Shire Global QCTS Scientist in Lexington, Massachusetts

Primary Role:

Primary duties of this position will include serving as a lead for the Global Quality Control Technical Support Critical Reagents (CR) & Reference Standards (RS) subteam based in Lexington. Position will provide both subject matter expertise as well as technical leadership on activities such as CR and RS projects (ex. Qualification, CR and RS production, inventory management), investigations, quality events, data analysis and trending, key program oversight (ex. reference standard program), and cross-functional interaction on various teams to enable appropriate overall QC support on projects and programs, as well as external coordination to contract organizations. Position will also assist in managing departmental and/or cross-functional teams occasionally.

Discretion/Latitude:

  • Works autonomously and receives general instructions on new assignments.

  • Proposes technical strategies and frequently discusses soundness of technical judgment and reviews progress in meeting objectives and timelines as a supervisor.

  • Operates under compliance requirements. May independently refer to or seek guidance on policies and practices.

Impact:

Exerts some influence on the overall objectives and long-range goals of the organization. Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.

Specific QC Focus Areas:

  • Technical Support:

  • Area is focused on various global technical projects in support of the GMP laboratories, such as critical reagents and reference standard program management (ex. procurement, qualification, release, inventory management, distribution, monitoring), CR&RS manufacturing , monitoring and trending, authoring of submission content related to CR &RS, projects activities and management .

Responsibilities:

50 % of Time: Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer

40% of Time: Organization support and project team participation; may include managing people

10% of Time: Continuous improvement, strategy development for CR&RS Lexington subteam

Education and Experience Requirements

BA/BS in relevant scientific discipline with a minimum of 8 years relevant industry experience.

Additional Specific Experience:

  • Technical expert in one or more analytical technologies.

  • Knowledge of theories, principles and techniques of relevant scientific areas and basic understanding of industry practices and standards.

  • Excellent communication, interpersonal and organizational skills.

  • Proactive at keeping current with literature and latest technologies.

  • 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.

Key Skills, Abilities, and Competencies

Knowledge:

  • Understands and applies advanced scientific principles, theories, concepts, practices and standards to process and product development. Keeps current with scientific knowledge in areas of expertise. Provides input to the development of new scientific knowledge.

  • Stands accountable and systematically operates with the desired outcomes in mind to consistently deliver high quality results for work assignments and personal objectives.

  • Effectively plans activities and anticipates difficulties in delivering results.

  • Nurtures network built on trust and respect beyond immediate circle of established relationships. Gains quick access to relevant parties and information using effective communication.

  • Addresses partners’ business issues and concerns beyond immediate needs. Assimilates different points of view to enhance collaboration. Is an active and reliable team player.

  • Actively seeks ways to improve current systems and processes related to own activities.

  • Maintains focus and professionalism amongst frequently changing situations, circumstances and priorities.

  • Proactively and systematically seeks and applies best practices for problem-solving and gap identification beyond one’s comfort level. Expands problem-solving abilities by assimilating new effective approaches.

  • Understands Shire’s business, objectives and operations and how own activities fit within the company strategy.

  • Applies knowledge of product development and biotech industry to decision making and proactively reaches out to others for perspective and guidance.

Key Skills:

MS Office, Minitab or equivalent, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding, statistical basics

Complexity and Problem Solving

  • Demonstrates independent judgment in technique and method selection, protocol and study design and execution, data analysis and use of standard practices and procedures for a variety of problems of moderate scope and complexity to meet assigned objectives.

  • Contributes to setting assignment objectives, plans and prioritizes activities. May manage moderately complex projects and initiatives.

  • Designs and independently performs studies to troubleshoot issues encountered during development, or GMP manufacturing.

  • May provide input on product design, development and project execution.

  • Documents and reviews data as per established company guidelines and SOPs. Authors documents such as protocols, memos, data summaries, reports and procedures and contributes to publications and relevant CMC sections of regulatory filings.

  • Presents issues and results at department and project team meetings. Presents at external meetings or publishes in peer-reviewed journals.

  • Under general direction, designs and implements scientifically sound and creative solutions to a variety of problems of moderate scope and complexity to support company products.

  • Supports overall department strategy within area of expertise.

Internal and External Contacts

  • Communicates effectively and frequently with manager, line function, peers and direct reports. Successfully conveys complex information in both written and oral forms.

  • Networks internally and externally in own area of expertise.

  • May act as departmental project team leader and interdepartmental project team participant.

  • May act as team or project representative on external collaborations and with contract laboratories.

Other Job Requirements

Limited travel expected. Travel between sites is required.

The following physical abilities are required in order to fulfill the job duties:

  • Ability to work around chemicals (if working around the laboratories)

  • Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases

  • Ability to walk and stand for periods of time

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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, 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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Reasonable Accommodations

Shire 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.