The Director/Sr Director, CMC Business Operations and Vendor Management is responsible for developing and managing supplier relationships, and for defining and tracking material requirements including planning, packaging, labelling, and distribution activities, while monitoring and reporting metrics.

The scope of this role includes oversight of both internal activities at Frontier and its contract development and manufacturing organizations (CDMOs), suppliers, testing laboratories, and logistics vendors. The role is accountable with Quality Assurance ensuring that vendors are compliant with global regulations, prepared for potential Sponsor and Regulatory Inspections and that the appropriate processes, systems and activities are in place and performed to protect patient safety, product quality, and data integrity. The role will interface with the Frontier development team regarding project packaging, labeling, and related characteristics.

The successful candidate will have a strong understanding of pharmaceutical production, clinical supply chain management, and GMP requirements. This expertise, along with a pharmaceutical manufacturing background and the organizational and interpersonal skills required to build and foster strong relationships with collaborators, will be needed for success. The ideal candidate will demonstrate the ability to be both detail oriented and to think strategically.

This position is a hybrid role based in the Greater Boston area. Occasional travel may also be required for in - person meetings.

Requirements

• Responsible for business operations and management of vendors engaged with the Chemical Manufacturing Controls (CMC) group
• Support CMC project management and integration of CMC plans with overall development plan
• Develop, lead, and execute sourcing strategies with consideration and results for end-to-end supply chain excellence through technical collaboration, product introduction, cost modeling, logistics, manufacturing, quality control, ordering/distribution, integration and reusability
• Execute agreements with strategic suppliers with an emphasis on meeting and exceeding cost, quality, and delivery goals
• Identify and qualify (in collaboration with QA) suppliers with appropriate quality, capacity, and competitive pricing to support the highest possible service levels to CMC customers
• Develop and manage supplier relationship and negotiate (in collaboration with Finance) most favorable terms to support current demands, while assuring future requirements are met
• Engage actively in supplier performance management
• Identify supplier performance gaps and develop action plans to achieve desired performance levels
• Identify and initiate cost reduction opportunities
• Address concerns and issues from customer service, sales, and procurement relating to customer needs
• Proactively communicate/escalate supply issues in a timely manner
• Evaluate and recommend actions to improve upon customer deliveries
• Share information and provide reporting on key supply chain metrics
• Develop and issue Request for Proposals (RFPs)
• Budget preparation and adherence
• Invoice reconciliation and investigation

QUALIFICATIONS

• Minimum BS degree in Science or Engineering, advanced degree a plus, and 10+ years of applicable pharmaceutical experience
• Strong working knowledge of global GMP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct
• Must have proven clinical and/or commercial drug product supply chain experience
• Experience with logistics supervision
• Excellent leadership skills including an effective written and oral communicator, including experience preparing and making presentations to executive level management and interacting effectively with internal and external organizations, collaborators, and customers

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Training & Development
• Free Food & Snacks
• Wellness Resources
• Stock Option Plan

The salary range for this role is $200,000 - $270,000. Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits.

This compensation and benefits information is based on Frontier's knowledge as of the date of publication, and may be modified in the future.