CMO Technical Services Lead

Shire

  • Lexington, MA
  • Permanent
  • Full-time
  • 7 days ago
OBJECTIVES/PURPOSE
  • 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.
  • 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
ACCOUNTABILITIES
  • 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 substance and 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 substance and 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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential:
  • 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
ADDITIONAL INFORMATION
  • Travel required approximately 25% (national and international)
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.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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