Senior Director, Manufacturing
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 Manufacturing professional who can help us prepare for commercialization. You have deep manufacturing experience and have taken a drug product from the clinic to market. 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 and transactional activities for product manufacturing, release testing, and logistics including oversight for material movement (i.e. POs, Invoices, Quality Systems for transport)
- Coordinate internal compliance processes with supplier quality, such as handling non-conformances, change control, investigations, CAPAs, inspection preparedness, etc.
- Ensures alignment between CMOs to safeguard and control all processes required for receiving products from CMOs in terms of quality, time, volume and costs during the overall contract life cycle.
- Resolves issues with CMO and decides when issues need to be escalated.
- Drives continuous improvement at the CMO and at Curemark through target setting and performance management; coordinates input from Quality and provides regular feedback/ feedforward; acts as interface with CMO for optimization ideas on specific products
- Responsible for the day to day execution of production plan to meet annual market demands; conversion of bulk to finished goods based on Supply Planning FG demand/release plan; success measured in large part by zero backorder and minimal obsolescence
- Continuously evaluate processes, practices and policies to support on-time delivery of product, cycle time reductions, improved reliability and cost reduction
- Works with management and interdepartmental team constructing production forecasts.
- Facilitate/lead regularly scheduled cross-functional product support team meetings
- Coordinates and facilitates regularly scheduled meetings with CMOs for oversight of product manufacturing and improvement initiatives
- Provide updates to diverse audiences, including executive level leadership as required.
- Consistently manages stakeholders within a matrix environment, building productive relationships in project and departmental forums.
- Seeks input to ensure consistency in making independent judgment calls and guidance for more complex/sensitive.
- Experience required in process development, pilot plant or commercial biologics manufacturing under cGMP: 7-10 years’ experience with Bachelor’s or 5-7 years’ experience with Master’s
- Expert knowledge of biopharmaceutical manufacturing processes, systems and equipment
- Solid knowledge of:
- Application and practices of cGMP, international regulatory requirements and guidelines (e.g. European directives & ICH guidelines)
- Late stage clinical and commercial manufacturing regulatory requirements and best practices
- Supply chain operations and business processes
- Trouble-shooting/root-cause analysis tools
- Working knowledge of Lean Manufacturing, Six Sigma or other continuous improvement tools preferred
- Execution-oriented philosophy with proven ability to develop and implement operating plans from strategic business and project plans.
- Demonstrated 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 excellent leadership and 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
- Solid understanding of regulatory process variations and Module 3 improvements that would be required as part of the normal lifecycle management of products.
- 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.