Associate Vice President, Program Management & Technical Operations at Cerapedics, Inc.
Westminster, Colorado, United States -
Full Time


Start Date

Immediate

Expiry Date

15 Apr, 26

Salary

270000.0

Posted On

15 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Program Management, Technical Operations, Compliance, Leadership, Analytical Skills, Problem Solving, Communication, Relationship Building, Project Management, Risk Management, Continuous Improvement, Vendor Management, Strategic Planning, Cross-Functional Collaboration, Medical Writing, Regulatory Standards

Industry

Biotechnology Research

Description
Description ABOUT US Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics’ product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics’ next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. OVERVIEW Healing lives through bone repair – this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as an Associate Vice President, Program Management & Technical Operations in our Westminster office. In this role, you will contribute to our mission through overseeing areas of the business that impact product compliance, appropriate product specifications, and ensure that external and internal compliance changes are incorporated into best practices and functions within the organization. As an Associate Vice President, Program Management & Technical Operations working on the Operations team, you will be empowered through meaningful work and career development as a key member of the leadership team and are responsible for overseeing all Program Management supporting several functions in the company including but not limited to commercial, operations, manufacturing, organizational and departmental long-range planning and strategy, and infrastructure. A typical day will include overseeing the Technical Operations department to ensure uninterrupted operations between and across various functions including external suppliers, R&D, manufacturing, quality, etc. POSITION OBJECTIVES: Responsible for ensuring that any changes (e.g., raw materials, regulations, equipment, process) meet requirements (e.g., FDA, BSI, quality systems). Only after the requirements are met can manufacturing incorporate changes and ensure continuity of product supply. External Vendors: Manage all critical partners so that we can proactively manage changes. Internal Processes: Ensure all changes including raw materials from non-critical vendors, process changes, equipment changes, etc. meet requirements. External Standards: Monitor changes in regulations and standards and ensure that we have done all the work to ensure that our products are compliant. Develop internal processes that audit changes made by vendors to ensure compliance. Strategize and develop the sourcing function by evaluating different vendors, including dual sourcing of key components. Ensure that external and internal changes meet specifications and conform to industry standards. Build, mentor and lead a high-performing Program Management and Technical Operations team. Foster a culture of continuous improvement, professional development and inclusion. Develop and maintain project plans, schedules, budget, ad hoc analysis and resource tracking for assigned projects. Ensure timely and effective stakeholder communication on progress and potential issues. Develop project risk management plans and ensure key risks are mitigated, and additional resources identified to ensure successful project execution. Ensure alignment between core teams and stakeholders. Requirements POSITION REQUIREMENTS: Communicate succinctly, clearly and accurately in both verbal and written communications. Experience in managing publications, medical writing, and external scientific communications. Experience with orthopedics or spinal medical devices is highly desirable. Ability to manage timelines, multiple priorities under time constraints. Aptitude to develop technical expertise in new therapeutic areas. Strong analytical and problem-solving skills. Ability to work effectively in a cross-functional, fast paced, rapidly changing environment. Must be self-motivated, assertive and able to approach with a positive ‘can-do’ attitude. Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through requests from thought-leaders. Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to ensure a clear understanding of project status and direction. Excellent communicator, skilled at diplomacy, tactful and capable of effectively combining technical aptitude and relationship building for internal and external Company stakeholders. Advanced in Excel, PowerPoint, and Project and Program Management tools and resources like Power BI, Microsoft Project and other Project Management Software tools. EDUCATION AND PREFERRED TRAINING REQUIREMENTS: Bachelor’s degree in engineering, scientific or related field (required) Advanced degree or MBA (preferred). Minimum of 12 years of relevant work experience with progressively increasing responsibility or complexity of organizational strategy, program and technical leadership. Minimum of 10 years leading programs and projects in a medical device, biomedical, pharmaceutical, or high technology industry. WORK CONDITION/PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions. This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely. This position requires the incumbent to experience periods of prolonged sitting and occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs. This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination. TRAVEL REQUIREMENTS: 25% travel; each trip could be 2-3 days meeting with external or internal stakeholders depending on business needs. BENEFITS/COMPENSATION (including, but not limited to): Medical, vision, and dental insurance, group life insurance, 401k matching, short & long term disability, potential target bonus, paid time off, 11 paid holidays. SALARY RANGE: $230,000 - $270,000 Base Salary: Annually Target Annual Bonus: 30% - 35% Position will be posted through 01/18/2026. EEO STATEMENT: Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Responsibilities
Oversee areas of the business impacting product compliance and specifications, ensuring changes meet regulatory requirements. Manage the Technical Operations department to ensure uninterrupted operations across various functions.
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