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fig. 1 —
Our Culture

Life at JOINN Bio

JOINN Biologics (JOINN Bio) is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We will work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry.

Culture
Culture

fig. 2 —
Current Openings

We are looking for highly motivated and determined individuals.

  • Toggle Career Information GMP Manufacturing Associate I / Associate II / Associate III (Sr. Associate)

    JOINN Biologics is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies.  JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry.

    We are seeking exceptional candidate(s) for Manufacturing Associate (I, II, or III) role(s) in our cGMP facility. The incumbent will execute and coordinate biopharmaceutical unit operations in accordance with cGMPs to produce biopharmaceuticals. The incumbent will also perform start-up and testing of process equipment, support equipment implementation, qualification and validation activities.

    Responsibilities:

    • Independently perform unit operations in one or more of the following areas:
      • Cell Culture: including cell banking, culture scale-up, bioreactor operations, filtration, media prep, process monitoring, centrifugation
      • Purification/Formulation: including column chromatography (ProA, SEC, CEX, AEX), filtration, TFF, buffer prep, bulk filling
      • Fill/Finish: including filtration, component prep, buffer prep, aseptic processing and filling, visual inspections
    • Independently document work per cGMPs, adhere to all applicable regulatory and safety standards.
    • Independently assemble, standardize, prepare, clean and operate process equipment.
    • Independently perform process monitoring, daily analyses, and maintenance of analytical equipment
    • Support validation activities including IQ/OQ/PQ of process equipment and processes
    • Execute SOPs and batch records, revise and/or author new procedures as appropriate
    • Maintain work areas to meet cGMP requirements
    • Train on all area procedures, maintain up-to-date training records, and perform training of peers as needed
    • Adjust work schedule to meet production demand, which may include overtime.
    • Individual work shifts will likely include regular weekend work.

    Required Experience and Skills:

    • Associate/Bachelor's degree in science or engineering, or biotech certificate or equivalent
    • Experience in a biotech/pharma manufacturing environment is preferred for Manufacturing Associate I, and required for Manufacturing Associate II or III.
    • Team player, must have the skills and ability to work in a collaborative environment
    • Excellent communication and documentation skills

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit
    package.
    Job Type: Full-time
    To apply, send your CV to [email protected]

  • Toggle Career Information Head of Purification, Process Development

    We are seeking the Head of Purification, Process Development. The incumbent will work with internal and external partners, to develop purification strategies to support production of monoclonal antibodies and recombinant proteins. The candidate should possess extensive knowledge and experience in separation sciences, and basic understanding of GLP and GMP regulations applicable to the biologics product and process development. The individual will be responsible for smooth tech transfer within the organization and with our clients.

    Responsibilities:

    • Lead and manage a team of scientists/engineers focused on downstream purification process development activities. Provide leadership to resolve purification investigations and technical issues in the process development and manufacturing areas.
    • Establish and maintain familiarity with contemporary industrial practices and technology focused on purification process development. Manage day-to-day laboratory operations, including prioritizing samples and studies, scheduling analyst assignments, and tracking timely progress of critical samples and studies to support project timelines. Provide reports on department output that evaluate operating effectiveness.
    • Provide strategic leadership in resource allocation and prioritization of analyses to assure alignment of department objectives and timely execution of experiments to support clinical development programs.
    • Motivated to drive operational excellence, including support for efficiency/productivity initiatives, and GxP/safety compliance.

    Required Qualifications:

    • Doctorate (Ph.D.) degree in chemical engineering, bioengineering, biochemistry, biotechnology, biology, , or a related field, with at least 2 years of industrial experience is preferred. B.S./M.S. with at least 5 years of industrial experience are also considered.
    • Demonstrated ability to lead teams, including cross-functional initiatives & strong ability to foster a collaborative work environment.
    • In-depth understanding of methodology and data interpretation in separations sciences and processes.
    • Expert in purification technologies from lab to manufacturing scale, in operating chromatography equipment such as Akta or filtration equipment, and in application of statistical/DOE tools for process development and data analysis.
    • Excellent communication and people management skills.
    • Ability to execute studies and experiments in the context of supporting long-term commercialization plans

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit package.

    Job Type: Full Time
    Location: Richmond, CA 94806
    Work authorization: United States (Required)

    To apply, send your CV to [email protected].

  • Toggle Career Information Project Manager

    We are seeking a Project Manager to JOINN US and support our growing family!  This role will be responsible for total project management and delivery of complex research, development, and production projects from the proposal stage through to successful project completion, in close collaboration with clients, partners, internal business units, and other key stakeholders.

    Responsibilities:

    • Leads cross-functional project coordination with technical, engineering, production, facility, quality, business development, marketing, and other related business units, and manages overall integration of project activities to complete projects on time, within budget, to specifications, and with accuracy and efficiency.
    • Establishes project goals within broad outlines provided by top management, directs project design, outlines and delegates tasks involved, and reports progress to all key stakeholders.
    • Develops and implements policies, standards, and procedures for project management.
    • Assesses project feasibility by analyzing technology, resource needs, and market demand; investigates project challenges; implements corrective measures; evaluates results; and makes recommendations for future improvement.
    • Conducts cost analysis, estimating expected costs for projects.
    • Recommends, prepares, and implements project budgets, bids, and contracts based on estimates.
    • Acts as a liaison between the Company, partners, clients, and vendors; manages day-to-day, real-time communications and expectations to all stakeholders; and cultivates client relationships.
    • Organizes project meetings, prepares agenda and minutes, and follows up on action items.
    • Consults and negotiates with clients to prepare project specifications.
    • Presents and explain proposals, reports, or findings to clients.
    • Addresses questions, concerns, and complaints throughout projects.
    • Ensures compliance with federal, state, local, industry, contractual, and Company regulations, standards, specifications, and best practices.
    • Performs other duties as assigned.

    Experience / Skills

    • Bachelor’s degree in Biological Sciences, Chemistry or related, or equivalent experience.
    • 5+ years’ relevant biotech and/or pharmaceutical industry experience in Chemistry, Manufacturing, and Controls (CMC) process development and current Good Manufacturing Practice (cGMP) manufacturing.
    • 5+ years’ experience in project management or external research collaboration management of biological molecules.
    • Experience in managing multiple complex projects and total project delivery in a cGMP manufacturing environment.
    • Experience in a Contract Manufacturing Organization (CMO) or Contract Research Organization (CRO).
    • Experience in technical transfer.
    • Understanding of the functional requirements of pharmaceutical facilities and technical, engineering, and manufacturing best practices.
    • Understanding of federal, state, local, and industry, cGMP, regulatory, environmental, and safety, federal, state, local, industry, regulatory, environmental, and safety regulations,
    • Hands-on client experience, including negotiation and management of bids, contracts, and agreements.
    • Excellent presentation and verbal and written communication skills.
    • Excellent interpersonal and customer service skills.
    • Excellent organizational skills, attention to detail, and ability to maintain a high level of accuracy.
    • Excellent time management skills with a proven ability to meet deadlines.
    • Strong analytical and problem-solving skills.
    • Strong supervisory and leadership skills.
    • Ability to prioritize tasks and to delegate them when appropriate.
    • Ability to work independently and collaborate as part of a cross-functional team.
    • Thorough understanding of or the ability to quickly learn about the project or product being developed.
    • Proficient with Microsoft Office Suite (Excel, Outlook, Word, and PowerPoint), Enterprise resource planning (ERP), and project management software.
    • Equivalent education and experience may substitute for stated requirements.

    Preferred Qualifications

    • SAGE X3 ERP experience.
    • Bilingual (English/Mandarin) communication skills (written and spoken)

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit package.

    Job Type: Full Time
    Location: Richmond, CA 94806
    Work authorization: United States (Required)

    To apply, send your CV to [email protected].

  • Toggle Career Information Proposal and Inside Sales Manager

    JOINN Biologics is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies.  JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry.

     

    The Role is to Manage day-to-day CDMO proposal development, including but not limited to:

    • Prioritizing proposal development efforts in collaboration with the Proposal, Business Development and Commercial teams.
    • Coordination cross-functionally (i.e., Project Management, Process Development, GMP Operations, Quality, Finance, Senior Leadership) to obtain technical, budget and schedule information
    • Writing and editing proposal language and developing pricing and project timelines to deliver cohesive, compelling proposals to potential clients
    • Develop and maintain standardized tools to support Business Development, including templates, libraries of standard proposal language and company offerings, databases of project, personnel, facility and other company information
    • Set-up and prepare responses to Requests for Information (RFIs), including coordination with SMEs/functional leads to prepare technical components of submissions
    • Support project change order development, including prioritizing and coordination with Project Management and SMEs to prepare scope and pricing
    • Work with BD, SME’s and finance team to assess the project financial performance against the initial pricing assumptions to allow adjustments to be made in future proposals
    • Lead process improvement initiatives based on lessons learned from existing projects to increase efficiency, effectiveness and success of future projects
    • Contribute to team and departmental initiatives outside of day-to-day proposal activities
    • Conduct outreach sales calls, emails, and video conferences to targeted customers and inbound inquiries.
    • Create a strong, courteous, and positive relationship with sales leads while providing accurate information about the product and company.
    • Participate in sales planning with ability to hit described sourcing and conversation targets.
    • Possess strong customer service skills with a customer-first attitude.
    • Support of special campaigns and events through a variety of media.
    • Effectively collaborate with outside sales representatives and customer service representatives for the best wholistic customer experience.
    • Maintain strong organizational skills; attention to detail and documentation within a CRM system.

     

    Preferred Qualifications:

    • Bachelor’s degree (B.S./B.A.) in a scientific discipline, communications, business or related field AND 2+ years of hands-on proposal development and/or project management experience
    • Experience working in biotech/pharma industry and/or contract manufacturing environment (specifically CDMO) highly preferred
    • Ability to be flexible, motivated, resourceful, and organized; Excellent written and verbal communication skills
    • Advanced proficiency in MS Office suite (Word, Excel, Project and Power Point)
    • Proven ability to multi-task at a high level and the ability to prioritize and adapt to changing deadlines and needs. Ability to prioritize, including the ability to deliver client-ready materials under strict deadlines.

    Key leadership attributes:

    • Leads with Integrity and Respect
    • Delivers Results
    • Demonstrates Business Acumen
    • Fosters Collaboration and Teamwork
    • Champions Change
    • Engages and Inspires
    • Coaches and Develops
    • Potential for career growth within an expanding team
    • Defined career path and annual performance review & feedback process
    • Cross-functional exposure to other areas of within the organization
    • Medical, Dental, Vision, and 401K 
  • Toggle Career Information QA Documentation Clerk

    Job Description

    JOINN Biologics is a SF Bay Area, California-based company committed to the advancement of
    biopharmaceutics through its premier contract development and manufacturing services. We provide a complete
    range of services from early cell line, process and analytics development to clinical manufacturing to global
    clients. We work closely with our partners and clients to accelerate the development of high-quality biologics and
    deliver long-lasting value to the biopharmaceutical industry.
    Self-motivated, resourceful, and collaborative QA Document Clerk

    Essential Duties and Responsibilities:

    • Follow all document control policies and procedures
    • Index and file paper documents
    • Organize electronic files
    • Copying and scanning documents
    • Data entry and other administrative support, not limited to typing, emails, scanning, and copying
    • Ordering supplies as needed
    • Labeling and organization of files and cabinets
    • Other duties as requested

    Required Qualifications:

    • Bachelor’s degree or technical discipline related to biology, biotechnology, chemistry or pharmaceutics.
    • Must have excellent organizational, interpersonal, and communication skills.
    • Must exhibit professional integrity and maturity with high degree of discretion dealing with confidential
      information
    • Must be able to work as a team and independently
    • Must be willing to perform repetitious tasks such as updating databases, filing, copying and scanning
    • Proficient in computer skills including Microsoft office
    • General knowledge of Federal and State regulatory requirements in a GxP environment

    Job Type: Full-time

    Requirements:

    • Administrative: 1 year (Required)

    Work Location:

    • One location

    This job is ideal for someone who is:

    • Dependable — more reliable than spontaneous
    • People-oriented — enjoys interacting with people and working on group projects
    • Adaptable/flexible — enjoys doing work that requires frequent shifts in direction
    • Detail-oriented — would rather focus on the details of work than the bigger picture
    • Innovative — prefers working in unconventional ways or on tasks that require creativity

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit package.

    Location: Richmond, CA 94806
    Work authorization: United States (Required)

    To apply, send your CV to [email protected].

  • Toggle Career Information Quality Assurance Senior Specialist (Batch Reviewer)

    JOINN Biologics is a contract manufacturing service company, located in San Francisco Bay Area with professional team and cGMP facility in JOINN Innovation Park. JOINN Biologics offers process development, including cell line development and cell culture, upstream process
    development, downstream process development, analytical services. The company also provide therapeutic protein drug cGMP manufacturing, from GLP IND to clinical phase manufacturing. There is a collaboration opportunity for clinical phase III and commercial stage cGMP manufacturing.

    Your Opportunity:
    The QA Associate will be responsible for the overall strategy and oversight of JOINN Biologics Quality and Compliance for API and final product. This candidate will be writing protocols and must have strong communication, technical writing, and statistical analysis skills.

    Responsibilities:

    • Review and approve manufacturing batch records (MBRs), standard operating procedures (SOPs), sample tables (STs) and laboratory control records and associated records, specifications, sampling plan, Inspection Plan.
    • Compiling, reviewing, and approving cGMP production lot files, including the Test record Sheets TRS, Batch Production Records, associated records, specification, sampling plan, QC reports and sampling plan.
    • Provide QA evaluation of discrepancies offering suggestions on improvement.
    • Collaborating with internal partners in Quality Assurance (QA), Quality Control, and Supply Chain.
    • Support internal and external inspections and audits.
    • Support and execute improvements and troubleshoot manufacturing and QC operations.
    • Create and revise SOPs or other QA & Compliance documents.
    • Provide technical input to reject starting materials, packaging materials, and intermediate, components or bulk products, and drug product for use in production.
    • Sign Certificate of Conformance (CoC) and Certificate of Analysis (CoA), if not required to be executed by an authorized person (AP).
    • Manage the Quality System records storage and archival processes, assist in the record keeping development and tracking of critical quality processes such as CAPA, Complaints, Internal/External audit findings, and Non-Conforming Reports.
    • Support the document control function as needed ensuring documents are initiated, reviewed, revised, and filed and archived in a timely and compliant manner.
    • Perform other Quality System duties in support of the Quality Assurance function as needed.
    • Assist with and may be assigned lead role on special projects with considerable complexity.
    • Monitor risk management activities.

    Knowledge, Skills, & Abilities

    • Must possess strong technical and analytical understanding of Biologics Manufacturing and testing.
    • Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques.
    • Knowledge of scientific principles and concepts as they relate to Operations and GMP.
    • Knowledge of CAPA, change control and deviation programs and requirements.
    • Great team player who is collaborative and positive.
    • Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
    • Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
    • Strong interpersonal, written/oral communication and problem-solving skills.
    • Knowledge of GMP regulations and understanding of FDA and other regulatory guidelines.
    • Proficiency in IT systems and software.
    • Proven ability as a team player.
    • Strong analytical and problems solving skills.
    • Ability to professionally express views and opinions.
    • Good listening skills and ability to accept conflicting point of views.
    • Strong verbal and written communication skills.
    • Strong organizational skills with attention to detail.
    • Ability to navigate different personality styles in a large, complex organization in a professional manner.
    • Ability to juggle multiple priorities.
    • Strong leadership principles, focus on developing the best team and deliver result in line with expectations.

    Qualifications/Experience

    • Bachelor’s degree in a scientific/technical discipline related to biology, biotechnology, chemistry or pharmaceutics.
    • 2+ years of related experience in the biopharmaceutical industry with an emphasis in Lot Release, Quality Assurance, Quality Control, Engineering, or Manufacturing in a GMP regulated industry or equivalent combination of education and experience.
    • 2 years of relevant experience in the biopharmaceutical industry with an emphasis in Clinical Manufacturing lot release in a GMP regulated industry.
    • Previous work experience in a GMP environment and exposure to manufacturing records, testing reports and SOPs.

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit package.

    Job Type: Full Time
    Location: Richmond, CA 94806
    Work authorization: United States (Required)

    To apply, send your CV to [email protected].

  • Toggle Career Information Quality Assurance Senior Specialist (Deviation, CAPA, and Change Control)

    JOINN Biologics is a contract manufacturing service company, located in San Francisco Bay Area with professional team and cGMP facility in JOINN Innovation Park. JOINN Biologics offers process development, including cell line development and cell culture, upstream process
    development, downstream process development, analytical services. The company also provide therapeutic protein drug cGMP manufacturing, from GLP IND to clinical phase manufacturing. There is a collaboration opportunity for clinical phase III and commercial stage cGMP manufacturing.

    Your Opportunity:
    The QA Associate will be responsible for the overall strategy and oversight of JOINN Biologics Quality and Compliance for API and final product. This candidate will be writing protocols and must have strong communication, technical writing, and statistical analysis skills.

    Duties and Responsibilities

    • Tracks and investigates Deviation, CAPA, and Change Control.
    • Manages the Quality System such as, tracking and archival of Changes, CAPA, Complaints, and Non-Conforming Reports.
    • Supports customer project teams and efforts in continuous improvement at JOINN Biologics.
    • Demonstrates success using compliance knowledge, creativity and regulatory perspectives to solve problems.
    • Exercises judgment within generally defined practices and policies in interpreting and applying regulations to GMP systems.
    • Interprets regulations and guidelines critical for advancement of QA systems.
    • Independently leads compliance activities in CAPA, Change Control, and Deviation quality systems.
    • Takes an active role in planning and implementation of QA long range goals for further development of key QA initiatives.
    • Accountable for decisions and results that ensure timelines are met.
    • May lead projects or represent QA interests in multidisciplinary project teams. Works closely with other team members in a cooperative fashion to ensure project progression.
    • May support and contribute to the direction and decisions of JOINN Biologics project teams.
    • Responsible for making recommendations in accordance with federal and international regulatory requirements and industry standards.
    • Collaborating with internal partners in Quality Assurance (QA), Quality Control, and Supply Chain.
    • Support internal and external inspections and audits.
    • Support and execute improvements and troubleshoot manufacturing and QC operations.
    • Create and revise SOPs or other QA & Compliance documents.
    • Provide technical input to reject starting materials, packaging materials, and intermediate, components or bulk products, and drug product for use in production.
    • Perform other Quality System duties in support of the Quality Assurance function as needed.
    • Assist with and may be assigned lead role on special projects with considerable complexity.
    • Monitor risk management activities.

    Knowledge, Skills, & Abilities

    • Must possess strong technical and analytical understanding of Biologics Manufacturing and testing.
    • Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques.
    • Knowledge of scientific principles and concepts as they relate to Operations and GMP.
    • Knowledge of CAPA, change control and deviation programs and requirements.
    • Great team player who is collaborative and positive.
    • Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
    • Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
    • Strong interpersonal, written/oral communication and problem-solving skills.
    • Knowledge of GMP regulations and understanding of FDA and other regulatory guidelines.
    • Proficiency in IT systems and software.
    • Proven ability as a team player.
    • Strong analytical and problems solving skills.
    • Ability to professionally express views and opinions.
    • Good listening skills and ability to accept conflicting point of views.
    • Strong verbal and written communication skills.
    • Strong organizational skills with attention to detail.
    • Ability to navigate different personality styles in a large, complex organization in a professional manner.
    • Ability to juggle multiple priorities.
    • Strong leadership principles, focus on developing the best team and deliver result in line with expectations.

    Qualifications/Experience

    • Bachelor’s degree in a scientific/technical discipline related to biology, biotechnology, chemistry or pharmaceutics.
    • 2+ years of related experience in the biopharmaceutical industry with an emphasis in Lot Release, Quality Assurance, Quality Control, Engineering, or Manufacturing in a GMP regulated industry or equivalent combination of education and experience.
    • 2 years of relevant experience in the biopharmaceutical industry with an emphasis in Clinical Manufacturing lot release in a GMP regulated industry.
    • Previous work experience in a GMP environment and exposure to manufacturing records, testing reports and SOPs.

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit package.

    Job Type: Full Time
    Location: Richmond, CA 94806
    Work authorization: United States (Required)

    To apply, send your CV to [email protected].

  • Toggle Career Information Quality Control, Analytical Department – Analyst II / Senior Analyst

    We are searching for a highly motivated Senior Quality Control Analyst or Quality Analyst II who has a minimum of 4 years of experience working in cGMP quality control laboratory environment with expertise in wet and protein chemistry to join our team. The candidate will be responsible for the qualification and execution of analytical laboratory tests and evaluations of product performance and processes in the Quality Control Department, in accordance with approved methodologies, policies, and associated regulations.

    Responsibilities:

    • Perform and review assays, under minimal supervision, for protein and wet chemistry tests including but not limited to: pH, conductivity, TOC, Osmolality, UV-VIS, HPLC, Capillary Isoelectric Focusing, SDS-PAGE, qPCR, ELISA, etc.
    • Comply with cGMPs, SOPs, GLPs, safety requirements, and all company policies.
    • Write and revise SOPs, technical protocols, and reports.
    • Perform validations, studies, or transfers of new analytical methods and modifications to current methods in accordance with applicable policies or guidelines.
    • Generate highly compliant and reliable test results via documentation and by following cGMP principles.
    • Train and mentor other analysts in the quality control department, such as performing laboratory procedures and assays.
    • Evaluate test data against defined criteria and specifications.
    • Identify and troubleshoot equipment and method issues.
    • Participate in out-of-specification and failure investigations and recommend corrective actions.
    • Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations.
    • Maintain PM (Preventative Maintenance) for laboratory equipment.
    • Establish and maintain a safe and inspection-ready laboratory working environment.

    Preferred Qualifications:

    • Minimum of BS/BA degree and 5 years working in a cGMP environment.
    • Bioassay and cell based assay experience.
    • Experience working in a Quality Control work environment, preferably in the pharmaceutical industry with knowledge of cGMPs or ISO regulations is desired.
    • Familiarity with relevant and current FDA, USP, EP, 21CFR, ICH guidelines and regulations.
    • Demonstrated knowledge of method development and qualifications.
    • Strong technical writing and analytical skills.
    • Excellent written, verbal, communication and interpersonal skills.

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit package.

    Location: Richmond, CA 94806
    Work authorization: United States (Required)

    To apply, send your CV to [email protected].

  • Toggle Career Information Senior Scientist, Analytical Development, Dept: AD/CLD

    JOINN Biologics is a California Bay Area-based company that is committed to the advancement of biotech and biopharmaceutics through our premier contract manufacturing and development services for biologics and advanced therapies. We are searching for a highly motivated bioassay Senior Scientist for our analytical development group.

    This position of Sr. Scientist, Analytical Development team, will lead the development, optimization, and transfer of analytical methods to support our process development and quality control. The successful candidate will be experienced with development and validation of physicochemical assays and will drive the phase-appropriate method development, optimization, qualification and tech transfer. The candidate will be expected to design and perform experiments and, organize, document, analyze and interpret results with a high degree of independence and leveraging sound scientific principles.

    Responsibilities:

    • Establish and oversee a high-performing team capable of supporting analytical development activities with an emphasis on physicochemical, biological, and compendial methods.
    • Evaluate and implement new technologies within the Analytical Development group, with a particular emphasis on separation techniques (HPLC/UPLC and CE), and binding-based assays.
    • Write/review SOPs, test method protocols, assay development, and qualification plans/reports.
    • Write/review analytical sections of IND/IMPD filings. Provide mentorship and training of junior-level scientists in the laboratory.
    • Coordinate activities of outside resources such as consultants and vendors. Represent analytical development group in project meetings.

    Required Qualifications:

    • Ph.D. in Biochemistry, Analytical Chemistry, or a related discipline with a minimum of 2 years of relevant industry work experience or a Master’s or Bachelor’s degree with a minimum of 6 years of relevant industry experience.
    • Proven expertise/experience in developing and qualifying/validating analytical methods to support product development and QC batch release, preferably for biologic products.
    • Strong background in physicochemical methods (e.g. UPLC/HPLC, CE) and bioassays (ELISA, qPCR), excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis, approaches.
    • Understanding of regulatory requirements for early-stage development of biologics including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents.
    • General understanding of statistical principles supporting method performance and robustness assessments as well as Design of Experiment approaches used for method development/optimization.
    • Excellent communication skills. Experience managing people in project-based or functional teams.
    • Working experience in biologic formulation development is a plus.

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit package.

    Location: Richmond, CA 94806
    Work authorization: United States (Required)

    To apply, send your CV to [email protected].

  • Toggle Career Information Senior QC Analyst, Supervisor

    JOINN Biologics (JOINN Bio) is a company located in Richmond, CA that is committed to the advancement of biotechnological industry through its premier contract development and manufacturing services for biologics and advanced therapies (a CDMO company). JOINN Biologics provides a complete range of services from early custom development to clinical manufacturing to our clients, world-wide. We will work closely with our partners and clients to further accelerate the development of high-quality biologics.

     

    Job Requirements and Responsibilities:

    • A minimum B.S. degree in a scientific discipline with 5 – 10 years of experiences in a cGMP compliant environment or equivalent combination of education and experience
    • Demonstrated knowledge and experience performing assays used to assess the quality of biopharmaceuticals, including HPLC, SEC, IC, Glycan Analysis, SDS-PAGE, CE, ELISA, SD-PAGE, q-PCR based residual DNA and UV/Vis.
    • Experience in Test Method Validation and transfer of test method between Analytical Development and Quality Control.
    • Experience participating in laboratory investigations of Invalid, OOS/OOT results and CAPA initiation.
    • Excellent written communication skills and proven ability to translate technical data into concise narrative/summary.
    • Candidates must be authorized to work in the U.S.
    • Perform QC testing of drug substance and drug product samples in support of in-process, lot-release, and stability testing by following written procedure.
    • Demonstrated knowledge and experience with Agilent HPLCs, Chemstation and Open Lab operating system.
    • Maintains compliance status of laboratories by monitoring equipment, instruments and pipettes calibration status, reagents and ensuring adherence to GMP requirements.
    • Documents testing activities and results, ensuring completeness and accuracy per cGMP.
    • Contributes toward the development, revision, application, maintenance, validation and review of methods SOPs. Initiates and follows up on change request for SOP revisions.
    • Train others in the theory and practice of such techniques. Focus on leading/overseeing defined processes.
    • Works under minimal supervision. Refers to policies and practices for guidance and follows established procedures. Contributes to the completion of specific team objectives and assigned project milestones.

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit package.

    Location: Richmond, CA 94806
    Work authorization: United States (Required)

    To apply, send your CV to [email protected].

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