4D Molecular Therapeutics

4D Molecular Therapeutics Emeryville, CA, USA
Jun 14, 2019
This is not your ?everyday? manufacturing opportunity -- in this new and important role, your savvy business acumen and expertise in cGMP biologic manufacturing will help facilitate 4D?s road to a pivotal point in its history ? a fully integrated biopharmaceutical company with cGMP clinical manufacturing and future commercial facility. Reporting to the VP of Manufacturing/Supply Chain, you will manage & establish cGMP clinical pilot manufacturing plant operation and be a key driver to design, build, and commission state-of-the-art gene therapy clinical manufacturing plant. You will lead/manage cGMP pilot manufacturing and assist in quality, compliance and safety programs in line within defined timelines for the daily manufacturing operations of biologic products to support gene therapy clinical trial and product development. In addition, you will drive the implementation of process improvements/scale-up and liaise between various functional teams to ensure our cutting-edge gene therapy products are supplied of the highest quality and on schedule. You bring deep understanding of biologic manufacturing (API/DS background is preferred), Quality, Planning and Regulatory processes. The icing on the cake ? coupling your cGMP biologic manufacturing expertise with the most cutting-edge science in gene therapy! Responsibilities Manage supervisors/associates responsible for GMP production. Provide hands-on person-in-plant oversight and training as needed and ensure the operation within the pilot plant is conducted under current safety and cGMP guidelines. Ensure that plant operations SOPs are followed, batch records are adhered to, and that log books for room and equipment utilization are kept current with appropriate records. Manage production scheduling, including upstream, downstream, and fill/finish, coordinating with PD, QA, Analytical Sciences, and clinical development teams. Manage all aspects of GMP production, ensuring timely supply of raw materials, media/buffer, single use consumables and equipment spare parts, etc. to support the needs of each pilot manufacturing area. Maintain appropriate order records for audit purposes. Train scientists/engineers/associates on various process equipment and procedures. Coordinate third party/outside vendor trainings as necessary. Lead the reporting, investigation and resolution of deviations encountered during GMP production activities, working with manufacturing compliance and QA groups. Provide sufficient/regular training to ensure clinical batch records are complete with minimal documentation error and other deviations, and that the process deviation is investigated and complete in a timely manner following quality SOPs. Work with Process Development on a routine basis to ensure accuracy of tech transfer documentation to establish and execute batch records from solution prep, upstream cell culture, downstream purification, to fill finish operation. Guide manufacturing team to complete campaign report. Support scale-up and initiatives for new technology development and continuous improvement projects. Author, edit, and review master batch records based on tech transfer report, standard operating procedures, change controls, deviation reports, memos, and protocols/reports. Work with material management to ensure the ongoing security of the supply chain for raw materials and intermediates to assure the uninterrupted performance of vector production operations and provision of material for clinical programs; minimize downtime for utility & facility related to equipment failure, spare parts, calibration or related issues. Work with manufacturing support group/outside cleaning groups to supervise the cleaning crew to ensure facility is in good and appropriate condition for GMP manufacturing. Actively provide hands-on support for initial pilot plant facility commissioning, equipment qualification, start-up and operation for biopharmaceutical drug substance production. Work with engineering firm for manufacturing plant design/commissioning/qualification/ validation, and for material/instrument planning, crucial for initial operation for existing and future pilot plant. Work collaboratively with integrated CMC teams and support IND filings as related to clinical manufacture to advance Company goals. Ensures project deadlines and quality standards are established and met. Qualifications BS or MS in bioprocessing, chemical engineering, or biology with at least 10 (manager) to 15 years (sr. manager and associate director) of cGMP manufacturing experience in biopharmaceutical industry. Strong experience in the biotechnology or pharma industry with a primary focus on upstream cell culture (including disposable single-use bioreactor systems), transfection, downstream processing (including AKTA systems and Unicorn software), and fill finish operations for viral vectors and/or biologics. Specific experience with AAVs is desirable. Experience with large scalable processes for production of biologics including adherent and suspension bioreactor and downstream purification; drug product experience a plus. Ability to work independently or with minimal oversight; strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others; experience managing both people and projects; excellent communication skills, both written and verbal. Excellent time management skills (schedules, timelines, task prioritization) and the ability to multi-task and adapt to changing priorities. Ability to thrive and succeed in a team-oriented entrepreneurial environment. Current understanding and application of best practices related to process hygiene/microbial control, equipment cleaning, and change-over procedures. Background in equipment qualification (IQ/OQ/PQ) a plus. Ability to lift at least 25 lbs. We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT?s next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.
4D Molecular Therapeutics Emeryville, CA, USA
Jun 13, 2019
We seek a talented and motivated Analytical Development Scientist/Sr. Scientist (Potency Assays) to join our leading-edge Analytical Sciences team in developing assays for release, characterization, and process development for novel AAV vectors, with a focus on cell-based potency assays. In this important role, your creativity and innovative design, development and execution expertise in cell-based assays for biologic products will be critical to helping us take 4D to the next level. Responsibilities: Demonstrates innovative design, development and execution of analytical projects through literature review and scientific teamwork. Leverages strong understanding of cell-based assays, from early development through qualification and validation. Designs, assesses and interprets experimental data. May manage Associates in either assay development or assay execution/routine testing. Reviews data and supports troubleshooting; manages analytical deviations. Leads both from the bench (hands-on laboratory work) and from the desk (designing studies, analyzing data, preparing reports and documents). May work with CROs on assay development and transfer Writes assay development reports, assay qualification and validation protocols and reports, and regulatory documents. Authors manuscripts and presents results at appropriate scientific meetings Contributes to building a culture that embraces continuous learning, improvement and innovation, and encourages team members to expand their technical skill base and deepen their gene therapy expertise. Maintains a current awareness and contributes to current scientific literature; actively applies new concepts and technologies as appropriate Leads and supports research initiatives such as new technology development and continuous improvement projects Requirements: PhD (Chemical engineering, Bioengineering, Biology, Biochemistry, Virology, or related field) with 2+ years? experience, MS with 5+ years? experience, or BS with 10+ years? experience in analytical development/QC of large molecule or cellular therapies. Extensive working knowledge of cell-based assays for potency Experience with stem-cell and/or primary cell culture is strongly recommended Additional background in DNA and/or protein analytics for biologics is desired Strong background in assay qualification/validation Knowledge of viral gene therapy (adeno associated viral vectors) preferred Experience managing Research Associates is desired but not required Successful demonstrated ability to work independently and lead others in designing and developing experiments, analyzing and interpreting data in a rigorous way Ability to multi-task and support more than one project simultaneously Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches Understanding and knowledge of key scientific software programs Understanding and knowledge of regulatory requirements for biologic products Strong organizational skills, analytical and problem-solving skills Strong communication skills, both written and oral, with demonstrated ability to present ideas and information and data effectively via one on one discussions, team meetings and partnership interactions We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT?s next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.
4D Molecular Therapeutics Emeryville, CA, USA
Jun 12, 2019
You are a talented and motivated Scientist with a passion to join our team and support our viral drug therapy research efforts as we contribute to the future of gene therapeutics. Responsibilities: ? Demonstrate innovative design, development, and execution of research projects through literature review, expertise, and scientific teamwork. ? Develop complex in vitro cell culture systems. ? Create and characterize disease model systems to determine efficacy of therapeutic vectors. ? Assay development and testing for infectivity and potency of viral lots. ? Perform hands-on laboratory research to move several scientific projects forward. ? Contribute to the design, optimization, verification, and execution of current and new assays. ? Write study reports and manuscripts, and present results at appropriate scientific meetings. ? Maintain compliance to company Environmental Health and Safety policies, procedures, and practices. ? Effectively mentor junior level staff and act as a resource for providing scientific expertise. ? Contribute to building a culture that embraces continuous learning, improvement and innovation and encourages team members to expand their technical skill base and deepen their gene therapy expertise. ? Actively apply new concepts and technologies into the department and company. ? Leveraging a strong understanding of gene therapy principles to design, assess and interpret experimental data, then using the resulting information to inform selection of the optimal vector. Requirements: ? Ph.D. degree and at least two years of post-doctoral experience in one of the following disciplines: Cell Biology, Molecular Biology, Bioengineering, Virology, or a related field. ? A strong stem cell biology or organotypic cell culture background (central nervous system knowledge preferred). ? Solid proficiency in cell culture techniques, molecular biology, and immunocytochemistry/immunohistochemistry and flow cytometry procedures. ? Ability to multi-task and support more than one project simultaneously. ? Knowledge and working experience in viral gene therapy vector and/or product pre-clinical research and development (adeno associated viral vectors preferred). ? Successful demonstrated ability to work independently in designing, developing, and executing new assay methods. ? Successful demonstrated ability to rigorously analyze and interpret data. ? Ability to work cooperatively in a team-based environment; supportive of multiple viewpoints and approaches. ? Understanding and knowledge of key scientific software programs (including Microsoft Office, JMP or Prism, and Adobe Photoshop). ? Strong organizational skills, analytical and problem-solving skills. ? Strong communication skills (written and oral) with demonstrated ability to present ideas, information and data effectively via one-on-one discussions, team meetings, and external partnership interactions. We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT?s next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.
4D Molecular Therapeutics Emeryville, CA, USA
Jun 12, 2019
We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT?s next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. 4D is seeking an individual interested in pursuing a career in Facilities Management within the Biotech industry. The Facilities Associate will report directly to the Facilities and EH&S Lead and work closely with scientists and administrative staff. Responsibilities: Work closely with 4DMT Facilities Lead to provide support for a variety of office and lab needs. Positively interact with employees, identifying maintenance projects in lab environment and office environments. Organize lab and office maintenance projects, coordinating with outside vendors to ensure maintenance is completed in a timely and efficient manner. Perform a variety of tasks including but not limited to small scale facilities projects such as furniture assembly, plumbing (such as setting up tubing in the labs), general maintenance, wall hangings and shelving. Other supportive tasks may include: Coordinate logistics related to scheduling of maintenance and repair of equipment. Provide general support with minor environmental, health, and safety compliance in the lab. Work in conjunction with hazardous and biohazardous waste company to remove waste from labs . As necessary, support facility operations during off hours in the event of equipment moves, emergency errands, maintenance and/or utilities disruption. Support the logistics of office moves and desk set-ups for new and current employees. Minor cleaning and janitorial duties may be required. Qualifications High School diploma, GED equivalent, or higher. Experience in the life sciences/pharmaceutical industry or other comparable field preferred. 1-2 years? maintenance/facilities experience required, lab experience a plus. Familiarity with and ability to safely operate a variety of hand and electric equipment/tools. Willingness to learn. Ability to prioritize tasks and follow through on projects in a timely manner. Proficient in relevant software: Excel, PowerPoint, Word, with MS Project a plus. Excellent interpersonal skills with the ability to professionally engage with a variety of teams and individuals across the organization in a customer-service oriented manner, but also work independently. Good verbal and written communication skills. Strong attention to detail and organizational skills. Ability to independently lift up to 50 pounds. Possession of a valid driver?s license and ability to operate a motor vehicle. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.
4D Molecular Therapeutics Emeryville, CA, USA
Jun 07, 2019
Full time
We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT's next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. 4D is seeking an individual interested in pursuing a career in Facilities Management within the Biotech industry. The Facilities Associate will report directly to the Facilities and EH&S Lead and work closely with scientists and administrative staff. Responsibilities: Work closely with 4DMT Facilities Lead to provide support for a variety of office and lab needs. Positively interact with employees, identifying maintenance projects in lab environment and office environments. Organize lab and office maintenance projects, coordinating with outside vendors to ensure maintenance is completed in a timely and efficient manner. Perform a variety of tasks including but not limited to small scale facilities projects such as furniture assembly, plumbing (such as setting up tubing in the labs), general maintenance, wall hangings and shelving. Other supportive tasks may include: Coordinate logistics related to scheduling of maintenance and repair of equipment. Provide general support with minor environmental, health, and safety compliance in the lab. Work in conjunction with hazardous and biohazardous waste company to remove waste from labs . As necessary, support facility operations during off hours in the event of equipment moves, emergency errands, maintenance and/or utilities disruption. Support the logistics of office moves and desk set-ups for new and current employees. Minor cleaning and janitorial duties may be required. Qualifications High School diploma, GED equivalent, or higher. Experience in the life sciences/pharmaceutical industry or other comparable field preferred. 1-2 years' maintenance/facilities experience required, lab experience a plus. Familiarity with and ability to safely operate a variety of hand and electric equipment/tools. Willingness to learn. Ability to prioritize tasks and follow through on projects in a timely manner. Proficient in relevant software: Excel, PowerPoint, Word, with MS Project a plus. Excellent interpersonal skills with the ability to professionally engage with a variety of teams and individuals across the organization in a customer-service oriented manner, but also work independently. Good verbal and written communication skills. Strong attention to detail and organizational skills. Ability to independently lift up to 50 pounds. Possession of a valid driver's license and ability to operate a motor vehicle. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.
4D Molecular Therapeutics Emeryville, CA, USA
Jun 07, 2019
Full time
This is not your "everyday" manufacturing opportunity -- in this new and important role, your hands-on operation experience in cGMP biologic manufacturing will help facilitate 4D's road to a pivotal point in its history - a fully integrated biopharmaceutical company with cGMP clinical manufacturing and future commercial facility. Reporting to the Associate Director (leader of clinical manufacturing), you will support cell culture and/or solution prep in cGMP clinical pilot manufacturing plant operation and assist in quality, compliance and safety programs for the daily manufacturing operations of biologic products to support gene therapy clinical trial and product development. In addition, you will support the implementation of process improvements/scale-up. Shift/weekend work or lifting 40 lbs. unassisted is required at times. Summary of Key Responsibilities Supervisory responsibilities including performance management for a group of cell culture manufacturing associates/technicians, minimal of one, depending on the expansion progress of new clinical manufacturing plant and company goal. Provide hands-on on-the-floor operation for upstream/solution prep unit operations for the manufacture of AAV vector products in a cGMP environment, using proper aseptic technique, good documentation practices, and sound scientific methods. Duties include: Mammalian cell culture processing in flatware/shake flask and adherent/stirred tank bioreactors for both cell expansion and/or vector production Transfection Depth filtration and tangential flow filtration Leverage knowledge and application of the theories and principals utilized to solve operational, as well as routine tasks in the operation of cell culture processes, including media/buffer prep, cell passaging, bioreactor production, DNA digestion and harvest clarification operations. Cross-trained to different operational areas, e.g., column chromatography using the chromatography system/Unicorn software, and fill/finish with both manual and automated methods. Work with Process Development team, following tech transfer documents, transfer new projects into GMP manufacturing; gain understanding of scientific principles underlying unit operations, and support initiatives for process optimization, identify and elevate processing issues and support solutions. Provide feedback and/or suggested changes to operational procedures. Complete batch production records under cGMP & tech transfer systems and through the use of SOPs/forms and BPRs for the processes and manufacturing steps to meet both operational and compliance requirements. Generate operational protocol(s), internal documents including SOPs, BPRs, deviations and, if needed, campaign summary reports. Troubleshoot cell culture/solution prep processes and equipment problems; work with Facilities to maintain calibration, maintenance and operation requirements of manufacturing equipment. Work closely with plant management for planning new manufacturing projects and help develop/scale-up processes/techniques with Process Development to meet timelines and avoid operational delays. Ensure manufacturing associates are fully trained on all cGMP manufacturing operations and SOP/BPR documentation, and adhering to operation SOPs and safety guidelines. Participate in new facility expansion and equipment validation activities as needed. Have a strong understanding of GMP procedure for clinical production of complex biologics. Follow all QA procedures, including deviation reporting. Support deviation investigations. Qualifications BS/MS in bioprocessing, chemical engineering, biochemistry or biology with 7-10 years of cGMP manufacturing experience in biopharmaceutical industry. Familiarity with cGMP requirements is essential. Excellent understanding and knowledge of mammalian, insect and viral vector processes. Experienced with both adherent and suspension cell cultures, as well as disposable single-use adherent/stirred tank bioreactors. Current understanding and application of best practices related to process hygiene/ microbial control, equipment cleaning, and change-over procedures. Excellent time management skills (schedules, timelines, task prioritization) and the ability to multi-task and adapt to changing priorities. Ability to thrive and succeed in a team-oriented entrepreneurial environment. Familiarity with Excel, Word, and PowerPoint. Excellent written and oral communication skills. Capable of strenuous, repetitive, physical work, including bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 40 pounds. We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT's next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.
4D Molecular Therapeutics Emeryville, CA, USA
May 28, 2019
Full time
We seek a talented and motivated Analytical Development Scientist/Sr. Scientist (Potency Assays) to join our leading-edge Analytical Sciences team in developing assays for release, characterization, and process development for novel AAV vectors, with a focus on cell-based potency assays. In this important role, your creativity and innovative design, development and execution expertise in cell-based assays for biologic products will be critical to helping us take 4D to the next level. Responsibilities: Demonstrates innovative design, development and execution of analytical projects through literature review and scientific teamwork. Leverages strong understanding of cell-based assays, from early development through qualification and validation. Designs, assesses and interprets experimental data. May manage Associates in either assay development or assay execution/routine testing. Reviews data and supports troubleshooting; manages analytical deviations. Leads both from the bench (hands-on laboratory work) and from the desk (designing studies, analyzing data, preparing reports and documents). May work with CROs on assay development and transfer Writes assay development reports, assay qualification and validation protocols and reports, and regulatory documents. Authors manuscripts and presents results at appropriate scientific meetings Contributes to building a culture that embraces continuous learning, improvement and innovation, and encourages team members to expand their technical skill base and deepen their gene therapy expertise. Maintains a current awareness and contributes to current scientific literature; actively applies new concepts and technologies as appropriate Leads and supports research initiatives such as new technology development and continuous improvement projects Requirements: PhD (Chemical engineering, Bioengineering, Biology, Biochemistry, Virology, or related field) with 2+ years' experience, MS with 5+ years' experience, or BS with 10+ years' experience in analytical development/QC of large molecule or cellular therapies. Extensive working knowledge of cell-based assays for potency Experience with stem-cell and/or primary cell culture is strongly recommended Additional background in DNA and/or protein analytics for biologics is desired Strong background in assay qualification/validation Knowledge of viral gene therapy (adeno associated viral vectors) preferred Experience managing Research Associates is desired but not required Successful demonstrated ability to work independently and lead others in designing and developing experiments, analyzing and interpreting data in a rigorous way Ability to multi-task and support more than one project simultaneously Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches Understanding and knowledge of key scientific software programs Understanding and knowledge of regulatory requirements for biologic products Strong organizational skills, analytical and problem-solving skills Strong communication skills, both written and oral, with demonstrated ability to present ideas and information and data effectively via one on one discussions, team meetings and partnership interactions We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT's next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.
4D Molecular Therapeutics Emeryville, CA, USA
May 26, 2019
Full time
You are a talented and motivated Scientist with a passion to join our team and support our viral drug therapy research efforts as we contribute to the future of gene therapeutics. Responsibilities: · Demonstrate innovative design, development, and execution of research projects through literature review, expertise, and scientific teamwork. · Develop complex in vitro cell culture systems. · Create and characterize disease model systems to determine efficacy of therapeutic vectors. · Assay development and testing for infectivity and potency of viral lots. · Perform hands-on laboratory research to move several scientific projects forward. · Contribute to the design, optimization, verification, and execution of current and new assays. · Write study reports and manuscripts, and present results at appropriate scientific meetings. · Maintain compliance to company Environmental Health and Safety policies, procedures, and practices. · Effectively mentor junior level staff and act as a resource for providing scientific expertise. · Contribute to building a culture that embraces continuous learning, improvement and innovation and encourages team members to expand their technical skill base and deepen their gene therapy expertise. · Actively apply new concepts and technologies into the department and company. · Leveraging a strong understanding of gene therapy principles to design, assess and interpret experimental data, then using the resulting information to inform selection of the optimal vector. Requirements: · Ph.D. degree and at least two years of post-doctoral experience in one of the following disciplines: Cell Biology, Molecular Biology, Bioengineering, Virology, or a related field. · A strong stem cell biology or organotypic cell culture background (central nervous system knowledge preferred). · Solid proficiency in cell culture techniques, molecular biology, and immunocytochemistry/immunohistochemistry and flow cytometry procedures. · Ability to multi-task and support more than one project simultaneously. · Knowledge and working experience in viral gene therapy vector and/or product pre-clinical research and development (adeno associated viral vectors preferred). · Successful demonstrated ability to work independently in designing, developing, and executing new assay methods. · Successful demonstrated ability to rigorously analyze and interpret data. · Ability to work cooperatively in a team-based environment; supportive of multiple viewpoints and approaches. · Understanding and knowledge of key scientific software programs (including Microsoft Office, JMP or Prism, and Adobe Photoshop). · Strong organizational skills, analytical and problem-solving skills. · Strong communication skills (written and oral) with demonstrated ability to present ideas, information and data effectively via one-on-one discussions, team meetings, and external partnership interactions. We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT's next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.
4D Molecular Therapeutics Emeryville, CA, USA
May 26, 2019
Full time
This is not your "everyday" manufacturing opportunity -- in this new and important role, your savvy business acumen and expertise in cGMP biologic manufacturing will help facilitate 4D's road to a pivotal point in its history - a fully integrated biopharmaceutical company with cGMP clinical manufacturing and future commercial facility. Reporting to the VP of Manufacturing/Supply Chain, you will manage & establish cGMP clinical pilot manufacturing plant operation and be a key driver to design, build, and commission state-of-the-art gene therapy clinical manufacturing plant. You will lead/manage cGMP pilot manufacturing and assist in quality, compliance and safety programs in line within defined timelines for the daily manufacturing operations of biologic products to support gene therapy clinical trial and product development. In addition, you will drive the implementation of process improvements/scale-up and liaise between various functional teams to ensure our cutting-edge gene therapy products are supplied of the highest quality and on schedule. You bring deep understanding of biologic manufacturing (API/DS background is preferred), Quality, Planning and Regulatory processes. The icing on the cake - coupling your cGMP biologic manufacturing expertise with the most cutting-edge science in gene therapy! Responsibilities Manage supervisors/associates responsible for GMP production. Provide hands-on person-in-plant oversight and training as needed and ensure the operation within the pilot plant is conducted under current safety and cGMP guidelines. Ensure that plant operations SOPs are followed, batch records are adhered to, and that log books for room and equipment utilization are kept current with appropriate records. Manage production scheduling, including upstream, downstream, and fill/finish, coordinating with PD, QA, Analytical Sciences, and clinical development teams. Manage all aspects of GMP production, ensuring timely supply of raw materials, media/buffer, single use consumables and equipment spare parts, etc. to support the needs of each pilot manufacturing area. Maintain appropriate order records for audit purposes. Train scientists/engineers/associates on various process equipment and procedures. Coordinate third party/outside vendor trainings as necessary. Lead the reporting, investigation and resolution of deviations encountered during GMP production activities, working with manufacturing compliance and QA groups. Provide sufficient/regular training to ensure clinical batch records are complete with minimal documentation error and other deviations, and that the process deviation is investigated and complete in a timely manner following quality SOPs. Work with Process Development on a routine basis to ensure accuracy of tech transfer documentation to establish and execute batch records from solution prep, upstream cell culture, downstream purification, to fill finish operation. Guide manufacturing team to complete campaign report. Support scale-up and initiatives for new technology development and continuous improvement projects. Author, edit, and review master batch records based on tech transfer report, standard operating procedures, change controls, deviation reports, memos, and protocols/reports. Work with material management to ensure the ongoing security of the supply chain for raw materials and intermediates to assure the uninterrupted performance of vector production operations and provision of material for clinical programs; minimize downtime for utility & facility related to equipment failure, spare parts, calibration or related issues. Work with manufacturing support group/outside cleaning groups to supervise the cleaning crew to ensure facility is in good and appropriate condition for GMP manufacturing. Actively provide hands-on support for initial pilot plant facility commissioning, equipment qualification, start-up and operation for biopharmaceutical drug substance production. Work with engineering firm for manufacturing plant design/commissioning/qualification/ validation, and for material/instrument planning, crucial for initial operation for existing and future pilot plant. Work collaboratively with integrated CMC teams and support IND filings as related to clinical manufacture to advance Company goals. Ensures project deadlines and quality standards are established and met. Qualifications BS or MS in bioprocessing, chemical engineering, or biology with at least 10 (manager) to 15 years (sr. manager and associate director) of cGMP manufacturing experience in biopharmaceutical industry. Strong experience in the biotechnology or pharma industry with a primary focus on upstream cell culture (including disposable single-use bioreactor systems), transfection, downstream processing (including AKTA systems and Unicorn software), and fill finish operations for viral vectors and/or biologics. Specific experience with AAVs is desirable. Experience with large scalable processes for production of biologics including adherent and suspension bioreactor and downstream purification; drug product experience a plus. Ability to work independently or with minimal oversight; strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others; experience managing both people and projects; excellent communication skills, both written and verbal. Excellent time management skills (schedules, timelines, task prioritization) and the ability to multi-task and adapt to changing priorities. Ability to thrive and succeed in a team-oriented entrepreneurial environment. Current understanding and application of best practices related to process hygiene/microbial control, equipment cleaning, and change-over procedures. Background in equipment qualification (IQ/OQ/PQ) a plus. Ability to lift at least 25 lbs. We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids). 4DMT's next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.