Associate Director- API Process Science

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OBJECTIVES:

• The Associate Director, MSAT Synthetic Molecule API is responsible for managing technical issues relating to the global external manufacturing of commercial Drug Substance.  The focus for this position is to provide technical leadership within MSAT Synthetic Molecule, Drug Substance group for the management of specialty small molecules that are relevant to key therapeutics drug substance. 
• The individual will be directly responsible for commercial manufacturing of drug substance, process design, optimization, scale-up, technology transfer, validation and maintaining the Life-Cycle Management (LCM) of the product. 
• The individual will lead to resolve technical issues relating to a product line or major technical projects within MSAT Synthetic Molecule.  The individual will lead a small group (internal and external) of Technical Operations staff to manage technical programs and contract manufacturing organizations (CDMOs).
• Additionally, the candidate will provide technical leadership keeping patient safety and business requirements as a key attribute on individual key technical projects in support of Takeda products.

ACCOUNTABILITIES:

• Provide direct leadership for day-to-day technical activities for Takeda’s synthetic commercial drug substance manufacturing – i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation, process analytical tools, statistical analysis using software such as JMP etc.
• Must have working knowledge of phase appropriate CMC development throughout the drug development which includes understanding and implementation of “Process Performance Qualification (PPQ)/Validation”, LCM activities etc. strategies and protocol development and implementations.
• Lead and act as the primary interface on technical issues between MSAT Synthetic Molecule and third-party drug substance manufacturers and with Takeda’s quality (QA and QC), CMC regulatory, compliance, and supply chain group.
• Lead the exercise in the compilation and analysis of production data, such as IPC, release, DoE, and manufacturing process information relating to Takeda’s synthetic molecule product portfolio to improve the quality and ROIs on the projects.
• Lead discussions on the presentation in multi-disciplinary meetings (QA, QC, CMC RA, Drug Product, compliance) of manufacturing data summary to improve manufacturing efficiency.
• Must have the knowledge and phase appropriate implementation strategies of QbD during Life-cycle management of the product.
• Must have knowledge and understanding of current ICH guidelines and related industry practices such as ISO etc.
• Author pertinent SOP’s and manufacturing process instructions.
• Direct and provide technical leadership on Change Controls, investigations, and CAPAs.  This would include writing the appropriate justifications to close out any investigation(s) and CAPAs implementation both internally and externally.
• Lead critical technical projects relating to the manufacturing of Takeda commercial MSAT Synthetic Molecule drug substance.

• Author and review relevant dossier sections (Module 3) related to commercial manufacturing submissions and relevant process knowledge documentations.
• Identify, and test, strategies to reduce manufacturing risks and maintain the product Life-cycle management.

• Manage/Supervise interns, contractors and FTE’s, as appropriate.

SCOPE OF SUPERVISION:

NUMBER SUPERVISED WORKERS

Direct: Employees: 0

In-Direct: Non-Employees: 1-2

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• The candidate should have an MS in chemistry, chemical engineering, pharmaceutical engineering or other scientific discipline and 5-10 years of experience or PhD with 5+ year’s experience working in commercial pharmaceutical/chemical industry for synthetic drug substance.
• The ideal candidate should have had direct management experience with external Contract Manufacturing Organizations.
• The candidate should have a good working knowledge of cGMP manufacturing operations, and/or drug substance manufacturing with experience with small molecules, preferred.
• The preferred candidate will also have a background in QA or other industry relevant background. The candidate needs to have working knowledge of CMC regulations, cGMP, and ICH guidance lines.
• The candidate should have working knowledge of process qualification for “Accelerated” and “Breakthrough designation” programs.
• The candidate should have an advanced knowledge of Excel as well as other Microsoft Office suite software. Other analytical software usage such as JMP or MATLAB is also preferred.
• The candidate should have working knowledge and understanding of DoE and QbD etc.
• The candidate should have demonstrated written and oral communication skills and ability to work in a cross functional team environment.

LICENSES/CERTIFICATIONS: N/A

PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).

• Office work

• Computer use

• Airline travel

TRAVEL REQUIREMENTS:

Ability to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

Position requires up to 5-20% domestic and international travel.

Base Salary Range:

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.

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