Project Manager, Chemistry, Manufacturing, and Control (CMC) Job at Ora
POSITION TITLE: Project Manager, Chemistry, Manufacturing, and Control (CMC)
DEPARTMENT: CMC
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
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The Role:
Ora's Chemical Manufacturing Control (CMC) Project Manager is responsible for the oversight of CMC projects. Our CMC division provides drug development and discovery for Aseptic Processing and sterile liquids to determine the drug's safety for clinical use. The Project Manager will actively contribute and help the teams to effectively and efficiently deliver on project goals on schedule and within budget, provides program direction and manages timelines across internal functional and organizational lines as well as with external clients and vendors.
What You'll Do:
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- Provide necessary program direction for planning, organizing, developing and integrating project across multiple functional areas.
- Create and maintain detailed project plans to ensure clarity of deliverables and timing.
- Provide feedback to management of project progress/scope changes/new business opportunities.
- Cultivate effective communication, cooperation and trust with clients.
- Work in partnership with project team of scientists to identify risks and opportunities and execute on project plan and strategy.
- Coordinate 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.
- Act as the primary contact for all project related information.
- Responsibilities may differ slightly from the above based on specific needs of the business.
- Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
What We Look For:
- Experience needed for the Role:
- Bachelor's degree in Biology, Chemistry or Chemical Engineering with 3 years' experience of Pharmaceutical Development Project Management experience or related work in the pharmaceutical or biotechnology industry. Relevant work and/or years' experience may be considered in lieu of education.
- Additional Skills & Attributes:
- Aseptic processing is strongly preferred.
- Educational background in chemistry, chemical engineering, or pharmaceutical sciences strongly preferred.
- Prior task management experience with proven record for effective cost and schedule control of multi-disciplinary technology-based tasks in the pharmaceutical or biotech industry.
- Previous manufacturing/quality operations support experience in the pharmaceutical or biotechnology industry.
- Ability to apply standard Project Management tools, and practices.
- Ability to provide support to Management in assessing resource needs to achieve timelines and quality milestones.
- Excellent communication skills, both oral and written.
- Strong interpersonal and communication skills with the ability to effectively interface across all levels of the organization.
- Expertise with Microsoft suite (Word, Excel, PowerPoint, Project, and Outlook).
- Multi-lingual communication is a plus.
- Competencies and Personal Traits:
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- Attention to Detail: Ability to analyze available data and take the time to understand as full a picture as possible to drive successful solutions to complex problems.
- Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy. Possess the capacity to understand others and to be aware of and sensitive to the feelings, thoughts, and experience of your colleagues and customers.
- Intellectual Curiosity: A person's willingness and desire to learn new things and dig deeper than the surface. Intellectual curiosity makes learning a much more natural process, instead of just a duty or a chore. When you're intellectually curious, you're more willing and interested to acquire knowledge. You naturally ask more questions and seek to understand why things are the way they are.
- Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again; collaborative and progress-loving, you honor the past but embrace change because the new is always coming!
- Organization and Goal Setting: Ability to set goals, delegate appropriate tasks, maintain a focused approach to critical path work and develop structure for yourself and your team to allow for productive, high-quality workflows and decision making.
- Resolve Conflicts: Practice radical candor in your communication with your team and colleagues as well as participating in active listening to help the other person feel heard and understood.
- Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team with diverse and complimentary skill sets that works together under shared values to achieve significant positive impact in the wider world. Live a clear and sustained demonstration of the daily practice of Ora's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor and the linked behavioral expectations.
Who We Are: The Ora Way: Flexible. Functional. Sustainable. Global.
At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia.
Our Mission and Vision
Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see.
As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability and a fulfilling work-life balance for every team member.
Destination Workplaces
At Ora, we believe collaboration is the result of inspiration, not the catalyst for it. Destination workspaces are being introduced to provide immersive brand experiences that bring our culture, values, and vision to life. They will bring teams together for purposeful work and restorative connection with the natural world. Our first two locations, Moose Island in Eastport, Maine, and Waldingfield in Ipswich, Massachusetts, are currently under development with a focus on conservation and preservation of the environment. As a global company, we are also investing in ways to share inspiration with all — experiential teambuilding initiatives regardless of proximity to Ora owned properties.
Why Ora?
Constant innovation is a foundational tenet of Ora. The search for a better way. We are building a global, people-first work model for every Ora employee — regardless of role or location — that they can naturally embrace and succeed in; a model that anticipates professional needs, enables personal freedom, and rewards high levels of accountability and productivity. How we support our employees not only influences their personal experiences at Ora, it also determines who we are as a company. At Ora, you will have:
- Well-defined career paths with flexibility to learn different areas of the business
- Opportunities to work with international teams
- A chance to research new therapies that will impact patients across the globe
- The opportunity to have a significant impact on your team and the organization
- A receptive and adaptable community
- Access to collaborative and innovative-centered workspace
- Full time and per diem work opportunities
At Ora, we know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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