Hiring company: Takeda
As the largest pharmaceutical company in Asia and among the top 20 largest pharmaceutical companies in the world by revenue, Takeda (NYSE: TAK) is a values-based, R&D-driven biopharmaceutical leader committed to discover and deliver life-transforming treatments to patients globally. Our Purpose – to create better health for people, and a brighter future for the world – guides us as we continue to build a workplace supporting future ways of working and the well-being of our employees. Certified as a four-time Top Global Employer by the Top Employers Institute for Excellence, life at Takeda empowers you to grow in a meaningful career.
Role:
The Manufacturing Science and Technology department provides technical solutions to support external suppliers. Key facets of a Takeda Chemical Process Engineer include:
- Technical and Functional Expertise to ensure new and existing drug product technology, finished goods, and related processes are developed and transferred to the contract manufacturing operations (CMOs) in the highest regulatory and quality standards.
- Leadership to inspire, motivate, problem-solve, innovate, optimize, and achieve outstanding results with your team.
- Decision-making and Autonomy to understand market and organizational needs, and translate the learnings into agile business cases
- Effective Communication to clearly interact with multiple departments, concisely present complex scientific information, and develop credible relationships with a broad spectrum of people, including CMO’s, Vendors / Suppliers and Colleagues.
- Innovative thinking to develop plans and strategies to change the future of Takeda and positively impact the industry
Responsibilities:
- New product introduction and process validation
- Technology selection and acquisition
- Process design, development, optimization and verification
- Technology transfer
- Continuous improvement
- Routine technical support
- Operate Clean-in-Place (CIP) and Steam-in-Place systems
- Assemble and operate filtration systems
- Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.)
- Monitor and record critical process parameters
- Complete all relevant paperwork following GDP/GMP guidelines
Education, Behavioral Competencies and Skills:
- An advanced degree in Chemistry, Pharmacy or Chemical Engineering with 15+ years industry experience
- Hands-on experience in drug product process development, optimization and validation
- Direct experience in technology transfer and in supporting drug product manufacturing
- Strong knowledge of pharmaceutical formulation and modern analytical methods
- Experience in global product launches and the associated CMC regulatory requirements
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations are preferred.
- Recognized as an expert or leader in their specific field
- Strong technical, interpersonal, communication and leadership skills
At Takeda, our global, engaged workforce is committed to continuously innovate on our ways of working to keep our competitive edge and deliver the highest quality therapies to for patients all over the world.
Join us in shaping the future of healthcare. Be empowered to make a difference. Apply now.
Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.
This posting excludes Colorado applicants.
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Takeda is an equal opportunity employer.
EEO Statement
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, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.