We are seeking a motivated Associate Director, CMC Vendor and Project Management, reporting to the Senior Director, CMC Tech Ops, who will proactively manage multiple CMC projects and coordinate with key internal and external stakeholders to advance our transformative therapies. The primary responsibility of this position is to work collaboratively with and focus on effective communication, planning, coordination of activities, and efficient implementation of CMC integrated project plans and supply strategy. Using extensive CMC Project Management knowledge and experience in the drug development industry, the AD provides operational leadership, direction and support to the CMC department including working with internal preclinical, CMC and Quality teams, contract development and manufacturing organizations (CDMOs), and contract testing organizations (CTOs).
· Responsible for ensuring CMC projects are delivered to time, quality, budget, project standards, company quality standards, and align with Arbor’s strategy
· Manages projects to ensure plans are optimal and meet overall strategic goals and are aligned with clinical development plans
· Collaborate with team members to create and maintain detailed, integrated CMC project plans; use plans to drive on-time release of supplies for complex programs
· Support CDMO management, development of Statements of Work (SOW) for outsourced activities, and track deliverables for finance to enable invoicing
· Proactively manage project risks and mitigation plans
· Identify critical path, risks, and impediments to successful development and drive the identification and development of solutions to mitigate these risks
· Drive timely decisions and accountability within CMC teams and facilitate active communication and information flow
· Prepare status updates for project review forums and communication to senior management
· Facilitate CMC team meetings and ensure that clear agendas are set, and actions and decisions are documented, communicated and commitments made.
· Acts as a source of knowledge in area of expertise associated with defining, communicating and implementing project management strategy
· Bachelor's, Master's, PhD or equivalent industry experience in a relevant technical discipline such as Biochemistry, Molecular Biology, Microbiology, Genetics, Immunology or Chemical Engineering.
· 5+ years of PM experience
· Project Management experience in CMC is required
· Demonstrated knowledge and application of Project Management tools
· Experience in planning and managing the cross functional aspects of biopharmaceutical product development
· Ability to work in a fluid environment and foster a strong collaborative spirit
· Ability to negotiate and sustain networking relationships with external vendors
· Possess excellent written, verbal and interpersonal skills and the ability to effectively interact with all levels both within and outside the organization
· Able to balance multiple CMC projects and priorities with outstanding organizational and time management skills (both CMC project and self).
· Excel at resolving and mitigating conflicts or problems with tact, subtlety and composure.
Our values govern the work we do at Arbor, and we’re hoping that they resonate as strongly with you as they do with us!
- Astonishingly Connected: The best work happens when we do it together. At Arbor, we believe strong, clear communication is crucial to our success and emboldens collaboration in all of us.
- Our People are Gems: And we treat each other as such by celebrating our growth and development. We invest in our team and encourage everyone to have both a learners mindset and a willingness to teach others.
- Remarkably Mighty: You'll be intrigued when you take a closer look at Arbor. We approach our work with integrity and thoughtfulness. We are brave, which leads us to take smart risks and make bold discoveries.
- Authenticity is Encouraged: From eating cheese puffs with chopsticks, to doing cartwheels on our balance beam, we're all about embracing your true self and showing up as you really are. Our differences make us extraordinary.
At Arbor, we are discovering, developing and making available to all patients the next-generation of genetic medicines. We are disrupting the field through our proprietary discovery engine to develop a portfolio of differentiated genetic editing and delivery capabilities. We have an unencumbered portfolio of multiple CRISPR based genetic modifiers that can be tailored to correct the underlying pathology of each genetic disease. Our pipeline of genetic medicines will focus on bringing cures to all patients with genetic disease.
We seek highly-motivated individuals with the dedication, integrity, and creative spirit needed to thrive in an innovative company. Working at Arbor offers a unique opportunity that combines the fast pace and growth opportunities of a startup with the intellectual rigor and creativity of academia. Our salaries are competitive, our benefits are generous, and our team is exceptional.
Arbor Biotechnologies is proud to be an inclusive workplace and an Equal Opportunity Employer.