Posted to MedZilla on 8/17/2019


Takeda Pharmaceuticals

US-MA, Senior Project Manager SR0037379-MZ


 
 

Primary Role:

The Project Manager will lead projects of varying scope and complexity which will include the implementation of process & product improvements, corrective & preventative actions, and business efficiency efforts relevant to clinical and commercial manufacturing . The individual will own projects and quality systems for manufacturing initiatives from initial planning and initiation through implementation and closeout.

Responsibilities:

60%

Actively own and manage CAPA and Change Controls (initiation through closure) as they relate to Manufacturing operations, processes and equipment. This includes project development, execution, implementation, closure, and overall management of process, product, and manufacturing equipment related projects and quality systems through effective use of advanced project management & OE tools (options analysis, risk facilitation, decision matrix, ROI, communication, escalation plans, etc):

  • Demonstrates knowledge in bridging technical and business disciplines.
  • Obtains agreement on project definition, scope and priorities.
  • Ensures that resources, capabilities and processes are in place for proper project execution, sponsorship and governance.
  • Leads the planning and implementation of assigned projects and ensures they stay on track and are implemented / closed on time by resolving conflicts and removing obstacles or through the proper use of escalation.
  • Provides status reports defining project progress, risks / problems and solutions.
  • Ensures that appropriate risk management analyses are performed and mitigation plans are in place for project implementations.
  • Applies efficient work practices for project management and ensures continual improvement of practices with the use of lessons learned.

20%

Represent manufacturing s interests on cross-functional projects and teams. This may include the following:

  • Provide manufacturing impact assessments for change controls owned by other functional groups (e.g. Tech Transfer, Engineering, Materials Management, QC, etc.).
  • Facilitate, lead and/or participate on risk assessment and options analysis teams.
  • Provide manufacturing support and coordination for capital projects, technology transfers, and continuous improvement efforts.
  • Influence team direction / execution to ensure manfacturning interests and long term needs are met.
  • Empowered decision maker on behalf of the PIER team.

20%

Perform base business activties:

  • Strive to meet defined metrics through the utilization of visual management boards.
  • Maintain adherence to assigned cGMP training requirements.
  • Participate in system improvements and optimization efforts to improve the output and throughput of various systems / processes (which may include OE or other efficiency intitiatives).
  • Participate in regulatory and internal audits including direct interaction with inspectors for CAPA or CC records, scribe duties, facilitation of audit requests, and development of responses.

Education and Experience Requirements

  • Bachelor s degree or equivalent experience in Engineering or Science and 5 (5+)years of relevant experience in commercial biotechnology or pharmaceutical production managing projects and schedule development is required.
  • Working knowledge of project controls in cost and financial assessments is desirable.
  • PMP or comparable certification and direct management experience is preferred.
  • Strong knowledge of cGMPs and applicability to manufacturing operations in a biologics or API environment is preferred.
  • Working knowledge of Quality by Design (QbD), Quality Risk Management (QRM),Good Engineering practices (GEP), and PM practices is preferred.

Key Skills, Abilities, and Competencies

  • Must be proficient with Microsoft applications, including Project, Word, Excel and Power Point.
  • Demonstrates ability to be nimble, maintain a positive outlook, and remain composed under pressure.
  • Proven organizational / time management skills and ability to coordinate and prioritize multiple projects in a fast-paced, deadline-driven environment.
  • Strong interpersonal skills and ability to work effectively and collaboratively in a cross-functional team environment.
  • Strong written and verbal communication skills.
  • Proven ability to analyze and organize information logically.
  • Experience with troubleshooting / problem solving and risk assessment / mitigation.
  • Comfortable making risk based recommendations based on science , data, or relevant experience.
  • Excellent communication, technical, and organizational skills are required. Must be a team player prepared to work in and promote a team-based culture.

Internal and External Contacts

Advises, consults and collaborates with cross-functional teams including but not limited to: Facilities and Engineering, Quality, Validation, Process Development and Health, Safety & Environment, Materials Management, Supply Chain, and Regulatory.

Other Requirements:

Some travel 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

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.