Senior Manager, Material Science for Combination Product
Bio-Life Plasma, LLC
Lexington, MA
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Job Description
About the role:
Plasma-derived therapies are critical, life-saving medicines, which patients with rare and complex diseases around the world rely on every day. Global demand for these therapies, immunoglobulins, has increased dramatically over the last 15 years, and continues to grow. Takeda is established as second largest provider of plasma-derived therapies (PDT) globally. Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet expectations of patients and health care providers with plasma-derived therapies for patients with immunologic, hematologic, autoimmune and other complex diseases. As a member of the PDT R&D team based in our Cambridge, MA office, you will report to the Drug Device Combination Lead. You will lead the technical activities on developing primary packaging design, materials, specifications and qualifications.
How you will contribute:
Provide technical ownership during development of primary container or combination products while ensuring compliance to requirements and standards around material compatibility, stability, Extractables and Leachables, Container Closure Integrity
Lead material qualification activities during product development
Work with formulation fill/finish, device development and quality functions to support container closure system selection, implementation, and troubleshooting for new and on-market products.
Develop container closure integrity testing method and execute testing per project timelines
Design, execute and manage extractable/leachable studies on primary packaging systems
Coordinate stability studies during feasibility and development following product specificationsCoordinate activities across several contract labs while managing timeline expectations and mitigating for risk
Minimum requirements/qualifications:
B.S. degree in material science, pharmaceutical packaging, chemistry, or related science
9 years’ experience in pharmaceutical sciences or devices
Knowledge in the field of primary container systems such as flexible bags, vials and pre-filled syringes in development
Previous experience in the field of primary container systems such as flexible bags, vials and pre-filled syringes in development
Experience with aseptic process and sterility, container closure integrity and testing of primary container closure systems
Understanding of USP, JP, and EU requirements for primary packaging components and regulatory requirements for integrity testing.
Knowledge in cGMP and design control to facilitate design and validation of combination products
Knowledge of extractables/leachable requirements for primary container with a clear understanding of Toxicological analysis.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Flexible Work Paths
Tuition reimbursement
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.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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.
