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 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
- 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
- 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.
No Phone Calls or Recruiters Please.