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9557
Contract

Upstream Principal Scientist-MS&T - 8907358

Location: Emeryville, California

Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:

 

Date Posted: 2/7/2019

Hiring Organization: Connexion Systems & Engineering

Job Title: Upstream Principal Scientist – MS&T

Industry: Manufacturing/Medical

Location: Emeryville, CA

Employment Type: Full Time, Contract

Pay Range: Open

Duration: 1 Year

Job#:bh9557

 

Upstream Principal Scientist -MS&T - Manufacturing Sciences and Technology

Successful candidate will provide technical or scientific expertise & leadership in the upstream process development of mammalian cell culture derived recombinant proteins & monoclonal antibodies.

In addition to upstream process development candidate will lead efforts for developing & optimizing cell culture processes including process parameter optimization, process characterization & scale-up/tech transfer for large scale product production.

Candidate will also have experience with microbial fermentation-based processes & associated process development, technical transfer & support successful implementation of production fermentation processes at commercial scale.

Has considerable knowledge in area of protein & monoclonal antibodies production using mammalian host cell systems, experience with microbial based host cell systems for recombinant protein production is a plus.

Responsible for design & execution of experiments regarding cell culture media screening/development, evaluate feeding strategies, process parameter optimization & scale-up to support large scale production

Candidate will monitor, explore & evaluate next generation technologies to speed up process development.

Be responsible for technology transfer to third parties including partners & CMO Supports process technology transfer & scale-up to commercial facilities Individual will be accountable for scientific data review including data integrity verification, statistical analysis & technical report writing.

Directly interfaces with other departmental groups (R&D, Quality Assurance, Regulatory Affairs, Supply Chain & Manufacturing)

Skills:

Technical/scientific knowledge of biopharmaceutical processes, both process development & manufacturing scales of operation

Knowledge of process scale-up & scale-down methodologies, including process characterization & design of experiments

Understanding/experience with wave bag systems & SUBs is essential.

Familiarity with Finesse Delta V control systems & PI systems is highly desirable.

Experience in process technology transfer within & between organizations, manufacturing support & troubleshooting

Demonstrated teamwork, organizational & leadership skills

Writes procedures & technical reports that include data interpretation.

Extensive working knowledge of cGMP environments

Attention to detail, strong organizational skills, ability to multitask, effective interpersonal & communication skills are required.

Can identify & request needed resources within or across functional areas.

Must have advanced written & oral communication skills.

Independently applies sound scientific principles in development of innovative solutions to complex technical problems.

Skilled in application of standardized root cause analysis, investigation tools & methodologies.

Proficient with the use of MS Office (Excel, Word, PowerPoint), application software including Unicorn, JMP, Minitab, Design Expert, etc.

Keywords:

Education: Master's or PhD in science or engineering preferred

Minimum of 10 yrs. experience in product development, manufacturing science & technology, process engineering within the pharmaceutical industry required

7 yrs. experience working in a pharmaceutical manufacturing site

Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements

Skills and Experience:

Required Skills:

BIOPHARMACEUTICAL

CGMP

CONTROL SYSTEMS

DATA INTEGRITY

DELTA V

Additional Skills:

FERMENTATION

JMP

LEADERSHIP SKILLS

MEDICAL DEVICES

MINITAB

OPTIMIZATION

ORGANIZATIONAL SKILLS

PHARMACEUTICAL MANUFACTURING

PROBLEM SOLVING

PROCESS DEVELOPMENT

PROCESS ENGINEERING

PRODUCT DEVELOPMENT

QUALITY ASSURANCE

REGULATORY AFFAIRS

REPORT WRITING

ROOT CAUSE ANALYSIS

STATISTICAL ANALYSIS

SUPPLY CHAIN

TECHNICAL LEADERSHIP

TECHNICAL REPORT WRITING

ANTIBODIES

APPLICATION SOFTWARE

CELL CULTURE

EXCEL

MAMMALIAN CELL CULTURE

MICROSOFT EXCEL

MICROSOFT OFFICE

MICROSOFT POWERPOINT

MICROSOFT WORD

MONOCLONAL

MS OFFICE

POWERPOINT

WORD

 

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

                 

Contact Info:                                                                                                                                             

 

ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776

jobpostings@csetalent.com