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Scientist, Technical Services

ROLE SUMMARY: The primary role of the Scientist, Technical Services - Lyophilized Vialed Product, is to:
+ Identifying and implementing commercial product/process improvements for lyophilized vialed parenteral products.
+ Technology transfer to new/different manufacturing areas, to/from current facility.
+ Participating in start-up efforts of new equipment or processes in manufacturing.
+ Develop risk assessments, risk mitigation strategies and risk plan.
+ Establish experimental protocols, conducting experiments, analyzing results, and documenting the information.
+ Provide technical leadership in the investigations of lyophilisation-related challenges to determine root cause and implement appropriate corrective and preventive actions.
+ Ensure project deliverables meet their quality, safety, and functional goals, and satisfy the customer.
+ Serving as a scientific and technical representative for process-/product-related highly technical challenges.
+ Partnering with manufacturing to meet the production schedule, ensure commercial supply , uphold quality standards and driving towards zero defects
+ Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
+ Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
+ Develop technical impact assessments for all changes and develop execution plan.
+ BS or MS in Mechanical, Chemical or Industrial Engineering or Chemistry/Pharmaceutical Science is required. Plus 5+ or more years in a pharmaceutical product and/or manufacturing facility.
+ OR PhD in Mechanical, Chemical or Industrial Engineering or Chemistry/Pharmaceutical Science with experience at a pharmaceutical product and/or manufacturing facility preferred.
+ Expertise in lyophilization and parenteral product manufacturing processes required.
+ Familiar with global parenteral product Regulatory Affairs CMC requirements.
+ Excellent communication skills and attention to details.
+ BS or MS in Mechanical, Chemical or Industrial Engineering or Chemistry/Pharmaceutical Science is required. Plus 5+ or more years in a pharmaceutical product and/or manufacturing facility.
+ OR PhD in Mechanical, Chemical or Industrial Engineering or Chemistry/Pharmaceutical Science with experience at a pharmaceutical product and/or manufacturing facility preferred.
+ Expertise in lyophilization and parenteral product manufacturing processes required.
+ Familiar with global parenteral product Regulatory Affairs CMC requirements.
+ Excellent communication skills and attention to details.
+ R ole Responsibilities:
+ Plays leadership role in technical teams for discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures
+ Proposes process/product/device improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance.
+ Provides technical support for equipment and process validation activities conducts process overview training to support implementation of new process technologies and assists in defining the scope of capital projects.
+ Leads process/product/device 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.
+ Supports change management and implementation for changes to device products or the associated manufacturing processes and associated systems, provides training for technical staff on these changes.
+ Executes laboratory runs and writes technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancies and investigations.
+ 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. Other Job Details:
+ Last Date to Apply for Job: December 31, 2018Eligible for Relocation Package - YES
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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