Careers

Careers

Current Open Positions


Position:  Associate Director/Director, CMC

Location:  Fremont, CA

Position
The Associate Director/Director of CMC is a scientific leader with a strong chemistry and drug development background and at least 10 years of experience in managing all CMC aspects of late stage development programs to launch .

The Associate Director/Director of CMC will oversee all aspects of Quark’s API and drug product development and manufacturing operations, and coordinate activities of CMC consultants. Individual will be responsible for managing activities at CMO sites to meet corporate timelines and objectives.  Individual must be experienced in leading outsourced development activities and must be knowledgeable in EU and US regulatory requirements for late stage and commercial products. Individual must also have experience with drafting CMC sections for regulatory filings. 

 

Responsibilities

·  Coordinate and manage development and manufacturing activities at CMOs, including CMO selection and technology transfer.  Apply technical and project management expertise to meet corporate goals, budget and timelines.

·  Review and approve protocols, reports, Master Batch Records and associated validation/production documents.

·  Coordinate the resolution of manufacturing deviations and corrective actions, with the support of CMC consultants.

·  Work closely with Quality group to support lot release of clinical supplies in a timely manner.

·  Coordinate clinical supplies labeling and packaging as needed.

·  Manage clinical supply inventory and plan/coordinate replenishment, as required.

·  Work with QA to ensure CMOs are in compliance with regulatory requirements and cGMPs.

·  Serve as the subject matter expert in drug development on CMC team.

·  Author relevant sections of CMC documents for regulatory submission.
 

Requirements

·  At least a M.S. in a relevant scientific discipline (PhD is an advantage), with a minimum of 10 years relevant industry experience in drug development and at least 3 years managing outsourced development and manufacturing activities.

·  Good understanding of drug development process.  Experienced across all phases of drug development especially late stage development. Specific experience in managing Phase III to launch manufacturing campaigns and other CMC activities.

·  Must have aseptic manufacturing expertise.  Previous experience with oligo-nucleotide or peptide drug development will be an advantage.

·  Solid working knowledge of cGMP requirements and familiar with FDA and EU regulatory requirements. Experience in preparation of CMC sections in regulatory filings

·  Good influence and interpersonal skills; strong written and verbal communication and presentation skills with the ability to function effectively in a fast-paced, multi-tasking, matrix environment.

·  Strong leadership and project management skills with a proven ability to manage multiple technical projects effectively.  

 

How to Apply

To apply for a current open position please send your resume or curriculum vitae to Quark Pharmaceuticals as follows:

For US positions:
Quark Pharmaceuticals, Inc .
Attn: Human Resources
Email:
HR_USA@quarkpharma.com

For Israel positions:
QBI Enterprises, Ltd.
Attn: Human Resources
Weizmann Science Park, P.O.B. 4071
Ness Ziona, 70400, Israel
Email:
ISRAEL

Notice to Recruitment Agencies/Search Firms:

Please be aware that external placement fees are only available to Search Firms that have an executed Search Agreement with Quark Pharmaceuticals and that a specific search must be expressly authorized by Quark Pharmaceuticals. All unsolicited resumes/CV’s submitted through our Web site or to personal e-mail accounts of employees of Quark Pharmaceuticals shall be deemed property of Quark Pharmaceuticals. Quark Pharmaceuticals explicitly reserves the right to pursue and hire those candidates without any financial obligation to the recruiter or search firm. If you wish to develop a business relationship with Quark, you may do so only by providing your name, email address, phone number, agency name, and area(s) of specialty to the hyperlink to the appropriate HR group listed above. Quark does not accept phone solicitations . Quark will contact your company if there is a business need for your services.


To apply for a current open position please send your resume or curriculum vitae to Quark Pharmaceuticals as follows: Quark Pharmaceuticals, Inc . Attn: Human Resources Email: QBI Enterprises, Ltd. Attn: Human Resources Weizmann Science Park, P.O.B. 4071 Ness Ziona, 70400, Israel Email: Please be aware that external placement fees are only available to Search Firms that have an executed Search Agreement with Quark Pharmaceuticals and that a specific search must be expressly authorized by Quark Pharmaceuticals. All unsolicited resumes/CV’s submitted through our Web site or to personal e-mail accounts of employees of Quark Pharmaceuticals shall be deemed property of Quark Pharmaceuticals. Quark Pharmaceuticals explicitly reserves the right to pursue and hire those candidates without any financial obligation to the recruiter or search firm. If you wish to develop a business relationship with Quark, you may do so only by providing your name, email address, phone number, agency name, and area(s) of specialty to the hyperlink to the appropriate HR group listed above. . Quark will contact your company if there is a business need for your services.