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Project Manager, Chemistry Manufacturing Control (CMC)/SmartSheets/Sharepoint- (JP14338)
Newbury Park, CA · Biotech/PharmaceuticalJob Title: Project Manager, Chemistry Manufacturing Control (CMC)/SmartSheets/Sharepoint- (JP14338)
Location: Thousand Oaks, CA. 91320 - HYBRID
Employment Type: Contract
Business Unit: Final Product Technologies/Development Product Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 07/31/25
Pay Rate: $67 - $77/hour W2 with benefits
Notes: Hybrid (85% remote) local candidates preferred. 8 am- 5pm however, projects are global and selected candidate must align to assigned projects. Only qualified candidates need apply.
3 Key Consulting is hiring a Project Manager, Chemistry Manufacturing Control (CMC)/SmartSheets/Sharepoint for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Why is the Position Open?
Backfill.
Top Must Have Skills:
Day to Day Responsibilities:
Responsible for overall creation, coordination, status reporting and stability of technical, projects oriented work efforts for medical devices and combination products.
Establishes and implements project management processes and methodologies for the Final Combination Product Platform community to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.
Responsible for assembling highly complex project plans and teamwork assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review; and escalating functional, quality, timeline issues appropriately.
Responsible for tracking key project milestones and adjusting project plans and/or resources to meet the needs of customers.
Coordinates communication with all areas of the enterprise that impacts the scope, budget, risks and resources of the work effort being managed.
Assists Program Manager(s) in partnering with senior management of the business community to identify and prioritize opportunities for utilizing Final Combination Product platform activities to achieve the goals of the enterprise.
Must possess extensive knowledge and expertise in the use of project management methodologies and tools (Smartsheet is a must for this position, MS Project, One Pager), resource management practices and change management techniques.
Manages one or more cross-functional projects of medium to high complexity.
Basic Qualifications:
Employee Value Proposition:
This project is heavily technical. Candidates must be a self starter and have ability to understand combination product. You will work with all cross functional teams from quality to human factors.
Red Flags:
Location: Thousand Oaks, CA. 91320 - HYBRID
Employment Type: Contract
Business Unit: Final Product Technologies/Development Product Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 07/31/25
Pay Rate: $67 - $77/hour W2 with benefits
Notes: Hybrid (85% remote) local candidates preferred. 8 am- 5pm however, projects are global and selected candidate must align to assigned projects. Only qualified candidates need apply.
3 Key Consulting is hiring a Project Manager, Chemistry Manufacturing Control (CMC)/SmartSheets/Sharepoint for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
- Manages one or more high-level, complex TECHNICAL combination product 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, business plan, design, testing, and implementation planning, among other).
- 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.
Why is the Position Open?
Backfill.
Top Must Have Skills:
- ***Extensive smartsheet experience is required***
- *** No IT or capital project candidates***
- Extensive working knowledge on Chemistry Manufacturing Control
- Combination products background and Medical devices savvy and deep understanding of design control process of medical devices.
- Smartsheet work knowledgeable on the creation, development and maintenance of fully integrated timelines, reports and dashboards. Candidates without Smartsheet extensive knowledge will not be considered.
Day to Day Responsibilities:
Responsible for overall creation, coordination, status reporting and stability of technical, projects oriented work efforts for medical devices and combination products.
Establishes and implements project management processes and methodologies for the Final Combination Product Platform community to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.
Responsible for assembling highly complex project plans and teamwork assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review; and escalating functional, quality, timeline issues appropriately.
Responsible for tracking key project milestones and adjusting project plans and/or resources to meet the needs of customers.
Coordinates communication with all areas of the enterprise that impacts the scope, budget, risks and resources of the work effort being managed.
Assists Program Manager(s) in partnering with senior management of the business community to identify and prioritize opportunities for utilizing Final Combination Product platform activities to achieve the goals of the enterprise.
Must possess extensive knowledge and expertise in the use of project management methodologies and tools (Smartsheet is a must for this position, MS Project, One Pager), resource management practices and change management techniques.
Manages one or more cross-functional projects of medium to high complexity.
Basic Qualifications:
- Doctorate degree or Master’s degree and 2 years of experience or Bachelor’s degree and 4 years of experience or Associate’s degree and 8 years of experience or High school diploma / GED and 10 years of experience
- Expertise in running medium to large scale Combination Products (drug and device) project
- 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 Smartsheet, MS Project, MS Word, Visio, MS PowerPoint, SharePoint, One Pager skills.
- Understanding of systems for sharing and collaboration
- Excellent communication skills to work with cross-program resources.
Employee Value Proposition:
This project is heavily technical. Candidates must be a self starter and have ability to understand combination product. You will work with all cross functional teams from quality to human factors.
Red Flags:
- Required: Extensive Smartsheet and SharePoint working knowledge.
- Very important: Will not consider IT, Supply Chain or Construction Project Managers. This is a totally different area and out of their expertise.
- Local candidate preferable the person may be required to be onsite at some point. Remote workers may be considered if really strong candidate.
- Interview process:
***Virtual interviews*** - Initial screening with hiring manager. Will include working assessment on Smartsheet knowledge and design control of medical devices.
- Panel interview with different customer the team is currently supporting.
Regards,
3KC Talent Acquisition Team