Scientist CMC

Takeda • Lexington, MA

11h

About The Position

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 study’s 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

• Master’s degree in Science, Biochemistry, Pharmaceutical Science or related field plus 2 years of related experience.
• 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 P.aeruginosa to multiple RND efflux pump knockouts. Create individual knock-out mutants of P.aeruginosa 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

Responsibilities

• 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 study’s 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
• Independently design and execute experiments to produce a summary of results

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level