Shire Quality Control Senior Analyst - Bioassay in Lexington, Massachusetts
Provide a brief summary describing the major role, responsibilities and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable.
This position focuses on the daily lab operations and execution of testing to support manufacturing operations, validation, or development studies. Testing typically includes samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods. The role may also provide support for sample control activities, and on-call responsibility for critical temperature units.
This position requires competent understanding and ability to perform techniques such as cell-based assays, ELISAs, gels and westerns.
This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business-appropriate quantities. Based on the level of this position, the individual is expected to participate in more complex projects including new product introduction, operational excellence initiatives, and various quality systems (deviations, change controls) with limited supervision.
Testing Execution: 30-40%
Method transfer, validation and other quality projects: 10-30%
Operations Support – including data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary): 30-40%
Compliance and Quality Systems – including document revisions, participation on investigation teams, input to quality systems (change control, CAPA, deviations): 10-20%
Other – Participate in training analysts, troubleshoot test methods: 20-30%
Works under limited supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
Contributes to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
Education & Experience Requirements
- Minimum of a bachelor’s degree in a scientific discipline and 7-10 years related experience in a Biotech environment, esp. Quality Control laboratory preferred.
Knowledge of cGMPs/GDPs
Knowledge of quality systems
Experience with LIMS systems
Experience with PLA (Parallel Line Analysis)
Experience with Softmax Pro Gxp
Experience or training in continuous improvement/operational excellence
Key Skills and Competencies
- Living our leadership behaviors is a basic expectation for all employees. All employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
Excellent communication, interpersonal and organizational skills.
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
Other Job Components
Complexity and Problem Solving
Solve routine problems of limited scope and complexity following established policies and procedures.
Works on problems of limited scope.
Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Builds stable working relationships internally.
Internal and External Contacts
The role is directly accountable to the QC Bioassay Team Lead or Manager
Key internal partners include the personnel in the HPLC, Biochemistry, Cell Biology, and Raw Materials groups in Lexington, Assay Development teams, and personnel in the global Quality Control organization
External: interacting with vendors as needed
Routine travel is not expected, but periodic opportunities for training and development may require limited travel.
The following physical abilities are required in order to fulfill the job duties:
Repetitive bending and reaching to setup and break-down equipment
Ability to work around chemicals
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
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.
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.