Technical Services Lead, Manager
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Technical Services Lead, ManagerApply Now
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Technical Services Lead, Manager.
As our successful Technical Services Lead, Manager, you will lead, manage and coordinate technical support activities for Takeda Biologics Drug Substance and Drug Product 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.
In this position you will work closely with colleagues in Development, Supply Chain Operations, Quality Assurance and CMC-regulatory Affairs, while serving as a key point of technical contact between Takeda and multiple contract manufacturing organisations.
You will serve as our 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, you will serve as our technical review/approval for manufacturing related documents such as Change Notifications, APQR and MBR.
- Build and maintain strong relationships with key internal and external partner organizations and will be expected to develop and deliver shared objectives with key partner groups.
- Be accountable for delivering on specific financial targets such as departmental budget and key performance indicators, including but not limited to: Documentation cycle time (Product Specifications, Technical Protocols and Reports, Validation Master Plan, Regulatory Filing Support Documentations, etc), Cost of goods and CMO productivity improvement.
- Work with the Manufacturing Science network to create or enhance technical capabilities to deliver the needed capacity, quality and quantity of products required by our patients. You will partner with CMO’s to ensure quality in product manufacturing.
- Define the capability we need to deliver our services and the actions we need to take to maintain and continuously improve capabilities.
- Identify and manage process improvement activities for existing commercial manufacturing operations. And highlight the appropriate resources needed to quickly resolve technical issues (quality, capacity, and cost) and drive process reliability and improvements.
- Effectively support strategic corporate initiatives
- Provide department-wide operations support for system/process improvement, evaluation of new technologies and CROs/CMOs, budget management, and resource prioritization
- Provide technical support to Manufacturing and Quality into deviations, process yield issues and any technical issues that may arise during production and testing of commercial products at CMOs.
- Work closely and build strong relationships with external organizations including: Contract manufacturing drug substance and drug product sites and Manufacturing equipment suppliers
- Lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy
- Consult and collaborate across all pertinent Global Manufacturing and Supply Functions to identify and solve manufacturing issues, provides opportunities and creates value proposition, e.g: Quality, Site Operations, Maintenance, Engineering, Production Planning, Global Logistics, Manufacturing Science (CMC) and Validation Teams.
- This role requires a significant wide-spectrum understanding of pharmaceutical manufacturing and the associated requirements. You will be required to assess ongoing development plans, devise improvements and outline opportunities for success under tight time-frames. Decisions will include: Technology selection criteria, CMO and site selection criteria and Process, equipment selection and technology transfer criteria
Education, Behavioural Competencies
- A Degree in a technical/ scientific subject with 5 years technical industry experience in a development and/or manufacturing environment.
- Experience managing technical capabilities in a global capacity
- Experience in managing budgets, resource allocation and project portfolio management.
- Successful track record of change management projects and processes
- Experience in global product launches and the associated CMC regulatory requirements.
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and other Regulations.
- Strong technical, interpersonal, communication and leadership skills.
- Demonstrated technical skills in aseptic manufacturing, systems and process technologies with strong regulatory and cGMP background for drug substance and drug product manufacturing.
- Applied Statistics experience to support process understanding and product characterization including design, process controls, troubleshooting through statistical modelling and Quality by Design.
- Demonstrated ability to anticipate and address conflicts or issues in timely manner that supports long term success of the organization
- Strong ability to communicate and present complex scientific information to all business audiences
- Demonstrated strength in cross boundary communication, influencing others, building cross-functional teams
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.
Job ID SR0038704