Primary duties of this position will include serving as a lead for qualification, transfer, and validation of manufacturing-based methods, including cell counting methods, protein concentration determination methods, etc. This position will require subject matter expertise on method validation lifecycle activities as well as technical leadership on activities such as driving completion of method related projects (ex. method transfers and validations), technical writing, and frequent cross-functional interaction with manufacturing development, manufacturing, equipment validation, and QC teams.
Experience with bioburden and endotoxin methods is required, experience with microbial identification methods is preferred, as well as project management skills. The candidate will interact with multiple and often concurrent project teams of varying levels of experience in method validation; therefore, communication and consistency is key to success.
- 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.
70% of Time
- Qualification, method transfer and validation of manufacturing environment methods as well as the quality control Laboratory and authoring associated protocol/report documentation; presentations.
- Methods would include but not be limited to cell counting methods, Immuno assays and Separation technology.
20% of Time
- Organization support and project team participation; may include managing people
10% of Time
- 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 and hands-on expertise on microbiological assays, strong technical writing, and data analysis skills.
- Knowledge of regulatory guidelines, theories, principles and techniques of relevant scientific areas and basic understanding of industry practices and standards.
- Excellent communication, project management, interpersonal and organizational skills.
- Proactive at keeping current with literature and latest technologies.
- Ability to work well both independently and in a multi-department, collaborative team environment.
- Ability to prioritize work and multitask.
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.
- Understands Takeda 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 andproactively reaches out to others for perspective and guidance.
- MS Office, including Project, 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, creates and drives project plans, and prioritizes activities. May manage moderately complex projects and initiatives.
- Designs and independently performs studies to troubleshoot issues encountered during development, method transfer and validation.
- Provides input on experimentaldesign, method qualification,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. Writing typically requires revision.
- Presents issues and results at department and project team meetings. Presents at external meetings.
- 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 potentially externally in own area of expertise.
- Willact 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
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
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.