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R&D Project Lead


  • Location: Mountain View (United States)
  • Contract: Permanent
  • Working day: Full time
  • Sector: Pharmaceutical and biopharmaceutical
  • Vacancies: 1
  • Discipline: R&D

Ferrer

Job description

Who we are

At Ferrer we are a group of people who believe in the power of purpose. And our purpose is to make a positive impact in society and bring about change in an unjust world. We are the 24/7 activists fighting for a sustainable planet, equal opportunities for all and a healthy workplace. We reject greenwashing and empty promises - we are about action. That is why in 2022 we became a B Corp company.

In order to fulfil our purpose, we offer transformative therapeutic solutions, with an increasing focus on pulmonary vascular and interstitial lung diseases and neurological disorders. Founded in Barcelona in 1959, our products are present in more than a hundred countries, and we have a team of over 1,800 people. Professionals that we empower to became leaders of change and to build meaningful careers.

 

Your mission 

The R&D Project Lead will be the key player of R&D project management at Alexza-Ferrer. The role includes project feasibility analysis and management of pharmaceutical projects up to commercialization including launch readiness. The R&D Project Lead is responsible for the R&D project strategy and operational management of cross-functional teams by applying industry standard project management tools, processes and principles to meet timelines and deliverables. This position will interact with almost all company departments in multidisciplinary team’s matrix organization and will be fully accountable for Project Strategy and Performance. The R&D Project Lead facilitates cross-functional communication and strategic decision-making within project teams and among project sponsors. The position is based in Alexza Ferrer’s US R&D Centre (Freemont, California) with report to the Director of R&D Portfolio Management based in EU (Barcelona). Assigned projects will be mostly related with the Staccato technology developed in our R&D Centre in US.

 

Responsabilities

  • Validation of viability and profitability of new projects proposed by the New Product Planning Committee (value proposition, competitive landscape analysis, technical viability, development plan, costs and target market)
  • Develop Target Product Profile, Business Case, R&D Project Plan and Costs
  • Leading the strategic, scientific and operational planning and decision-making processes of assigned R&D Project.
  • The R&D Project Lead will provide content expertise to the strategy, competitiveness, timing, costs, and resources required for development project and be able to successfully deliver their project(s) milestones and goals. As the strategic partner and operational lead for development, the R&D Project Lead works to ensure that cross-functional teams operate effectively, fostering positive team dynamics and championing Ferrer’s operating model.
  • Responsible for driving the development of an integrated project timeline that represents the appropriate level of detail and task interdependencies. The integrated project plan outlines the project scope, deliverables, and timing for the project and may include various scenarios. Ensures timeline is aligned with the overall project plan and corporate objectives.
  • Work closely with the project sponsors and cross-functional team members to clarify  task ownership, and manage the coordination of activities, determining critical path activities, proactively tracking the project plan, monitoring variances, and alerting the teams and sponsors when there are potential deviations from the plan that will likely impact corporate goals and project milestones. Drives timely and successful resolution of open issues and decisions.
  • Works with team members to identify resource constraints, project risks, and conflicts that could impact the project schedule and work with team members and management to develop appropriate solutions. Providing strategic guidance to ‘pressure-test’ program team’s assumptions, drive scenario planning / trade off analysis, and cross-functional planning into the overall integrated project plan.
  • Keep realistic baselines (scope, time & cost)
  • Coordinate assigned resources
  • Pro-actively monitor project performance and gather Project Performance Data
  • Synthesize and track information from the teams for inclusion in monthly status reports and in preparation for periodic projects reviews and decision point meetings.
  • Ensure team meetings are efficient and meaningful by preparing agendas, facilitating discussions, and publishing minutes and action item logs.
  • Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
  • Establish and maintain a work environment that fosters learning, respect, open communication, collaboration and teamwork.
  • Generate and share project’s information and knowledge
  • Manage partners, alliances and contracts related with assigned projects

 

Why Ferrer?

  • Make a positive impact in society
  • Participate in volunteering activities
  • Grow in a culture of trust, responsibility, and constructive feedback
  • Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
  • Make a real difference to the team and to yourself
  • Take advantage of opportunities for development & learning
  • Discover a range of benefits to support your physical, emotional and financial wellbeing
  • Customize your remuneration and benefit

Requirements

What you’ll need to succeed 

 

You will rock at this company if you are a person with empathy, humility, curiosity and optimism.

  • In depth knowledge of the drug/device development process relevant to the pharmaceutical Knowledge of design controls per FDA Quality System Regulation, risk management per ISO 14971, and ISO 13485 preferred.
  • Extensive understanding of the drug development process (i.e. Pharmaceutical Development, Clinical Research, Regulatory Affairs, Medical Affairs, etc…)
  • Extensive understanding of manufacturing operations for system automation and integration, IQ/OQ/PQ, manufacturing scale up and process validation, CMC, quality and regulatory per design control process (pharma and medical device), packaging/ labeling for global launch, risk management and supply chain
  • Experience in launch readiness
  • External partner management experience, working with (CMOs, CROs, vendors)
  • Able to support highly complex multiple activities simultaneously
  • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
  • Capability of understanding and communicate both scientific and business-related elements of R&D projects
  • Team player with sound decision making skills, able to build strong, sustainable relationships and efficient teams
  • Transparent communication and influencing skills
  • Empathy, and active listener
  • Ability to work both at strategic and operative level
  • Leadership, and capable of allowing expression of ideas/opinions diversity
  • Learning agility
  • Sense of urgency
  • Strong proficiency with project management practices, tools and
  • Excellent analytical skills, with an ability to communicate complex issues in a simple way Effective written and oral communication, interpersonal, problem solving, and facilitation skills. Must be able to prioritize and work independently.
  • Requires strong computer skills with proficiency in Microsoft Project and Microsoft
  • Bachelor’s Degree in an engineering and/or scientific discipline required with an advanced degree preferred, PhD highly recommended
  • A minimum of 5 years professional experience in pharmaceutical/biotech industries. Drug delivery and medical device experience a plus.
  • 3+ years of experience in project management, clinical project management, team leadership, and/or functional line management in one or more of the major R&D functions is also required
  • Master’s in project management (highly valuable)
  • Previous experience in neurodegenerative, pulmonary or rare disease (highly valuable)
  • Prolonged periods of sitting at a desk and working on a computer
  • Potentially prolonged periods standing
  • Must be able to lift up to 15 pounds at times
  • Must be willing to travel

 

If this great challenge matches your profile, then we are waiting for you!

At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.

https://www.ferrer.com/en/join-us

 

 

 

Job closed

  • Location: Mountain View (United States)
  • Contract: Permanent
  • Working day: Full time
  • Sector: Pharmaceutical and biopharmaceutical
  • Vacancies: 1
  • Discipline: R&D