Principal Scientist - Project External Development

Pfizer

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 Principal Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be recognized as a technical expert and a significant scientific contributor. With your deep knowledge of the discipline, you will work with analytical vendors around the world to execute units of Active Pharmaceutical Ingredient (API) and drug product development and GMP analytical work partnering with the vendors to solve technical problems and deliver critical data. You will use strong communication skills to ensure technical and business alignment across a variety of stakeholders within multidisciplinary teams. It is your scientific diligence, knowledge and focus on execution that will help in making Pfizer ready to achieve new milestones and help patients across the globe. You will play a lead role in establishing an outsourcing culture and mindset within ARD.

How You Will Achieve It

  • As a member of the Global Strategic Outsourcing and Business Operations team in ARD you will collaborate with project leads, development analysts, GMP analysts and external vendors to deliver multiple units of analytical work in parallel. You will partner to develop and then independently manage analytical testing protocols through to successful, timely data delivery to ARD project teams. You will have the opportunity to work with global vendors to complete larger units of work or support entire workflows using external resources. You will use your expertise in chromatography, spectrometry, spectroscopy, dissolution, and other established analytical methodologies to enable drug development utilizing external resources.
  • The candidate will be responsible for independently delivering technical work packages in support of API and drug product development during all clinical development phases.
  • Work will be predominantly focused on analytical development activities including validating and transferring analytical methods, developing, and executing general testing protocols aligned with ARD development workflows, critically evaluating vendor generated data and compiling summaries as required.
  • The role requires collaboration with ARD colleagues to identify appropriate analytical approaches, ensuring vendors clearly understand Pfizer’s needs, managing technical risks and developing appropriate contingencies across a dynamic portfolio.
  • This role also may require direct interaction with outsourcing colleagues in partner groups (e.g., CRD, DPD, PGS) and therefore requires knowledge of API and DP development workflows.
  • The candidate will manage differences in analytical instrumentation and operating procedures between the vendors and Pfizer ensuring minimal technical impact on the work packages and data being delivered.
  • The candidate will capture relevant feedback and facilitate the evolution of best practices and process improvements with the vendor.
  • The role may require some coaching of internal colleagues in working with vendors and the identification of areas where targeted training of analytical development vendors would help improve the value offering to ARD.

Qualifications

Must-Have

  • Ph.D in Analytical Chemistry or related field, with 4+ years of R&D experience OR B.S. with 12+ years of relevant industry analytical development experience.
  • Significant hands-on experience of the development and application of common analytical methods to support the progression of candidates through the API and / or DP development workflows.
  • Good knowledge of the development workflows used by ARD’s key partners within PSSM.
  • Demonstrated ability to manage parallel projects, prioritize activities in a dynamic environment, meet timelines, and interact with multi-disciplinary teams and stakeholders.
  • Demonstrated ability to learn new techniques and apply theoretical knowledge of commonly used analytical techniques to solve technical problems.
  • A breadth of diverse leadership experiences and the ability to lead change and work in new paradigms.
  • Attention to detail, strong organizational skills, and effective interpersonal and communication skills are required.
  • Demonstrated strength in oral and written communication across a variety of media and settings.
  • Proficient with a wide variety of software and information systems.

Nice-to-Have

  • Prior experience as ARD Project Lead or recent lab analyst experience.
  • Prior experience working with external analytical vendors to deliver development and / or GMP work in support of project progression and regulatory submissions.
  • Proven ability to develop and coach others and oversee the work of colleagues and external partners to achieve meaningful outcomes and create business impact.
  • Good understanding of GMP as applied to analytical development.

PHYSICAL/MENTAL REQUIREMENTS

  • This role requires ability to perform mathematical calculations, as well as data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • This role requires adherence to standard operating procedures.
  • It is highly likely to require some regular US and international travel (~10%).

Other Job Details:

  • Last Date to Apply for Job: 02 MAY 2024
  • Eligible for Employee Referral Bonus
  • Eligible for Relocation Assistance

Work Location Assignment: On Premise

On Premise colleagues work in a Pfizer site because it’s needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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. This position requires permanent work authorization in the United States.

Research and Development

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Confirmed 16 hours ago. Posted 13 days ago.

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