Pfizer Sr. Analytical Chemist in Lake Forest H3, Illinois

ROLE SUMMARY:

The analyst will primarily be responsible for laboratory activities for assigned projects, including but not limited to developing timelines and work plans. This position normally reports to a group leader. The incumbent will support product development, specifically extractables/leachables and impurity identification. Investigates method performance, reliability and improvement issues, and evaluates proposed changes to compendial or in-house methods. Also, works directly with external CDMO's as needed, including some domestic and international travel. This individual also assists with preparing and reviewing technical documents, including validation protocols and reports, analytical test procedures and technical reports. Independently performs all chemistry technique assignments including chromatography and mass spectrometry, and is able to troubleshoot all analytical instrumentation. Routinely designs complicated experiments that lead to a fundamental understanding of extractables, leachables (E&L) and drug's stability characteristics as a function of the designated drug delivery system. Makes routine use of scientific literature, and has a good understanding of the disciplines beyond chemistry and pharmaceutics that also play into drug development including intellectual property (IP) protection, regulatory strategy, process technology, etc. Effectively functions as a PEH PharmSci representative on project teams. When assigned direct reports (technical supervision), responsible for colleague professional growth and for contributing to performance reviews.

ROLE RESPONSIBILITIES

  • Leads and plans analytical laboratory assignments and activities to meet established project goals and timelines. Provides extractable/leachables, impurity identification/profiling support in developing new products.

  • Directly or through others, performs LC/MS, LC/MS/MS or GC/MS method development and executes method validations and method transfers.

  • Designs and executes studies to meet requirements in USP and .

  • Prepares and reviews technical documents, including validation protocols and reports, analytical test procedures, technical reports, and change controls. Provide the necessary documentation for regulatory submissions as required and writes deficiency responses

  • Ensures that the analytical procedures they develop, review or establish conform to current and appropriate scientific, compendial and regulatory standards, and are suitable for use for their intended purpose.

  • Conducts investigations in the areas of method performance and reliability and evaluates proposed changes to compendia or developed methods.

  • Writes protocols or propose specifications based on USP, ICH or other compendial or regulatory requirements.

  • Assists in performing laboratory investigations.

  • Work directly with parties beyond PEH PharmSci/R&D, including but not limited to 3rd party analytical labs, Contract Manufacturing Organizations (CMO's), and involvement with other divisions of Pfizer.

  • Provides training, technical expertise and support to the analytical staff.

  • Identifies opportunities for quality enhancement and operational efficiencies and develops efficient methodologies to track the progress.

  • Evaluates new or state-of-the-art technology for potential use for characterization and assessment of key drug product attributes.

  • Performs duties with a high level of independence.

QUALIFICATIONS

  • Bachelor's degree in the physical or biological sciences with 12 to 15 years of industry experience, MS with 8 to 10 years of industry experience or PhD degree with 4 to 5 years of industry experience.

  • Must have strong experience in extractables/leachables, chromatography, mass spectrometry (LC/MS, LC/MS/MS, GC/MS) and other spectroscopic techniques.

  • Experience with polymers and material selection for container closure systems or devices is a plus.

  • Strong written and oral communication skills and the use of MS Office (Word, Excel) are required

PHYSICAL/MENTAL REQUIREMENTS

This position involves frequent work within an analytical testing lab, in the presence of chemicals, with appropriate Personal Protective Equipment (PPE). Occasional work within a cytotoxic analytical lab in the presence of potent and cytotoxic compounds is required (with appropriate PPE).

EEO Statement

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 Offer Details:

  • Last Date to Apply for Job: August 23, 2017

  • Grade: Legacy Hospira 17 Additional Location Information : Lake Forest, IL

  • Eligible for Relocation PackageEligible 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.