Hiring company: Takeda
Are you looking for a patient-centric, passion-driven company that will inspire and empower you to shine? Join us as a Principal Packaging Engineer (A.D. level) in our Lexington, MA location.
At Takeda, we are transforming patient lives through our breakthrough therapies. To do this, we empower our people to realize their full potential. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
The Global Corporate Principal Packaging Engineer will:
Have oversight of product packaging-related technical processes and provide end-to-end packaging technology leadership and activities throughout the supply chain; across multiple sites, to maintain and improve production process capability, quality, and compliance.
Provide strategic visioning of new primary, secondary and tertiary bio-pharmaceutical packaging systems and processes including Launch, Global Product Expansion, Continuous Improvement, and Supply Chain Integrity (including serialization and EUFMD).
Work with internal and external stakeholders to develop implementation timelines and oversee packaging initiatives.
Serve as the primary technical point of contact for the CMO Packaging Engineering organization within our internal sites and teams, including the Operating Units, Process Development and Pharmaceutical Sciences, and external, Contract Manufacturing Organizations as necessary.
Provide technical oversight of existing packaging production, technology, methods, procedures, and specifications to ensure effective ongoing production and process improvements
Requires demonstrated leadership to lead, develop and organize teams and proven international experience in a regulated environment.
The candidate will assess, develop, design, specify, test, and implement packaging projects at external and/or internal manufacturing and packaging sites.
Additional responsibilities include leading in package trial runs, project start-ups (FATs/SATs), resolving manufacturing issues, and in packaging validation efforts.
In addition, the candidate will lead or own change control, non-conformances, and CAPA activities working with Quality and Global Labelling Operations
Scope of Work
Scope of work includes all commercial products in the Oncology, Small Molecule portfolio (Solid Oral Dosage, Liquid Fill, and other Small Molecule product packaging).
Assess the international regulatory environment impacting packaging and labeling; providing the leadership and strategy to meet these requirements (USP, JP, FDA, EMEA, etc.).
Develop and maintain the technology capability strategy, including continuous improvement metrics /optimizations.
Work to establish and harmonize packaging by developing global standards, identify opportunities and develop new and improve existing processes.
Ensure robust process alignment with packaging partners internally and externally.
The leader will be expected to develop and deliver shared objectives with key partner groups.
As required, engage and proactively influence regulatory agencies, professional organizations, and industry committees to develop and adopt policies /practices /guidelines that are aligned with Takeda’s vision.
Contribute support and lead team in due diligence activities for new product acquisition and/or introductions/launches.
Lead global cross-functional/interdisciplinary teams in the resolution of complex technical problems or the development of a supply chain solution (quality, capacity, expansion, and cost)
Lead Continuous Improvement initiatives and Exceptional teamwork experiences.
Effectively and actively participate in strategic corporate initiatives such as Agile, lean six sigma
Recruit and manage external resources, such as Consultants and Contractors, as needed to deliver projects, as agreed upon by management
Represents Packaging Engineering OESSM on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations, and other internal or external customers on new and existing product introductions, ensuring the highest level of customer satisfaction.
Education and Skills:
- Requires a Bachelor's degree in a scientific/technical discipline with 15 years of technical hands-on industry experience in development and/or manufacturing (both highly preferred).
- Ten or more years experience in leading highly effective technical teams and developing people and technical capabilities in a global capacity
- Ten or more years experience in organization management including responsibility for budgets, resource allocation, and project portfolio management.
- Global product launch experience
- Knowledge and expertise in the associated CMC regulatory requirements.
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents, and DEA Regulations
- Strong technical, interpersonal, communication, and leadership skills.
- Knowledge of techniques utilized in the pharmaceutical sciences.
- Strong organizational and strategic thinking skills are required.
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
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.
Empowering Our People to Shine
Discover more at takedajobs.com
This job posting excludes CO applicants.
No Phone Calls or Recruiters Please.
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.