Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Job Title: Scientist - Process Development - IV
Location: Foster City, CA 94404
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
- The Scientist, Biologics Pivotal Formulation and Process Development role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the-art technologies and innovative methodologies to advance medicines into the clinic.
- The success candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and spearhead innovations related to formulation and DP process development. will have growth opportunities through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.
Responsibilities:
- Design and execute formulation and drug product process development work packages, including formulation development, Drug Product manufacturing process development, and clinical in-use evaluations.
- Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.
- Demonstrate understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions.
- Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentation.
- Authors technical documents such as protocols, reports, regulatory dossier, etc for internal and external audience.
- Effectively collaborates with both internal and external stakeholders in project meetings.
- Support and contribute to department initiatives or cross-functional projects to drive business process excellence and scientific innovation.
Qualifications:
- Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related scientific fields with 0+ years of industrial experience.
- M.S. with 6+ years of industrial experience.
- B.S. with 8+ years of industrial experience.
- Hands-on laboratory experience required.
- Experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats strongly desired.
- Publications, external presentations, and the desire to innovate through research strongly preferred.
Numbers & Facts
| Location | Foster City, CA |
| Industry | Computer/IT Services |
| Salary | $60–$70 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
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