The incumbent is responsible for leading and supporting a team performing routine and characterization analytical chemistry tests and conducting analytical chemistry projects / technology transfers within the Analytical Technology (AT) group. The Sanford AT group is comprised of analytical scientists who work on multiple biologically derived intermediate and drug substances (i.e. proteins, polysaccharides, and protein-polysaccharide conjugates).
The team of AT scientists will:
- Collaborate with other scientists (process and analytical) in MSAT and AT on all projects,
- Test samples and document analytical results,
- Interpret the data of tested materials
- Lead transfer of analytical methods (in and out) between MSAT Sanford and analytical development, Quality Control (QC) Lab, other MSAT departments, and/or 3rd Party Entities
- Develop new methods for characterization and comparability testing
The incumbent is expected serve on cross-functional projects and teams within the Pfizer network. Projects must achieve business, quality, and compliance objectives; and must be executed in a manner that assures full compliance with government regulations and internal company standards and values.
The incumbent will interact regularly with their manager and with their fellow analytical chemists for guidance and coaching.ROLE RESPONSIBILITIES
- Acts as a technical/functional expert providing guidance and oversight to direct reports and other teams within the department
- Identifies existing method and process improvements and may develop innovative, advanced concepts that improve robustness, efficiency, etc.
- Identifies work processes that need improvement and provides solutions
- Manages and leads people, technological and financial resources for multiple projects and on-going work activities of moderate complexity within department typically involving cross-functional representatives
- Performance evaluation, salary recommendations and career development of all team members
- Operate and maintain laboratory equipment and instruments.
- Review and witness electronic lab notebooks.
- Author, Review, and Approve technical reports, methods, and regulatory documents.
- Serve on various teams as analytical representative and/or subject matter expert. Role of a network SME requires frequent participation in teleconference / WebEx meetings with internal and external collaborators.
- Adhere to and enforce site safety standards. Participate in safety training events and ensure that all staff safety training is conducted in a timely manner
- Ensure the group is fully trained in all relevant policies and procedures as well as all federal and global regulations
- Maintain the depth and scientific capability of the group
- Establish contacts across the network to foster development, innovation, and replication of best practices
- High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
- Knowledge of fundamental analytical chemistry principles (i.e. use of standards and controls, matrix effects, sample preparation, sample management, calculations, control charting, spectroscopy, chromatography, ELISA, use of laboratory equipment, protein methods, etc.)
- Attention to details
- Excellent organizational and documentation skills - If the work is not documented clearly and completely, then the work will be of no value.
- Intermediate to advanced MS Excel skills
- BS / MS / or PhD in Chemistry, Biochemistry, or equivalent science or engineering degree.
- Demonstrated record of success in leading cross functional teams and mentoring technical staff with varying levels of education and experience
- Familiar or experienced in Good Manufacturing Practices (GMP)
- Experience working with proteins or carbohydrates is desired
- Experience with electronic Laboratory Notebooks (eLN) is desired
- Analytical method development experience is desired
- Knowledge of quality control and Pharmacopeias
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Must be able to lift 40 lbs on infrequent occasion (equipment transfer, large volume reagent preparation, etc).
Position is for first shift but may require flexible scheduling on rare occasions to accommodate process schedules for critical samples with an immediate requirement for analysis. Travel is not anticipated but may be required on an infrequent basis.
Work Location Assignment:Flexible
Last Date to Apply for Job: December 14, 2022
Eligible for Relocation Package: Yes
Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility
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.
Research and Development