Project Management Associate

Associate Project Management with Synthetic Drug, Small Molecules, Chemistry/Biochemistry, GMP and Project Management Experience (Fully Remote Job)

Location: Thousand Oaks, CA

Terms: Contract W2 Only

Duration : 12 Months Contract (Will Get Extended for Long)

Description:

Fully Remote role

Work Schedule: Dayshift

The client Contract Development and Manufacturing (ACDM) organization is seeking a highly qualified candidate to support synthetic-related outsourcing associated with execution of external development, commercial and clinical supply of drug substance (DS). The position will be focused on synthetic small molecule drug substance/process chemistry and serve as a key enabling role in a high-performing cross-functional organization. Individual projects may span development, sourcing (e.g., requests for proposal and site selection), supplier onboarding, manufacturing, and continuous improvement activities for both non-GMP and GMP commercial / clinical deliverables.

Job Responsibilities:

Day-to-day oversight for external synthetic/process chemistry-related projects:

- Overseeing and supporting ongoing activities at selected sites along with any subcontracted sites to ensure project deliverables, including compliance, timelines, product quality, and cost

- Working closely with the ACDM team, Process Development, External Quality, Supply Chain, and other internal stakeholders to support sourcing activities, including managing scope of work (SoW) and quotation request documents

- Coordinating requests for shipment of materials/samples between sites

- Managing purchase orders, invoices, and project-related budget

- Overseeing deviations investigations and change managements as needed

- Maintain and update business related trackers as needed

- Support continuous improvement projects and operational excellence within ACDM

- Performing other related duties and tasks as necessary or as assigned

Basic Qualifications:

- Bachelor's Degree in Engineering, Chemistry, or Science-related field

- 4+ years of Manufacturing or Operations experience

Preferred Qualifications:

- Knowledge of synthetic drug development and manufacture

- Experience in Project Management

- Understanding of cGMP, Operations and Regulatory/CMC policies and requirements, especially in the Pharmaceutical Industry

- Experience with interfacing and managing CRO and CDMO relationships

- Experience with change management, deviation investigations and implementation of corrective/preventive actions

- Understanding of tech transfer, drug development and commercialization of synthetic therapeutics

- Experience working in cross-functional settings, as part of cross-functional team or matrix team

- Strong interpersonal relationship and communication skills both written and verbal

Skill Sets:

- Chemistry related industry/environment experiences

-Knowledge of synthetic drug development and manufacture

-Experience in Project Management

-Understanding of cGMP, Operations and Regulatory/CMC policies and requirements, especially in the Pharmaceutical Industry