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Technical Services Lead - Fixed Term Contract
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?
Here, you will be a vital contributor to our inspiring, bold mission.
In this role, you will contribute to Takeda’s mission by having the 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. A typical day will include:
- Lead, manage and coordinate technical support activities for Takeda Biologics 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.
- The position works 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 organizations.
- 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
- The incumbent must 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.
- The incumbent is 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),
- Right first time documents,
- 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. 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.
- The incumbent will highlight the appropriate resources needed to quickly resolve technical issues (quality, capacity, and cost) and drive process reliability and improvements.
- The incumbent is expected to 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
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Give 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.
- 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.
- Knowledge of techniques utilized in pharmaceutical sciences.
- Strong organizational and strategic thinking skills.
- Demonstrated technical skills in aseptic manufacturing, systems and process technologies with strong regulatory and cGMP background for drug product manufacturing.
- Applied Statistics experience to support process understanding and product characterization including design, process controls, troubleshooting through statistical modeling and Quality by Design.
- Demonstrated organizational skills including project and budget management
- Demonstrated ability to anticipate and address conflicts or issues in timely manner that supports long term success of the organization
Energy & Drive – committed to Takeda values
Be Positive and embrace change – help others understand rationale and positive impact of change
Be Results Oriented
Be An Excellent Manager of Self and Others
Decision-making and Autonomy
- Demonstrated ability to communicate and present complex scientific information to all business audiences
- Demonstrated strength in cross boundary communication, influencing others, building cross-functional teams
- 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
- 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)
- Validation Teams
- Interacts closely and builds strong relationships with external organizations including:
- Contract manufacturing drug product sites
- Manufacturing equipment suppliers
- Enlists sound judgment and implements analytical, creative approaches to solve complex problems. Demonstrates innovative problem solving and analytical skills.
- Demonstrated success in technical proficiency, scientific creativity, and independent judgment. Works on complex problems which require in-depth analysis and collaboration with others and exercises judgment within broadly defined procedures and practices. Determines methods and procedures on new assignments and provide guidance to all levels of employees. Thinks broadly and identifies opportunities and develops solutions that impact beyond their role/function.
- This role requires a significant wide-spectrum understanding of pharmaceutical manufacturing and the associated requirements. The incumbent will be required to assess ongoing development plans, devise improvements and outline opportunities for success under tight timeframes. Decisions will include:
- Technology selection criteria,
- CMO and site selection criteria
- Process, equipment selection and technology transfer criteria.
- The candidate must be able to successfully interpret sometimes incomplete information and design cost effective opportunities to fill data gaps.
- Impacts business development by ensuring that longer-term strategic innovation and business development on a global basis are delivered.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Requires a degree in technical / scientific education with 5 years technical industry experience in development and/or manufacturing.
- Experience managing technical capabilities in a global capacity
- Experience in managing budgets, resource allocation and project portfolio management.
- Broad knowledge and experience within the GMP environment, and regulatory affairs.
- Successful track record of change management projects and processes
- Travel required approximately 25% (national and international)
WHAT TAKEDA CAN OFFER YOU
- Excellent conditions & benefits including generous holidays
- Genuine career progression and development
- Opportunity to work with a world class leader in the pharmaceutical sector
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People to Shine