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Job Description

The API Manufacturing Science & Technology (API MST) department provides technical solution to support Small Molecules and Oncology Operating Unit (SMO OpU). This is a technical role in a rapidly growing pharmaceutical company where we use an outsourcing model for some of our manufacturing and testing activities. Products supported are primarily complex synthetic molecules.

About the role:

As Sr. Principal Scientist, you will be the primary technical point of contact for the API SMO OpU with external Contract Manufacturing Organizations (CMOs). The main role will be to provide scientific and technical expertise for all drug substance related activities, ensuring that new and existing drug substance technology and related processes, procedures and specifications are transferred to our CMOs in a manner compliant with all regulatory and quality standards and to support cost-effective technical processes suitable for robust commercial production.

How you will contribute:

• New product introduction, New Chemical Entity process validation and CPV.

• Technology selection and acquisition.

• Process design, development, optimization and verification.

• Technology transfer.

• Continuous improvement.

• Change Management.

• Technical support and oversight of commercial API manufacturing.

• Define capabilities required at the CMOs to successfully support new product introduction.

• Assess gaps in capabilities and implement plans to build required capabilities at the CMOs to support technology transfer.

• Partner with Pharmaceutical Sciences (PS) and Global Manufacturing Sciences (GMSci) in late-stage process development with technology selection, process design and optimization.

• Design, develop and optimize product manufacturing processes using robust DoE and QbD principles.

• Implement right first time (RFT) Technology Transfers and manage commercial API manufacturing to meet business needs ensuring timing, quantity, quality, costs and regulatory requirements.

• Define and implement process, equipment and scale related critical process parameters.  Assess the risk levels for scale up and equipment changes to enable supply chain flexibility.

• Author, review and approve relevant technical documentation, protocols, reports and regulatory submissions including Process risk and safety Assessment, Technology transfer plan, Validation master plan etc.

• Assure proposed vendors are capable of passing regulatory inspections by the FDA and other government regulatory agencies.  Support regulatory inspections and audits. 

• Author and review regulatory documents for technical consistency and compliance for NDA and DMF. Provide responses to technical queries from the agencies.

• Lead, prioritize and drive deviation investigations and RCAs using standardized approaches. Ensure the necessary CAPAs are implemented at the CMOs.  Raise and manage change controls.

• Develop and maintain technical product knowledge database and technical documents for assigned products.  Dissect and interpret data from various sources, using the information to create scientific reports. 

• Build and maintain robust relationships with regulators, CMOs, CROs and Key Opinion Leaders in their respective technical field.

• Stay abreast of the relevant cGMP, ICH and global Regulatory CMC guidance documents.

• Communicate successfully to present complex scientific information and develop credible relationships with a broad spectrum of people, including CMO’s, Vendors / Suppliers and Colleagues.

• Interact internally in person or remotely with individuals from Product Strategy, Quality, Compliance, External Supply Management, PS, GMSci, Regulatory Affairs and SMO OpU.

• Interact externally in person or remotely with key Suppliers, CMOs, Equipment Manufacturers, Consultant Groups, Regulators and Scientific Experts.

• Serve as an effective project team member and inspirational leader.  In this capacity should be able to effectively communicate with cross-functional team members as well as stake holders.

• Be Positive, Be Accountable, Be Results Oriented and Be an Excellent Manager of Self and others. 

• Demonstrated ability to anticipate and address conflicts or issues in a timely manner that support long term success of the organization. 

• Work across boundaries to establish common purpose and goals to deliver value to the business.

• Work independently and make decisions quickly to support an agile organization.

What you bring to Takeda:

• PhD in Organic Chemistry or Chemical Engineering with 10+ years or MS with 15+ years industry experience.

• Hands-on experience in API process development, optimization and validation. 

• Direct experience in technology transfer and in supporting API manufacturing. Proven record for commercial process problem solving. 

• Strong knowledge of synthetic organic chemistry and modern analytical methods. Experience in global product launches and the associated CMC regulatory requirements.

• In-depth knowledge of QbD, technology transfer, process development, scale up, optimization, DoE, PAT and risk assessment.

• Strong knowledge of cGMP/GLP regulations, ICH and FDA CMC Guidance Documents.  Knowledge of DEA Regulations is preferred.

• Strong technical, interpersonal, communication and leadership skills.

• Up to 20% domestic and international travel required.

Desired

• Project Management Experience.

• Six Sigma Certification.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$174,500.00 - $274,230.00

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, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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