FierceBiotech and FiercePharma Jobs
Upstream Process Development Engineer - Discovery Solutions
Nov 13
Location: Gaithersburg, MDCategories: Biotherapeutic
Website: http://www.discoverysolutions.net
Position Description
Our company, located in Gaithersburg, MD, is a biotechnology company developing innovative therapeutics to treat cancer, heart disease and ophthalmic disorders. Each of our gene-based product candidates uses a common patent-protected technology platform to deliver genes that produce medically beneficial proteins directly at the site of disease. We have three product development programs in various stages of clinical testing. We also are using proprietary adenovector technology to develop vaccines for infectious diseases.
We our currently seeking a Process Development Engineer
GENERAL JOB RESPONSIBILITIES
The responsibilities of the Process Development Associate include but are not limited to:
• Development and/or optimization of adenovector upstream processes (from cell thaw through clarification).
This includes designing experiments, analyzing data, developing batch records,
SOPs and protocols, and writing and/or reviewing technical reports.
This may also include the evaluation of alternative methodologies and/or materials for various process operations and steps.
• Serve as a member of the team responsible for the technology transfer of processes to contract manufacturing sites. This includes writing and/or review of batch records and contract manufacturing staff, and providing the necessary technical support to the contract manufacturer once the process has been transferred and cGMP manufacturing has begun.
• Maintenance of upstream process development equipment including bioreactors, cell counters,
metabolite analyzers, pumps and gauges.
• Maintenance of inventory for commonly used lab supplies.
• Other responsibilities as required by the department, team or business needs.
GENERAL JOB DESCRIPTION
-The Process Development Engineer will perform upstream process development activities including: mammalian cell culture, medium evaluation, small-scale viral vector production, bioreactor operation and filtration unit operations.
Additional responsibilities include:
-Optimization and scale-up of upstream adenovector processes (i.e. from cell thaw to clarification), technology transfer to cGMP contact manufacturing sites, providing technical support to manufacturing site(s), and writing technical reports.
REQUIRED SKILLS AND TRAINING
• Mammalian cell culture in serum-free conditions using aseptic technique
• Use of shaker flasks and bioreactors
• Filtration unit operations (i.e., clarification, tangential flow filtration, etc.)
• Process optimization
• Excellent oral and written communication skills
• Basic computer skills in Microsoft Office Suite software
MEASURES OF SUCCESSFUL PERFORMANCE
• Ability to effectively manage the time demands of laboratory experiments, documentation
requirements and team meetings.
• Active participation in the design and planning of laboratory experiments
• Active participation in the Technology Transfer of processes to contract manufacturing
organizations
• Ability to write technically sound Process Development protocols and reports.
• Ability to prepare and give clear, concise oral presentations to the group.
MINIMUM QUALIFICATIONS
-It is required that the incumbent has a B.S. or M.S. degree in Biochemical Engineering, or Chemical Engineering, with 1-2 years industrial experience in mammalian cell culture,
-Bioreactor operation and optimization, and filtration unit operations. Experience with cGMP manufacturing and/or large-scale production is a plus, as is experience in writing batch records and/or SOPs for cGMP manufacturing. Experience in technology transfer to cGMP manufacturing sites is also a plus. Candidate must demonstrate a strong commitment to quality work with attention to detail.
-Must be able to work both independently and within multi-functional teams in a fast-paced environment.
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless
of personal characteristics, are encouraged to apply.
