Our client is looking for a DP Manager to join their team that looks after their EU CMO's.
This role reports directly into their Tech Ops Director and is based out of their Dublin City Centre office.
As a Drug Product - Manager working on the Biologic Drug Product registration and post-registration stages of the product life-cycle, you will be empowered to Coordinate global technical (CMC) support activities and be a key knowledge link between Process Development, Supply Chain Operations and other technical services groups.
The position works closely with colleagues in Process Development, Supply Chain Operations, Quality Assurance and CMC-regulatory Affairs, while serving as a key point of technical contact between the site and multiple contract service providers. The position serves as a key knowledge link between Process Development, Supply Chain Operations and other technical services groups, providing technical support for quality systems governing GMP manufacturing (e.g., deviations, investigations, CAPA and change control), regulatory submissions, and facility inspections. In addition, the position will serve as technical review/approval for manufacturing related documents such as Change Notifications, APQR and MBR.
- At least 5 years professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology
- 6 Sigma and Statistical knowledge is an advantage.
- Broad knowledge and experience within the GMP environment, and regulatory affairs.
- Successful track record of change management projects and processes
- High level of customer orientation and organizational skills
- Flexible in mind / out of the box thinking
- Enthusiastic, decisive, motivating and convincing personality
- International background appreciated
- Excellent communication skills, verbal and written communication skills
Key Skills, Abilities, and Competencies
- Ability to lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy.
- Knowledge and experience relating to the application of Quality by Design principles and statistical analysis tools for evaluation of Drug Product manufacturing processes.
- Strong interpersonal skills, with the ability to interact professionally and effectively with peers, managers, and leaders within and outside of the company
- Strong oral and written communication skills, including the ability to deliver presentations and prepare high-quality technical documents.
- Effective program management/leadership skills.
- Ability to anticipate technical issues and proactively develop creative solutions to ensure that projects stay on schedule.
- Must be a self-starter, able to work in a matrix environment, and effectively manage multiple projects simultaneously.
Complexity and Problem Solving
- Demonstrate sound scientific judgment in decision-making while keeping open communications to ensure that all work and deliverables are of high quality.
- Lead the development and successful implementation of new concepts, techniques, and standards.
- Maintain a high level of technical expertise and stay current with regulatory trends.
- Alignment of cross-functional goals and objectives
- Identification of gaps & initiation of improvement programs
- Use of innovation to drive competitive advantage
- Ability to lead cross functional global teams
- Ability to influence and communicate effectively to stakeholders & leadership
- Escalate and resolve issues/roadblocks as appropriate
Internal and External contacts
- Interact and influence with external partners, e.g., CMOs and CROs.
- Technical Services and other PDTS Functional Groups
- BioOpU for External Manufacturing
- External Quality
- Regulatory Affairs
- Product Strategy
- Supplier Relationship & Management
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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