Technical Services Lead

Job Description

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Job Description

Job Title: Technical Services Lead

Location: Baggot Street

About the role:

• 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 organisations.
• 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

Optional hybrid work model .

How you will contribute :

• 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

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

Leadership

Energy & Drive – committed to Takeda values

Be Positive and embrace change – help others understand rationale and positive impact of change

Be Accountable

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

Interaction

Internal

• 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

External

• Interacts closely and builds strong relationships with external organizations including:
  • Contract manufacturing Drug Product sites
  • Manufacturing equipment suppliers

Innovation

• Enlists sound judgment and implements analytical, creative approaches to solve complex problems. Demonstrates innovative problem solving and analytical skills.

Complexity

• 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 manufactuirng 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.

What you bring to Takeda :

• 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:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programs including onsite flu shots and health screenings

Educational Assistance

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our 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:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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