Senior Manager, Commercial Biologics Product Science Lead
- Build and maintain a comprehensive understanding of product structure, critical quality attributes, impurities, stability and structure-function relationships.
- Define and justify product specifications using process and analytical history, ensuring consistency across sites and over the product lifecycle.
- Design and own analytical comparability strategies and non‑GMP analytical methods for assigned products.
- Lead preparation and review of CMC dossier sections related to product quality, characterization and analytical control strategy.
- Provide technical leadership for complex investigations and cross-site initiatives affecting product quality, driving alignment and timely decision-making.
- Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical Sciences, Global Manufacturing Sciences and Quality.
- Ensure effective product knowledge sharing across sites and functions to support reliable commercial supply.
- Influence stakeholders across functions and regions to resolve complex issues, balancing patient, quality, business and regulatory considerations.
- Mentor colleagues and contribute to the development of future talent in biologics product sciences.
- Degree in Engineering, Life Sciences, or closely related area
- B.Sc. with a minimum of 10 years of experience in a pharma/biotech environment; an advanced degree (M.Sc. or PhD) is preferred.
- Deep expertise in analytical methods and characterization for biologics with capability and interest in analyzing and solving complex problems through innovative thought and experience.
- Experience with activities associated with commercial launch and release as well as interactions with Health Authorities to support submissions.
- Experience operating globally in a matrixed organization would be greatly appreciated.
- Clear, concise communication skills, with the ability to convey complex concepts in writing and in person to technical and non-technical audiences.
- Fluent English required; proficiency in verbal and written Mandarin is beneficial but not required.
- Demonstrated enterprise mindset, strong prioritization and quality focus.
Lexington, MA U.S. Base Salary Range:
$137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 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. Locations Lexington, MAVienna, Austria Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt
Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Recommended Jobs
Cook Full Time - DoubleTree by Hilton Boston Bayside
A Cook is responsible for preparing food items in accordance with recipes and established standards in the hotel's continuing effort to deliver outstanding service and financial profitability. T…
Director - Genetic Toxicology Expert
Summary #LI-Hybrid Position can be based in the US (Cambridge, MA or Emeryville, CA). Are you passionate about advancing pharmaceutical research and ensuring drug safety at Novartis? …
Radiation Therapist - Weekly Pay
We are seeking a dedicated Radiation Therapist in Worcester, MA, offering $2,751/week. Responsibilities Include Administering radiation treatments accurately following prescribed protocols Op…
Veterinary Dermatologist
is seeking a full-time small animal dermatologist to join our 24/7 Emergency, General Practice and Specialty referral hospital in Lawrence, MA. Located north of Boston, Bulger offers a highly tea…
Data Engineer
SoHo Dragon represents a tech-driven, AI-native pharmaceutical company that’s shaping the future of healthcare. We’re looking for a mid-to-senior-level Data Engineer to play a key role in building an…
Onboarding Consultant
FuturePlan is the nation’s largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch personalized …
Software Engineer - Mobile
Intro to Folia Measure what matters. Nell and Dan founded Folia Health because it has been simply too hard for their family members to receive personalized, data-driven healthcare that dire…
K-1 Tax Operations Specialist
K-1 Tax Operations Specialist We’re hiring a K-1 Tax Operations Specialist to support our growing tax documentation process across multiple investment partnerships. This role is critical for kee…
Caring for seniors in their home in Lee
Come join our team and become a part of making a difference in someone's life! Caregiving is a significant responsibility that becomes more challenging as people age. Their needs tend to grow over…
Medical Assistant - Dermatology
Boston Medical Center (BMC) is more than a hospital. It's a network of support and care that touches the lives of hundreds of thousands of people in need each year. It is the largest and busiest prov…