API Analytics Early and/or Late Phase Project Lead (Secondment 6-12 Months)

WHY PATIENTS NEED YOU

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. At the core of this mission is Research and Development, where we strive to transform advanced science and cutting-edge technologies into the most impactful therapies and vaccines. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, your role is crucial. You will leverage innovative design and process development capabilities to accelerate the delivery of best-in-class medicines to patients globally.

WHAT YOU WILL ACHIEVE

An exciting growth assignment in ARD API Analytical designed to develop scientists into Analytical API Project Leads with the capability to support programs across the drug development lifecycle (R1 through WF4). The selected candidate will gain hands-on experience leading analytical strategy elements within cross-functional teams, while receiving structured mentoring and coaching to accelerate readiness for future project leadership roles. This role can provide exposure to both early-phase (R1/WF2) and late-phase (WF3/WF4) development, with emphasis on technical leadership, regulatory communication, and delivery of fit-for-purpose analytical strategies.

The successful candidate will have a good background in analytical chemistry, an eye for detail, good communication skills and a basic knowledge of GMP concepts.

HOW YOU WILL ACHIEVE IT

• Support and progressively lead analytical workstreams within project teams.

• Contribute to and align on analytical strategy and control strategy development.

• Track and communicate risks, timelines, and deliverables.

• Author or contribute to analytical sections of regulatory documentation.

• Support specification setting and justification using risk-based approaches.

• Partner with key stakeholders (Process Chemistry, Quality, Regulatory, Supply).

• Actively participate in issue resolution and decision-making discussions.

• Communicate effectively within a matrixed team environment.

• Demonstrate ability to lead analytical discussions with increasing independence.

• Apply phase-appropriate analytical strategies across R1–WF4.

• Deliver regulatory-ready analytical documentation.

• Clearly articulate and manage risk-based decisions.

QUALIFICATIONS

Must-Have

• Applicant must have a PhD or JD with 8+ years of experience.

• Experience in analytical chemistry or related field.

• Demonstrated ability to meet timelines with minimal supervision and experience leading multi-disciplinary teams.

• Demonstrated ability to learn new techniques and solve complex analytical problems.

• Demonstrated oral and written communication skills, including visualization of data and drafting reports.

• Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills.

• Proficient with a breadth of relevant methodologies such as, chromatography, dissolution, IR/Raman spectroscopy, mass spectrometry, particle size analysis, and NMR, with expertise in one or more of these techniques. 

 Nice-to-Have

• MD/DVM with 2+ years of experience.

• Experience in the pharmaceutical industry.

• Prior experience with analysis of peptide therapeutics.

• Experience with trace level impurity analysis

• Understanding and prior experience in global regulatory submission processes.

• Familiarity about separation technology including liquid chromatography, gas chromatography, SFC, etc.

• Experience with a wide variety of software and information systems utilized in the pharmaceutical industry (eg LIMS, Chromatographic Software, Veeva, electronic notebooks).

• The ability to use computational predictive tools, modelling software or data visualization tools.