Principal Research Scientist III CMC Purification Development
Principal Research Scientist III CMC Purification Development
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Job Description
The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco the team leverages its comprehensive endtoend CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies such as bispecifics and novel modalities to human clinical studies and eventual licensure. This Senior Scientist I role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20 novel oncology and successfully filed two BLAs.
As one of CMC purification development group leaders you will apply your strong expertise in CMC purification to develop robust phaseappropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. You will be responsible for all aspects of CMC purification program deliverables and help drive substance purification development strategy though program lead assignments in crossfunctional CMC teams.
This position is an onsite role in a labbased function. To be successful candidates must enjoy and thrive in an onsite facetoface highly collaborative lab environment.
Responsibilities include:
- Effectively function as a principal investigator generating original technical ideas and development strategies
- Lead development optimization and scaleup of purification processes for biologics candidates to support early and latestage development
- Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific advances and respond with appropriate new strategies. Conceive and evaluate novel advanced separation technologies and techniques
- Lead purification strategy for biologic candidates and take accountability for project deliverables
- Independently responsible for project science within his/her area of expertise on one or more project teams.
- Represent purification development team and actively influence development strategy on crossfunctional CMC teams
- As a group leader make significant contributions to the project team through labbased activities and execute lab and pilot scale operations to meet project deliverables
- Proactively seek out new tools techniques and strategies to implement into individual programs(s) as well as the overall downstream platform
- Transfer processes to GMP manufacturing
- Work with contract labs and carry out viral clearance studies
- Write technical publications reports presentations and regulatory filings including publishing research in peerreviewed journals and presenting work at scientific conferences
- Work efficiently collaboratively and crossfunctionally toward project timelines and goals
- Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals
Qualifications :
Basic:
- Bachelors Masters or Doctorate (Ph.D. degree in chemical engineering bioengineering or a related field with at least 14(BS) 10(MS) or 6(PhD) years of experience in purification process development
- Recognized and sought out as a downstream process development expert in his/her discipline within the company and possibly externally
- Must be a subject matter expert in purification of monoclonal antibodies (mAb) or other mAbbased biologics including chromatography separations and filtration operations (depth deadend virus and ultrafiltration/diafiltration)
- Expert user of AKTA chromatographic instruments (such as AKTA Avant AKTA Purifier AKTA Pure AKTA Ready or similar)
- Must have excellent attention to detail and ability to keep detailed written records
- Direct experience in designing planning and executing virus clearance studies
- Demonstrated ability to function as a principal investigator generating original technical ideas and development strategies
- Demonstrate creative out of the box thinking to solve difficult technical problems and champion new technologies to achieve project goals
- Interact well with diverse groups within function and maintains strong working relationships with internal and external collaborators
- Demonstrated ability to influence others across areas of scientific disciplines
- Mast have strong communication skills including verbal written and scientific data presentation
- Experienced and demonstrated success as primary author of publications presentations regulatory documents and/or primary inventor of patents
- Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences
- Has proficiency with Microsoft Office software ability to learn new software applications
Preferred:
- Strong understanding of analytical techniques using HPLC ELISA and mass spectrometry based methods
- Proven experience in chromatography or membrane separation mechanistic modeling
- Experience in developing and executing high throughput process and/or lab scale process automation tools
- Direct experience with of downstream processes at GMP and/or pilot scale for mAb or other mAbbased biologics
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our shortterm incentive programs.
This job is eligible to participate in our longterm incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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No
Employment Type :
Fulltime
Employment Type
Full-time
