Pharmaceutical Development Project

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What are we looking for?

From BioNanoPharma we are looking for a Pharmaceutical Development Project & Alliance Manager who will manage cross-functional teams focused on pre-clinical and clinical stage pharmaceutical product development based on BioNanoPharma's proprietary drug delivery technologies to achieve project goals within schedule, scope, and budget. Responsible for a range of pharmaceutical project management activities to internal and external project teams (customer, partners) including contract and budget management, risk management, alliance management, implementation of project management software and tools, process creation/improvement. It also covers the identification of new cooperation opportunities within the same account/client, to be materialized in close collaboration with the acquisition team (BD) which rounds up the ownership of a customer relationship in the project/pre-launch phase.

The challenge

• Project Planning:
  Defining project scope with an agreed upon (customer, R&D) Target Product Profile (TPP) based on which objectives, timelines, and deliverables will be included in a Statement of Work (SoW). This involves creating detailed project plans and connected resource allocation in close cooperation with R&D leadership
• Regulatory Compliance:
  Ensuring all stages of development adhere to regulations set by governing bodies such as the FDA and EMA – always in cooperation with BNP's/Insud's reg. affairs team and the customer
• Risk Management:
  Proactively identifying potential risks (e.g., safety concerns, inefficacy, supply chain issues) and developing mitigation strategies to prevent delays or failures.
• Cross-Functional Team Coordination:
  Collaborating with diverse teams, including R&D, manufacturing, quality assurance, regulatory affairs, and BD internally as well as externally (customer), to ensure alignment and efficient progress.
• Stakeholder Communication:
  Serving as the central point of contact for internal and external stakeholders, such as Head of Commercial and senior management as well as to the project team at customer side
• Monitoring and Reporting:
  Tracking project progress, milestones, and expenditures, making adjustments to the plan as needed, and providing regular status reports to management and clients, escalating if necessary
• Quality and Cost Management:
  Ensuring the project meets quality standards (TPP, SoW), monitoring project costs to stay within budget, and managing resources effectively.
• Client/Account management:
  identification of new collaboration opportunities within the accounts by knowing about the customer's commercial strategy and therapeutic focus, frequent updates of BioNanoPharma's technology advances, annual client/supplier meetings, and materializing new project in close cooperation with BioNanoPharma's Business Development team

Specific responsibilities:

• Developing and delivering project workplans (SoW, GANTT), financial and progress reports, and presentations to customers, partners, management and staff.
• Conducting evaluation visits as needed.
• Overseeing project finances including but not limited to developing budget proposals, monitoring expenditures on project and subcontract levels.
• Developing integrated product development timelines; maintain and monitor timelines and milestones for the project(s).

What do you need?

• Degree in Chemistry, Pharmaceutical Science, Biochemistry, or related field
• Project Management (PM) Certification preferred
• Master's Degree with minimum 3 years or Bachelor's degree with 5 years of project management experience within pharmaceutical product development
• Background in pharmaceutical product development
• Fluent in Spanish and English

What will the Selection process be like?

Stay tuned to your phone and email The first thing we will likely do is contact you through one of the two channels.

Prepare well We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.

Wait for the result We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.

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COMMITMENT TO EQUAL OPPORTUNITIES

The InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.