Proclinical is currently recruiting for a Scientist with a pharmaceutical company located in Rockville, MD.
- Performs purification process development and activities in support of vaccine antigen development programs in line with business priorities, following the Quality by Design framework.
- Must be able to coordinate activities, prepare and execute experiments independently.
- Utilizes technical process knowledge to meet regulatory requirements appropriate for stage of development; communicates effectively within TRD and with external stakeholders and is able to defend scientific and technical decisions at the appropriate technical board.
- Contributes to regulatory filings and interactions with health authorities to ensure successful registration vaccine candidates.
- Works on multiple projects internally, at other sites and at external manufacturers requiring initiative and judgment.
- Prepares and presents scientific data within Technical R&D including Technical Development.
- Team and may represent externally (conferences, etc); authors and reviews technical protocol, reports and manufacturing support documents in support of various project development stages.
- Benchmarks specific technologies in own functional area to bring technology to state of the art.
- Contributes to and drives strategy and technical development planning and accountability in the execution thereof; act as a voice and ambassador of its department at various governance bodies / meetings.
- Encourage adaptation and proactive promote the GxP / EHS / QA rules application.
- Authors and reviews technical protocol, reports and manufacturing support documents in support of various project development stages.
- Utilizes technical process knowledge to meet regulatory requirements appropriate for stage of development and scientific knowledge and experience to suggest improvements in area of experience.
- Makes sound scientific/technical and business decisions based on a balance of data, analysis and experience.
- Participates in writing technical protocols and reports in support of various project development stages.
- Troubleshoot laboratory processes and equipment, including high throughput systems.
- Play a significant role on solving complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment.
- Solves complex problems through collaborations with others, taking a new perspective on existing solutions.
Skills and Requirements:
- PhD with 1+ years of experience OR MS with 3+ years of experience OR BS with 5+ years of experience, degree must be in Biology, Biochemistry or Chemical Engineering Scientific level of experience required due to the complexity of Vaccine products
- Hands-on understanding of different purification techniques such as chromatography and tangential flow filtration and associated instrumentation such as Akta chromatography systems and Unicorn software.
- Hands-on experience with bioanalytical assays associated with purification processes, such as SDS-PAGE, Western blotting, HPLC, etc. Level of experience required due to variety of purification techniques performed.
- Experience with high throughput protein purification techniques is a plus
- Knowledge of technology transfer and design of experiments and process characterization
- Good understanding of cGMP and manufacturing, and regulatory requirements for filing and registration of vaccine and/or biologics.
- Excellent presentation and communication skills.
- Collaborates with more senior scientific staff to design and interpret the data from development projects.
- Demonstrate knowledge and competences through participation to seminars, peer-reviewed report and/or publications Communicates effectively with his/her colleagues and within other TRD functions
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.