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Company Description
Crystal Bio Solutions, a member of Crystal Pharmatech, is a leading biologics analytical organization with operations in the San Francisco Bay Area and New Jersey. We specialize in bioanalytical and CMC analytical services for biotech and pharmaceutical companies developing biologics. Our expertise spans a wide range of therapeutic modalities, supporting projects from discovery through clinical development.
Role Description
Reporting directly to the CEO, the Director of Quality Assurance (QA) will be responsible for the development, management, and continuous improvement of quality systems ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards for our bioanalytical GLP lab in Pleasanton, California. This role ensures that facilities, equipment, personnel, and procedures meet all regulatory requirements and effectively supports nonclinical and clinical testing activities.
Key Responsibilities
Host client and regulatory inspections, including preparing and submitting responses to findings.
Support regulatory activities across all BABM sites within the organization.
Audit raw data, summary tables, and reports associated with GLP and GCLP protocols to ensure compliance with regulatory requirements.
Maintain inspection readiness, including preparing and managing site-specific documentation.
Establish and ensure compliance with GLP, GCLP, and applicable FDA and international regulatory standards.
Develop and manage the company’s Master Schedule.
Create, administer, and maintain QA Standard Operating Procedures (SOPs), QA files, and QA audit logs.
Process, archive, and maintain QA department inspection reports and supporting documentation.
Monitor and interpret regulatory requirements to ensure alignment with business processes and procedures.
Author and review SOPs and Statistical Analysis Plans (SAPs).
Provide GLP and GCLP training to staff.
Recruit, develop, and mentor QA professionals, fostering a culture of growth and excellence.
Conduct and report inspections of internal facilities and audits of external vendors to assess compliance with regulatory standards.
Establish and administer a company Risk Register.
Identify and address regulatory compliance issues, providing guidance to other departments.
Deliver monthly compliance status reports to Test Site Management (TSM), highlighting issues and corrective actions.
Represent the QA function in company meetings.
Qualifications & Educational Requirements
Bachelor’s degree in biological, chemical, or physical sciences (required); advanced degrees (e.g., Master’s, Ph.D.) preferred.
10+ years of relevant regulatory affairs experience in the bioanalytical CRO or biotechnology/pharmaceutical industry, or a combination of education and experience.
Proven ability to provide regulatory leadership and guidance in cross-functional and matrixed environments.
Strategic thinker with strong planning skills and the ability to propose innovative solutions to regulatory challenges.
How to Apply
Resume can be e-mailed directly to: Career_Us@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
Employment Type: Full-Time or Contractor
Position Summary:
Crystal Bio Solutions is a CRO providing advanced analytical services for biological drug discovery and development area. Our clients include multinational pharmaceutical companies and biotech companies.
The company focuses on analytical and bioanalytical services for biologics in CMC development with further extension to support pre-clinical and clinical analysis.
The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects. The role is responsible to support lab operation in non-GLP area.
Key Responsibilities:
Cover all ongoing sample management and shipping tasks, being assistant to senior research scientists, as well as to support certain cell-based work.
Understand and adhere to corporate standards regarding code of conduct and Environment Health & Safety (EHS).
Perform other related duties as assigned.
Qualifications:
Associate degree, B.S., or M.S. degree in Chemistry or related scientific fields.
Hands-on experience in cell-based assays is preferable.
Pay good attention to details.
How to Apply
Resume can be e-mailed directly to: career_us@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
Position Summary:
Crystal Bio Solutions is a CRO providing advanced analytical services for biological drug discovery and development area. Our clients include multinational pharmaceutical companies and biotech companies.
The company focuses on analytical and bioanalytical services for biologics in CMC development with further extension to support pre-clinical and clinical analysis.
The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects. The role is responsible to support lab operation in non-GLP area.
Key Responsibilities:
Independently conduct LC-MS method development for biologics (e.g., ADC, mAb, protein, peptide, oligonucleotide, etc.) in support of developability assessment, comparability assessment, in-depth characterization, biotransformation, and CQA related analysis.
Present and interpret data internally and/or externally as needed.
Serve as Subject Matter Expert (SME) for LCMS platform.
Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.
Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
Assist in establishing and improving policies, procedures, work instructions and SOPs.
Understand and adhere to corporate standards regarding code of conduct and Environment Health & Safety (EHS).
Perform other related duties as assigned.
Qualifications:
Ph.D., M.S., in Chemistry, Biochemistry or related scientific fields required, including a minimum of 4+(Ph.D.) or 9+(Master’s) years of CRO/Pharma/Biotech experience.
Hands-on experience with high-resolution LCMS method development and in-depth characterization.
Supervisory experience in both project and talent (people) management is preferred.
Ability to work independently and pay good attention to details.
Ability to achieve objectives/timelines through collaborative efforts with co-workers, managers, and clients.
Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.
Effective writing and communication skills.
How to Apply
Resume can be e-mailed directly to: career_us@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
Department: Project Management & Business Operation (PMBO)
Reports To: Group leader of PMBO
Employment Type: Full-Time
Job Overview:
The company needs a highly organized and detail-oriented PMBO Specialist to support cross-functional collaboration between US and China teams. This role focuses on ensuring seamless execution of NJ-based projects, including business operation support, data management, proposal development, and end-to-end project tracking. The ideal candidate will have a strong background in polymorph research, exceptional communication skills, and the ability to thrive in a fast-paced, multicultural environment.
Key Responsibilities:
1. Business Operation Support
Partner with BD teams to input and manage client/order data in Salesforce, ensuring accuracy and compliance.
Draft, review, and execute CDAs/MSAs and support BD and clients regarding other documentation work.
Collaborate with R&D and BD to draft proposals, including technical scoping, pricing strategies, and timeline.
Optimize and maintain the Price Book by analyzing market trends and internal cost structures.
Facilitate cross-site subcontracting processes.
2. Project Management
Monitor progress of R&D projects, update status, and flag risks/delays proactively.
Track and manage change orders in the project.
Oversee accurate labor hour recording by R&D teams and analyze resource allocation efficiency.
Collaborate with China-based teams to analyze project metrics (e.g., timelines, budgets, deliverables) and generate actionable insights.
3. Cross-Functional Coordination
Serve as a liaison between US and China teams to align priorities, resolve conflicts, and ensure data consistency.
Drive process improvements to enhance operational efficiency and scalability.
Qualifications:
Education: Bachelor or Master’s degree in Chemistry, Pharmaceutical Sciences, or related field.
Experience: at least one year in polymorph/crystallization research, familiar with polymorph/crystallization project workflows, timelines, and technical requirements.
Skills:
Excel/data analysis skills (e.g., pivot tables, dashboards).
Strong cross-cultural communication and stakeholder management abilities.
Deadline-driven with meticulous attention to detail.
Logical problem-solving and process optimization mindset.
Fluency in English; Mandarin proficiency is a strong plus for collaboration with China teams.
How to Apply
Resume can be e-mailed directly to: career_us@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
Position Summary
Crystal Bio Solutions is a CRO providing global-standard services in GLP/GCLP bioanalysis and biomarker. Our clients include multinational pharmaceutical companies and biotech companies.
The Bioanalysis & Biomarkers Department specializes in Method Development, Method Validation, GLP/GCLP Bioanalysis for PK, and biomarkers. The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects. The role is responsible for providing bioanalytical support for both pre-clinical and clinical projects and partnering with our clients for project success.
Key Responsibilities
Independently propose assay design and/or strategy, develop, validate, conduct, and troubleshoot LCMS-based bioanalytical methods for the quantification of small molecule (and its metabolites) and biologics (e.g. ADC, mAB, protein, peptide, oligonucleotide etc) in support of PK, and Biomarker measurement
Conduct or oversee GLP/GCLP sample testing and data reporting.
Present and interpret data internally and/or externally as needed.
Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.
Serve as Subject Matter Expert (SME) for LCMS platform.
Ensure GLP/GCLP compliance
Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports.
Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
Assist in establishing and improving policies, procedures, work instructions and SOPs.
Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance.
Perform other related duties as assigned.
Qualifications & Educational Requirements
Ph.D., M.Sc., M.A., B.A., in Biology, Immunology, Chemistry, Pharmacology, or other related scientific fields required, including a minimum of 4+(Ph.D.), 9+(Master’s) or 12+(Bachelor’s) years of CRO/Pharma/Biotech experience.
Experienced with LCMS or tandem Mass-Spec method development and validation for PK and/or biomarker analysis
Experience with liquid handlers and other automation platforms for sample preparation and assay process
Hands-on experience and strong knowledge of GLP/GCLP bioanalysis.
Experience with Watson LIMS and in CRO environment is preferred.
Supervisory experience in both project and talent (people) management is preferred.
Ability to work independently and pay good attention to details.
Ability to achieve objectives/timelines through collaborative efforts with co-workers, managers, and clients.
Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.
Effective writing and communication skills.
How to Apply
Resume can be e-mailed directly to: Career_Us@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
Position Summary
Crystal Bio Solutions is a CRO providing global-standard services in GLP/GCLP bioanalysis and biomarker. Our clients include multinational pharmaceutical companies and biotech companies.
The Bioanalysis & Biomarkers Department specializes in Method Development, Method Validation, GLP/GCLP Bioanalysis for PK, immunogenicity and biomarkers. The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects. The role is responsible for providing bioanalytical support for both pre-clinical and clinical projects and partnering with our clients for project success.
Key Responsibilities
Independently propose assay design and/or strategy, develop, validate, conduct, and troubleshoot bioanalytical methods, including PK, ADA (Immunogenicity) and Biomarker, for GLP/GCLP sample testing and data reporting. Present and interpret data internally and/or externally as needed.
Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.
Serve as Subject Matter Expert (SME) for LBA (ELISA multimode reader & Meso-Scale Discovery (ECL)).
Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports.
Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
Assist in establishing and improving policies, procedures, work instructions and SOPs.
Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance.
Perform other related duties as assigned.
Qualifications & Educational Requirements
Ph.D., M.Sc., M.A., B.A., in Biology, Immunology, Chemistry, Pharmacology, or other related scientific fields required, including a minimum of 4+(Ph.D.), 9+(Master’s) or 12+(Bachelor’s) years of Pharma/Biotech/CRO experience.
Hands-on experience and strong knowledge of GLP/GCLP bioanalysis.
Experience in LBA-based Method Development, Validation for PK, ADA (Immunogenicity) and PD Biomarker assays.
An extensive knowledge of Immunogenicity Method Development, Validation and Sample Analysis is highly desirable.
Experience with Watson LIMS and in CRO environment is preferred.
Supervisory experience in both project and talent (people) management is preferred.
Ability to work independently and pay good attention to details.
Ability to achieve objectives/timelines through collaborative efforts with co-workers, managers, and clients.
Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.
Effective writing and communication skills.
How to Apply
CV can be e-mailed directly to: career_us@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
Position Summary
Crystal Bio Solutions is a CRO providing global-standard services in GLP/GCLP bioanalysis and biomarker. Our clients include multinational pharmaceutical companies and biotech companies.
The Bioanalysis & Biomarkers Department specializes in Method Development, Method Validation, GLP/GCLP Bioanalysis for PK, immunogenicity and biomarkers. The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects. The role is responsible for providing bioanalytical support for both pre-clinical and clinical projects and partnering with our clients for project success.
Key Responsibilities
Independently propose assay design and/or strategy, develop, validate, conduct, and troubleshoot bioanalytical methods, including PK, and Biomarker, for GLP/GCLP sample testing and data reporting. Present and interpret data internally and/or externally as needed.
Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.
Serve as Subject Matter Expert (SME) for FLOW Cytometry
Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports.
Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
Assist in establishing and improving policies, procedures, work instructions and SOPs.
Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance.
Perform other related duties as assigned.
Qualifications & Educational Requirements
Ph.D., M.Sc., M.A., B.A., in Biology, Immunology, Chemistry, Pharmacology, or other related scientific fields required, including a minimum of 4+(Ph.D.), 9+(Master’s) or 12+(Bachelor’s) years of Pharma/Biotech/CRO experience.
Hands-on experience and strong knowledge of GLP/GCLP bioanalysis.
Experience in Flow Method Development, Validation for PK, and PD Biomarker assays.
Knowledge and hands on experience in one or more of the following assay platforms, Cell-Based Assays, qPCR, dPCR, ELISpot, are highly desirable
Supervisory experience in both project and talent (people) management is preferred.
Ability to work independently and pay good attention to details.
Ability to achieve objectives/timelines through collaborative efforts with co-workers, managers, and clients.
Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.
Effective writing and communication skills.
How to Apply
CV can be e-mailed directly to: career_us@crystalpharmatech.com. Be sure to denote the Job Title of the position you are applying.
Crystal Formulation Services Co., Ltd.,
Crystal Formulation Services (CFS), a wholly owned subsidiary of Crystal Pharmatech Co., Ltd., was founded in July 2021 in Suzhou, China. CFS provides oral formulation development and manufacturing services of innovative drug products to pharmaceutical companies around the world.
As a formulation CDMO, our core technical team possess rich drug product development experience (worked on more than 100 new chemical entities (NCE),19 of which have been successfully commercialized). We embrace a molecule-material-medicine (M3) philosophy, whereby we set the formulation strategy of any given NCE according to its clinical needs, molecular properties and API characteristics and develop the most suitable composition and process to make the envisioned formulation a reality. Our technical strength is a deep understanding of the interplay among material properties, formulation process and product performance. The M3 philosophy and technical strength enable CFS to deliver, right the first time, robust formulations tailor-made for our clients’ molecules that are bioavailable, stable, and scalable with a line of sight to market and commercial production. We dive deeply into oral formulation science and strive to become a first-class CDMO in this area.
Job Description
The BD salesperson is responsible for developing formulation CDMO and clinical supply business in the US market, identifying and nurturing client opportunities to increase CFS' revenue and market share. Responsibilities also include effectively acquiring new business in small and medium-sized biotech as well as large pharmaceutical companies. The BD sales person will directly report to the Head of Business Development of CFS (China) with a dotted line to the US BD head of Crystal Pharmatech.
This BD sales position will be primarily based on the west coast of the US with travels across the country on special business needs, e.g. conference, company meeting, etc.. It is a work from home position with flexible working hours. The position is based most preferably in the San Francisco Bay area, though San Diego or Los Angeles area can also be considered.
Roles and Responsibilities
Serve as Business Development Representative in the US for CFS CDMO and clinical supply business and perform all associated duties as resourcing requires; Interact with clients as needed to explain Company’s operational strategy and related budgeting approaches; and conduct pricing negotiations
Responsible for the client and opportunity data collection and integrity in CRM tool(e.g., Track and report the status of upcoming opportunities, calculate, and track corporate win rates on a regular basis)
Identify CDMO business opportunities and secure them by getting the BDM or SME to the client meeting. Advises BD team on prospecting and closing new projects. Monitor monthly, quarterly, and annual BD proposals and review with the global team on regular basis.
Work closely with R&D team and PM team to streamline project execution and completion
Responsible for development and management of annual BD budget for the US market
Work with the CFS Business Development Team, as well as Crystal Pharmatech US BD team to ensure consistent messaging and approaches on global projects, proposals, and marketing materials, attend annual marketing events at industry conferences
Qualifications Requirements
High school, BS, or MS Degree (scientific/engineering disciplines preferred but not excluding liberal arts fields) with 0-3 years of business development experience
Strong passion for sales with entrepreneur mindsets
A people person with excellent interpersonal, communication and networking skills
Proactively explore business opportunities and develop business needs
Experience or background with science and engineering, formulation development, CRO/CDMO is preferred
Ability to work effectively as an individual or a part of a team
Understands clients' needs and proactively develop business needs
Up to 50% travel is required, domestic, with occasional international travels (e.g., China, Europe)
Physical Requirements
Be able to travel for long distances in various methods of transportation (i.e. car, airplane, shuttle bus, etc.)
Be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop
How to Apply
CV can be e-mailed directly: cfs_recruit@crystalpharmatech.com
Please denote the Job Title of the position you are applying for.
