OneTrust

Director, Strategic Programs – Portfolio MSAT Advanced Therapies

OneTrust

full-time

Posted on:

Location Type: Remote

Location: Remote • New Jersey, North Carolina • 🇺🇸 United States

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Salary

💰 $150,000 - $258,750 per year

Job Level

Lead

About the role

  • Own the development and execution of strategic advanced therapies product technology roadmaps/programs and ensure strategy-to-execution discipline with the ability to translate objectives into actionable milestones and clear decision pathways to enhance product life cycles
  • Lead roadmap business planning strategies in partnership with implementation teams, value chain, and manufacturing platforms across a matrix of functions to define and advance business processes.
  • Lead global, multi-site, and cross-functional team members in the strategic implementation of high-value solutions required to achieve commitments in new technology, science, facilities, processes, and products.
  • Support MSAT portfolio governance & analytics; managing portfolio health, visibility, and communication such as ROI, benefits realization, risk, and readiness with executive leadership, finance, and other key stakeholders.
  • Ensure technical and manufacturing requirements are addressed throughout the lifecycle of new solutions and drive continuous improvements.
  • Foster an operational excellence culture among teams to enhance productivity and efficiency of operations.
  • Proactively align decision making with enterprise-wide strategy, evaluating short- and long-term goals against potential consequences and benefits/risks analyses.
  • Devise strategies and solutions to deliver rapid growth ambitions including enhancing reliability, compliance, efficiency of product value chains end-to-end including product life cycle management.
  • Maintain a robust technical support network related to lifecycle management, new technologies, automation, comparability, change management, and technology transfers for products, including material science assessments, sourcing strategies, and critical to quality processes.
  • Continuously analyze network performance and produce concepts which support COGM reduction, robustness, and efficiency.

Requirements

  • University/Bachelor's Degree in Science/Engineering or equivalent with 10-12 Years Biotech/Pharmaceutical experience or Masters/PhD degree with 6+ years Biotech/ Pharmaceutical experience or equivalent industry experience
  • Hands-on experience in manufacturing operations and/or R&D in a biopharmaceutical manufacturing setting (i.e. cell/gene therapy products, vaccines, or any other products).
  • Deep knowledge of cGMP guidelines, regulatory standards, and compliance requirements.
  • Knowledge in manufacturing sciences change management methodology.
  • Self-directed, detail-oriented, with excellent critical thinking, problem-solving, decision-making, program management, and communication skills.
  • Understanding data analytics/statistics and communicating strategic takeaways and messaging to support decision-making and messaging to stakeholders.
  • Lead program investment analyses, forecasting, and scenarios to ensure portfolio-level value realization in partnership with finance and other key stakeholders.
Benefits
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
  • Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
manufacturing operationsR&DcGMP guidelinesregulatory standardscompliance requirementschange management methodologydata analyticsprogram managementportfolio governancetechnology transfers
Soft skills
critical thinkingproblem-solvingdecision-makingcommunicationself-directeddetail-orientedleadershipstrategic planningcollaborationoperational excellence
Certifications
Bachelor's DegreeMaster's DegreePhD