Process Development Product Lead - Dun Laoghaire, Dublin

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:  Site Based

Pay: €55 - €65 per hour

Experience: 8+ years

Visa: EU passport or Stamp 4 visa required

Process Development Product Lead - Dun Laoghaire, Dublin

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

The Product lead – Process Development will report to the Sr. Manager Process Development in the Portfolio Management and Delivery group and will be responsible for leading a cross-functional product team in a matrix organisation to deliver new technologies and products to site. 

The successful candidate will have at least five years experience within the pharmaceutical or biotech industry and will have demonstrated program leadership skills.

Experience in a leadership role in a pharmaceutical or biotech manufacturing facility that engages with site SMEs and managers, and global functions

The ability to influence and lead cross functional teams to deliver to ensure the smooth introduction of new products and the health of existing products

The ability to work independently and identify risks and mitigation pathways for new and existing products

A passion for continuous improvement applied to product and program leadership

Act as the Product Health Steward and own product health for the products in their brief through product governance and effective product team leadership

Manage and develop product lifecycle management programs (multiple products)

Assist in developing long term site product vision and strategy

Serve as main point of contact for global operations leads (GOLs) & product delivery teams (PDTs)

Ensure that site’s needs are presented and prioritized appropriately at site and global level

Build and manage the relationship with the product & process knowledge SMEs at network and site level

Develop site product risks and implements plans to remediate risks

Make critical decisions and provide Process Transfer Technical Leadership on the cross-functional Tech Transfer/NPI project team and at Technology Development and Transfer Governance Forums

Engage at site product governance meetings i.e., Product Weekly Review meeting, Site Ops meeting

Ensure changes to global product roadmap and contract books are fed back to site through Product governance and prioritized appropriately

Influence key stakeholders on site and above site and protect site strategy while meeting Network demands

Support new product/market launch

Compliance Related Tasks:

Always ensure compliance to cGMP 

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

Requirements

Technical Degree and/or Masters’ or equivalent

5-7 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

Ability to identify gaps/risks and put appropriate remediation plans in place

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

Transversal working & collaborative style - must be able to work with and maintain trust at all levels of the organization

Strong understanding of development, technical, manufacturing, validation, quality and regulatory processes and Product Lifecycle management

Strong understanding of current GMP regulations and industry practices & trends

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 co-ordination

Customer-focused decision-making skills.

Ability to prioritize complex projects

Package

Contract role - Hourly rate €55 - €65 per hour

Minimum 12 month contract with the possibility of an extension. 

Contact

Karen McHugh is the consultant managing this position.

If you area a Process Development Product Lead interested in roles based in Dublin , you can contact Karen by e-mail at karen@jobcontax.com Karen or phone 353 1 7979720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Process Development Product Leads in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

taglife