Principal Scientist, Formulation and Process Development, PSSM Innovative Flex Team

Why Patients Need You

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most.

What You Will Achieve

As a Principal Scientist in the Pharm Sciences Small Molecule (PSSM) Innovative Flex Team, you will play an important role during all phases of pharmaceutical development. This colleague will take an active role by leading the formulation and process development strategies and performing lab work to help advance our pipeline. You will work with cross-functional development teams globally (US, UK, and India) and design/development experiments to help identify formulations and processes key to advancement of our pipeline.

As a Principal Scientist in the Formulation and Process Development group at the Lake Forest, IL site, the colleague is involved in the collaborative development of products for PSSM (PharmSci Small Molecule), with a focus on either (or both) oral dosage and parenteral dosage formulations. The role provides technical leadership and is essential in key decisions as it relates to new product and process development, including technology evaluations. The Principal Scientist integrates a Quality by Design (QbD) approach focusing on development of formulation and process, with emphasis on reliability and consistency.

Works directly with external CDMO’s/CRO’s as needed. Additionally, this individual prepares and reviews technical documents, including Product Development reports, Formulation development plans/reports, QbD protocols/reports, Co-Development plans, general technical reports, and CTD sections for global submissions. Presents information at key forums for the business unit, both internally (i.e. technical reviews) and external (i.e. governance meetings).

Additionally, this individual provides higher level subject matter expertise in a consulting fashion within his/her own team as well as across the broader organization. They are very technically capable, fully independent, and motivated to mentor other scientists. This individual must be able to work in a collaborative environment and must be able to effectively communicate to both internal and external customers. To be successful, the position must interface effectively with multiple organizations including (such as analytical, tech transfer, microbiology, regulatory, operations, and quality).

How You Will Achieve It

• Ensures sound drug product development and regulatory strategies are prepared for the design and development of robust, oral and/or injectable formulations and manufacturing processes. Leverages Pfizer and external best practices where available.
• Achieves project and division goals by utilizing digital tools for formulation and process design.
• Provides technical leadership and communicates clearly and concisely across multiple scientific and business functions, building effective relations with internal and external customers.
• Ensures that project teams have needed formulation/process development support and technologies. Achieves objectives through both formal channels and informal networks.
• Initiates and develops constructive relationships across organizations (PGS, Medical, Commercial, Business Development, Regulatory, Portfolio Management, IP/Legal, external vendors, etc.) to ensure an effective integration of development strategies and activities across those interfaces and collaboratively assess new product and technology opportunities.
• Able to recognize project gaps and identify/create scientific means to address using multidimensional approaches.
• Able to coach, develop and mentor others on experimental approaches to solve complex problems and achieve improved scientific and operational excellence.
• Supports key initiatives and infrastructure by leading and/or serving on committees, work teams, etc., as needed. Translates strategy into focused objectives for successful execution.
• Establish and maintain group mastery of basic to complex methodology/technology to develop formulations and processes from simple to complex/differentiated drug products, including utilization of digital tools.
• Develops corrective action plans and implements such plans to resolve project issues and maintain business commitments.

Basic Qualifications

• PhD in Chemistry, Biochemistry, Pharmaceutics, Chemical Engineering or related field and at least 4 years of Experience in formulation and process development of parenteral dosage forms (e.g. sterile injectable suspension/emulsion, nanoparticles, peptide, ophthalmic solutions, etc.) and/or oral dosage formulations in the pharmaceutical industry.
• M.S. in Pharmaceutics, Biochemistry, Chemistry, Chemical Engineering or related field and at least 9 years of Experience in formulation and process development of parenteral dosage forms (e.g. sterile injectable suspension/emulsion, nanoparticles, peptide, ophthalmic solutions, etc.) and/or oral dosage formulations in the pharmaceutical industry.
• BS in Pharmaceutics, Biochemistry, Chemistry, Chemical Engineering or related field and at least 12 years of Experience in formulation and process development of parenteral dosage forms (e.g. sterile injectable suspension/emulsion, nanoparticles, peptide, ophthalmic solutions, etc.) and/or oral dosage formulations in the pharmaceutical industry.
• Prior demonstration of scientific problem solving and multidisciplinary collaborations
• Track record of leadership and achievement for multiple development projects
• Experience implementing digital tools to advance formulation and/or process development of pharmaceutical products to achieve project goals
• Written and oral communication skills and the use of MS Office (Word, Excel) are required.
• Ability to collaborate
• Able to thrive in a dynamic, ever-changing environment

PHYSICAL/MENTAL REQUIREMENTS

• At times, role will require work in a laboratory or pilot plant environment in the presence of chemicals. Use of appropriate Personal Protective Equipment (PPE) is required. Occasional work within a potent compound laboratory – using isolator or other safety technology will also be necessary.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must be able to participate in occasional video/teleconferences outside normal work hours in support of global projects/initiatives and PharmSci groups based in other global regions.
• Domestic and International travel may be required. Although travel should not exceed 10% on average, more frequent travel may be required at times.

Additional Posting Information

• Eligible for Employee Referral Bonus
• Eligible for Relocation Assistance

#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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.