Pfizer Principal Scientist, Technical Services in McPherson, Kansas
The Principal Scientist, Technical Services will provide technical leadership and function as the site subject matter expert for elastomer and polymer formulations used in manufacture of sterile injectable pharmaceuticals. This includes direct product contact components, container closure systems, devices and product delivery components. The Principal Scientist responsibilities will include:
authoring analytical testing protocols and technical reports, method development and qualifications, extractable / leachable studies and stabilities technical / risk assessments technical and scientific support for related projects, remediation activities and investigations manage related change control lead associated continuous improvement initiatives Manage contract laboratory services
Develop and Lead technical execution of defined analytical strategies for elastomer and polymer formulation changes, supplier changes, qualifications and investigations. Author analytical protocols and reports Develop and execute extractable /leachable studies, stability studies and other laboratory studies related to container closure systems and formulation interactions. Provide leadership and serve as subject matter expert for elastomers and polymers formulations used in manufacture of sterile injection pharmaceuticals. Work collaboratively with Global Technical Services (GTS) Package Technology, Package Testing and Technology and Supply Chain and Procurement teams to support packaging and component projects. Ensure container closure systems and direct product contact materials comply with USP standards, regulatory requirements and guidelines, and Pfizer quality standards. As a component formulation SME, support SCNs, SCARs, CAPAs and component related investigations and remediation activities. Executes Change Control, Engineering trials and lab studies and authors associated technical reports in support of packaging component engineering / process trials and studies.
Act as a project lead for site initiated quality improvements, cost reduction projects and key initiatives. Lead site initiated packaging cost improvement and continuous improvement projects. Travel to Pfizer and supplier sites in support of projects and PGS initiatives. Work with package component suppliers on design and formulations while seeking to meet marketing requirements. Provide guidance and leadership to site colleagues concerning container closure systems and elastomer and polymers used in the manufacture of products. Devise innovative solutions to unique packaging problems. Support EHS and Safety initiatives. Train and coach Pfizer colleagues in areas of technical expertise. Create/Revise component specifications.
Bachelor's Degree in Analytical Sciences or related Science required. Preferred MS Degree or Higher in Analytical Sciences or related Science.
Expertise in state-of-the art analytical techniques for pharmaceutical products including HPLC/UPLC and spectroscopic methods, including experience with the development and qualification/validation of analytical methods. Knowledge of parental drug container closure systems and elastomers and polymers used in the manufacture of parental drug products.
Understanding of FDA and Global regulations and guidelines for the analytical testing requirements and methods used in the qualification and validation of parental drug products and associated container closure systems.
Knowledge of USP Testing Methods for the analytical testing of parental drug products and container closure systems.
Experience with authoring protocols, technical reports, method development and validation.
7+ years of experience in parental product pharmaceutical development/manufacturing preferred.
Experienced with leading cross functional teams in technical project execution, investigations and issue resolution.
Excellent communication skills coupled with a self-starter attitude and resolve to get tasks accomplished, project and task management skills, an ability to manage priorities while working under pressure and aggressive time constraints.
Demonstrated ability to coach, lead and develop others technical professionals.
Knowledge of extractables/leachables method development and qualification.
Experience with stability program development, testing methods and requirements and authoring related protocols and reports .
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.
Ability to appropriately manage ambiguity and work autonomously.
Develop positive relationships with multiple manufacturing disciplines.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Limited travel required. Occasional non-standard work hour support engineering runs or process trials, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements.
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.
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Last Date to Apply for Job: October 10, 2018
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.