Sr. Project Manager - Biopharma Chemistry Manufacturing & Control (JP7997)
Thousand Oaks, CA. (Onsite Essential)
1+ years with likely extensions or conversion to FTE
3 Key Consulting is hiring a Senior Project Manager - CMC
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Must be able to work on site and remote (remote-for limited time until site opens back up). 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, 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.
Why is the Position Open?
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- MS Project.
- Chemistry, Manufacturing and Control (CMC) methodology knowledge: Late Stage and Life Cycle Management.
- Drug Substance and Drug Product experience (Commercial process development and Commercial advancement).
Employee Value Proposition:
- Must have Biology/Biochemistry/Biomedical/Chemistry background.
- Must have experience with late stage, product development, and life cycle management, commercial process development, Process characterization, Tech transfer.
- 2+ years of project management & 10+ years of experience within the Pharmaceutical, Biotechnology or other Healthcare related field, direct CMC experience is highly desirable.
- Must have strong CMC experience.
- 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, MS PowerPoint and MS Excel skills, SharePoint.
- Understanding of systems for sharing and collaboration.
- Excellent communication skills to work with cross-program resources.
- Key words on resumes: drug substance, drug product, drug development, cross functional support, combination product, late stage, LCM, CMC operations, process development
Exposure to variety of products & many developments, high visibility to senior leadership.
Only IT or facility project management experience, lack of CMC.
Video Skype Panel Interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.