Pfizer Senior Analytical Chemist, Pharmaceutical R&D in Lake Forest H3, Illinois
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.
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).
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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Eligible for a relocation package
Eligible 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.