Analytical Technologies Associate III

PCI Pharma Services•San Diego, CA

15h•Onsite

About The Position

The Analytical MSAT Associate III optimizes, qualifies, verifies, validates, and transfers analytical methods for Active Pharmaceutical Ingredients (API), in-process, release and stability testing in support of drug product manufacturing. This role involves planning, coordinating, and executing method development, qualification, validation, and transfer activities. The Associate will also troubleshoot complex analytical method and instrumentation issues, serve as a subject matter expert (SME) for specific analytical techniques, and perform method validations for QC testing of drug products used in clinical trials. Additionally, the role requires authoring and reviewing technical documentation, planning validation strategies, reviewing technical transfer documents, and collaborating cross-functionally to drive project deliverables. Continuous improvement initiatives to optimize technical transfer processes, support for Technical Transfer History Files, capturing comprehensive product details, providing feedback on specifications, partnering with Validation, developing trending programs, validating calculations, providing analytical technical support for quality events, supporting equipment onboarding, and preparing/delivering training materials are also key aspects of this position. The role also includes providing technical mentorship and guidance to junior staff.

Requirements

Bachelor’s or master’s degree in chemistry, Biochemistry, or related scientific discipline.
Master’s degree with 2-3 years of relevant laboratory experience in GMP regulated environment preferred or bachelor’s degree with greater than 4 years of relevant experience.
Knowledge of analytical method validation, transfer, qualification, and GMP regulatory requirements.
Strong technical writing, organizational, and communication skills.
Experience in a laboratory setting with an emphasis on HPLC, UV-Vis, ELISA, SDS-PAGE and/or wet lab methods.

Nice To Haves

Familiarity with laboratory software such as LIMS and Chromeleon is an asset.

Responsibilities

Independently plan, coordinate, and execute analytical method development, qualification, validation, and transfer activities to support manufacturing and lot release.
Troubleshoot complex analytical method and instrumentation issues; leverage vendor technical support as needed to maintain project timelines.
Serve as a subject matter expert (SME) for specific analytical techniques and methods, demonstrating mastery of at least two moderate to complex analytical methodologies (e.g., chromatography, biologic assays).
Perform concurrent moderate analytical method validations to support QC testing of drug products used in clinical trials.
Author and review high-quality technical documentation including validation protocols, reports, SOPs, and method transfer packages, ensuring alignment with ICH, GMP, and regulatory expectations.
Plan and coordinate validation strategies for method qualification, validation, and transfer activities.
Review technical transfer documents, statements of work, and participate in financial discussions to drive key performance indicators (KPIs) for projects.
Collaborate cross-functionally to drive project deliverables, lead data reviews, and present scientific findings to internal and external stakeholders with clear risk assessments and recommendations.
Drive continuous improvement initiatives to optimize technical transfer processes, ensuring quality, efficiency, and implementation of solutions for process enhancements.
Support Technical Transfer History Files to support knowledge management, investigations, and risk assessments.
Capture comprehensive product details, including Statements of Work (SOW), Engineering Runs (ERs), Change Orders, Clinical through PPQ, and Commercial data to ensure complete transfer records.
Provide feedback on specification and acceptance criteria appropriateness to support robust method validation and product quality.
Partner with Validation to include process control data and drive data-driven decision making.
Develop and implement trending programs to monitor analytical and process performance proactively.
Validate calculations to ensure data integrity and compliance in analytical reporting.
Provide analytical technical support to enable timely closure of quality events, with emphasis on technical root cause analysis and corrective actions.
Support equipment onboarding to ensure data integrity compliance on QC instruments and equipment.
Prepare and deliver training materials and sessions related to validation topics, analytical best practices, and regulatory guidance.
Provide technical mentorship and guidance to junior staff to build team capability.
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.