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Product Lead (Biotechnology/Pharmaceutical)

  • Job reference: 924693
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 05/04/2019

Orion group are recruiting a Product Lead (Biotechnology/Pharmaceutical) on behalf of our Client based in Dublin, Ireland - 12-month contract

Purpose of Role: 7

Manage and develops site product lifecycle (multiple products)

  • * Assists in developing long term site product vision and strategy
    * Serves as the main point of contact for global operations leads (GOLs) & PDT's.
    * Ensures that site product needs are presented and prioritized appropriately at the site and global level
    * Develop and manage site product lifecycle (multiple products)
    * Owns product health for the site through product governance: capacity, changes, risks.
    * Serves as the main point of contact for global operations leads and ensures that site product needs are presented and prioritised appropriately at a global level
    * Builds and manages the relationship with the product & process knowledge SMEs at the network and site level
    * Develops site product risks and implements plans to remediate risks
    * Makes critical decisions and provides Process Transfer Technical Leadership on the cross-functional Tech Transfer/NPI project team & at Technology Development and Transfer Governance Forums
    * Attendance at above site product governance meetings i.e. Product Review meeting, Site Ops meeting
    * Ensures changes to global product roadmap and contract books are fed back to the site through Product governance and prioritized appropriately
    * Ability to influence key stakeholders on site and above site; Protecting site strategy while meeting network demands
    * Long range vision of the product
    * Understanding of major market regulatory requirements
    * Ability to prioritize complex projects
    * Support new product/market launch

Compliance Related Tasks


* Ensure compliance to cGMP at all times
* Ensure safety & compliance standards are maintained to the highest standards
* Ensure financial compliance in line with Business & Financial guidance
* Support a culture of personal responsibility within reporting structure

Qualifications:


* Technical Degree and/or Masters or equivalent

Experience


* 7- 10 years in biopharma/pharma industry
* A working technical knowledge in a range of products and their associated manufacturing sciences, technologies and analytical processes from within parenteral fill-finish, or oral dosage forms and/or packaging
* Strategic understanding of Product Lifecycle management
* Ability to identify gaps/risks and put appropriate remediation plans in place
* Have technical or program leadership experience
* A proven track record in the ability to transfer goals and objectives into measurable plans
* Strong process and manufacturing background
* Strong understanding of current GMP regulations and industry practices & trends

Skills & Knowledge


* Transversal working & collaborative style - Must be able to work with and maintain trust with all levels of the organization
* Strong understanding of development, technical, manufacturing, validation, quality and regulatory processes.
* Demonstrated project/programme management skills
* Excellent Communication Skills - continually communicating with peers and to stakeholders both internally and globally.
* Strong interpersonal skills
* Strong leadership skills, especially with respect to collaboration, influencing, and coordination
* Customer-focused decision-making skills.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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