5 open positions available
Manage business analysis and information tasks including data analysis, dashboard creation, and data governance using tools like Smartsheet, Tableau, and Excel. | Requires experience with Smartsheet, Tableau, Excel, data analysis, and preferably SAP, along with skills in master data management, metadata management, data governance, and KPI/dashboard development. | Job Title: Business Analysis & Info Manager Location: Remote Duration: 12+ Months (Possible Extension) Terms: Contract W2 Top Skills: - Experience with Smartsheet, tableau, excel is a must have - Rapid Response and/or SAP highly preferred - Data analysis experience Other Important Skills - Master data management, metadata management, data governance - KPI/Metrics, Dashboards
Manage CMC project lifecycles including technology transfer, process development, regulatory documentation, and cross-functional team leadership to support drug product development and manufacturing. | Experience in sterile fill/finish drug product project management, formulation and process development, authoring CMC regulatory documents, leading cross-functional teams, and using project management tools like Smartsheet and MS Project. | Role: CMC Project Manager Senior Location: Thousand Oaks, CA/Remote Duration: 24+ Months (Possible Extension) • • Pharmaceutical Product Development & CMC Strategy • • Technology Transfer and CDMO Management • • Biological Drug Substance Manufacturing • • Small Molecule Drug Product Development & Manufacturing Skills & Experience in: • Project Management and Lifecycle Management Support for clients’ Sterile Fill/Finish Drug Products in the cGMP CDMO manufacturing facility. • Formulation & Process development, and cGMP manufacturing of semi-solid drug products. • Authored technical documents including batch records, material and product specifications, SOPs. • Authored CMC sections of INDs, ANDAs, and NDAs submissions • Managed CMC teams and ensured seamless integration of CMC deliverables into program milestones for early and late-stage programs, providing drug product for clinical supply and commercial launch. • Led cross-functional teams for technology transfer, process development, and manufacturing of drug substances and drug products, including small molecules and biologics, ensuring quality and regulatory compliance. • Prepared CMC sections for various regulatory submissions (IND, IMPD, NDA, J-NDA, BLA), ensuring compliance with guidelines and timely submission. • Collaborated with internal stakeholders and external partners/CMOs. • Developed program plans utilizing Smartsheet, MS Project. Utilized Planisware for budget and resource tracking. • Led weekly client meetings, provided minutes and action item updates, and developed project plans. • Led departmental initiatives for improved efficiencies including: 1) Standardized CMC development roadmap by delivering a MS Project template, and 2) Procedural zed CMC Governance process through creation of a playbook.
Design and implement role-specific training curricula and measure training success within biotech/pharma R&D departments. | Bachelor's degree with 5+ years or advanced degree with 3+ years experience in adult education focused on biotech/pharma R&D learning and instructional design. | Role: Training & Development Manager Location: Thousand Oaks, CA/Remote Duration: 6+ Months (Possible extension) Ideal Candidate: # B.S. degree and 5 years of experience/ M.S. or PhD degree and 3 years of experience # Familiar with developing, designing, and orchestrating adult educational learning for R&D. # Designing learning curricula, building learning/training assets # Adult Learning and Instructional Design # Strong focus on role-specific training and measuring success of training within R&D # Hands-on experience in Biotech and/or Pharma R&D Adult Education Previous titles: Trainer, R&D Learning Specialist, Clinical Trial Execution Learning & Development, Learning Specialist Not looking for general training and learning developers (e.g., LMS course creators) unless there is deep understanding of R&D learning across targeted departments
Manage finance projects including capital projects, project forecasting, headcount, and operations expenses while collaborating with executives. | Strong finance background with experience in SAP, Anaplan, Excel, understanding forecast cycles, capital project requirements, and executive communication. | Role: Finance Project Manager – Capital Projects & Operations Location: Remote Duration: 12+ Months (Possible Extension) Ideal Candidate: • **Strong finance background required (The selected candidate will manage projects and project forecast, headcount, operations expense) Top Skills: # Experience with tools like SAP, Anaplan & Excel # Understanding of forecast cycle and principles of capital project requirement # Strong key collaborator management and communication skills, including experience with executive-level/C Suite reporting
Manage financial forecasting, project budgets, stakeholder communication, and reporting for capital projects ensuring compliance and collaboration across teams. | Strong finance background, experience with SAP, Anaplan, Excel, project management methodologies, and excellent communication skills for executive-level reporting. | Job Title: Project Manager Location: Thousand Oaks CA – 100% Remote Duration: 6 Months with possible extension Terms: Contract W2 Description: • **Remote PST majority of the time but EST hours may be required to meet business needs** • **Strong finance background required. The selected candidate will manage projects and project forecast. headcount, operations expense ETC*** Job Details: Manages one or more high-level, complex non-technical projects within the constraints of scope, quality, time, and cost, to deliver specified requirements. Projects may be strategic in nature. Responsibilities may include resource allocation and all phases of development life cycle (i.e. feasibility study, requirements, analysis, ROI, business plan, design, testing, and implementation planning). Regularly interacts with management. Coordinates and directs the activities of project team members. May be responsible for cross-functional teams. Ensures all project requirements and/or objectives are documented. May obtain and manage external resources required for project completion.; Skills: ; expertise in running medium to large scale projects ; excellent understanding of project management processes and procedures ; experience with project management and analyst methodologies and best practices ; strong analytical skills ; business process development best practices, change management ; strong MS Project, MS Word, Visio, MS PowerPoint and MS Excel skills ; understanding of systems for sharing and collaboration ; excellent communication skills to work with cross-program resources Top 3 Must Have Skill Sets: • Experience with tools like SAP, Anaplan & Excel • Understanding of forecast cycle and principles of capital project requirement • Strong key collaborator management and communication skills, including experience with executive-level reporting. • Must be able to hit the ground running with mimimal supervision Day to Day Responsibilities: • Provide financial guidance and support for capital projects • Lead stakeholder sessions to capture and refine needs across areas • Maintain and update the project forecast with monthly actuals vs. forecasts; conduct regular financial reviews with project managers. • Deliver insightful reporting (Actuals vs. Forecast/Latest Estimate) to senior management and business stakeholders, highlighting risks, opportunities, and recommendations. • Manage purchase orders (POs) to prevent delays; resolve invoice and accrual issues efficiently. • Facilitate and coordinate accruals, reclasses, and capital funding requests in collaboration with finance, Property Accounting, and Technology Governance team. • Ensure compliance with ETDG process and capital governance requirements. • Partner with IS Managers, Project Support, MyBuy, Anaplan, and SAP teams to ensure accurate project funding and forecasting. • Provide project management guidance to Technology business partners and serve as a liaison between finance and project teams. • Prepare and present ad hoc financial and project reports to senior leadership. • Lead productive conversation that require both financial analysis and project management expertise. • Support and assist operation expense and headcount forecast.
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