Close

Let's talk.

Your Full Service Premier CDMO

Careers

careers

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 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 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].

  • Toggle Career Information Associate Scientist, Analytical Development

    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 searching for a highly motivated associate scientist for our analytical development group. This is a great opportunity for research associates with background in biochemistry, chemistry or biology.

    Summary

    The Associate Scientist position in Analytical Development is responsible for routine analytical test, project specific analytical method development, method qualification/validation and transfer throughout the biotherapeutic CMC project. The candidate will characterize, establish and monitor the purity, potency and structure of drug substances and products using various analytical techniques, including but not limited to HPLC, LC-MS, CE, SDS-PAGE, ELISA, UV/Vis spectroscopy. The Associate Scientist will work in a team environment with members of the analytical, process development and QC group.

    Duties and Responsibilities

    Include but are not limited to:

    • Responsible for routine analytical sample testing.
    • Responsible for project specific assay development/qualification and protein characterization.
    • Transfer method to QC for product release.
    • Technical support to manufacturing, Quality and QC during manufacturing and/or QC investigations.
    • Prepare and/or review written technical reports, SOPs, test methods, etc.
    • Maintain accurate and well-organized laboratory records and notebooks.
    • Other duties as assigned.

    Required Qualifications

    • Bachelor degree or higher in Biochemistry, Chemistry or related discipline with 0-4 years’ experience. Job title will depend on education and related experience.
    • Experience with related techniques including but not limited to UV-Vis, HPLC, CE-SDS, cIEF, ELISA, light scattering, and Mass Spectrometry is desirable.
    • Experience working with proteins, antibodies, and associated analytical methods is highly desired.
    • Ability to solve challenging problems.
    • Self-motivated, reliable team member.
    • Excellent written and verbal communication skills.

    Other Qualifications

    • COMPUTER SKILLS – Demonstrate the ability to use a computer and applicable computer software effectively. Intermediate knowledge of Excel & Word, Adobe, and Outlook.
    • LANGUAGE SKILLS and MATHEMATICAL SKILLS – Demonstrate the ability to read, comprehend, and respond appropriately through written or verbal form; demonstrate tactfulness when communicating including internal communication with staff members of all levels; ability to communicate with a variety of audiences effectively. Ability to add, subtract, multiply, and divide in all measure units, using whole numbers, common fractions, and decimals.
    • REASONING – Demonstrate the ability to effectively apply common sense and follow through to daily tasks; demonstrate the ability to work with little or no supervision; demonstrate excellent analytical skills; demonstrate the ability to efficiently conduct research and ask appropriate probing questions to complete necessary tasks.
    • PHYSICAL DEMANDS – The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit and stand; use phone and headset; use hands, arms, finders to type; answer phones; write; use calculator; demonstrate strength to lift and carry materials weighing up to 10 pounds; demonstrate clear vision to read printed materials and a computer screen; hearing and speech to communicate in person and over the telephone.
    • SENSORY DEMANDS – The incumbent must spend long hours in intense concentration. The incumbent must also spend long hours on the computer entering information which requires attention to detail and high levels of accuracy.
    • MENTAL DEMANDS – There are a number of deadlines associated with this position, which may cause significant pressure. The incumbent must also deal with a wide variety of people on various issues.
    • REGULAR WORK SCHEDULE – Schedule varies depending on business needs; however, company normal business hours are 8:00am to 5:00pm, Monday – Friday.

    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 Associate Scientist / Scientist — Process Development Upstream

    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. The near-term goal of the company is to recommission the cGMP facility in JOINN Innovation Park and provide contracted manufacturing services soon.

    We are seeking Associate Scientists or Scientists in Department of Process Development Upstream, the incumbent will work with internal and external partners, to support bulk process development, characterization, technology transfer, and validation studies associated with the development and implementation of manufacturing processes, systems and facilities related to therapeutic mAbs and proteins.

    Responsibilities

    • Develop methods for transferring procedures/processes from laboratories to commercial-scale manufacturing production
    • Design, develop and execute cell culture studies using aseptic technique in shaker flasks, glass bench scale bioreactors, and single-use bioreactors
    • Acts as a Subject Matter Expert (SME) to train others in areas of expertise. Assists and offers guidance to the Process Development group and Manufacturing group as necessary to train on correlated processes
    • Responsible for the data review and analysis; prepare presentations, project plans as needed for internal and external discussions
    • Authoring/reviewing development reports, process transmittals, and manufacturing records
    • Identify and evaluate new/innovative technologies and work to implement new platforms with cross-functional early and late stage development teams
    • Collaborate with Manufacturing, Quality, Engineering, Validation staff to ensure manufacturing process equipment meets quality standards and is acceptable for use in clinical and/or commercial manufacturing
    • Good understanding of Quality by Design and Risk Management

    Required Experience and Skills

    • Knowledge and skill of mammalian cell cultures and concepts of cell metabolism, protein production, and characterization
    • Experience in upstream biologics process development and manufacturing sciences, such as cell cultivation in shaker flasks and bioreactors
    • Skill and knowledge of scaling up to 50 L or more in single-use technologies
    • Working knowledge of design of experiments and use of statistics for data analysis
    • Ability to think critically with excellent problem solving and troubleshooting skills
    • Excellent communication and ability to work independently and in a collaborative environment
    • Ability to execute studies and experiments in the context of long-term commercialization plans

    Education Requirements

    • Ph.D. degrees in chemical engineering, bioengineering, biochemistry, biotechnology, biology, or a related field and 0-2 years of work experience or B.S./M.S. and 0-5 years of work experience.

    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 Associate Scientist / Scientist — Process Development Downstream

    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. The near-term goal of the company is to recommission the cGMP facility in JOINN Innovation Park and provide contracted manufacturing services soon.

    We are seeking Associate Scientists or Scientists in Department of Process Development Downstream, the incumbent will work with internal and external partners, to support bulk process development, characterization, technology transfer, and validation studies associated with the development and implementation of manufacturing processes, systems and facilities related to therapeutic mAbs and proteins.

    Responsibilities

    • Set-up, operate and maintain lab/pilot scale separation and purification equipment
    • Prepare experimental plans, execute bench-top experiments and pilot trials including monitoring parameters, sampling, sample submission and data/ observations recording
    • Establish and develop processes from research to clinical and large-scale manufacturing for all aspects of the purification process including (but not limited to): resin screening studies, filtration studies, DOE, etc.
    • Assess the impact of process parameters on product performance, establish optimal parameters and controls, and execute phase appropriate process characterization experiments with considerations on upstream and downstream process impacts.
    • Serve as the SME to lead troubleshooting of equipment and processes. Oversee tech transfers and monitor GMP production runs as needed.
    • Analyze data and prepare presentations, data graphs, technical reports, and regulatory documents to support process related decision making and actively engage in scientific and technical discussions to support the decision.
    • Routine maintenance and operation of laboratory instrumentation.
    • Perform daily calibration, regular preventative maintenance and maintain instrument/equipment history logbook.
    • Collaborate with Manufacturing, Quality, Engineering, Validation staff to ensure manufacturing process equipment meets quality standards and is acceptable for use in clinical and/or commercial manufacturing.
    • Good understanding of Quality by Design and Risk Management

    Required Experience and Skills

    • In-depth understanding of protein chemistry and industry-standard purification processes (Affinity, IEX, SEC, Viral inactivation and filtration, depth filtration, TFF, UFDF, etc.) and equipment (AKTAs).
    • Hands-on purification experience with lab, pilot, or commercial scale processing.
    • Experience in process development, process characterization, and tech. transfer processes.
    • Self-motivated individual while being able to work well in a team environment.
    • Working knowledge of design of experiments and use of statistics for data analysis
    • Ability to think critically with excellent problem solving and troubleshooting skills
    • Excellent communication and ability to work independently and in a collaborative environment
    • Ability to execute studies and experiments in the context of long-term commercialization plans

    Education Requirements

    • Ph.D. degrees in chemical engineering, bioengineering, biochemistry, biotechnology, biology, or a related field and 0-2 years of work experience or B.S./M.S. and 0-5 years of work experience.

    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 Sr. Research Associate / Scientist / Sr. Scientist

    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.

    Summary

    The protein engineering and modification (PEM) department is a newly expanded capability of JOINN Bio with facility located at Sacramento, about 70 miles from JOINN Bio Richmond Campus. The PEM depart has a facility of a 20,000 sqft building equipped with state-of-art instrument for antibody discovery, molecular and cell biology, protein engineering, formulation, etc.

    Cell Line Development – Scientist Position
    We are seeking a highly motivated and detailed oriented research associate or scientist with background in immunological techniques and cell biology to join our Antibody Discovery group. The successful candidate will participate in all aspects of the discovery, characterization and early profiling of antibodies. This will involve extensive hands-on experiment in collaboration with the lead scientist or self-initiated. We are seeking for exceptional and highly motivated individuals to join our Cell Line Development team. A technical lead position is available in our Cell Line Development group for passionate, experienced scientist who committed working in an innovative and collaborative team. As a key member, you will contribute to designing, optimizing and executing cell line development workflows and platform improvement.

    Duties and Responsibilities

    Include but are not limited to:

    • Support/or lead therapeutic antibody discovery in the conduct of immunization in rodents, hybridoma and cloning;
    • Assist in antibody lead selection with ELISA assays and other platforms;
    • Assist with routine maintenance and operation of flow cytometry instruments;
    • Prioritize work on multiple projects and perform general lab organization and maintenance
    • Support and closely work with other divisions to advance departmental goals;
    • Plan experiments and outline research procedures to be followed;
    • Ability to follow Standard Operating Procedures and effectively document and present results to colleagues; and
    • Other duties as assigned

    Required Qualifications

    • Bachelor’s or higher degree in biological sciences or bioengineering;
    • Minimal 3-year experience in mammalian cell culture and in vivo pharmacology;
    • Experience with rodent handling is required, such as intravenous dosing;
    • Experience with flowcytometry is highly desired;
    • Experience with recombinant protein expression is desired;
    • Experience in molecular biology is highly desired
    • Excellent data analysis and problem-solving skills
    • Ability to multitask and work collaboratively with other team members; and
    • Excellent organization and communication skills.

    Other Qualifications

    • COMPUTER SKILLS – Demonstrate the ability to use a computer and applicable computer software effectively. Intermediate knowledge of Excel & Word, Adobe, and Outlook.
    • LANGUAGE SKILLS and MATHEMATICAL SKILLS – Demonstrate the ability to read, comprehend, and respond appropriately through written or verbal form; demonstrate tactfulness when communicating including internal communication with staff members of all levels; ability to communicate with a variety of audiences effectively. Ability to add, subtract, multiply, and divide in all measure units, using whole numbers, common fractions, and decimals.
    • REASONING – Demonstrate the ability to effectively apply common sense and follow through to daily tasks; demonstrate the ability to work with little or no supervision; demonstrate excellent analytical skills; demonstrate the ability to efficiently conduct research and ask appropriate probing questions to complete necessary tasks.
    • PHYSICAL DEMANDS – The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit and stand; use phone and headset; use hands, arms, finders to type; answer phones; write; use calculator; demonstrate strength to lift and carry materials weighing up to 10 pounds; demonstrate clear vision to read printed materials and a computer screen; hearing and speech to communicate in person and over the telephone.
    • SENSORY DEMANDS – The incumbent must spend long hours in intense concentration. The incumbent must also spend long hours on the computer entering information which requires attention to detail and high levels of accuracy.
    • MENTAL DEMANDS – There are a number of deadlines associated with this position, which may cause significant pressure. The incumbent must also deal with a wide variety of people on various issues.
    • REGULAR WORK SCHEDULE – Schedule varies depending on business needs; however, company normal business hours are 8:00am to 5:00pm, Monday – Friday.

    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].

Partner With JOINN Biologics

Contact Us