Pfizer

Principal Scientist, Formulation and Process Development

Employer
Pfizer
Location
Lake Forest, Illinois
Salary
Competitive
Posted
July 16 2021
Ref
4818360
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY

As an individual contributor in the GPPD (Global Parenteral Product Development) Formulation and Process Development team, the Principal Scientist is involved in the collaborative development of products for PCOE (Parenteral Center of Excellence) and PSSM (PharmSci Small Molecule). The role provides technical leadership and is essential in key decisions as it relates to new product and process development, including technology evaluations. Implements a Quality by Design (QbD) approach focusing on development of formulation and process, with emphasis on reliability and consistency. Advances product development from post-concept through commercial launch with special focus on advanced drug delivery and drug-device interface and technology. Also, works directly with external CDMO'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 GPPD/PCOE/PSSM. 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 analytical, tech transfer, microbiology, regulatory, operations, quality and other departments.

ROLE RESPONSIBILITIES

  • Provides technical leadership and communicates clearly and concisely across multiple scientific and business functions, building effective relations with internal and external customers.
  • Ensures sound drug product development and regulatory strategies are prepared for the design and development of robust, cost-effective 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.
  • 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 mentor others on experimental approaches to solve complex problems and achieve improved scientific and operational excellence.
  • Supports GPPD and PCOE initiatives and infrastructure by leading and/or serving on committees, work teams, etc., as needed. Translates GPPD/PCOE/PSSM 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 with 3-6 years of experience, Master's Degree with 7+ years of experience or a Bachelor's Degree with 9+ years of experience of laboratory/technical experience required.
  • Strong written and oral communication skills are required.


PREFERRED QUALIFICATIONS
  • Moderate experience and expertise in formulation and process development of parenteral dosage forms (e.g. sterile injectable suspension/emulsion, nanoparticles, peptide, ophthalmic solutions, etc.) in the pharmaceutical or related industries.
  • 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.


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% of work days on average, more frequent travel may be required at times.


Other Job Details:
  • Last Day to Apply: July 23, 2021
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus


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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

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