Associate Project Management

Aequor Technologies LLC

Thousand Oaks, CA(remote)

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JOB DETAILS

SKILLS

Billing, Biotech and Pharmaceutical, Budgeting, Business Practices, Change Management, Chemical Processes, Chemistry, Communication Skills, Continuous Improvement, Contract Manufacturing, Contract Research Organization (CRO), Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Drug Development, GMP (Good Manufacturing Practices), Interpersonal Skills, Manufacturing, Manufacturing Operations, Onboarding, Operational Improvement, Outsourcing, Presentation/Verbal Skills, Process Development, Product Costing, Project/Program Management, Purchase Orders, Regulations, Request for Proposals (RFP), Small Molecule Drugs, Sourcing Strategy, Statement of Work (SOW), Supply Chain, Vendor/Supplier Selection, Writing Skills

LOCATION

Thousand Oaks, CA

POSTED

30+ days ago

Note:
Fully Remote role
Work Schedule: Dayshift

The *** 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.

The *** Contract Development and Manufacturing team develops and implements the external sourcing strategy for *** s portfolio from early phase through commercial delivery. This role will support engagement and oversight of *** Contract Development and Manufacturing sites through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices.

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

About the Company

Aequor Technologies LLC

COMPANY SIZE

100 to 499 employees

INDUSTRY

Staffing/Employment Agencies

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