Pfizer Sr. Analytical Chemist in Lake Forest H3, Illinois
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 biopharmaceutical 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 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.
Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued.
Legacy Hospira - Grade 17
Hospira, a Pfizer company, is the global leader of injectable drugs committed to putting patients first by improving access and care worldwide.
The candidate provides technical leadership to the sterile injectable product development group within Pfizer Essential health.
The analyst will primarily be responsible for laboratory activities (e.g. analytical method development, validation, formulation support and method transfers) for assigned projects, including but not limited to developing timelines and work plans, and mentoring Jr analysts. This position normally reports to a group leader.
The incumbent will lead development of complex analytical and/or bioanalytical techniques internally and through external collaborations. Routinely designs experiments that lead to a fundamental understanding of drug's stability characteristics as a function of the designated drug delivery system. Supports formulation development, generates analytical data to be used for regulatory submissions, and participates in technology transfer activities to manufacturing sites (internal and external), This individual also will prepare and review technical documents, including validation protocols/ reports, test procedures and regulatory submission modules. Independently performs all technical assignments, and is able to troubleshoot analytical instrumentation. Investigates method performance, reliability and improvement issues, and evaluates proposed changes to compendial or in-house methods. Also, works directly with external CMO's as needed. 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 needed, visit the manufacturing facilities to support product manufacture for regulatory submission. When assigned direct reports (technical supervision), responsible for colleague professional growth and for contributing to performance reviews.
Relocation packages are available.
• Leads and plans analytical laboratory assignments and activities to meet established project goals and timelines. Provides formulation support in developing new products.
• Directly or through others, performs analytical method development, and executes method validations and method transfers.
• Supports developmental and exhibit batch stability testing, as well as other studies to support regulatory submission
• Prepares and reviews technical documents, including validation protocols and reports, analytical test procedures, investigation reports, and change controls.
• Provides the necessary documentation for global regulatory submissions, drafts and reviews submission documents, and writes deficiency responses.
• Evaluates method performance and reliability as well as proposed changes to compendia or developed methods.
• Work directly with parties beyond PEH Pharm Sci/R&;D, including but not limited to 3rd party analytical labs, Contract Manufacturing Organizations (CMO's), and effectively collaborates with other divisions of Pfizer.
• Provides training, technical expertise, mentorship and support to the analytical staff.
• Provides timely project updates to management.
• 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.
• Ph.D. (analytical, organic, physical) with approximately 3-5 years of experience. Alternatively, a BS degree with approximately 10 years of experience or MS with approximately 6 years of experience. Experience in the pharmaceutical industry space is preferred.
• Must have strong proven experience in separation sciences with diverse detection techniques.
• Knowledge of analytical techniques including but not limited to LC-MS will be considered a plus.
• Strong written and oral communication skills and the use of MS Office (Word, Excel) are required
• Independent, accountable, attention to detail, ability to effectively balance multiple projects, and strong interpersonal/communication skills are required.
This position involves frequent work within an analytical testing lab, in the presence of chemicals, with appropriate Personal Protective Equipment (PPE). The position also entails working in cytotoxic analytical labs and requires handling potent and cytotoxic compounds (with appropriate PPE).
II. 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.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.