AbbVie

Senior Scientist I, Pharmaceutical Development, CMC Biologics

Posted on: 25 Feb 2021

Redwood City, CA

Job Description

About AbbVie
AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products Imbruvica, Venclexta, and Empliciti and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

AbbVie has expanded its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at AbbVie Biotherapeutics, AbbVie's oncology research site in Redwood City, CA.

We have an exciting opportunity available for a Senior Scientist I within the Pharmaceutical Development Group in the CMC Biologics department at AbbVie, Redwood City, CA. AbbVie at Redwood City is an R&D; organization focused on development of innovative biologics in the field of Oncology. This position will support CMC drug product development for oncology pipeline that include mAbs, ADCs, and novel bispecific antibody formats, through clinical proof-of-concept.

KEY RESPONSIBILITIES INCLUDE:

* Develop preclinical and clinical formulations, including liquid and lyophilized dosage forms, and related drug product manufacturing processes
* Transfer drug product manufacturing process to internal and external fill-finish facilities and provide on-site support as needed
* Responsible for stability testing of representative lots and clinical in-use studies to guide dose solution administration
* Generate high quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations and regulatory documents
* Actively participate in drug product development teams and contribute to the planning and execution of product development studies including formulation and drug product process development, based on project goals and timelines
* Actively interact with CMC members and other AbbVie stake holders to enable successful development of AbbVie drug products
* Drive innovation by investigating and developing novel experimental approaches and/or technologies in the field of drug product development, and raise visibility within the scientific community through external presentations and publications

Qualifications
* Ph.D in pharmaceutical sciences, chemical engineering, analytical sciences or equivalent field with 0-3 years of experience or BS/MS degree with 8-10 years of relevant experience in the biotechnology or pharmaceutical industry.
* A strong technical background encompassing protein chemistry, analytical development, andformulation development is required
* Candidates must have hands-on expertise in analytical techniques used for protein characterization and stability testing
* Prior experience in development of protein product formulations and lyophilization expertise is highly desirable
* Demonstrated experience in driving innovation is a strong plus
* Prior experience with aseptic processing, and drug product manufacture processes transfer is preferred
* Excellent communication and written skills required

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.

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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