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Principal Scientist / Associate Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

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 / Associate Director, Other , Cambridge, Massachusetts

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