9 days old

Program Manager

Aktiv Pharma Group
Broomfield, CO 80021
  • Job Code
    122029581
Aktiv Pharma Group

Our Company

Aktiv Pharma Group is a Specialty Pharmaceutical company developing and commercializing drug products in a portfolio of proprietary prefilled delivery devices, emphasizing improved usability, safety and drug stability. Our highly scalable Specialty Pharma model is based on a minimal core internal development team, supported by consultants and manufacturing subcontractors. Our leading development program is an emergency auto-injector for medical countermeasure treatment.

Our Mission

We look to develop products and treatments that improve the lives of the communities we serve. Our mission is to bring peace of mind to individuals and their communities through the work we do. Our vision is to be recognized for our innovative solutions that care for patients and communities. Our values are Truth, Goodness, Caring and Perseverance.

Our Culture

We emphasize a safe, inviting, and inclusive culture. We are striving for a combination between a demanding and challenging work style and promoting a balanced life for our employees. We expect people to work hard, but we also encourage play (skiing on good snow days, meeting after work for pool, morning smoothies). We want you to bring your whole self to work. Our values are central to our culture and we believe that every position in this company will help lead us to greater innovation.

Job Purpose

The Program Manager ensures that products meet all internal requirements, external expectations, quality standards and reliability targets and works with the Leadership Team to develop strategies to ensure that project timelines and scope are defined, project risks are identified and mitigated and that creative, disciplined efforts are made to deliver on time and within budget.

Responsibilities and Duties

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Drives cross-functional high-performing teams in the execution of new product development, from concept through commercialization.
  • Leads planning and execution discussions across multiple disciplines/teams to ensure coordinated cross functional work efforts and effective communication.
  • Creates, reviews and updates project plans and Gantt charts.
  • Prepares summaries for dissemination to Company Management and external stakeholders.
  • Partners with management and functional leaders to direct cross-functional teams to complete projects within deadlines and quality targets.
  • Develops and maintains healthy vendor relationships, active channels of communication, and clear expectations by integrating internal resources, external consultants and manufacturing subcontractors.
  • Oversees quality system implementation including: Design History File (DHF), risk registry, and similar.
  • Ensures projects are executed according to applicable regulatory and compliance standards.
  • Creates and improves work processes to ensure we are adopting the best practices for our culture and work.
  • Other duties as required and necessary to ensure the success of the organization.

Qualifications

Competencies, Knowledge, Skills, and Abilities:

  • Ability to consistently promote, support, work, and act in a manner in support of Aktiv Pharma Group's mission, vision and values.
  • Extensive experience in the development of one or more drug-device combination products, medical device development, drug development, transfer of processes and methods from bench to production, GMP manufacturing, and regulatory filings.
  • Deep knowledge of project management best practices and methodologies and end-to-end product lifecycle management is critical to long term success.
  • Demonstrated experience in successfully delivering projects requiring initiative and influence in a cross-functional setting, ability to drive team decisions, and proactive risk management.
  • Demonstrated understanding of project management concepts and subsystem interactions.
  • Skilled in creating and maintaining project and portfolio plans and Gantt charts using MS Project or equivalent.
  • Able to identify and manage to critical path.
  • Effective oral and written communication skills to effectively communicate internally and externally in formal and informal settings at all levels and composed of multiple disciplines.
  • Skilled in developing and delivering effective presentations and graphics designed for the specific audience.
  • MS Outlook, Excel, Word, PowerPoint, and MS Project or equivalent.

Education or Formal Training:

  • Bachelor's degree in Engineering, Chemistry, or closely related discipline.

Experience:

  • Minimum of ten (10) years of project management experience in device development, pharmaceutical development, or combination products development is required.
  • An equivalent combination of education and experience may be substituted on a year to year basis.

Additional Requirements/Licenses/Certifications:

  • Active Project Management Institute (PMI) Project Management Professional (PMP) certification or ability to attain within one year from start required.
  • Reliable transportation required.
  • Valid driver's license required.

Aktiv Pharma Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.



PI122029581

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Posted: 2020-07-29 Expires: 2020-08-29

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Program Manager

Aktiv Pharma Group
Broomfield, CO 80021

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