Senior Scientist, Analytical Development

Company: Pfizer
Location: Lake Forest
Posted on: June 12, 2021

Job Description:

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. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

As a Senior Scientist, you will be Independently performs all analytical assignments. Able to troubleshoot all analytical methods and instrumentation. Routinely designs complex experiments that lead to a fundamental understanding of generic drug's stability characteristics as a function of the designated drug delivery system. Makes routine use of scientific literature. Has a strong understanding of GLP and GMP principals. Strong understanding of the disciplines beyond chemistry and pharmaceutics that play into drug development, including IP protection, regulatory strategy, process technology, digital advancements, etc. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide team members.

It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Has expert knowledge of multiple analytical techniques and instrumentation and independently plans analytical/process development experiments and activities to meet established project goals and timelines.
• Leads/participates in key initiatives to enhance digital capabilities within the drug development process.
• Independently develops analytical methods or techniques.
• Independently performs method qualification, verification and/or validation activities.
• Responsible for independently producing protocols and reports for analytical method development, stability or formulation/process development reports, and raw material/control/procedural monographs as required.
• Responsible for providing feedback or critique to more junior team members.
• Tutors/ trains other group members on using and troubleshooting all analytical methods and instrumentation.
• Routinely designs complex experiments that lead to a fundamental understanding of drug's stability characteristics as a function of the designated drug delivery system.
• Interacts with peers outside of the department in a multi-faceted team approach to drug development.
• Makes routine use of scientific literature. Has a good understanding of the disciplines beyond chemistry and pharmaceutics that also play into drug development including IP protection, regulatory strategy, process technology, etc.
• Represents the department at internal and external meetings.
• Directly or through others, leads and supports analytical for complex drug product projects from concept up to commercialization.
• Leads and supports method transfers to internal and external testing labs.
• Work directly with parties beyond Parenteral Center of Excellence (PCOE) including but not limited to 3rd party analytical labs, CMOs, and involvement with other divisions of Pfizer.

Basic Qualifications

• PhD in chemistry, biochemistry, pharmaceutics, chemical engineering or similar technical discipline and at least 2 years of injectable product development experience is required.

OR

M.S. in Pharmaceutics, Chemistry, Chemical Engineering or related field and at least 5 years of injectable product development experience.

• OR

• BS in Pharmaceutics, Chemistry, Chemical Engineering or related field and at least 10 years of injectable product development experience.
• Written and oral communication skills and the use of MS Office (Word, Excel) are required. High proficiency in advanced digital tools and technology.

Preferred Qualifications

• cGMP laboratory experience is highly preferred.
• Analytical experience with complex sterile injectable drug products including peptides, liposomes, emulsions, suspensions, solutions, and/or lyophilized drug products is desirable.

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 potent compound analytical laboratory - using isolator or other safety technology

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Expected travel 5 -10%

Other Job Details:

Eligible for Employee Referral: YES

Eligible for Relocation: YES

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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.

Research and Development

Keywords: Pfizer, Lake Forest , Senior Scientist, Analytical Development, Other , Lake Forest, California