About Us

Company Mission

 

JOINN Biologics is a Bay Area, California-based CMO 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 will work closely with our partners and clients to further accelerate the development of high-quality biologics to meet patient’s needs and deliver long-lasting value to biopharmaceutical industry.

 

Management Team

Tao He, PhD

20+ years in pharma (Novartis, Wyeth, and Pfizer). Led and supported multiple biologics programs from preclinical through IND filing.

Jonathan Blackie

25+ years leadership roles (Bayer, Biomarin) in Manufacturing Sciences, Commercial and Clinical Manufacturing Operations, and Global Business Process Integration.

Liang Xia, PhD

15+ years in biopharma (DesigneRx) led protein therapeutics development from early clinical through pre-commercialization stages. Broad experiences in QA/QC, cGMP manufacturing, and IND filing.

Shumin Yang, PhD

15+ years in Biologic Product and Process Development, especially Upstream Process Development (Boehringer Ingelheim, Catalent)

Zhiping Yao, PhD

15+ years in pharma and biotech for Drug R&D (Merck, Novartis, Harbour Biomed), 20+ years in Protein Production and Analytics

Wen-Rong Jiang, PhD

20+ years in pharma (Roche, Pfizer) for Drug R&D, expert in Antibody Drug & Cell Line Development

Vincent Rubino

18+ years in Validation, QA, Commissioning and Qualification for biopharmaceutical manufacturing (Bayer, Biomarin, Sumsung Biologics)

Zelalem Mengesha

20+ years in Engineering for pharmaceutical manufacturing (Bayer)

JOINN GROUP

JOINN Biologics

Pre-Clinical and Clinical Manufacturing

Pre-clinical Evaluation

JOINN Laboratories is the sister company of JOINN Biologics, and has an excellent track record spanning over two decades for non-clinical safety evaluation.

NEWS

JOINN Biologics gave an oral presentation regarding Case Study of Antibody Developability Assessment at BioProcess International Conference (Gene to Market Track) on September 10, 2019, at Boston Convention and Exhibition Center (BCEC).
JOINN Biologics was invited to a panel discussion of “Innovative and Collaborative Contract Services to Accelerate Drug Development” at CABS 2019 BioPacific Conference, June 22, 2019, San Mateo, CA
JOINN Biologics presented a poster regarding cell line development at the Cell Line Development and Engineering Conference, June 18-20, 2019, San Francisco, CA
JOINN Biologics presented a poster regarding developability assessment at PEGS the Essential Protein Engineering Summit, April 8-12, 2019, Boston, MA

Careers

Life at JOINN Biologics

JOINN Biologics is a young company filled with energy. Life here is exciting. Here you can fully utilize your own expertise and you can be cross-trained by different departments, for skills from development to manufacturing, and to quality. No matter what field you were in, you can still learn new skills here.

Benefits

JOINN Biologics is an equal opportunity employer offering competitive compensation and benefits, which includes:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off
  • Parental leave
 

We are looking for highly motivated and determined individuals to fill the positions below.

To apply, please send your CV and cover letter to career@joinnbio.com

GMP Process Controls Systems Engineer

Joinn Biologics US Inc. is looking for a highly motivated and determined individual with expertise in Good Manufacturing Practice (GMP), biomanufacturing, facilities and laboratory support.

Essential Duties and Responsbilities:
  • Manage software backups, archiving, perform periodic review, provide assistance in retrieving trends and data based on manufacturing needs.
  • Provide technical automation support and troubleshooting to Manufacturing, Quality Control, Utilities, and Facilities according to established SOPs and departmental practices
  • Assist process engineering with the development of P&ID’s and process control requirements, as well as Functional Requirement Specifications (FRS).
  • Perform investigations related to manufacturing deviations and anomalies associated with automation systems and control system software
  • Perform automation related job functions as assigned, including, I/O lists, Instrumentation lists and the specification of instrumentation and control element.
  • Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines as they relate to assigned projects
  • Support IQ/OQ development and participate in systems analysis, validation and verification.
  • Support engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, and testing to meet end user requirements
  • Support automation activities by updating or authoring system specifications, user and functional requirements specifications, generating and executing necessary FAT and SAT protocols
  • Support small manufacturing process control projects related to corrective action, equipment performance improvement, and new equipment
  • Design, develop, and implement software/hardware improvements to automated process control and process monitoring equipment according to change control procedures
  • Communicate effectively with engineering staff and cross functional departments
  • Follow standard operating procedures and automation engineering documents
  • Experience programming and troubleshooting PLC’s, HMI’s and computerized system design, IQ/OQ, and support in a cGMP industrial setting preferred
  • Skilled at troubleshooting PLCs and HMIs and systems in a pharmaceutical or biopharmaceutical manufacturing facility. Specific knowledge of Allen-Bradley and SCADA control system products and video graphic chart recorders is required
  • Basic knowledge of ladder logic, electrical systems, instrumentation, and controls
  • Demonstrated knowledge of process control and machine automation in biotech or pharmaceutical manufacturing facility
  • Strong written and verbal communication skills
  • Able to interact with employees at all levels and cross functionally across multiple departments, team player.
Education and Experience
  • Bachelor’s degree in Engineering or equivalent degree from an accredited university.
  • Minimum of 2 years of diversified engineering experience with in-depth knowledge of industry requirements and applications within the Process Automation for BioPharmaceutical Manufacturing.
  • Minimum of 2 years of experience with industrial process control system including Siemens, PLC and SCADA based systems
  • Experience with the development of cGMP and GAMP automation lifecycle documents (URS, FRS, I/O List, etc.).
Physical Demands With or Without Accommodation:
  • Ability to stand for extended periods of time (approximately 6-8 hours)
  • Ability to repeatedly stoop, kneel, reach, stand, and walk throughout an 8-10 hour shift
  • Ability to lift, push, and/or pull up to 25 kg (55 lbs.)
  • Ability to have clarity and sharpness of vision for activities such as preparing data, transcribing, viewing a computer terminal, and expansive reading
  • Ability to be exposed to considerable noise from machinery
  • Ability to wear PPE as required

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

Work visa sponsorship not available; local candidates preferred.

Job Type: Full-time

To apply, send your CV to career@joinnbio.com.

GMP Plant Engineer

Essential Duties and Responsibilities
  • Responsible for the operation and maintenance of all development laboratory and GMP facilities and utilities.
  • Manage the maintenance program for all process and laboratory equipment.
  • Manage facilities systems and maintenance staff, including training, scheduling and review of activities.
  • Responsible for Environmental Health and Safety (EHS) within the scope of responsibilities.
  • Establish SOPs and performance metrics.
  • Prepare, review and execute qualification and validation documents for facilities and clean utilities.
  • Manage changes and deviations, as appropriate.
  • Perform facility risk management and implement corrective plans.
  • Ensure client confidentiality and data integrity.
Experience / Qualification
  • Minimum ten (10) management experience in GMP pharmaceutical facilities operation is required.
  • System owner and process lead for all site sterilization systems (CIP/SIP, Autoclaves, clean steam)
  • Minimum of bachelor’s degree with major in mechanical, electrical or chemical engineering, or equivalent facilities experience is required.
  • Experience in operation of GMP and non-GMP utilities and systems including HVAC, WFI, pure steam, clean dry air, process gases, plant steam, chilled water, waste water, fire protection, electrical power, etc.
  • Knowledgeable about cGMP compliance requirements for pharmaceutical manufacturing facilities.
  • Project management skills and ability to coordinate complex projects under demanding timelines.
  • Excellent communication skills, leadership, and learning ability.
  • Experience with implementation and system ownership of IT systems (ERP, CMMS, MS Project).
  • Lean, 6-sigma and operational excellence background.
  • Self-motivated and organized.
Physical Demands With or Without Accommodation
  • Ability to stand for extended periods of time (approximately 6-8 hours)
  • Ability to repeatedly stoop, kneel, reach, stand, and walk throughout an 8-10 hour shift
  • Ability to lift, push, and/or pull up to 25 kg (55 lbs.)
  • Ability to have clarity and sharpness of vision for activities such as preparing data, transcribing, viewing a computer terminal, and expansive reading
  • Ability to be exposed to considerable noise from machinery
  • Ability to wear PPE as required
  • Work visa sponsorship not available; local candidates preferred.

Job Type: Full-time 

Experience: Management: 5 years (Required) 

Education: Bachelor’s (Preferred) 

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

GMP Manufacturing Associate: Cell Culture

Essential Duties and Responsbilities:
  • Perform unit operations including, but not limit to, inoculum seed train, batching, inoculation of bioreactors, process monitoring, centrifugation, depth filtration and micro filtration; performs and documents work per cGMP; adheres to all regulation and safety standards required by site.
  • Assemble process equipment for CIP/SIP, autoclaving or production, prepare media and transfer into stainless steel or disposable bioreactor.
  • Perform daily analysis of cell culture, maintenance of analytical equipment.
  • Support Installation Qualification/Operational Qualification/Performance Qualification of process equipment.
  • Create or revise SOP and batch records.
  • Maintains work areas to meet cGMP requirement; maintains own training within compliance.
  • Flexible to adapt schedule to meet production demand.
  • May be required to support part cleaning, process assembly preparation, media/buffer preparation.
Experience / Qualification
  • Associate/Bachelor’s degree in science related area or engineering; or biotech certificate with two plus years of experience in a biotech manufacturing environment.
  • Experience in upstream biologics manufacturing is preferred, such as cell cultivation in shaker flasks, stainless steel/disposable bioreactor, cell culture harvest.
  • Ability to work a collaborative environment.
  • Excellent communication skills.

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

GMP Sr. Manufacturing Associate

We are seeking Senior Manufacturing Associate in cGMP facility. The incumbent will perform start-up and test of equipment, execute and coordinate unit operations in upstream manufacturing, support equipment implementation, qualification and validation activities.

Essential Duties and Responsbilities:
  • Independently perform unit operations including, but not limit to, ProA HPLC, SEC, CEX, AEX, UF/DF, Viral Filtration inoculum seed train, batching, inoculation of bioreactors, process monitoring, centrifugation, depth filtration and micro filtration; performs and documents work per cGMP; adheres to all regulation and safety standards required by site
  • Independently assemble process equipment for CIP/SIP, autoclaving or production, prepare media and transfer into stainless steel or disposable bioreactor
  • Perform daily analyses of cell culture, maintenance of analytical equipment
  • Support Installation Qualification/Operational Qualification/Performance Qualification of process equipment
  • Authoring/reviewing SOP and batch records
  • Maintains work areas to meet cGMP requirement; maintains own training within compliance; performs training to peers if needed
  • Flexible to adapt working schedule to meet production demand
  • May be required to support part cleaning, process assembly preparation, media/buffer preparation
Required Experience / Skills
  • Associate/Bachelor’s degree in science related area or engineering with two year experience; or biotech certificate with four plus year experience in a biotech manufacturing environment
  • Experience in upstream biologics manufacturing sciences, such as cell cultivation in shaker flasks and bioreactors, cell culture harvest
  • Experience in stainless steel or disposable bioreactor operation and maintenance
  • Ability to work a collaborative environment
  • Excellent communication skills

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

GMP Fill and Finish Manager

The Manager of GMP Manufacturing for Fill Finish is responsible to lead a team of professionals while overseeing the GMP manufacturing process, through the broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the fill finish area of bioprocessing.

Essential Duties and Responsbilities:
  • Independently plan and manage all aspects of tech transfer, fill finish and assembly operations as required
  • Review vendor batch records and provide oversight for all specified manufacturing operations undertaken
  • Throughout ensure cGMP compliance and all its related elements in documentation, reports and records
  • Responsible for managing a team of professional production associates
  • Oversight of GMP Fill Finish manufacturing associates and area
  • Ensures the successful technical transfer of projects from the Tech transfer group to the GMP production group
  • Works closely with the production staff to troubleshoot process and equipment problems
  • Actively participates in all recruiting efforts to secure, onboard and develop new staff members
  • Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improve and production records
  • Generates operational protocol(s) and production records
  • Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives
  • Liaise closely with Quality Assurance (QA) activities with respect to Drug Product manufacture, release, inventory management and distribution, and as pertains to vendor selection, qualification and monitoring and all other activities related to cGMP, GCP and ICH guidelines
  • Will overview PD materials, equipment, methods for GMP compliance and scalability
  • Expands the technical capabilities of the GMP Group
  • Effectively communicates results of departmental work through team discussions and documentation
  • Initiate non-conformances when identified and complete investigations to support on-time closure of deviation records
  • Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns
  • Recommends equipment, supply purchases within the production areas
Experience / Skills
  • B.S. in Engineering or Science discipline and 8+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Science discipline plus 6+ years of GMP biologic manufacturing experience. Some or all of this experience should be in fill/finish processing.
  • Experience with GMP fill finish operations and sound understanding of the drug development process
  • Minimum of 3 years of leadership experience required
  • Has considerable knowledge/expertise relevant to fundamental lab technologies, particularly focused on protein expression, isolation and analysis
  • Has excellent understanding and knowledge of all fill finish operations including aseptic hand filling and automated filling of liquid vials
  • Has demonstrated track record of managing hands-on cGMP manufacturing operations
  • Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules
  • Ability to produce successful results in a fast-paced environment, under minimal supervision while leading a team of professional production associates
  • Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

GMP Manufacturing Supervisor

We are seeking Supervisor of Manufacturing in cGMP facility. The incumbent will perform start-up and test of equipment, execute and coordinate unit operations in upstream and downstream manufacturing, support equipment implementation, qualification and validation activities.

The Manufacturing Supervisor has a balanced focus on effective leadership and high, technical competency. To be successful, the Supervisor must execute on; strong leadership principles, focus on developing the best team and deliver result inline with expectations.

Essential Duties and Responsbilities:
  • Leadership
    • Accountable for the day-day operations of an area that requires making appropriate decisions including the trouble shooting of equipment, action to process deviations and schedule adjustments with minimal oversight
    • Accomplishes tasks through direct effective supervision of staff
    • Provides direction and training to staff using established policies and standards
    • Management of staff that is result-focused and driven by efficiency and productivity
    • Lives company values and sets the standards for others to operate
  • Contribution
    • Ability to independently manage assigned projects and deliver results within expectations
    • Responsible for projects that span multiple functional areas
    • Receive assignments in the form of objectives with goals and steps to meet as defined
    • Administers and executes policies and procedures that affect individual staff
    • Work is reviewed by management to measure meeting of defined objectives
    • Maintain work areas to meet GMP requirements
  • Process Knowledge
    • Working knowledge and relationship of process equipment, operation and compliance
    • Working knowledge of biopharmaceutical manufacturing process including mammalian cell culture, filtration, column chromatography, protein purification, bulk drug manufacturing.
    • Ability to troubleshoot, support resolution and communicate processing issues.
    • Collaborate with technical support groups as operations representative
    • May perform ongoing operational tasks of the area
    • Support Installation Qualification, Operational Qualification and Performance Qualification of process equipment.
    • Uses scientific thinking and decision making in daily work
  • Technical Documentation
    • Lead or participate on team responsible for drafting and approving operation procedures
    • Incorporate new technologies, practices and standards into procedures
    • Write and review process reports to support Quality commitments
    • Authoring and reviewing of SOPS and batch records
  • Quality and Compliance
    • Complete understanding and adherence of cGMP as related to commercial operations
    • Ensure timely completion of quality documentation to meet established expectations
    • Initiate and own required Corrective and Preventative actions and lead change control actions
  • Business
    • Support trending and communication of defined department metrics
    • Identify and drive opportunities for process optimization
    • Translates company and department goals into actionable objectives for self and staff
Experience / Skills
  • Associate/Bachelor’s degree in science related area or engineering with six year experience; or biotech certificate with four plus year experience in a biotech manufacturing environment
  • Experience in upstream biologics manufacturing sciences, such as cell cultivation in shaker flasks and bioreactors, cell culture harvest.
  • Experience in stainless steel or disposable bioreactor operation and maintenance
  • Ability to independently manage work, action and expectations is essential.
  • Proven organizational, leadership and communication skills
  • Ability to work a collaborative environment
  • Experience with process development, process transfer and start up preferred.

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

Manager of Manufacturing Operations

Essential Duties and Responsbilities:
The Manager of the Manufacturing Operations department is responsible for the production of clinical/commercial biopharmaceuticals in a multi-product environment. The duties include media/buffer solution preparations, cell culture and bioreactor operation and all protein purification operations. This position provides centralized oversight and administration of Contract Manufacturing Operations.
 
The Manager is accountable for managing the activities of the staff, monitoring the maintenance of production equipment and facilities in the Manufacturing Suite, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices.
 
Experience / Qualification
Supervisory and Management:
  • Manage the bulk manufacturing work unit to meet market or inventory demand for two commercial biotechnology products. Monitor inventories and departmental budget. Staff positions as required.
  • Ensure optimal staffing and scheduling of personnel
  • Assure that production equipment and facilities are maintained in proper working condition and in a validated mode by assuring use of Change Control procedures.
  • 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 supervisors.
  • Review and approve all technician, lead and supervisor performance evaluations and promotion recommendations.
  • 50% or more of time is spent in work directly and closely related to carrying out exempt functions.
  • Provide a safe environment for employees. Ensure that monthly Safety and Housekeeping Audits are conducted. Ensure that Departmental Safety Training is performed and documented.
  • Handle Employees’ complaints and disciplining when necessary.
  • Interview, select and train employees.
Scheduling and Training
  • Schedule all manufacturing operations with the facility and regularly communicate the schedule within the manufacturing department and to other groups as necessary.
  • Distribute and delegate work.
  • Supervise the training of operations staff in cell culture and/or purification processes.
  • Technical Leadership:
  • 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.
Documentation
  • 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 adequate training of departmental personnel in cGMPs and SOPs. 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).
  • Work visa sponsorship not available; local candidates preferred.

Job Type: Full-time

Experience: Management: 5 years (Required)

Education: Bachelor’s (Preferred)

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

IT Support Technician

We are seeking a service-oriented and self-motivated professional to join our IT support team. In this role, you will work on maintaining and monitoring the computer systems and networks for our business. You will be tasked with solving complex technical issues and will also collaborate with team members across all departments to assist them with their technical requirements. Responsibilities include but not limited to,

Essential Duties and Responsbilities:
  • Installing and configuring IT hardware, software, systems, networks, printers and scanners
  • Monitoring and maintaining computer systems and networks
  • Responding in a timely manner to service issues and requests
  • Providing technical support across the company
  • Establish accounts for new users and assist with password or login problems.
  • Troubleshoot and resolve issues with software or hardware.
  • Researching, testing and evaluating new technology.
  • Maintain procedures and reports that provide technical support to the entire organization.
  • Analyze records and logs to spot underlying trends and potential issues.
  • Support the implementation of new solutions or applications.
Education and Experience
  • Associate’s or bachelor’s degree in computer science or a related field.
  • 0-2 years of experience in a technical support role.
  • Certifications are preferred, but not required.
  • Working knowledge and expertise with Windows and a variety of software, hardware, and applications.
  • Able to climb ladder and crawl through tight spaces to pull Ethernet cables
  • Experience working with various IT hardware preferred, like installing Wi-Fi access points, network jacks and crimping Ethernet cables, etc.
  • Willingness to solve complicated problems and see projects through to completion.
  • Troubleshooting skills to study problems and records and identify solutions.
  • Team-oriented attitude to help other colleagues and departments with technical problems.
  • Must be a good listener to understand co-workers’ needs
  • Ability to manage time and effectively prioritize numerous projects at one time.
Physical Demands With or Without Accommodation:
  • Ability to stand for extended periods of time
  • Ability to repeatedly stoop, kneel, reach, stand, and walk throughout an 8 shift
  • Ability to lift, push, and/or pull up to 25 kg (55 lbs.)
  • Ability to have clarity and sharpness of vision for activities such as preparing data, transcribing, viewing a computer terminal, and expansive reading
  • Ability to stand on lifts to install components on places over 20 feet high
  • Ability to wear PPE as required

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

Work visa sponsorship not available; local candidates preferred.

Job Type: Full-time

To apply, send your CV to IT@joinnbio.com

Process Development Scientist / Sr. Scientist

We are seeking a scientist or Sr. scientist in Biologics Process Development, 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.

Essential Duties and Responsbilities:
  • Design, develop and execute cell culture studies using aseptic technique in shaker flasks, glass bench scale bioreactors, and single-use bioreactors
  • Produce, analyze, organize, and manage critical data
  • Support definition and development of process control strategy
  • Authoring/reviewing development reports, process transmittals, and manufacturing records
  • Partnering with clinical manufacturing teams to provide upstream technical support to ongoing manufacturing activities
  • Identify and evaluate new/innovative technologies and work to implement new platforms with cross-functional early and late stage development teams
  • Good understanding of Quality by Design and Risk Management
Experience / Qualification
  • M.S./Ph.D. degree in bioengineering, chemical engineering, or a related field with 2+ years of industry experience, is preferred
  • Experience in upstream biologics process development and manufacturing sciences, such as cell cultivation in shaker flasks and bioreactors
  • Experience in benchtop bioreactor operation and maintenance
  • Ability to work a collaborative environment
  • Excellent communication
  • Ability to execute studies and experiments in the context of long-term commercialization plans

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

Principal Scientist, Biologics Formulation

Essential Duties and Responsbilities:
The Formulation Principal 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.
 
  • 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.
  • Preformulation 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 Experience / Qualifications
  • 10+ years’ industry experience with BS degree in related scientific discipline, or 8+ years’ industry experience with MS degree in related scientific discipline.
  • Will have expert understanding of preformulation 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

Job Type: Full-time

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

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.

Essential Duties and Responsbilities:
  • 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.
Experience / Skills
  • 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

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

Purification Scientist/Engineer, Process Development

We are seeking a Purification Scientist/Engineer, in the Process Development group. The incumbent will work with internal and external partners, to develop purification strategies in support of 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.

Essential Duties and Responsbilities:
  • Manage and execute in day-to-day laboratory operations, which includes planning and performing protein purification experiments, sample tracking and management, maintaining a scientific laboratory notebook, attending departmental/project meetings.
  • Perform comprehensive data analysis of process statistics, identify process deviations, and prepare technical reports and presentations.
  • Assist in the process transfer, lean & reliable execution of non-GMP scale-up or GMP scale-up production runs.
  • Motivated to drive operational excellence, including support for efficiency/productivity initiatives, and GxP/safety compliance.
Experience / Skills
  • 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.
  • Demonstrated ability to work both independently and within a team environment with multiple deliverables and timelines.
  • In-depth understanding of methodology and data interpretation in separations sciences and processes.
  • Experience in protein purification technologies from lab to manufacturing scale, such as operating chromatography such as Akata or filtration/ultrafiltration equipment, and in application of statistical/DOE tools for process development and data analysis.
  • Excellent written and verbal communication skills. Attention to detail and ability to keep detailed written records in a lab notebook.

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.

Business Development Associate / Manager

Essential Duties and Responsbilities:
  • Gain deep understanding about the company’s technology and services
  • Design and execute marketing campaigns to increase brand awareness and generate sales leads
  • Perform market research, identify potential customers, design and executive sales campaigns to reach target customers
  • Attend relevant scientific conferences and trade shows for networking and sales leads generation
  • Manage customer database
  • Follow up with clients to secure sales deals
  • Provide technical consultation to clients as needed
  • Prepare sales proposals to answer customers’ RFPs
  • Negotiate and close deals
  • Bridge between internal teams and external clients to fit sales and project needs
Experience / Qualification
  • Must be self-starter, results-driven, well organized
  • Bachelor’s degree required, in sales/marketing or biotech field
  • Previous business development experience with CRO or CMO preferred; Established network in biopharmaceutical field desired
  • Must be a good listener to understand clients’ needs;
  • Excellent written and oral presentation skills required
  • Must be a good team player, can work effectively with different departments within the company, and with external clients
  • Willing and able to travel up to 50% of time

Location: Richmond, CA 94806 

Work authorization: United States (Required) 

To apply, send your CV to career@joinnbio.com.