Staff / Sr. Staff Engineer CMC, Downstream

Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Sitting within R&D, Pilot Operations, Scale-Up Sciences, and Tech Transfer is the interface between lab-scale development and full-scale GMP manufacturing and operates at the 50-1000L bioreactor scale. Join Takeda as a Staff / Sr. Staff Engineer CMC, Downstream where you will be within a group responsible for executing large-scale downstream operations and development experiments, including chromatography, ultrafiltration/diafiltration, and/or depth/sterile/nano-filtration of non-GMP batches to support Takeda's modality-diverse pipeline, GMP investigations, life cycle management, new technology evaluation, and technical transfer of processes. Lead tech transfer of processes and manage all aspects of run (batch record authoring, inventory and planning, sample management). As part of the Pilot Operations, Scale Up Sciences, and Tech Transfer team, , you will report to the Head of Pilot Operations and Scale-Up Sciences, US Biologics.

How you will contribute:

• Lead/perform non-GMP purification campaigns (pilot scale) to support new product development, material supply needs, and demonstration runs for multiple programs spanning all phases of biopharmaceutical development.

• Support global process development, manufacturing sciences, or tech transfer groups to troubleshoot problems, support large-scale studies and tech transfers, and support project goals.

• Record, trend, interpret, and present data independently at departmental and project meetings. Author documents such as reports, protocols, internal/external presentations, and publications.

• Mentor junior team members in developing required skillsets.

• Identify and evaluate novel large-scale technologies that meet a generic platform across multiple processes.

Minimum Requirements/Qualifications:

• Bachelor's degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 8+ years relevant industry experience (11+ years for Sr Staff Engineer)

• Masters degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience (9+ years for Sr Staff Engineer)

• Ph.D. in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science (3+ years for Sr Staff Engineer)

• Previous Process Development, Manufacturing Sciences, or Manufacturing hands-on experience

• Knowledge of, experience in, and troubleshooting of activities performed in downstream processing (e.g., traditional and continuous chromatography, UF/DF, filtration, column packing, and buffer preparation). Practical experience around scale-up, technology transfer, and manufacturing support of large-scale GMP operation. Knowledge of upstream processing.

• Occasional travel (domestically and internationally) for conferences, seminars, and project specific needs (approximately 5% travel).

• Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information. Stands accountable and consistently follows through on work assignments and personal objectives to deliver high quality results despite obstacles.

• Teamwork -- Ability to work within department groups/team. Hold strong coaching and supervisory skills.

• Communication Skills - Expresses oneself clearly and concisely within function; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor. The candidate will be expected to effectively complete day to day operations while managing data and communicating with external stakeholders. 

• Organization – Exercises good time management skills. Effectively manages multiple priorities and outcomes of critical tasks. Provide quality and productive output that is consistently timely, reliable, and reproducible. Displays sense of urgency while completing critical tasks.

• Technical - The candidate should possess knowledge of, experience in, and troubleshooting of activities routinely performed in downstream processing (e.g., traditional and continuous chromatography, UF/DF, filtration, column packing, and buffer preparation). Practical experience around scale-up, technology transfer, and manufacturing support of large scale GMP operations is desired. Knowledge of upstream processing is a plus.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
 

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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