Primary duties of this position will include serving as a lead for various technical aspects of the QC areas. Position will provide both subject matter expertise as well as technical leadership on activities such as method related projects (ex. method transfers and validations), 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.
- 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 with supervisor.
- Operates under compliance requirements. May independently refer to or seek guidance on policies and practices.
- 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 FocusAreas:
- Product Testing: Requires knowledge and proficiency in the design, execution, and validation of analytical techniques used in the laboratory such as HPLC, SDS-PAGE and Capillary Electrophoresis with focus on large molecules. Ability to troubleshoot method performance and propose corrections is essential
- Raw Materials: Requires knowledge and proficiency in multiple analytical techniques required for raw materials testing and inspection including but not limited to HPLC, ICP-MS, Atomic Absorption, GC and Amino Acid Analysis.
- Technical Support: Area is focused on various technical projects in support of the GMP laboratories, such as automation support, method projects activities (ex. method transfer and validation support activities method remediation and troubleshooting, method monitoring), critical reagents and reference standard programs, global technical oversight program, cell bank adventitious agent safety testing.
- Stability: Area is focused on data analysis and trending of stability data, data reporting, coordination and planning of stability studies, involvement on quality events requiring stability input.
- 70% - Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer
- 20% - Organization support and project team participation; project management and may include managing people
- 10% - Evaluation of new technologies
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
- 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.
- Understandsbusiness, objectives and operations and how own activities fit within the company strategy.
- Applies knowledge of product development and biotech industry to decision making
- MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding
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.
- Writing typically requires revision.
- 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 supervisor, 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 to no travel expected. Travel between sites may be required.
The following physical abilities are required in order to fulfill the job duties:
- Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
- 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
- Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours
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.