Analytical Sciences Fellow AS Biologics

Takeda in Lexington, MA

  • Type: Full Time
position filled

Analytical Sciences Fellow AS Biologics

  • OBJECTIVES/PURPOSE Provides strategic cohesive oversight, direction, and leadership to the analytical methods, analytical method transfer, and testing aspects for Takeda´s Biologics commercial product portfolio.Provides strategic direction through method performance monitoring across sites, analytical method lifecycle management and method reviews to drive compliance and innovation.Provides leadership in support of analytical troubleshooting and remediation projects as and when needed.
  • ACCOUNTABILITIES Serve as an analytical single point of contact (SPOC) with internal and external stakeholders per commercial biologics productDevelop and own analytical method life cycle management (LCM) strategy and process tailored to each commercial biologics productDevelop and own process and strategy for analytical method transfer and comparability studiesDesigns a rational analytical control strategy and implement analytical risk mitigation plans in accordance with QbD principlesProvide 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)Reduce number of rapid response incidents by proactively mitigating risks associated with test methods and IPCWork cross functionally to continuously improve the process capability and supply chain resiliency for the products within their biologics portfolio.Actively contribute to the preparation of internal audits and regulatory inspections (on-site)Create and enhance collaborative and trusting relationships internally and externallyBuild analytical capabilities into local departments as neededProvide regulatory support for analytical methods and related aspects, which includes providing analytical submission content strategy, analytical content authoring and review as needed, analytical sections for RtQs and MoH interaction and support.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 groupsDrive innovation and continuous improvement
  • DIMENSIONS AND ASPECTS Serve as a analytical single point of contact (SPOC) with internal and external stakeholders per commercial biologics productProvides technical expertise to optimize and improve work stream with stakeholders (i.e. AD, GMS, OpUs etc).Evaluate analytical method validation status and robustness of methods during development and commercial transition status.Leverage fundamental understanding of formulations, product development, API and raw material characterization, and manufacturing processes to anticipate impact to analytical applications / testing methodologies.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 testingProvides direct global analytical technical oversight for commercial biologics products and coordination of compendial and non-compendial analytical testing for CTLs, CMOs and QC testing labs (HPLC, SDS-PAGE, capillary electrophoresis, immunoassays, potency, bioassays, wet chemistry, compendial testing, Raman, NIR, titration assays, cell based assays, ICP-MS, etc)Apply statistical analysis for data interpretation and apply chemometric principles to resolve complex analytical issues and applications.Serve as in-house analytical / technical expert for troubleshooting and investigating laboratory issuesLearn, Enhance, and manage technical knowledge for assigned and future products. Dissect and interpret data from various sources, using that information to create scientific reports that when compiled represent a comprehensive body of product knowledge.Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. Expected to escalate issues as appropriate in a timely fashion.Leverage knowledge and experience with Lean / Six Sigma methodologies to improve methods, processes, and systems.
  • Leadership With exceptional communication and stakeholder management, serve as owner and/or leader to manage assigned projects. Ensure timely delivery on budget, with high quality, and to customer satisfaction.Effectively articulate complex technical issues to management and non-technical stakeholders.Facilitate communication between departments, including meeting facilitation, progress tracking, and communications to leadership.Serve as a team leader and peer-leader to motivate / inspire colleagues and to mentor others in various aspects of leadership skills, soft skills, analytical methodologies, technical problem-solving, process improvements, and effective project management.Provides leadership for regulatory response strategy development, submission authoring and Regulatory support for IND, IMPD, BLA, MPA, RtQTake ownership of analytical issues and drive closure quickly, correctly, and permanently for commercial products.Learn continually, and share personal development goals and progresses with manager, peers and other stakeholders to inspire others and lead by examples
  • Decision-making and Autonomy Exercises independent judgment to determine 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.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 takes action as needed to ensure timely delivery of goals and to meet KPIsActively engage in professional industry forums with an eye towards staying current.
  • Interaction Create and enhance collaborative and trusting relationships internally and with 3rd party contract research and manufacturing personnel.Provide analytical technical management of critical CMOs and CTLs in collaboration with alliance partners. Conducts briefings and technical meetings for top management and customer representatives. Interacts with equivalent level managers concerning matters of significance to the company.Frequently presents challenging issues and results at department and cross-functional gatherings, and project team meetings. May act as organizational representative and present at external meetings or publishes in peer-reviewed journals.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.
  • Innovation Exemplifies and champions critical thinking in identifying and implementing highly innovative and effective solutions and strategies and leveraging established practices and procedures for a broad range of problems of diverse scope and complexity to sustain company products, objectives and priorities.Designs and implements scientifically sound, creative and innovative solutions to a variety of problems of broad scope and complexity to support company products in alignment with organizational objectives.
  • Complexity Prioritize and drive complex investigations to closure using standardized and effective techniques.Provide effective communications and presentations on complex technical subjects.Define problems and draw conclusions or provide recommendations based on limited data, as it relates to technical, regulatory/compliance and operational issuesConsiders all relevant aspects and understands the impact and ramifications to all areas of Supply Chain (and not just the technical area) so that decisions, solutions, and actions meet the technical requirements but also meets the needs of patients, supply chain and the business.
  • Education / experience
  • PhD with minimum of 10 yrs industry or BS, MS with minimum of 15 yrs industry
  • Core Competencies / Skills Experienced at leading and delivering successful Technology Transfer activities across the CMO and internal network.Relevant experience with pharmaceutical pipeline products and CMC aspects of regulatory filings.Deep and broad expertise in Analytical Chemistry in support of raw materials, intermediates, drug substances and drug product testing.Exceptional problem solving and troubleshooting skills related to analytical methodology (and relevant correlations to manufacturing processes). Proven expertise in problem-solving methodologies and able to mentor others in the use of effective methodologies.Strong verbal & written communication skills (including presentation skills). Can effectively articulate complex technical issues to non-technical audience. Proven ability to clearly articulate technical issues concisely and deliver effective presentations on complex technical subjects.Ability to work well both independently and in a team environment.Ability to prioritize work and multitask.Conducts work in compliance with cGMPs, safety and regulatory requirements.High level, highly skilled analytical professional with proven ability to influence, negotiate, drive change, and ultimately deliver results.Full understanding of relevant cGMPs, ICH and other global regulatory CMC guidance documents applicable to the manufacturing and testing of commercial products.
  • Behaviors Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trustCreating the environment that inspires and enables peopleFocusing on the few priorities and provide superior resultsElevating capabilities for now and the futureCreates the climate for others to act decisively by clarifying roles and responsibilities and limits of decision-making.Represents the needs of multiple customers in Takeda decision-making and planning.Demonstrated success in technical proficiency, scientific creativity / innovation, and independent judgment. Thinks broadly, identifies opportunities and develops solutions with impact beyond their immediate role/function.Works across boundaries to establish common purpose to deliver value to patients and the business.Anticipates and removes obstacles so teams can deliver results and succeed.Forster and demonstrate culture of learning, ‘positive’ thinking, and leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
  • ADDITIONAL INFORMATION Some travel is expected (both domestic and international) with varying demand dependent on number and criticality of projects and/or technical issues.Expected range is 10% - 30%.
  • Notice to Employment / Recruitment Agents:

    Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

    Equal Employment Opportunity

    Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

    EEO is the Law -

    EEO is the Law – Supplement -

    Pay Transparency Policy -

    Reasonable Accommodations

    Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

    Job ID SR0045320

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