulation Development. Represent Analytical and Formulation Development in project team meetings.
• Keep abreast of scientific/ technological developments by participating in scientific meetings/ seminars and through regular scientific review. Present experimental results at group meetings, project meetings and department meetings. Participate in scientific discussion with colleagues through internal journal clubs, as well as informal and formal scientific seminars and meetings.
• Manage daily, weekly and monthly laboratory activities, such as monitoring of equipment, completion and review of equipment logbooks, periodic laboratory cleaning and managing the laboratory waste, checking PMO status of lab equipment and resolving discrepancies. Manage storage of reagents and test solutions in accordance with departmental procedures.
• Satisfactorily completes all GLP and safety training in conformance with departmental requirements. Where applicable, performs job responsibilities in compliance with GLP and all other regulatory agency requirements.
• Represent the analytical development group in relevant project team meetings both internal and external to Vaccine Research and Development
The role will interact with:
• Analytical and Formulation Development
• Early BioProcess Development
• Vaccine Research &; Development
• BioPharmaceutical Sciences
• External vendors for sample analysis
• Identify the equipment and consumables required to accomplish the work.
• Identify off-site contract testing needs.
• PhD in Chemistry, Biochemistry, or related discipline with at least 8 years of pharmaceutical or biotechnology industry experience is necessary.
• Strong analytical skills are vital for this position.
• Strong management background is a must.
• Knowledge and skills in analytical and bioanalytical method development and characterization for biomolecules and viral-based entities using a range of analytical and bioassay techniques.
• Experience working with vaccines and viruses is desired.
• Planning and management of technical and strategic issues in support of assay development and qualification activities including providing guidance and support with respect to sample preparation, execution of analysis, and method development/ qualification.
• Knowledge and ability to assess new technology or methods for detection and quantitation of the target antigens for potential vaccines.
• Ability to write technical documents, including but not limited to method SOPs, development reports, qualification reports, method transfer protocols and method transfer report.
• Ability to prioritize assay development/ qualification and transfer activities based on project priorities and timelines.
• Standard laboratory conditions - sitting, standing, primarily lab based
• Ability to lift up to 30 lbs
• Ability to travel as required to meet business needs
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.
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.