Posted to MedZilla on 8/18/2019


Takeda Pharmaceuticals

US-MA, Lead, Primary Packaging and Combination Product Integration SR0035521-MZ


 
 

Primary Duties

Responsible for applying advanced principles of primary packaging technology and engineering in the independent initiation and execution of technical primary packaging aspects for combination products.

This position is to develop innovative new primary packaging concepts (CCS), qualify and implement optimal and cost-effective primary packaging solutions that offer best in class process efficiency to operations in the different Operation Sites. Another aspect of this role is LCM and proper support of existing products related to CCS.

This role will work very closely with the device development, packaging engineers and drug product groups to coordinate all aspects for primary packaging in accordance with best practice to ensure that regulatory requirements are being met.

This role will be involved in the development and launch of primary packaging components; assess, develop, design, specify, test and implement primary packaging solutions at external and/or internal manufacturing sites. Additional responsibilities include CCIT deliverables and resolving manufacturing issues.

Responsibilities

Primary

  • Develop innovative new concepts for primary packaging, qualify and implement CCS solutions
  • Manage primary packaging activities including developing, qualifying and implementing of CCS.
  • provide guidance to the laboratory for the testing of CCS and development of CCIT methods
  • Lead, manage and execute all CCS aspects of a project. Accountable for delivering on specific performance indicators, including but not limited to:
    • Primary packaging Component Specifications, Bill of Materials, Technical Protocols, feasibility & functional testing and trouble shooting
  • May be the Process Owner and /or the Execution Lead, for one or more processes, including but not limited to:
    • Development of Requirements
    • Selection of new and existing CCS for Combination Products
    • Support Development activities and own all CCS related aspects including CCIT testing
    • Support in CCS related investigation
    • Act as interface between Devices/combination Product development and drug product team
    • Support submission activities

Secondary

  • Will work with internal stakeholder to create or enhance primary packaging capabilities to deliver the needed quality required by our patients.
  • Will partner with packaging engineering group to ensure quality in product packaging and drive elimination of customer complaints relating to packaging.
  • Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, CMOs, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and Development and Manufacturing Teams.

Tertiary

  • Serve as a Point of contact for Primary Packaging aspects to the Product Technical Teams
  • Support protocols development for the feasibility testing
  • Support and lead labeling change process by evaluating the impact on primary packaging material on operations.
  • Recruit and manage external resources, such as, Consultants and Contractors, as needed to deliver projects.
  • To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations.
  • Represents device development and external manufacturing on
  • Investigate new sources and make recommendations on primary packaging materials and support material change and implementation.
  • Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.

Education and Experience Requirements

  • familiar with CCIT methods such as dye ingress, head space analysis, vacuum decay, and high voltage leak detection
  • Requires a Bachelor s degree in a scientific/technical discipline with a minimum of 8 years related experience. Applies expert knowledge of scientific/technical principles and concepts in managing technical programs such as Package design development for primary packaging systems
  • Experience in global product launches and the associated CMC regulatory requirements.
  • Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations is preferred.
  • Ability to simultaneously manage multiple projects of variable complexity.

Other Job Requirements

  • Travel of up to 25% may be 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.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.


Please visit our website at takedajobs.com

 
 


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