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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 Quality Control, Microbiology Department – Analyst II / Senior Analyst

    JOINN Bio is looking for highly motivated and determined individuals with expertise in microbiology to join our quality team. The successful candidate will perform both Microbiological Testing and Environmental Monitoring of clinical manufacturing process samples. Role as either an Analyst II or Senior Analyst will be decided depending on level of experience and qualification

    Reporting to Quality Control Management, the Analyst II / Senior Analyst position for the Quality Control Microbiology Department will be responsible for performing microbiological testing and sampling for the Environmental Monitoring program. The Analyst II will play a critical role in implementing, maintaining, and improving JOINN Biological US Inc.’s microbiology department at JOINN Bio’s Richmond, CA CDMO manufacturing facility. This position may require off-shift hours including nights and weekend.

     

    Responsibilities:

    • Effectively coordinate the execution of the environmental and critical utility monitoring program for the Richmond, CA manufacturing site
    • Perform microbiological testing such as Bioburden, Conductivity, TOC, and Endotoxin per USP guidelines
    • Collaborate effectively across all departments to meet key objectives
    • Conduct technical assessments of deviations and investigations
    • Conduct routine trend analysis of environmental monitoring data and prepare associated trend reports
    • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
    • Write/revise SOPs, technical protocols and reports
    • Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations
    • Be proactive at keeping current with literature and latest technologies associated with contamination control principals
    • Effectively communicate internal issues related to performance, processes, and procedures
    • Establish and maintain a safe laboratory working environment
    • Accept, complete, and report on special assignments within the agreed upon timeframe
    • Act as designee for Quality Control as appropriate

     

    Required Qualifications:

    • BS/BA and minimum 5-8 years or MS and 2-5 years in cGMP environment, with a minimum of 2 years in a leadership role (preferred)
    • Familiarity with relevant and current FDA, EU, ICH, USP guidelines and regulations
    • Strong knowledge of contamination control principals
    • Demonstrated knowledge of method development and qualifications
    • Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively
    • Ability to manage multiple projects in a fast-paced environment
    • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
    • Excellent communication skills (verbal and written)
    • Experience with risk management principals and their application to the development and execution of environmental monitoring and critical utility monitoring programs, preferred

     

    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 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 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 Qualifications:

    • 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
    • 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.
    • 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

     

    Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefits 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 Associate Scientist / Scientist, Bioassay Analytical Development

    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 Scientist for our analytical development group.

    This position of Associate Scientist / Scientist, Analytical Development team, will lead the development, optimization, and transfer of bioassays, to support our process development and quality control. The successful candidate will be experienced with development and validation of in-vitro potency 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:

    • Responsible for conducting scientific research for the development, troubleshooting and qualify/validate of potency/plate-based methods for biologics.
    • Make detailed observations and analyze data to provide an interpretation of results.
    • Draft standard operating procedure, test method, study protocol, reports, and related scientific documents. 
    • Technical support to manufacturing, Quality, and QC during manufacturing and/or QC investigations.
    • Provide regular updates to the project team and management on project timelines and deliverables.
    • Maintain accurate and well-organized laboratory records and notebooks.

     

    Required Qualifications:

    • For Scientist Level: Ph.D. in a biomedical/biologic related field with 0+ years of industry-related experience or Master degree with 2+ years of related industry experience, or Bachelor degree with 4+ years of related industry experience.
    • For Associate Scientist Level: Master degree with 0+ years of related industry experience, or Bachelor degree with 1+ years of related industry experience.
    • Knowledge and experience in ELISA are expected.
    • Experience in molecular biology and qPCR is highly desired.
    • Experience in SoftMax Pro and CFX Maestro Software is highly desired.
    • Experience in operation and data analysis of Octet is a plus.
    • Experience in cell culture and cell-based assay is a plus.
    • Experience in analytical method development for release, stability, in-process testing, and product characterization of antibodies and proteins is a plus.
    • Basic understanding of GLP, GDP, and GMP requirements.
    • Good oral and written communication skills.
    • Ability to work both independently and collaboratively. Willingness to take on multiple responsibilities and work in small team environment.

     

    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 Scientist /Senior Scientist, Biologics Formulation

    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 Formulation Senior Scientist for our analytical development group.

    The Formulation Senior Scientist will provide technical leadership for the development of pre-clinical and early clinical stage candidates forms following quality by design (QbD) principles for the delivery protein-based therapeutic agents. The successful candidate will be expected to drive programs from inception through pre-clinical manufacture/screening, technology transfer, early cGMP manufacture, working closely with Quality and CMC counterparts as well as any necessary analytical method development, specification development, and assessment of stability data/programs.

     

    Responsibilities:

    • Independently performs and implements formulation strategies
    • Development of inject-able biologics dosage forms following quality by design (QbD) principles
    • Identifies drug product critical quality attributes impacting safety, efficacy, and manufacturing robustness. Provides input to define phase appropriate regulatory specifications
    • Performs screening of buffers, excipients, solubilizers, etc.
    • Pre-formulation characterization of preclinical and clinical compounds
    • Authoring and review of written documents including development reports, technical memos, etc.
    • Serves as formulation lead in multidisciplinary project teams and/or sub-teams
    • Work effectively in a cross-functional matrix environment, with internal and external customers and proactively communicate with internal and external stakeholders.

     

    Required Qualifications:

    • Scientist: 1-2 years’ relevant experience with MS or PhD degree in related scientific discipline, or 3+ years’ industry experience with BS degree in related scientific discipline.
    • Senior Scientist: 3-5 years’ industry experience with MS or PhD degree in related scientific discipline, or 6+ years’ industry experience with BS degree in related scientific discipline.
    • Will have expert understanding of pre-formulation and formulation area and uses published literature to extend understanding as well as consulting internal and external experts as needed
    • Highly independent and self-motivated and integrates well within a team
    • Ability to establish and maintain effective working relationships
    • Strong ability to trouble-shoot technical problems
    • Detail oriented, with good organizational skills and project management skills
    • Able to work in a high paced team environment meet deadlines and prioritize work on multiple projects
    • Excellent oral and written communication 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 GMP Manufacturing Associate/ Sr. Manufacturing Associate

    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 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/ Sr. Manufacturing Associate 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 weekend work

     

    Required Qualifications:

    • Associate/Bachelor’s degree in science or engineering, or biotech certificate
    • 2+ years of experience in a biotech manufacturing environment for Manufacturing Associate, or four plus years of experience  for Sr. Manufacturing Associate
    • 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.

     

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

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

  • Toggle Career Information Senior Scientist

    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 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 Manufacturing Associate / Senior Manufacturing Associate

    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 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/ Sr. Manufacturing Associate 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 weekend work

     

    Required Qualifications:

    • Associate/Bachelor's degree in science or engineering, or biotech certificate
    • 2+ years of experience in a biotech manufacturing environment for Manufacturing Associate, or four plus
      years of experience for Sr. Manufacturing Associate
    • 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.

     

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

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

  • Toggle Career Information Manager, Manufacturing Operations – Fill / Finish

    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 for 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 looking for a full time, highly motivated manufacturing manager with expertise in aseptic filling, Good Manufacturing Practices (GMP), and personnel management. The Manufacturing Manager is responsible for the production of clinical biopharmaceuticals in a multi-product environment. The position is responsible for supervising and overseeing all drug product aseptic filling and finish manufacturing activities, including final formulation and filtration, component preparation, filling/capping, labeling and inspection operations. The position requires significant on-the-floor activities, and subject matter expertise in aseptic filling operations. Additional job responsibilities include generation, execution and review of manufacturing and technical documentation, equipment and process trouble-shooting, staff training, compliance, and scheduling. The manager may also participate in validation activities, continuous improvement activities, investigations and trouble-shooting activities, support regulatory and site inspections, and provide input for capital and expense budgets.

    The Manager is accountable for managing the activities of manufacturing staff, monitoring the maintenance of production equipment and facilities in the manufacturing area, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices.

     

    Responsibilities:

    • Supervisory and Management:
      • Manage the upstream manufacturing work unit to meet production requirements and schedules. Monitor inventories and departmental budget.
      • Staff positions as required, including interviewing and candidate selection. Ensure optimal staffing and scheduling of personnel.
      • Supervise the training of upstream manufacturing staff. Ensure that departmental cGMP and safety training is performed and documented.
      • Author, review and/or approve departmental documentation and procedures, including batch records, SOPs, validation protocols, etc.
      • Assure that production equipment and facilities are maintained in proper working condition and cGMP compliance.
      • Lead and roll out Operational Excellence programs targeting department efficiency, production improvements, cost reductions, and deviation reductions.
      • Provide leadership and career development to the manufacturing staff. Author and review staff performance evaluations and promotion recommendations.
      • Provide a safe and compliant work environment. Ensure that routine safety and in-house compliance audits are conducted.
      • Handle employees’ complaints and disciplining when necessary.
      • Schedule all upstream manufacturing operations and regularly communicate the schedule within the manufacturing department and to other groups as necessary.
    • Leadership and Documentation:
      • Act as subject matter expert for fill / finish manufacturing operations.
      • Troubleshoot equipment and process failures.
      • Provide technical expertise to resolve manufacturing issues.
      • Lead process control and optimization programs.
      • Lead process/technology transfer projects, and the final stages of process development.
      • Supervise and perform, as needed, the creation and revision of production documents in order to maintain GMP compliance and efficiency. Ensure that all SOPs and batch records are maintained to reflect current manufacturing methods and are in conformance with product licenses.
      • Ensure timely submission and completion of all manufacturing investigation reports and documentation of deviations to minimize production delays.
      • Ensure that all compliance commitments are completed on time and provide documented evidence to support closure of each item according to the established timeline.
      • Generate, review and/or approve all manufacturing operations related documentation, including process validation protocols and variance reports, and the respective follow-up (Document Change Request forms, Engineering and Facility Change Control Request forms, Purchase orders, and Instrumentation Deviation Reports).

     

    Qualifications:

    • 3 years direct supervisory experience in a GMP environment (required)
    • 5 years direct experience in aseptic filling
    • Cell culture experience (preferred)
    • Bachelor’s education (preferred)

     

    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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