Principal Scientist, Technical Services

Use Your Power for Purpose
This individual will be a key part of the McPherson Technical Services Group responsible for delivering science-based solutions on a day to day basis. The primary function of the Technical Services Principal Scientist is the application of advanced manufacturing, science and technology processes to a given production segment by serving as a scientific and technical representative who champions process improvements and knowledge management excellence at the site to identify and implement process improvements in conjunction with manufacturing operations. Emphasis on process improvements shall include building quality into processes during the Technology Transfer process, improving process robustness for new product launch and launch process. This position will provide technical leadership and function as a site subject matter expert for Technology Transfer. This includes the transfer of existing products to alternate manufacturing lines and new products to the site. This requires comprehensive knowledge of Pharmaceutical Sciences and applying these skills as the technical resource. Knowledge of product manufacturing processes including raw materials, container closure systems and devices. This position will identify and evaluate new and innovative technology, identify, and develop improved processes for new and existing products and drive critical investigations. This requires comprehensive knowledge of Pharmaceutical Science and good understanding of others and applies these skills as the technical resource. The responsibilities include but are not limited to authoring technical protocols and reports, extractable/leachable studies, process development and qualifications, technical and scientific support for critical investigations and leading continuous improvement initiatives.
What You Will Achieve
Role Responsibilities:

• Serves as the scientific/technical representative for process-related issues at the site, participate in investigation resolution using green belt/black belt tools, process validation activities, training on new process technologies and on significant changes to manufacturing procedures
• Proposes process improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs, decrease process variability while maintaining regulatory compliance.
• Identifies and executes on process improvements, creates data packages by justifying and outlining recommendations for changes to or improvements in production processes and collaborates with technical staff to implement process technology initiatives.
• Executes technology transfers of products in collaboration with cross-functional SME team, partnering with manufacturing to meet production schedules, ensure commercial supply and uphold quality standards.
• Champion all PGS knowledge management efforts and help develop a strong culture of knowledge management excellence at the site.
• Deliver Excellence in all aspects of product/process knowledge management at the site to improve robustness of manufacturing processes.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
• Understanding of FDA and Global regulations and guidelines for the analytical testing requirements and methods used in the qualification and validation of parenteral drug products and associated container closure systems.
• Experience with authoring protocols, technical reports, method development and validation.
• Must possess excellent communication skills and attention to details.
• Demonstrated problem solving capabilities.
• Ability to get tasks accomplished and manage priorities while working in high pressure situations with aggressive time constraints.
• Competency in PC software much as MS Word, Excel and Project

Bonus Points If You Have (Preferred Requirements)

• Relevant experience in Engineering or Science within the pharmacutical industry.
• Manufacturing experience related to global regulations on devices, drugs and validation requirements.
• Knowledge of extractables/leachables method development and qualification.
• Experienced with leading cross functional teams in technical project execution, investigations, and issue resolution.
• Experience in the management of complex investigations with analysis of data utilizing statistical software (JMP, Minitab). Experience in green belt/black belt investigative processes.
• Experienced project management skills with ability to meet agreed upon targets and plan development for short-term and long-term activities.
• Ability to think creatively and find innovative solutions is a plus.

PHYSICAL/MENTAL REQUIREMENTS

• No unique physical requirements
• Remains organized & positive in ambiguous and fast-paced, rapidly changing situations
• Ability to analyze data from detailed schedule and risk management tools
• Interface effectively with multiple stakeholder groups

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Limited travel required. Non-standard work hour support of global conference calls, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements.
Relocation support available
Work Location Assignment: On Premise
The annual base salary for this position ranges from $96 300,00 to $160 500,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12,5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Engineering