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Staff/Senior Scientist - Purification

Takeda California

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Location: San Diego, CA Posted Date: 4/29/2013 Position Type: Full time Job Code: 210 Required Education: Doctorate/PhD Areas of Expertise Desired: Biochemistry
Biology

Description


This position provides scientific and technical support to Core Sciences & Technologies and other relevant departments at Takeda California in the area of protein purification. The candidate is expected to contribute in the following areas:

*   Support purification of mAb and recombinant proteins for in vitro and in vivo studies
*   Design and characterization of IND-suitable purification processes for candidate Takeda mAb programs

Requirements


Provide support/leadership within group, managing all aspects of protein purification including:

* Purifying reagent quantities of mAb, antigen, fusion proteins, and other recombinant proteins to support in vitro and in vivo studies in Research. Activities may include:

* Working with colleagues in molecular biology to ensure strategy for protein engineering and expression is aligned with purification preferences and capabilities

* Leading efforts to purify and manipulate (i.e. deglycosylate, cleave) antigens, fusion proteins, and other recombinant proteins from a variety of different expression systems (mammalian and non-mammalian), with minimal process and product-related impurities

* Evaluating automated, high-throughput technologies to increase the throughput of protein purification

* Collaborating with Analytical group to develop methods to assist in troubleshooting and characterization of difficult-to-purify proteins (as needed)

* Support/lead efforts to develop and characterize purification processes for lead TCAL mAb programs. Activities may include:    

* Evaluating a variety of processing conditions (i.e. resins, residence times, buffers) across unit operations to maximize product recovery, while also minimizing impurities

* Providing technical leadership in cross-functional teams across the global Takeda organization to identify and implement best practices for antibody purification  

* Actively survey industry-standard and cutting-edge platforms for protein purification either through participation in workshops or conferences

May manage and provide technical guidance to junior staff members within the group


EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

*   PhD degree in life sciences, protein chemistry, or equivalent with Post Doc and 0-4+ years of relevant experience, preferably industry; MS/MA with a minimum of 10 years of relevant experience; BS/BA with a minimum of 12 years of relevant experience.  
*   Expertise in the purification and manipulation of a variety of recombinant proteins, including mAb, mAb-like scaffolds, and tagged proteins is required
*   The ideal candidate will have developed and executed purification processes for non-clinical or early clinical trials of therapeutic monoclonal antibodies. Requires state-of-the-art knowledge and proficiency in antibody purification techniques from cell harvest to production of bulk drug substance, including appropriate harvesting techniques, concentration techniques, viral removal steps, and various suitable chromatography modes.
*   The flexibility to manage large numbers of small volume (50 mL) samples to small numbers of samples at larger (5-20L) scale in either manual or automated (i.e. Akta) platforms.
*   Knowledge and experience of performing studies and process development work in accordance with ICH and other regulatory guidance, experience writing or contributing to Regulatory documents (e.g. INDs, BLAs) and understanding of cGMP requirements all are preferred.
*   Competency in standard computer software (e.g. MS Word, MS Excel, MS Powerpoint) and statistical analysis software (i.e. JMP) are required.
*   Effective verbal communication skills, interpersonal skills and ability to work and thrive in a collaborative cross functional team environment are required.
*   Demonstrated success as a leader, managing people and projects (required for Sr. Scientist level)
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