Scientist CMC
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Job Location:
Lexington, KY - USA
Yearly Salary:
$ 111800 - 191600
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
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Job Description
Pursuant to Section 20 C.F.R. 656.10 you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas Inc. for the following job opportunity:
JOB LOCATION: Lexington MA
POSITION: Scientist CMC
POSITION DESCRIPTION: Takeda Development Center Americas Inc. is seeking a Scientist CMC with the following duties: Coordinate with cross-functional teams in the execution of studies for multi-department stakeholders with a focus on project and study management as well as communication that contributes to CMC activities; prepare coordinate and execute fit-for-purpose method qualifications contributing to the CMC sections of regulatory documents; lead communications that go to project representatives on a studys status; execute liquid chromatography (LC) capillary electrophoresis (CE) and plate-based assays for studies that related to in-use compatibility product stability and product characterization; provide mentorship to junior team members with a focus on scientific and technical skills associated with assays which are utilized for the release and stability of biologics; work in alignment with project timelines and deliverables for the planning and execution of project studies; plan and execute fit-for-purpose method qualifications for various biochemical impurities and binding methods; establish communication plans for the coordination of in-house testing studies within AD-US and cross-functional teams; plan and implement resolutions to technical and logistical problems; review interpret and communicate data internally and cross-functionally; support the technical troubleshooting of LC CE-based and plate-based assays; build and maintain relationships with key stakeholders within AD-US and other functional teams; influence project strategy by communicating important issues and positions regarding technical study design; and independently design and execute experiments to produce a summary of results.
The estimated salary range reflects an anticipated range for this position. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.
REQUIREMENTS: Masters degree in Science Biochemistry Pharmaceutical Science or related field plus 2 years of related experience. Prior experience must include: Lead 7 direct reports provided administrative and technical assistance (training and mentorship) to them; Achieve training in Good Manufacturing Practices (GMP) to perform testing of in process drug substance and drug product samples in a quality control laboratory; Train on ELISA based techniques SDS-PAGE (Silver and Coomassie stain) SEC RP CEX Polysorbate 20 detection CE-SDS (PA800) IEF CGE residual DNA (qPCR) Western Blot and UV Vis Spectrophotometer; Analyze adaptive responses of to multiple RND efflux pump knockouts. Create individual knock-out mutants of minor efflux pump MuxABC-OpmB in different genetic backgrounds and identified its contribution to the physiology and antibiotic resistance of P. aeruginosa by drug susceptibility assays and uptake of fluorescence Hoechst 33342.
Full time. $111800.00-191600.00 per year.
Qualified applicants can apply at . Please reference job #R0174199. EOE
Any individual may provide documentary evidence bearing on this application with information on available workers and information on wages and working conditions to the Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW Room N-5311 Washington DC 20210.
Locations
Lexington MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeRequired Experience:
IC
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
