ROLE SUMMARY The qualified candidate will be a Scientist in an analytical organization (Analytical R&D) seeking to lead the industry in technologies applied to advance biotechnologically-derived products to the market through innovation and delivery of cutting edge analytical testing. The qualified candidate will be part of an organization that focuses on method validation and transfer of analytical methods and technologies for biological therapeutics. The group is responsible for the validation and late-stage analytical lifecycle management of quality controlled methods as they are established in commercial manufacturing sites. Qualified candidates will deliver results in a fast paced matrix-oriented setting, and be a contributor to method validations and strategies. The role is in support of products and process development for biotherapeutics and vaccines, including antibodies, antibody-drug conjugates, and therapeutic proteins, in late-stage clinical development. The candidate will work across analytical functions, projects, and global sites. Candidate will primarily author and oversee documentation associated with method validations and transfers. ROLE RESPONSIBILITIES Candidate should have in-depth scientific knowledge and experience in the development and validation of analytical methods, covering a wide array of techniques such as HPLC, CE, and wet-chemistries. They will be involved to ensure the proper and timely execution of all aspects of the validation activities to support process qualification and commercial launch. Colleagues in this group are expected to lead or be involved in cross-functional analytical technology transfer teams across many sites in the United States and Europe. These teams are responsible for the planning, coordination, execution, and communication of analytical responsibilities. Qualified candidates will serve as an analytical and biochemistry resource for the department and project teams, proactively keeping colleagues at the commercial launch sites aware of historical product knowledge and experience such as specifications, stability, reference materials, and any method development documentation. Individuals in this group will be the primary authors, reviewers, and approvers of regulated documents such as method validation reports, protocols, method transfer exercise reports. Colleagues in this group are expected to be updated with current scientific trends, strategies, and technical aspects from conferences, local meetings, and the literature. Furthermore, the candidate will be responsible for the development of novel approaches and methods with the latest analytical technologies for more informative and efficient product characterization in alignment with commercial manufacturing organizations. QUALIFICATIONS MINIMUM: M.S. with two years of experience or B.A./B.S. with five years of experience with interdisciplinary drug development teams and industrial experience developing analytical strategies and methods in support of product and process development and to assess the quality and characteristics of biotherapeutics. Demonstrated technical writing skills and effective communication are strongly desired. Experience with technologies focused on analysis of biomolecules and conjugates such as HPLC, and electrophoresis. Experience working in a regulated environment (e.g. GLP, cGMP). Experience with method validations and method transfers to commercial manufacturing receiving labs. DESIRABLE (one or more areas): Direct experience working with FDA or other regulatory authorities for programs in late-stage clinical development or approved products. Knowledge and experience in Critical Quality Attributes (CQA) principles and practices and product specifications and specification setting. Demonstrated technical skills and scientific expertise in analytical method development and troubleshooting. Able to deliver results in a fast paced environment and effective communication to project teams. OTHER ATTRIBUTES DESIRABLE: Desire to train and develop colleagues, comfortable delegating. Change agile, functional in a fast-paced team environment where multi-tasking required. Enthusiastic about communicating to a broad range of stakeholders (from novices to experts) and seeking agreement in complex situations. Curiosity about seeking and applying current relevant scientific literature. PHYSICAL/MENTAL REQUIREMENTS Position requires occasional light lifting and periods of standing, sitting or walking, ability to perform mathematical calculations and ability to perform complex data analysis. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Occasional work-related travel may be needed. 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. 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. Additional Details: Grade: 6 Eligible for Relocation Package Eligible for Employee Referral Bonus 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.