Bio Process Sciences Lead
Vor 5 Tagen
**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
**About** the role**:
- Member of the global team of process science experts responsible for the manufacturing process for Takeda’s large and diverse commercial biologics portfolio- Provides technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products
**How you will contribute**:
- Provide upstream and downstream technical expertise and leadership for various projects across the biologics portfolio, including: lifecycle initiatives to enable supply continuity, risk management, line extensions & discontinuation, process tech transfers, global expansion/contraction, regulatory activities, and capability & improvement.
- Ensure technical continuity of manufacturing processes across sites and time
- Provide technical expertise for initiatives and investigations which are complex or span across multiple products
- Lead process improvement projects that span sites or products
- Ensure alignment of CMC content for multi-site products
- Provide technical expertise required to maintain control strategy documents
**_
DIMENSIONS AND ASPECTS
- **
**Technical/Functional (Line) Expertise**
- Has a good understanding of biologics manufacturing, the regulatory environment, life cycle management, and trends in innovation
**Leadership**
- Ability to influence within teams to drive decisions, alignment, and conflict resolution for complex cross-functional issues
- Being a mentor developing future leaders
- Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality into the organization
**Decision-making and Autonomy**
- Represents Bio Process Sciences on various teams and is empowered to work within the team to align on decisions
**Interaction**
- Provides feedback within Bio Process Sciences to ensure LCM alignment across products
- Works with site MS teams on process improvement projects and other LCM projects
- Works within product governance teams to align on effective product LCM
- Works with Biologics Process Development on process improvements and other LCM projects
**Innovation**
- Provides technical input to Biologics Process Development for process improvement and other LCM projects
- Ensures process knowledge sharing across sites to ensure technical continuity for multi-site products
**Complexity**
- Provides leadership on cross-functional teams
- Provides leadership to drive highly complex projects including ones that span multiple sites and products
**What you bring to Takeda**:
Education / experience
- BS in engineering, life sciences, or related field with a Minimum 10 years experience, MS with a minimum of 8 years experience, or PhD with 2-5 years experience in pharmaceutical development and manufacturing
- Experience operating globally in a matrixed organization highly preferred
**Skills**:
- Must have technical knowledge and experience in upstream or downstream process development
- Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
Behaviors
- Focusing on the few priorities and provide superior results
- Elevating capabilities for now and the future
- Provide leadership on cross-functional teams
**Empowering our people to shine**:_
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law._
**Locations**:
Zurich, Switzerland
Lexington, MA
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time
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