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Job Description
Job Title: Biologics Product Sciences Lead
Location: Lexington, MA (Hybrid)
About the role:
Member of the global team of product science experts responsible for product knowledge for Takeda's large and diverse commercial biologics portfolio
Acts as a senior subject matter expert across one or more products
Provides technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products
How you will contribute:
Provides strong understanding of product structure, quality, impurities, stability, and characterization as well as structure-function relationships
Responsible for providing rationale for the justification of specifications considering history of the method and the manufacturing process
Responsible for the content of analytical comparability protocols
Accountable for non GMP analytical methods
Accountable for one or more products in the portfolio
Accountable for continuity of these aspects across time and sites
Responsible for CMC sections in dossiers related to these aspects
Provide strong leadership and alignment for initiatives and investigations related to these aspects which are complex
Technical/Functional Expertise
Has a strong understanding of biologic product quality characteristics, associated methods used for product characterization and release
Has a good understanding of the impact of the manufacturing process on product quality
Has good understanding of product quality structure-function relationships
Leadership
Ability to influence within the organization to drive decisions, alignment, and conflict resolution for complex cross-functional issues
Being a mentor for developing future talent
Displays and drives Takeda culture of Patient, Trust, Reputation Business, 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
Responsibly escalates critical decisions in a timely manner to line management or the correct authorities within a project team, if input is required
Interaction
Is a member of the cross-functional CMC sub-team for each product they represent
Works with Pharmaceutical Sciences as needed for product characterization or structure function issues
Works with Global Manufacturing Sciences Quality on GMP method related issues
Innovation
Ensures product knowledge sharing across sites and functions for effective management of products
Complexity
Manages effectively with a matrix of reporting lines and across functional areas
Provides leadership to drive highly complex products that are multi-site in scope
What you bring to Takeda:
Education / experience
Degree in engineering or life sciences
BS with a minimum of 12 years experience, MS with a minimum of 10 years experience, or PhD with a minimum of 6 years experience with deep expertise in analytical methods and characterization for biologics
Experience with activities associated with commercial release as well as interactions with Health Authorities to support submissions
Experience operating globally in a matrixed organization highly preferred
Skills
Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
Communicates effectively and frequently with supervisor, line function and peers.
Successfully and succinctly conveys complex information in both written and oral forms.
Behaviors
Strategic enterprise thinking
Ability to prioritize activities without compromising on quality
Eagerness to learn and grow
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
Professional training and development opportunities
Tuition reimbursement
Important Considerations:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
Base Salary Range: $130,200 to $186,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. This posting excludes Colorado applicants.
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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.
