Temp Senior Quality Control Specialist
Description
Temp Senior Quality Control Specialist
Headquarters Location: South San Francisco, CA
Candidate Location: Hybrid
Travel Required: 5%
Reports To: Director, Quality Control
Department: Quality Control
Position Type: Temporary, 40 hours per week, (8 months), Non-Exempt
About CytomX Therapeutics:
CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX has a broad pipeline, which comprises seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines and checkpoint inhibitors (“CPIs”). Learn more at www.cytomX.com.
Who You Are and What You’ll Do:
You are passionate about life sciences and making a difference to cancer patients, their families, and healthcare providers. You will be responsible for managing GMP release and stability testing in support of clinical programs while ensuring compliance with SOP’s, policies, and industry guidance. In addition, this role will be responsible for leading, facilitating and supporting US and Global processes for harmonizing and integration of stability-related activities and supporting various GMP Quality Systems. This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, forecasting, and reporting of metrics, creation, revision and approval of SOP’s, stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations. This role will interact with internal Product Development and Quality groups and with CytomX’s network of external CMOs/contract labs to develop and implement GMP analytical methods for in-process and lot release/stability testing of drug substance and drug products.
Job Responsibilities:
- QC Subject Matter Expert for release, stability, and compendial methods, sampling plans, method lifecycle management, deviations, OOS/OOT and testing investigations, root cause analyses, and CAPAs.
- Provide characterization and assay support for DS and DP early and late-stage clinical programs.
- Manage reference standard qualification, inventory, and bridging.
- Review and author QC related sections of IND, IMPD, NDA, and BLA submissions, and provide support addressing information requests.
- Manage and provide oversight for CDMO placebo, DS, and DP stability studies including CDMO documentation review, study design, sample management, data review, and trending analysis.
- Plan, manage, and communicate stability pull dates and ensure stability testing occurs within specified testing windows.
- Review CDMO stability testing packages, perform statistical trend analysis, provide stability updates, and manage internal QC data requests.
- Set DS and DP shelf lives with internal stakeholders to ensure uninterrupted clinical supply.
- Proactively manage mitigation and resolution of stability related issues such as OOS/OOT stability results or adverse stability trends.
- Proactively manage QC stability strategy including gap analyses of stability related SOPs and authoring of SOP revisions for continuous improvement.
- Manage QC review of release/stability method qualifications and validations.
- Perform QC review of release data and issue CoAs.
- Manage cell bank, DS, DP, and placebo release and stability GMP specifications including justification of specifications and specification revisions.
- Manage clinical site product temperature excursion QC impact assessments.
Minimum Qualifications:
- BS/MS with 10 years of industry experience
- Strong knowledge of QC principles, concepts, industry practices, and standards
- Experience in validation, and transfer of non-compendial and compendial analytical methods for biologics using various techniques such as HPLC, CE, CIEF, and mass spectrometry (MS), as well as biophysical characterization methods
- Extensive knowledge of cGMP regulations and guidelines
- Demonstrated experience, and independence with QC functions associated with the GMP production and testing of biologics in clinical and/or commercial settings
- Demonstrated ability to work effectively to timelines in a virtual environment (i.e., internal partners, external CROs, CMOs, CTLs, etc.) and manage QC deliverables
- Excellent written and verbal communication skills
Preferred Qualifications:
- Strong knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) with respect to biologics manufacturing and release / stability testing.
- Experience contributing to product quality risk assessments to identify critical quality attributes and developing associated limits/specifications.
- Comfortable in a fast-paced small company environment with minimal direction and able to prioritize and adjust workload based upon changing priorities.
- Travel Requirements: Travel required (up to 5% as required for projects)
- Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability, and Fun.
- Energetic, resourceful self-starter with high integrity
- Intellectually curious, enthusiastic, creative
- Adaptable and resilient with a problem-solving orientation
- Team-player comfortable in fast-moving, dynamic environments
How You Will Work:
- Demonstrates collaboration and teamwork. Works well with others and understands that collaboration leads to better results.
- Possesses strong communication skills. Communicates clearly, concisely, and professionally. Listens actively to build understanding.
- Exhibits strong interpersonal skills and self-awareness. Builds and cultivates strong and enduring relationships with others. Acts with humility and understands own strengths and weaknesses.
- Shows continuous improvement and a commitment to self-management and development. Operates with a continuous improvement mindset and continuously seeks to expand own knowledge and capabilities.
- Demonstrates a patient focus. Puts the patient first in actions and decisions taken.
Compensation, Benefits, and So Much More
- The expected salary range for this role based on the primary location for this position in California is starting at $59.00 per hour. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law.
- A great environment where we work collaboratively, leverage each other’s strengths, and work toward a shared vision with our common goals of doing the best thing for patients.
Conditions of Employment
- Background investigations are required for all positions at CytomX, consistent with applicable law.
CytomX’s Commitment to Diversity, Equity, Inclusion, and Belonging (DEIB)
CytomX believes that DEIB helps drive our success, and we encourage candidates from all identities, backgrounds, and abilities to apply. We are an equal opportunity employer committed to building an inclusive, innovative work environment with employees who reflect our values and ultimately, serve our patients. Therefore, in all aspects of the employment process, we provide employment opportunities to all qualified applicants without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity or expression, pregnancy, medical condition related to pregnancy, creed, ancestry, national origin, marital status, genetic information, or military status, or any other protected status in accordance with applicable law.
Further, we are committed to the full inclusion of all qualified individuals. As part of this commitment, we (and the agencies we work with) will assist individuals who have a disability with any reasonable accommodation requests related to employment, including completing the application process, interviewing, completing any pre-employment testing, participating in the employee selection process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship. If you have a disability and require reasonable accommodation, or need other assistance in applying for or interviewing for this position, please direct your inquiries to Human Resources, at [email protected]
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact CytomX Therapeutics through this page. We require that all Recruitment Vendors (e.g., search firms, recruitment agencies and staffing companies) have a fully executed, formal written agreement on file with CytomX prior to submitting candidates. Any resumes submitted through the website or directly by Recruitment Vendors will be considered unsolicited. Unsolicited vendor submissions do not constitute any actual or implied contract with CytomX, and CytomX will not be responsible for any purported fees. For more information, please contact our HR team at [email protected]
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