Posted to MedZilla on 11/23/2017


Takeda Pharmaceuticals

US-MA, Senior Scientific Manager 1702783-MZ


 
 

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Scientific Manager in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Scientific Manager working on the Pharmaceutical Sciences Program Management team, you will be empowered to play a key role in Pharm Sci strategy and communicate portfolio developments to stakeholders, and a typical day will include:


POSITION OBJECTIVES:
  • Independently leads development of Pharm Sci strategy and plans for multiple programs
  • Experience in leading Biologics, Combination and/or Device Product Development is preferred.
  • May provide Functional (Lab) expertise in specialized area(s)
  • Leads/contributes to Functional strategy and initiatives
  • Clearly communicates portfolio development to stakeholders.
POSITION ACCOUNTABILITIES:
Program Management:
  • Leads multiple global Pharm Sci teams while ensuring the defined scope, budget, and timelines of the program(s) are met with high-quality deliverables.
  • Participates as functional expert in divisional initiatives.
  • Leads/represents Pharm Sci on cross-divisional governance and development teams while providing strategy and accountability for Pharm Sci deliverables.
  • Leads the preparation of the Pharm Sci sections of global regulatory submissions (e.g. CTAs and commercial applications) and Pharm Sci responses to regulatory agencies; represents Pharm Sci at meetings with regulatory agencies as necessary.
  • Manages Pharm Sci development activities being performed by a contract lab or manufacturing facility to ensure project deliverables are being met; reviews contracts and invoices as necessary.
  • Identifies and communicates project or program risks and provides risk response strategies in a timely manner to appropriate stakeholders and Pharm Sci management

Technical Acumen:

  • Identifies, evaluates, develops and communicates/negotiates criticality of new scientific standards and tools for potential implementation on programs.
  • Applies scientific knowledge and principles to solve project problems and significantly influence the direction of projects/programs.
  • Critically reviews technical and scientific reports from external sources and coordinates Takeda-sponsored work.
  • Provides expert review of Pharm Sci documents, which may include method or technology transfer protocols, stability data, manufacturing batch records, quality investigations, other GMP documentation, and scientific reports.
  • Independently leads and performs Pharm Sci activities requiring extemporaneously prepared formulations including ADME, absolute BA, and other Phase 1 studies.

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education / Experience

  • BS + 12 years; MS + 8 years; Pharma D + 7 years; PhD + 6 years

Technical Skills/Competencies:

  • Thorough knowledge of pharmaceutical development, including an understanding of current laboratory techniques, instrumentation, problem solving techniques, process engineering and manufacturing development, and statistics used in experimental work.
  • Must have experience in global regulatory filings.
  • Must demonstrate knowledge of several allied fields, such as chemical engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs. Fundamental understanding in DMPK, Pharmacology and Toxicology.
  • Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, and compendial requirements
  • Must have knowledge in global regulatory submission requirements and processes.

Program Management Skills/Competencies

  • Experience with the application of project management knowledge, skills, tools, and techniques for complex multidisciplinary programs.
  • Leadership develops and uses knowledge and interpersonal skills to influence and guide stakeholders towards the accomplishment of program and divisional goals and objectives; adapts well to different personalities and manages others on the team in a respectful manner.
  • Risk Management ability to identify/solve technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies.
  • Communication ability to expresses one s self clearly and concisely to key stakeholders; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience.
  • Resource Management ability to manage internal and external resources (people, information, technologies, time, and capital) based on program needs.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx


No Phone Calls or Recruiters Please.

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Schedule

Please visit our website at takedajobs.com

 
 


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