Scientist, Process Development - San Francisco, CA | Biospace
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Scientist, Process Development

BioPhase Solutions Inc.

Location:
San Francisco, CA
Posted Date:
11/9/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Biochemistry, Biotechnology, Cell Culture, PhD,

Job Description

THIS POSITION IS LOCATED IN SAN DIEGO, CA.
RELOCATION IS OFFERED.

SUMMARY:
Lead the mammalian cell culture process group to focus on cell culture process development. This position will also be responsible for working alongside the team to produce mAbs and recombinant proteins to support R&D activities.

THIS POSITION IS LOCATED IN SAN DIEGO, CA.
RELOCATION IS OFFERED.

RESPONSIBILITIES:

Lead a technical team to develop mammalian cell culture and harvest process
Lead upstream of CMC development activities supporting tech transfer to CMO and IND filings
Provide leadership and management to a group of scientists and engineers. Ensure worker safety including training, supervision and control of safety guidelines
Identify, propose, and execute process and procedural changes to improve process performance, robustness, productivity and efficiency
Collaborate within department and cross-functionally to meet set objectives
Organize scientific presentations for internal discussion and as needed to inform both internal and external customers
Contribute to preparation and submission of CMC portions of regulatory submissions

Requirements


THIS POSITION IS LOCATED IN SAN DIEGO, CA.
RELOCATION IS OFFERED.

REQUIREMENTS:

Doctoral degree with minimum 8 years, Masters’ degree with minimum 14 years of relevant industry experience with a major in Biochemistry, Bioengineering, Biochemical Engineering, Chemical Engineering or related fields
At least 8 years of upstream process development experience
Thorough working knowledge of GMP manufacturing
Working knowledge of CMC regulatory requirements for biological pharmaceutical products at various stages of development as well as practical application of principles of QbD
In-depth knowledge of scale-up principles, scale-down models, tech transfer concepts, and bioreactor characterization
Must have working knowledge of applying DOE and statistical data analysis to development work. Familiarity with JMP or similar software is required
Working knowledge of cell culture medium development, high-throughput cell culture technologies, advanced in situ analytics for process monitoring and control, and process modeling is highly desired.
Understanding of validation of biopharmaceutical facilities, equipment and process
Previous experience in successfully managing scientific and engineering functions.
Proven skills in building and maintaining productive relationships with organizational partners such as manufacturing and quality
Proven track record of continual innovation in various areas of the process development business
Scientific eminence in the field of upstream process development demonstrated by consistent record of external presentations and publications
Excellent communication and management skills