Pfizer Senior Scientist, Technical Services in McPherson, Kansas

ROLE SUMMARY:

  • Support commercial products through analytical support of investigations, re-formulation, changes of container closures, etc.

  • Establish experimental protocols, conducting experiments, analyzing results, and documenting the information.

  • Provide technical leadership in the investigations of product failures 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 product discussions at the facility.

  • Performing trending and monitoring of critical quality attributes (CQAs) to maintain product quality and to control process drift.

  • Identifying and implementing product container closure and/or formulation improvements.

  • Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, product improvements, etc.

  • Develop technical impact assessments for all changes and develop execution plan.

ROLE RESPONSIBILITIES:

  • Lead technical execution of defined analytical strategies for biopharmaceutical and small molecule products, including CQA assessment and product characterization. Lead or participate cross-functional collaborations with process/formulation development or operations to define integrated product control strategies and support drug substance/drug product development/manufacturing.

  • P rovide coaching, training, and administrations of performance management to his/her direct reports and other scientists within the Technical Services Analytical group.

  • Develop project and resource plans to support the programs assigned to his/her team.

  • Drive and coordinate analytical evaluations/investigations.

  • Ensure timely completion of high-quality technical reports/protocols. Primary author and/or reviewer for analytical sections of regulatory submissions.

  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.

  • Supports change management and implementation for changes to 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.

QUALIFICATIONS:

  • MS or higher degree in Analytical Sciences or relates Science is required. PhD degree preferred.

  • Minimum of 7 years of experience in parenteral product pharmaceutical development/manufacturing preferred.

  • Must be familiar with global regulations of products. And product/process/method validation/qualification requirements.

  • Demonstrated scientific and people leadership skills. Experience leading teams of scientists with varying levels of experience and formal education (B.S./M.S. and/or Ph.D.) is required.

  • Expertise in state-of-the-art analytical techniques for product including HPLC/UPLC and spectroscopic methods, including experience with the development and qualification/validation of analytical methods for products or active ingredients.

  • Experience with regulatory filings.

  • Experience defining and implementing analytical control strategies for products.

  • Experience with cross-functional development of pharmaceutical products, including knowledge of key regulatory and quality/compliance expectations.

  • Excellent verbal/written communication skills and the ability to lead cross functional team.

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: August 17, 2018

  • Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.