|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:
- 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
- Leads/contributes to Functional strategy and
- Clearly communicates
portfolio development to stakeholders.
- 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
- 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
- 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:
- BS + 12 years; MS + 8 years; Pharma D + 7
years; PhD + 6 years
- 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
- 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.
- 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
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
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.