We are a small biopharmaceutical company located in Sorrento Valley. Our exciting product is entering into a new late phase of clinical trials.
We are looking for a hands-on CMC Project Manager to oversee internal CMC team in collaboration with the project team leader, integration of project deliverables/ activities and proactive communication with stakeholders. Facilitates the creation and maintenance of clear, concise Integrated CMC Plan consistent with guidance documents and drives the interactions with the CMO to maintain timelines and budgets. Driving complex projects in a team setting to successful milestones and ultimately completion throughout all phases of the project management process (initiation, planning, execution, monitoring/control, and closure). Strong ability to independently identify and manage priorities/task assignments across multiple complex projects in-line with overall objectives/goals. Able to facilitate alignment across functional areas to achieve goals. Ensure sound decision-making principles are applied to develop team agreement. Ensure methods, tools and techniques are utilized correctly in order to maximize benefits.
Primary Duties and Responsibilities
To be considered, please submit a cover letter and CV or resume to Human Resources at firstname.lastname@example.org
- Work with team leaders to set agendas, plan activities and facilitate decision making.
- Facillitate interactions with CMO's to maintain timelines and budgets
- Coordinate all team and meeting logistics including scheduling the meetings, sending out the agendas, writing and distributing minutes, tracking goals and action items, collecting meeting materials from line functions and distributing them to the team before the meeting.
- Facilitate timely & productive team discussions.
- Assess team and member effectiveness and create improvement plans.
- Apply all standardized project tools to manage and document team progress as well as to communicate effectively to stakeholders.
- Establish team goals and objectives with the team and their respective functions.
- Update progress against set milestones.
- Establish and keep current development strategies, CMC integrated plan, WBS, and risk management plans.
- Coordinate all necessary CMC material/information needed for team success.
- Provide scenario analysis to support timely decision making to ensure execution per plans
- Discuss critical issues with team leader to devise appropriate escalation plan
- Ensure effective coordination of activities and/or deliverables across CMC functions.
- Assess for improvement existing business processes.
- Identify solutions for project management improvement opportunities across the teams.
- Bachelor degree in life science, business, industrial engineering or equivalent required.
- Minimum 8 years Project Management experience in a Chemistry, Manufacturing & Control (CMC) environment, with 5-8 years in the biotechnology / pharmaceutical industry.
- MBA degree and/or PMP certification desirable.
- Demonstrated ability to coordinate and work effectively with cross-functional teams.
- Superb attention to detail.
- Ability to manage multiple CMO's to maintain timelines and budgets
- Basic understanding of biologic CMC processes
- Phase 3 and commercial CMC experience
- Ability to multi-task in a time pressured environment.
- Excellent written and verbal communication skills.
- Ability to problem-solve independently.
- Good organizational skills and ability to adhere to timelines.
- Excellent project management computer skills with the following programs: MS Word, PowerPoint, Excel and MS Project;
- Proficiency in strategizing, planning, monitoring and problem-solving.
Alcock & McFadden - 10 months ago