CMC Project Manager
Curemark is looking for a CMC Project Manager!
Why join us?
We are focused on developing novel therapies to treat serious disorders and diseases for which there are limited treatment options – disorders like Autism and ADHD that impact millions of children and their families. We love coming to work every day because we know that our work is going to make a difference in the world.
If that isn’t enough… Curemark has been recognized by Red Herring as one the Top 100 most promising and innovative private companies to watch (previous winners include Google, Facebook, Yahoo, Skype, LinkedIn, Zynga, YouTube and eBay).
With a Phase III trial well underway, plans for other clinical trials in the works and a strong pipeline of preclinical and clinical candidates – Curemark is ready to bring on a Project Manager with a manufacturing speciality who has been through the NDA process and has experience with commercialization. You know (and are excited about) being in a start-up environment and you aren’t afraid to roll-up your sleeves and get the work done!
Curemark currently uses an outsourced manufacturing model which depends on external contract manufacturers. This position will work closely with our contract manufacturing organizations (CMOs) to ensure that our manufacturing strategy is aligned with our needs. In addition, this position will work with our Quality function to ensure that our products are made according to the highest quality standards for our patients.
- Ensure day-to-day coordination and collaboration among site and operational functions (manufacturing, QC, QA etc…), Regulatory Affairs and CMOs to ensure successful manufacture of products) from plan to execution (up to and including delivery to the storage/distribution centers, focusing on one-year planning horizon).
- Execute and coordinate business processes for product manufacturing, release testing, and logistics including oversight for material movement (i.e. POs, Invoices, Quality Systems for transport).
- Assist the QA department with coordinating internal compliance processes with supplier quality, such as handling non-conformances, change control, investigations, CAPAs, inspection preparedness, etc.
- Responsible for assisting the Manufacturing Team on the day to day execution of production plan.
- Works with management and interdepartmental team constructing production forecasts.
- Facilitate/lead regularly scheduled cross-functional product support team meetings with Manufacturing and QA departments.
- Coordinates and facilitates regularly scheduled meetings with CMOs for oversight of product manufacturing and improvement initiatives.
- Bachelor’s Degree with 5+ years experience.
- PHARMACEUTICAL MANUFACTURING EXPERIENCE REQUIRED.
- Project oversight experience required in a Manufacturing environment as a Project Manager (PMP certification preferred but not required).
- Understanding of application and practices of cGMP.
- Solid experience with Gannt Charting and Project Planning.
- Execution-oriented philosophy with proven ability to develop and implement operating plans from strategic business and project plans.
- Demonstrated proactive leadership in cross-functional and culturally diverse team settings.
- Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met.
- High energy, enthusiasm and well-organized management skills.
- Strong leadership and experience in managing diverse personalities and functions to achieve successful integration of the team with positive results.
- Demonstrates excellent written, spoken, listening and presentation skills and an ability to influence within the wider project community at the level of functional leadership.
- Demonstrates a composed and independent manner when dealing with issues, challenges, conflicts and opportunities.
- A strong desire to work in a rapidly growing smaller company environment where contributions will have significant impact on the future positioning of the company.
What Curemark offers?
- A chance to be a part of a company that is focused on making a difference
- A competitive compensation package in a well-funded, high-growth company
- Generous vacation and holidays
- Excellent healthcare coverage
- An incredible team of fun, bright coworkers
If you’re interested in this position, please send your cover letter and resume to firstname.lastname@example.org.