Principal Research Scientist I Process Engineering
Principal Research Scientist I Process Engineering
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1 Vacancy
Job Description
Process Engineering a part of AbbVie R&Ds Development Sciences organization is responsible for designing and developing scalable processes to make drug substances and drug products including small molecules peptides and antibody drug conjugates (ADCs) throughout preclinical and clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry Manufacturing and Controls) Development and Aesthetics R&D functions to provide active engineering support to enable robust process scaleup and manufacturing of biologics drug substances and drug products including toxins and cosmetic active ingredients (CAIs). We contribute to the development of innovative engineering technologies and create valuable intellectual property through the composition of matter chemical processes and technologies resulting in costeffective commercial manufacturing processes. We support the development of the supply chain for pipeline molecules and help prepare and defend CMC regulatory content.
Chemical/Bio Engineers within Process Engineering support pipeline projects through all phases of development. Early in development engineers focus on establishing an enabling process that can be scaled up successfully. In the later stages of development engineers optimize the drug substance and drug product processes and lead manufacturing campaigns. Engineers also work crossfunctionally to transfer the optimized process to manufacturing sites develop control strategy and prepare reports to support regulatory filings.
Role Overview
The successful engineering candidate will play a key role in the BioProcess Engineering (BPE) Center a part of the R&D Process Engineering function. The core deliverable of BPE is to develop robust manufacturing processes and advance innovative technologies using strong engineering fundamentals. The ideal candidate will have prior peptide development experience and a passion for handson laboratory process development. The candidate is also expected to lead the identification and development of novel approaches and technologies to enhance process development efficiency and commercialization. The candidate must exhibit a collaborative nature in identifying process challenges on a wide range of projects take part in a crossfunctional team to deliver specific project needs and take on a leadership role in developing and implementing solutions.
Key Responsibilities:
- Develop robust manufacturing processes supporting peptide assets through all phases of development.
- Participate in and/or lead project teams towards development and characterization of new peptide assets. Establish communicate and execute research plans.
- Develop commercial ready manufacturing processes in the laboratory and demonstrate the processes in the pilot plant.
- Set project strategies define project responsibilities and timelines and provide leadership in a matrixed team setting.
- Address challenging problems with peptiderelevant reactions separations and/or isolations using expertise in reaction kinetics transport phenomena and mathematical modeling.
- Author and/or review technical documents summarizing process development efforts and contribute to regulatory filings.
- Exhibit a collaborative nature in identifying process challenges on a wide range of projects and communicate findings and recommendations effectively by multidisciplinary interactions with organic chemists analytical chemists process development engineers pilot plant engineers drug product development scientists program managers and regulatory affairs specialists.
- Author publications and present at scientific conferences.
Qualifications :
- BS MS or PhD in Chemical/Bio Engineering or a related field and 14 (BS) 12 (MS) or 6 (PhD) years of relevant industrial experience.
- Ph.D. candidates with pertinent research exposure are also encouraged to apply.
- Job level will be commensurate with academic and/or industrial work experience.
- Candidates are expected to have a strong background in chemical engineering as well as peptide development and the proven ability to demonstrate their skills in this field.
- The candidate is expected to demonstrate the ability to solve difficult technical problems and champion new technologies to achieve project goals.
- The candidate is required to be a strong team player and demonstrate scientific leadership possessing effective oral and written communication skills for facilitating collaborations and leading crossfunctional process development teams.
Preferred:
- Peptide development experience particularly in synthesis and purification techniques.
- Working knowledge of analytical techniques such as UV/Vis HPLC FTIR Raman and microscopy.
- Experience with laboratory experimentation and process scaleup.
- Experience with mechanistic and/or process modeling or computational fluid dynamics.
- Experience with design of experiments and statistical tools.
- Familiarity with operation of chemical/biochemical process equipment and systems.
- Experience with control strategy development risk assessments and tech transfer.
- Experience with GxP compliance.
- Experience with leading crossfunctional pharmaceutical development teams.
Key Leadership Competencies:
- Comfortable with multidisciplinary interactions. Builds strong relationships with peers and crossfunctionally with partners outside of team to enable higher performance.
- Learns fast grasps the essence and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment open to suggestions and experimentation for improvement.
- Embraces the ideas of others nurtures innovation and enables innovation to reality.
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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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No
Employment Type :
Fulltime
Employment Type
Full-time
