Quality Control Scientist I
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
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Quality Control Scientist IApply Now
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. Designs technical strategies with and regularly reports on progress in meeting objectives to supervisor.
- Understands and follows compliance requirements and independently refers to policies and practices for guidance.
- Effects of decisions are long-lasting and heavily influence the future course of the organization.
- Errors in judgment or failure to achieve results would result in the expenditure of large amounts of company resources.
- Project management, methods transfers, Validation of analytical techniques used in the laboratory such as HPLC, Capillary Electrophoresis, and other separation technologies.
- Ability to troubleshoot method performance and propose corrections is essential.
- 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.
- Provide SME support to all methods related to separating technologies. Area is focused on data analysis and data reporting.
Job Function and Description
- 70% of Time: Development, qualification, method transfer and validation of Separating technologies and authoring associated protocol/report documentation; presentations.
- 15% of Time: Organization support and project team participation.
- 10% of Time: May require some laboratory hands-on work
- 5% of Time: Evaluation of new technologies
- Minimum of BA/BS degree in relevant scientific discipline with a minimum of 6-8 years relevant industry experience.
- Technical and hands-on expertise on HPLC technologies, capillary electrophoresis, etc., strong technical writing and data analysis skills.
- Knowledge of ICH guidelines, 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.
- Understandsand appliesadvanced scientificprinciples,theories,concepts,practices and standardstoprocessand product development.
- Keepscurrentwith scientific knowledge in areasofexpertise.
- Providesinputtothedevelopmentofnewscientific 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, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding.
- Demonstratesindependentjudgmentintechnique andmethodselection, protocol and studydesignand execution,data analysisand use ofstandard practicesand procedures fora varietyofproblemsofmoderate scope andcomplexityto meetassigned objectives.
- Contributestosettingassignment objectives,plansand prioritizesactivities.
- May managemoderatelycomplexprojectsand initiatives.
- Designsandindependentlyperformsstudiesto troubleshootissuesencounteredduring development,method transfer and validation.
- Mayprovide inputon experimentaldesign,developmentandproject execution.
- Documentsandreviewsdata asper established companyguidelinesandSOPs.
- Authors documentssuchasprotocols,memos, datasummaries,reportsandproceduresand contributesto publicationsandrelevantCMC sectionsofregulatoryfilings.
- Writing typicallyrequiresrevision.
- Presentsissuesand resultsat department and projectteammeetings.
- Presentsat external meetingsor publishesin peer-reviewed journals.
- Undergeneraldirection, designsandimplementsscientificallysound and creative solutions toa varietyofproblemsofmoderatescope and complexityto support.
- 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
- Limitedto no travel expected.Travel between sites may be required.
Thefollowingphysical abilitiesare requiredin ordertofulfill thejobduties:
- Repetitive bending andreaching tosetup andbreak-down equipment(ifrequiredby specificactivity)
- Abilityto workaroundchemicals(ifworking around thelaboratories)
- Abilityto wearpersonalprotective equipmentsuch asgloves,gowning, and respiratory protection in somecases
- Abilityto walkand standforperiodsoftime
LocationsUSA - MA - Lexington - BIO OPS
Time TypeFull time
Job ID R0028169