Senior Analytical Method Lead (Analytical Sciences-Small Molecule)
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Sr. Analytical Method Lead in our Lexington, MA or Vienna, Austria office.
As a Sr. Analytical Method Lead 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 forTakeda´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.
- Provide leadership in support of analytical troubleshooting and remediation projects as and when needed.
- Ensure compliance to all applicable GMP regulations globally.
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.
REQUIRED QUALIFICATIONS - TECHNICAL EXPERTISE
- Provides technical expertise to optimize and improve work stream 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 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.
REQUIRED QUALIFICATIONS - 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.
REQUIRED QUALIFICATIONS - DECISION-MAKING AND AUTONOMY
- Determines 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
- PhD with minimum of 4 years industry or BS, MS with minimum of 6 years industry
- Experience with Lean / Six Sigma methodologies preferred.
- High level, highly skilled analytical professional with proven ability to influence, negotiate, drive change, and ultimately deliver results.
- Relevant experience with small molecule 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). 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 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.
- Forster and demonstrate culture of learning, ‘positive’ thinking, and leadership (vision, strategy and business alignment, people management, communication, influencing others, managing change).
- Some travel is required (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.
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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.