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Analytical Sciences Fellow, Small Molecule

Lexington, Massachusetts

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Analytical Sciences Fellow, Small Molecule

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Job ID R0028627 Date posted 03/25/2021 Location Lexington, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Analytical Sciences Fellow in our Lexington, MA office.

Here, you will be a vital contributor to ourinspiring, bold mission.

As an Analytical Science Fellow on the Analytical Sciences Quality Small Molecule Team you will:

  • Provide strategic cohesive oversight and leadership to the analytical methods, analytical method transfer, and testing aspects for Takeda´s small molecule commercial product portfolio.
  • Provide strategic direction through method performance monitoring across sites, analytical method lifecycle management and method reviews to drive compliance and improve method performance.
  • Provide leadership in support of analytical troubleshooting and remediation projects as and when needed.
  • Ensure compliance with all applicable GMP regulations globally.
  • Mentor team members and colleagues to resolve complex problems, provide training as needed in analytical methodology, troubleshooting and regulatory strategy.

In this role, you will contribute to Takeda’s mission by:

  • Serving as an analytical single point of contact (SPOC) with internal and external stakeholders for assigned small molecules products
  • Developing and owning analytical method life cycle management (LCM) strategy and process tailored to each commercial small molecule product
  • Developing and owning process and strategy for analytical method transfer and comparability studies
  • Designing rational analytical control strategy and implementing analytical risk mitigation plans in accordance with QbD principles
  • Providing analytical technical guidance regarding complex analytical issues to internal and external QC labs, and manufacturing sites by investigating and resolving complex analytical troubleshooting, deviations, and investigation (Rapid Response).
  • Actively contributing to the preparation of internal audits and regulatory inspections (on-site).
  • Providing regulatory support for analytical methods and related aspects, which includes providing analytical submission content strategy, analytical content authoring and review as needed. 
  • Considering all relevant aspects and understanding the impact and ramifications to all areas of Supply Chain (not just the technical area) so that decisions, solutions, and actions meet the technical requirements but also meets the needs of patients, GMP regulations, supply chain and the business.
  • Participate and represent Takeda in key industry Quality forums (i.e. PQRI) to benefit patients by influencing, leading, and collaborating with key academia, industry and regulatory groups.

REQUIRED QUALIFICATIONS

TECHNICAL EXPERTISE

  • Deep and broad expertise in Analytical Chemistry in support of small molecule products, including raw materials, intermediates, drug substances and drug product testing.
  • Knowledge and expertise in all or some of the following analytical technologies:  separation technologies (HPLC, GC, Chiral, etc), dissolution, spectroscopy (NMR, IR, MS, UV, Ramen etc.), impurity/degradant characterizations, solid state characterization (XRPD, SEM, etc.), powder and particulate characterization (PSD), compendial methods.
  • Knowledge of CMC aspects of regulatory filings.  Ability to author relevant analytical sections.
  • Provides technical expertise to optimize and improve workstream with stakeholders (i.e. AD, GMS, OpUs, etc). Build analytical capabilities within internal departments as needed.
  • Lead and deliver successful Technology Transfer activities across the CMO and internal network. 
  • Evaluate analytical method validation status and robustness of methods from development through transition to commercial status.
  • Provide analytical evaluation and impact/risk assessment for proposed changes to API, raw materials, manufacturing processes, specifications, and methods.
  • Implement risk mitigation plans proactively for analytical test methods associated with in-process control, release, and stability testing.
  • Provides direct global analytical technical oversight for commercial small molecules products and coordination of compendial and non-compendial analytical testing for CTLs, CMOs and QC testing labs.
  • Serve as an in-house analytical/technical expert for troubleshooting and investigating laboratory issues.
  • Learn, enhance, and manage technical knowledge for assigned products, creating scientific reports that when compiled represent a comprehensive body of product knowledge.

LEADERSHIP AND COLLABORATION

  • Create and enhance collaborative and trusting relationships internally and externally (CMO, CTL, CRO).  Facilitate communication between departments, including meeting facilitation, progress tracking, and communications to leadership.
  • Own and/or lead assigned projects. Ensure timely delivery on budget, with high quality, and to customer satisfaction.
  • Effectively articulates technical issues to management and non-technical stakeholders.
  • Take ownership of analytical issues and drive closure quickly, correctly, and permanently for commercial products.
  • Build and maintain a network of robust relationships with Analytical Experts, Regulators, Suppliers, Contract Research Organizations, Contract Manufacturing Organizations, and Key Opinion Leaders in the pharmaceutical industry.

DECISION-MAKING AND AUTONOMY

  • Determines the most appropriate course of action including technique and method selection, protocol and study design and execution, in-depth data analysis, factor evaluation and use of established practices and procedures for a variety of problems of broad scope and complexity, in alignment with organizational objectives and management oversight.
  • Ensure timelines for various responsibilities and tasks are met. If needed, implement corrective actions to overcome significant obstacles or adverse events to get back on track.
  • Monitors all operations and project-related activities and reacts as needed to ensure timely delivery of goals and to meet KPIs.
  • Actively engage in professional industry forums with an eye towards staying current.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • Ph.D. with a minimum of 8 years industry or BS, MS with a minimum of 12 years industry
  • Experience with Lean / Six Sigma methodologies preferred.

CORE COMPETENCIES/SKILLS

  • High level, a highly-skilled analytical professional with proven ability to influence, negotiate, drive change, and ultimately deliver results.
  • Relevant project management experience required.
  • Exceptional problem solving and troubleshooting skills related to analytical methodology (and relevant correlations to manufacturing processes). Anticipates and removes obstacles so teams can deliver results and succeed.
  • Strong verbal & written communication skills (including presentation skills). Can effectively articulate complex technical issues to a non-technical audience.
  • Ability to work well across boundaries, both independently and in a team environment; Ability to prioritize work and multitask.
  • Full understanding of relevant cGMPs, ICH and other global regulatory CMC guidance documents applicable to the manufacturing and testing of commercial products.
  • Foster and demonstrate a culture of learning, ‘positive’ thinking, and leadership (vision, strategy and business alignment, people management, communication, influencing others, managing change).

ADDITIONAL INFORMATION

  • Some travel is required (both domestic and international) with varying demands dependent on the number and criticality of projects and/or technical issues.
  • Expected range is 10% - 30%.

This job posting excludes CO applicants.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0028627
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