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25 days old

Scientific Project Manager, REMOTE

Kelly Services
Tustin, CA 92781 Work Remotely
Senior Project Manager - Dedicated contract development and manufacturing organization CDMO focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.


With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services.


Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.


Covid-19 Hiring Update: We are continuing to interview and hire during this time. Our organization is committed to caring for the safety and well-being of applicants and employees; all interviews will be completed over the phone or virtually.


Summary:


Support the project management office PMO effort for the drug development projects as assigned by planning and coordinating cross-functional activities of designated project s to ensure that goals or objectives of project s are accomplished within prescribed time frame and funding parameters. Functional involvement with external clients and internal stakeholders includes but is not limited to facilitating activities related to operations, regulatory, clinical, pre-clinical, and Chemistry/Manufacturing/Controls.


Essential Duties and Responsibilities include the following:


Supports the PMO implementation of standardized templates, project governance, project process flow, and resource allocation tools and techniques. Supports the planning/preparation/facilitation of extended meetings with external clients and internal stakeholders pre-BLA, commercialization plan review, etc. . Supports project readiness activities related to process validation and commercialization while liaising with external clients documentation, schedule, resources, risk assessment, budgeting, and ability to function as a member of PIP team during engineering and process validation runs . Supports project interface with operations/outside contractor/supply chain for commercial production readiness, schedule and facilitate sub-team as assigned meetings. Provides Project Management support to all assigned projects including oversight of project charter, project plan/timeline, risk management and risk elevation. Responsible for effective meeting facilitation, maintenance of meeting minutes, and action item generation, follow-up, and elevation for all assigned projects with external clients and internal stakeholders.


Qualifications:


B.S. in a scientific discipline with 5 years of biotechnology or pharmaceutical experience or an equivalent combination of education and experience in a project management role directly interfacing with external clients Attention to detail, ability to multi-task, familiarity with the drug development process, and strong written and oral communication skills are required. Proficiency in MS Project is required. Project Management certification is desirable.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-03-26 Expires: 2021-04-26

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Scientific Project Manager, REMOTE

Kelly Services
Tustin, CA 92781

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