Contract Associate, Analytical Chemistry, Project Management

4 days ago

Rockville, Maryland, United States Aurinia Full time $80,000 - $120,000 per year

Description

Contract Associate – Analytical Chemistry, Project Management & Clinical Supply (Temporary Position)

Location: Remote

Contract Duration: 6 months with possibility of extension

Position Summary: We are seeking a proactive and detail-oriented Contract Associate to support the CMC Team in executing key CMC activities with a focus on analytical development, project management, and clinical supply coordination. This temporary role is critical in ensuring that analytical strategies align with manufacturing timelines and clinical study needs for programs.

The ideal candidate will have a scientific background paired with experience in project coordination and clinical supply operations within a regulated environment.

Key Responsibilities:

Project Management Support:

Track and manage analytical development timelines, deliverables, and cross-functional dependencies.

Coordinate with internal teams and external CDMOs/CROs to ensure timely execution of project milestones.

Support project planning and resource forecasting for analytical and CMC-related activities.

Monitor and report on project risks, budgets, and timelines; escalate issues as needed.

Prepare meeting agendas, minutes, and follow-up trackers for cross-functional and vendor meetings.

Analytical Chemistry Support:

Assist with the planning and documentation of analytical method development, qualification, validation, and transfer.

Organize and maintain documentation and databases related to analytical testing, specifications, and method lifecycle management.

Support interactions with QA, regulatory, and manufacturing teams to ensure alignment on analytical deliverables.

Clinical Supply Support:

Support planning of clinical supply timelines to align with analytical readiness and regulatory commitments.

Work with IRT system, logistics support for clinical supply delivery as needed

Familiarity with Harmonized Tariff Schedule, customs duty etc with international shipments

Liaise with internal stakeholders and external vendors to ensure compliant and timely delivery of clinical trial supplies.

Qualifications:

Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.

7+ years of experience in the pharmaceutical or biotechnology industry, preferably in CMC, analytical development, or clinical supply.

Hands-on project management experience in a cross-functional environment.

Familiarity with analytical techniques (e.g., HPLC, CE, bioassays) and regulatory expectations for CMC submissions.

Understanding of clinical supply chain processes and GMP requirements for drug product release.

Proficient in Microsoft Office Suite, Smartsheet, or project management tools.

Excellent communication, documentation, and organizational skills.

Preferred Experience:

Experience working with CDMOs/CROs and external testing/release partners.

Exposure to clinical supply logistics and labeling for global trials.

Experience with regulatory filings (IND, IMPD, BLA/NDA).

PMP certification or formal project management training is a plus.

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