Process Development Manager
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Operations & Manufacturing |
| Start Date | |
| Advertiser | Hilda Lynn |
| Job Ref | #1002078 |
| Job Views | 168 |
- Description
- We are seeking applications for an exciting contract opportunity for our client, who is a leading biopharmaceutical company based in Dublin. If you are successful, you will be responsible for leading a cross-functional product team to deliver new technologies and products. You will have at least seven to ten years of experience within the pharmaceutical or biotech industry and will have demonstrated program leadership skills.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Owning product health for the products
Managing and developing product lifecycle management programs
Developing long term site product vision and strategy
Acting as main point of contact for global operations leads & product delivery teams
Making sure that site’s needs are presented and prioritized appropriately
Relationship building with the product & process knowledge SMEs at network and site level
Developing site product risks and implements plans to remediate risks
Making 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
Attend site product governance meetings
Communicate and prioritise changes to global product roadmap and contract
Influence key stakeholders on site and above site and protect site strategy
Supporting new product/market launch
Complying to safety, cGMP standards
Ensuring financial compliance in line with Business & Financial guidance
Building a culture of personal responsibility within reporting structure
Cross 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
What you need to apply:
Technical Degree and/or Masters’ or equivalent
7+ years’ experience in biopharma/pharma industry
Strong process and manufacturing background
Technical knowledge across various products and their associated manufacturing sciences, technologies and analytical processes from within parenteral fill-finish, or oral dosage forms and/or packaging
Risk management skills, identify risks and mitigation pathways for new and existing products
Leadership experience - technical or program in a pharmaceutical or biotech manufacturing facility that engages with site SMEs and managers, and global functions
Demonstrated planning experience
Manage the introduction of new products and ensure the health of existing products
Self-starter with a passion for continuous improvement
Demonstrated project/programme management skills
Excellent Communication Skills – continually communicating with peers and to stakeholders both internally and globally.
Strong interpersonal skills
Customer-focused decision-making skills.
Ability to prioritize complex projects