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Drug Substance - Manager CMO EU

20 days ago: Takeda Pharmaceutical Company Ltd.

Job Description

PRIMARY DUTIES
Coordinate global technical (CMC) support activities for the company's Biologic Drug Substance Department at registration and post-registration stages of the product lifecycle, including but not limited to troubleshooting, process improvement, cost reduction, capacity expansion, technical transfer and validation. 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 company and multiple contract service providers. Participation on commercial CMC (cCMC) teams may also be required.
The position serves as a key knowledge link between Process Development and Supply Chain Operations, providing technical leadership in support of 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.
JOB DUTIES & RESPONSIBILITIES
+ 60% of the time: Provide technical leadership and support for technical transfer activities, and deviations, investigations, CAPA and change control for global commercial biologic Drug Substance manufacturing
+ 10% of the time: Author/review manufacturing documents and support regulatory submissions, responses and inspections
+ 10% of the time: Identify and manage process improvement activities for existing commercial manufacturing operations
+ 10% of the time: Represent Technical Operations within cross-functional project teams
+ 10% of the time: Provide department-wide operations support for system/process improvement, evaluation of new technologies and CROs/CMOs, budget management, and resource prioritization
EDUCATION & EXPERIENCE REQUIREMENTS
+ Minimum: M.Sc. degree in pharmaceutics, chemical/biochemical engineering, chemistry, or related physical or biological science.
+ Minimum: 10 years’ experience in pharmaceutical development and manufacturing.
+ Experience with the development and/or manufacturing of DS, relating to cell culture, fermentation, recovery and purification processes for biologics and associated analytics.
+ In-depth knowledge of global GMPs and regulatory requirements for product registration.
+ Experience with statistical experimental design and data analysis preferred.
KEY SKILLS, ABILITIES & 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 Substance 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 & 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.
+ Serve as a subject matter expert (SME) for Drug Substance manufacturing science and technology.
+ 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
INTERNAL & EXTERNAL CONTACTS
+ Work closely with project leads, Supply Chain Operations, Quality (QA, QC, and Validation), CMC-regulatory Affairs, Process Development, and Manufacturing Sciences and Technology groups.
+ Interact with external partners, e.g., CMOs and CROs.
OTHER JOB REQUIREMENTS
+ Full-time position
+ Office-based
+ Some domestic & international travel required
_Notice to Employment / Recruitment Agents:_
_Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration._
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
PRIMARY DUTIES Coordinate global technical (CMC) support activities for the companys Biologic Drug Substance Department at registration and post-registration stages of the product lifecycle, including but not limited to troubleshooting, process improvement, cost reduction, capacity expansion, technical transfer and validation. 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 company and multiple contract service providers. Participation on commercial CMC (cCMC) teams may also be required.The position serves as a key knowledge link between Process Development and Supply Chain Operations, providing technical leadership...