Current Open Positions
Position: Associate Director/Director, CMC
Location: Fremont, CA
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.
- 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.
- 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.
Location: Boulder, CO
The primary responsibility of the QA Manager will be to assure the compliance and quality of drug substance and drug product manufacturing and testing activities with respect to procedures and applicable domestic and international regulatory expectations and requirements.
- Maintain employee training program.
- Provide support to development groups regarding process and analytical method transfer activities.
Provide quality oversight of contract manufacturing organizations.
Perform external audits of suppliers, contract manufacturing organizations, and contract testing laboratories, as necessary.
Excellent problem solving and communication skills.
Ability to interface with all levels of management.
Ability to manage multiple priorities with aggressive timelines at a high level of productivity in a fast-paced environment.
Promote quality culture throughout the organization.
Ensure progress and completion of responsibilities in accordance with established departmental goals and project plans.
Identify and implement continuous improvement initiatives that seek to eliminate inefficiency, reduce cost and improve product quality.
- Bachelors of science degree in a scientific discipline or equivalent.
- 7 years experience in pharmaceutical or biotechnology industry with 5 years of direct responsibility in Quality Assurance.
- Phase 3/NDA experience preferred.
- Knowledge of FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations.
- API and drug product formulation, aseptic filling, and finishing experience.
Position: Assistant Director/Director Pharmacovigilance
Location: Fremont, CA
The Assistant Director, Pharmacovigilance (PV) is responsible for ensuring compliance with SOPs and FDA and other health authorities for the reporting of adverse events to regulatory agencies, including 21CFR11 compliance for any applicable Quark Pharmaceuticals utilized electronic safety database, and for assisting the Vice President Pharmacovigilance with implementation of PV policy and procedures, medical review and validation of adverse experience reports.
- Assists VP Pharmacovigilance in assuring global reporting requirements are identified and met.
- Responsible for coordination with regulatory department the integration of global reporting requirements into pharmacovigilance work processes.
- Coordinates with VP Pharmacovigilance integration of safety database management and output to health authorities globally.
- Responsible for coordination of periodic internal audit of pharmacovigilance records to assure compliance with regulations.
- Develops guidelines and ensures the uniform and timely processing of adverse event reports.
- Acts as liaison internally and externally to project teams.
- May contact reporters and collects information directly from healthcare providers relevant to completing reporting requirements if required.
- Assists in the preparation of relevant sections of investigator brochures, protocols, Data Safety Update Reports, Individual Case Safety Reports, investigator communications, product development plan, pharmacovigilance plan and other reports as necessary.
- Assists in or provides support for coding of clinical adverse events for clinical and safety databases
- Provides medical evaluation and coding of adverse event reports.
- May assist in training of other Quark Pharmaceuticals employees in their role in identification /recognition and reporting of adverse events for clinical and safety related processes.
- MD or PharmD degree and a minimum of 7 years of clinical, safety or epidemiology experience, with a minimum of 5 years in industry.
- MD license required.
- Must have excellent working knowledge of clinical research and the drug development process. Must have knowledge and experience with drug safety (global preferred). Knowledge of drug development or clinical trials optimal.
- Experience with electronic drug safety databases and E2B submissions required.
Position: Drug Safety Associate
Location: Fremont, CA
The primary responsibility of the Drug Safety Associate (DSA) is to provide support to the Pharmacovigilance Department.
- The DSA will receive initial intake of clinical trial safety correspondence and be responsible for initial data entry into appropriate drug safety database and/or safety files.
- The DSA will establish and maintain filing systems on department-related business to achieve quick retrieval according to company standards, and liaise with other members of the clinical trial project team such as clinical trial associates, to ensure maintenance of the pharmacovigilance system and any needed supporting documentation for the clinical trial master file therefrom.
- The DSA will type correspondence to support the PV Department, compile data for Power Point and statistical reports, maintain calendars and coordinate meetings for the PV group.
- The DSA will assist with meeting and support activity involving vendors and CROs.
- The DSA will handle PV support and administrative projects as assigned.
- Bachelors Degree in Life Sciences or related field or equivalent relevant experience.
- Medical terminology coursework or MedDRA experience preferred.
- Intermediate to advanced computer skills. Must be proficient in Microsoft Outlook, Word, PowerPoint and Excel.
- Excellent written and oral communication skills, the ability to work independently, be flexible and have strong organizational skills.
- Good interpersonal skills
- Ability to handle multiple priorities.
- Good problem solving skills and the ability to make suggestions to improve efficiencies.
- Experience with Safety databases preferred.
- Experience with ArisG preferred.
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
For Israel positions:
QBI Enterprises, Ltd.
Attn: Human Resources
Weizmann Science Park, P.O.B. 4071
Ness Ziona, 70400, 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.