Pfizer Sr Formulation Scientist, Aseptic Injectable Liquid/Suspension/Powder Fill Process Development 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
• Supporting the Pfizer Essential Health, the senior formulation scientist position will primarily be responsible for laboratory and manufacturing activities for assigned projects (e.g. formulation and process development, tech transfer, validation support), including but not limited to developing timelines and work plans. In collaboration with the analytical group, the incumbent will generate development and submission data for assigned projects. Use a Quality by Design (QbD) approach; investigate formulation and process performance, reliability and improvement opportunities. Also, works directly with external CMOs as needed, which may entail domestic and international travel as the project demands. This individual also assists with preparing and reviewing technical documents, including development plans, commercialization plan, formulation justification document, QbD/validation protocols &; reports and batch record review.
• Independently performs all lab and processing technique assignments, and is able to troubleshoot most processing equipment. Performs DOE studies lead to a fundamental understanding of how critical formulation and process variables affect a complex drug product's critical quality attributes. Makes routine use of scientific literature, and has a good understanding of the disciplines beyond pharmaceutics and analytical chemistry that also play into drug development including intellectual property (IP) protection, regulatory strategy, microbiology, etc. Effectively functions as a PEH Pharmaceutical Sciences representative on project teams. When assigned direct reports, will be responsible for colleague professional growth and for contributing to performance reviews.
This position is located at a flagship R&;D site in north suburban Chicago/Lake Forest; relocation provided.
• Leads and plans formulation/process development assignments and activities to meet established project goals and timelines.
• Directly or through others, leads and supports formulation and process development for projects from formulation design through exhibit batch manufacture and support for validation studies/commercial launch. Development of manufacturing processes at lab scale that are suitable for transfer to commercial manufacturing using DOE studies
• Technical transfer to manufacturing site, including providing on-site assistance during batch manufacture to facilitate knowledge transfer and solve problems
• Supports technical due diligence for potential CDMO's and in-licensing opportunities. Determines feasibility of overcoming the technical challenges identified.
• Prepares and reviews technical documents, including reports and protocols. Provides the necessary documentation for regulatory submissions as required and writes deficiency responses
• Based on expert knowledge, is frequently brought into multi-faceted problem solving or strategy teams to resolve wide-ranging problem issues affecting drug development.
• Stays abreast of the scientific literature looking for new technological approaches.
• 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. Acts as a coach to junior staff.
• Identifies opportunities for quality enhancement and operational efficiencies and develops efficient methodologies to track the progress.
• Performs duties with a high level of independence.
• Ph.D. (+2 yrs), MS (+5 yrs) or BS (+8 yrs) in pharmaceutics, pharmaceutical chemistry, chemical engineering or similar discipline with experience in pharmaceutical industry space. Experience in sterile cGMP manufacturing is a plus.
• Formulation and process development experience with drug products including peptides, liposomes, emulsions, suspensions, solutions, powder blends, and/or lyophilized drug products is desirable. Demonstrated practical knowledge of QbD, DOE is a plus.
• Strong written and oral communication skills and the use of Microsoft Office (Word, Excel, PowerPoint, Outlook) are required
• Strong interpersonal/communication skills are required.
• Effectively collaborates with colleagues from cross functional areas.
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.