Job Summary/Operations Involvement:
Primary duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies. Testing may include but not limited to samples from in process, drug substance/product and various protocol studies using analytical test methods derived from non-compendial sources. The position is expected to maintain operational and GMP readiness of the QC area. In addition, the individual will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and various quality systems (deviations, change controls, investigations) with little to no supervision, and maybe asked to take lead roles for the QC organization on these projects. Position is expected to act as a role model for junior staff in the various QC areas.
- Work is performed under general direction with little to no supervision.
- Participates in determining objectives of assignments.
- Plan schedules and arranges own activities in accomplishing objectives.
- Work may be reviewed upon completion for adequacy in meeting objectives
- 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 HPLC Focus Areas:
- Role is responsible for HPLC laboratories performing a broad range of analytical based techniques such as SE-HPLC, RP-HPLC, IEX, CE-SDS, glycan and peptide analyses in order to support in-process, release and stability testing.
- Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation.
- Introduction of new equipment and technology to improve sustainability and compliance is expected.
- Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
Specific QC Focus Area:
- Product testing: Areas of focus on techniques such as HPLC and SDS-PAGE for purity, identity, potency and charged heterogeneity.
- Perform and troubleshoot HPLC based assays (SE-HPLC, IEX, RP-HPLC, CE-SDS, Peptide Mapping, and Glycan Mapping) of release and stability
- Review QC analytical assays
- Execute and lead method qualification and validation assays as needed
- Perform and lead OOT, OOS, GMP Investigations, data analysis, deviation and data trending
- Maintain GMP condition of the lab
- 30-40%: Testing execution, participate in training analysts, trouble shooting of methods
- 40-60%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
- 20-30%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
- Receives assignments in the form of objectives and establishes goals to meet objectives.
- Provides guidance to subordinates to achieve goals in accordance with established policies.
- Work is reviewed and measured based on meeting objectives and schedules.
- Establishes and recommends changes to policies which effect subordinate organizations.
Education and Experience Requirements
- Typically a bachelor s degree and a minimum of 5+ years of related experience. (science related degree is preferred)
- Excellent communication, interpersonal and organizational skills.
- Ability to work well both independently and in a team environment.
- Ability to prioritize work and multitask.
- Previous experience in a GMP QC role is preferred.
- 5S/OE experience.
- Method transfers/validation
Key Skills, Abilities, and Competencies
- Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices. Position requires critical thinking.
- Key Skills: MS Office, LIMS, SAP, Trackwise, Waters Empower, Thermo Fisher Chromeleon, EDMS, compliance and strong science understanding.
Complexity and Problem Solving
- Develop solutions to a variety of complex problems.
- May refer to established precedents and policies.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
- Networks with senior internal and external personnel in own area of expertise.
Internal and External Contacts
- Represents organization as a prime contact on contracts or projects.
- Interacts with senior internal and external personnel on significant matters often requiring coordination between organization.
- Contacts external to QC may include: Analytical Development, R&D, Quality Assurance and other Quality functions, Regulatory , Manufacturing, Facilities and Engineering
Other Job Requirements
- Limited to no travel expected. Travel between sites is 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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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.