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Manager of CDMO Manufacturing Operations
4 weeks ago
Job Title: Manager, External Manufacturing Operations
Location: Boston- Hybrid
Pay: $50-60/hr
The Manager of External Manufacturing Operations (ExM) is a critical role that interfaces with assigned key Finished Goods Contract Development Manufacturing Organizations (CDMOs) to support both internal and externally facing cross-functional teams and assist in managing the operations of our external network of suppliers. Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain team’s role in ensuring that the company effectively and efficiently delivers medicines to patients. This team member will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.
The Manager of External Manufacturing Operations reports directly to the Director of External
Manufacturing Operations. This position will be based in our corporate headquarters in Boston, MA. This role will be accountable for supporting external commercial manufacturing operations activities globally for small molecules and will partner closely with colleagues across our team to ensure the support of seamless supply of commercial products.
KEY RESPONSIBILITIES:
- Assist with management of long-term strategic finished goods suppliers and driving execution of production plans at CDMOs.
- Identify and escalate business critical risks impacting supply and/or timelines with related mitigations and/or possible solutions.
- Monitor CDMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
- Coordination and support of Business Review Meetings with CDMOs.
- Supports when required identification and resolution of business/contract issues (bring In legal, CMSC (Commercial Manufacturing & Supply Chain) Leadership Team, Strategy + Bus Ops, Strategic Sourcing).
- Implements process improvements to reduce lead time and eliminate non-value-added activities as well as proactively identify future improvements.
- Partners with Tech Ops, Quality, and CMSC Strategy and Business Operations to champion a culture of quality with our CDMOs and to ensure that all activities and documentation comply with regulatory requirements.
- Travel onsite as required to CDMOS for assistance in overseeing operations and/or critical business activities.
- Partners with Global Supply Chain and Tech Ops to assist in developing long-term manufacturing network strategy.
- Represents External Manufacturing Operations department on assigned project sub-teams and/or task forces and, with guidance.
- Aids in building External Manufacturing Operations capabilities and standard business processes.
REQUIRED SKILLS:
- Understanding of the science and technology underlying small molecule manufacturing as well as analytical techniques that support commercial manufacturing activities.
- Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, maintenance, quality, and engineering.
- Strong result orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
- Excellent written and interpersonal communication skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprisewide, from the executive team to the manufacturing floor.
- Excellent team player and able to build and sustain organization respect and trust at all levels
- Problem solver with a hands-on approach and the ability to anticipate adverse scenarios and provide contingency plans to address them
- Resilient and able to work well in a demanding, fast-paced entrepreneurial environment
- Sound judgment and business acumen with personal versatility and flexibility as business and team evolve
- Keeps current on professional knowledge, expertise, and best practice
- Strong organizational skills
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