Principal Scientist / Associate Director
Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020
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Job Description:
Principal Scientist / Associate Director Company: Cue Biopharma,
Inc Location: Cambridge Posted on: September 12, 2020 Job Description: Principal Scientist / Associate Director, Drug Substance CMC
andExternal Manufacturing The Company Cue Biopharma, Inc., a clinical-stage biopharmaceutical
company,is engineering a novel class of injectable biologics to
selectivelyengage and modulate targeted T cells within the body to
transformthe treatment of cancer and autoimmune diseases. Cue
Biopharma is ahigh growth company and is listed on NASDAQ (CUE).
The company islocated in Cambridge, Massachusetts in the heart of
the lifesciences corridor. Cue Biopharma is building a world-class team of highlymotivated,
dedicated scientists to help us advance our research anddevelopment
programs. The company culture is fast-paced andcommitted to
scientific excellence, innovation, and teamwork. Candidate Profile The successful candidate will have a strong scientificbackground
with hands-on experience developing and troubleshootingbulk drug
substance processes for protein-based biologic products.The
candidate must also have experience succesfully managing thirdparty
contract development and manufactring partnerships andcrafting and
supporting the drug substance portions of US andinternational
regulatory filings. Key Responsibilities Be the drug substance development and manufacturing
subjectmatter expert in the CMC department. Liaise with corporate
partnersfor all aspects of Cue Biopharma’s drug substance
development andmanufacturing programs. Manage the development and optimization of drug
substancemanufacturing processes at third party vendors and
troubleshootingissues that arise. Serve as in-plant person for process development
andmanufacturing efforts with contract manufacturing
organizations Optimize and further refine the existing drug
substancemanufacturing processes to support later stage
clinicaldevelopment. Design manufacturing processes to be compliant with
globalregulatory requirements. Remain current with upcoming
regulatorytrends so that the company’s manufacturing processes are
compliantwith FDA, EMA and global regulatory requirements. Draft the drug substance sections of INDs, IMDP and
theiramendments. Requirements BS in an applicable field of study with at least 12 years
ofindustry experience, or MS in an applicable field of study with
atleast 8 years of industry experience, or PhD in an applicable
fieldof study with at least 4 years of industry experience. Significant experience developing and troubleshooting
biologicsdrug substance manufacturing processes required.
Experience with Fcfusion proteins strongly preferred, experience
with monoclonalantibodies preferred. Experience successfully managing CDMO relationshipsrequired. Ability to travel domestically and internationally to vendor
andpartner sites as needed to support product development
activitiesand corporate partnerships. To apply, please email your resume to careers@cuebio.com . Inthe
subject line include your name and the posted job title. Keywords: Cue Biopharma, Inc, Cambridge , Principal Scientist /
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