Principal Scientist/Engineer I - Drug Product
Posted on: 3 Oct 2022
Lake Country, TX
Job Description
Serve as a lead scientist/engineer on a given project/product, and contribute scientific insights into multiple other projects for oral dosage forms. Assume technical ownership of a given product across the various stages of development and commercialization in coordination with other functional areas. Maintains product knowledge and serves as product focused subject matter expert. May direct research and/or project activities and professional development of a scientist(s) within the individual’s area of expertise, by effectively mentoring, guiding and/or supervising scientific personnel.
Lead technical transfer and start-up of new solid dosage form processes while supporting the execution of lab- and plant-scale experiments.
Lead CMC teams including tech transfers while establishing and reviewing complex plans for multiple projects ensuring appropriate resource allocation and distribution.
Use statistical process control and other statistical tools for comparison and hypothesis testing. Apply engineering, pharmaceutical sciences or materials sciences fundamentals to model the product and process to solve complex technical problems.
Recommend and evaluate experimental design options for complex technical problems with controls and consideration of error and variation.
Demonstrate creative 'out of the box' thinking to solve difficult problems and champion new technologies to achieve project goals.
Generate new scientific proposals and lead those efforts while identifying opportunities for cost reduction, cycle time and other process improvements.
Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
Be the primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
Mentor/supervise a team of one or more and ensure high performing results from their team.
BS or equivalent education in engineering/pharmaceutical sciences/material sciences and extensive, typically 14+ years of experience; OR MS or equivalent education with 12+ years of experience OR PhD with 6+ years of experience in area or scientific area of discipline.
Experience in unit operations such as granulation, milling, compression, coating and/or extrusion processes for oral dosage form formulations including Amorphous Solid Dispersions and modified release products.
Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies with a reputation for solving difficult technical problems and championing new technologies to achieve project goals.
Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
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.
Demonstrated knowledge of statistical process control, multivariate modelling and/or process modelling techniques.
AbbVie
Chicago, IL
AbbVie Inc. discovers, develops, manufactures, and sells pharmaceutical products in the United States, Japan, Germany, Canada, Italy, Spain, the Netherlands, the United Kingdom, Brazil, and internationally. The company offers HUMIRA, a therapy administered as an injection for autoimmune and intestinal Behçet's diseases; IMBRUVICA to treat adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma, waldenström’s macroglobulinemia, marginal zone lymphoma, and chronic graft versus host disease; VENCLEXTA, a BCL-2 inhibitor used to treat adults with CLL or SLL; VIEKIRA PAK, an interferon-free therapy to treat adults with genotype 1 chronic hepatitis C virus (HCV); TECHNIVIE to treat adults with genotype 4 HCV infection; and MAVYRET to treat patients with chronic HCV genotype 1-6 infection.
It also provides KALETRA, an anti-human immunodeficiency virus (HIV)-1 medicine used with other anti-HIV-1 medications to maintain viral suppression in HIV-1 patients; NORVIR, a protease inhibitor indicated in combination with other antiretroviral agents to treat HIV-1; and SYNAGIS to prevent respiratory syncytial virus infection at-risk infants. In addition, the company offers AndroGel, a testosterone replacement therapy for males; CREON, a pancreatic enzyme therapy for exocrine pancreatic insufficiency; Synthroid to treat hypothyroidism; and Lupron to treat prostate cancer, endometriosis, and central precocious puberty, as well as anemia.
Further, it provides Duopa and Duodopa, a levodopa-carbidopa intestinal gel to treat Parkinson’s disease; Sevoflurane, an anesthesia product; and ORILISSA, a non-peptide small molecule gonadotropin-releasing hormone antagonist for women with moderate to severe endometriosis pain. It has collaborations with Alector, Inc.; Janssen Biotech, Inc.; Galapagos; Bristol-Myers Squibb Company; and Calico Life Sciences LLC. The company was incorporated in 2012 and is headquartered in North Chicago, Illinois.
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IndustryBiopharmaceuticals
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No. of Employees30, 000
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Website
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Jobs Posted3263
