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Manufacturing Support Services Lead Associate

Summary

The Manufacturing Support Services Lead Associate will serve as a role model to lead a diverse team towards achieving on-time delivery of manufacturing support by performing routine cGMP cleaning, assembling, transfer, and decontamination activities that aid in gene therapy production. The incumbent will embrace and promote right-first-time culture by supporting the manufacture of viral vectors, non-viral vectors, and advanced therapeutics while maintaining compliance to cGMP standards.

We are looking for individuals that have experience as a goal and solution-oriented team player, are hard-working, highly motivated, and eager to contribute to building a manufacturing operation. The individual will also have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team and show commitment to the highest safety and quality standards. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a supervisor role.

Responsibilities

  • Work in a hands-on capacity to prepare buffers, assemble jumper harnesses, and clean/sterilize equipment and materials.
  • Work closely with manufacturing personnel by transferring/stocking critical materials and delivering samples throughout the facility.
  • Clean GMP spaces, collect waste from production suites, and perform decontamination protocols.
  • Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Proactively assist in the resolution of manufacturing support deviations/non-conformances and troubleshooting of support process and equipment problems.
  • Lead and motivate operational staff by promoting a culture of inclusiveness, safety, continuous improvement, training objectives, and compliance.
  • Provides timely technical input, when necessary, to support ongoing operations.
  • Assist with on-the-floor review of batch records in real time.
  • Assist in the development of training material to support the initial and ongoing training of manufacturing support personnel.
  • Identify opportunities for improvements in process, safety, quality, and cost.
  • Lead training of new manufacturing support associates.
  • Leads initiative to assist in validation activities related to the qualification of the manufacturing support process, facility suites, and equipment.
  • Acts as qualified trainer for SOPs and procedures in functional area.
  • Verify inventory and escalate to supervisor when supplies are low.

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 4-6 years of experience in cGMP biological manufacturing. Contract, Development, and Manufacturing Organization (CDMO) experience preferred.
  • A minimum of 1-3 years of leadership experience.
  • Advanced experience working with autoclaves, washers, aseptic operations, and cleanroom decontamination procedures is highly preferred.
  • Advanced knowledge of cGMP regulations.
  • Proven ability to troubleshoot and resolve equipment and processing issues.
  • Advanced efficiency working in a Biological Safety Cabinet (BSC).
  • Demonstrated ability working with pipettes, micropipettes, and scales.
  • Demonstrated experience working with decontamination practices for materials and liquids.
  • Demonstrated experience handling and formulating cleaning solutions.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Exhibits extreme attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows eagerness to learn and problem-solve.
  • Innovative and efficient when solving problems with a strong focus on continuous improvement.
  • Possesses sound technical aptitude to learn and operate production equipment.
  • Ability to teach, lead and mentor co-workers.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Able to accommodate a flexible work schedule to support business demands.
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.
August 10, 2022

Vector Downstream Bioprocessing Lead Associate

Summary

The Vector Downstream Bioprocessing Lead Associate will serve as a role model to lead a diverse team towards achieving on-time delivery of manufacturing operations by performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. The incumbent will embrace and promote right-first-time culture while operating downstream equipment for adherent and suspension systems and performing production support activities while maintaining compliance to cGMP standards.

We are looking for individuals that have experience as a goal and solution-oriented team player, are hard-working, highly motivated, and eager to contribute to building a manufacturing operation. The individual will also have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team and show commitment to the highest safety and quality standards. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a supervisor role.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment to operate chromatography systems, ÄKTA chromatography controllers, UF/DF systems, ultracentrifuges, and perform sterile filtrations.
  • Lead and motivate operational staff on a daily basis by promoting a culture. of inclusiveness, safety, continuous improvement, training objectives, and compliance.
  • Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Proactively assist in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
  • Provides timely technical input to support ongoing operations.
  • Assist with on-the-floor review of batch records in real time.
  • Assist in the development of training material to support the initial and ongoing training of manufacturing personnel.
  • Identify opportunities for improvements in process, safety, quality, and cost.
  • Lead training of new Bioprocessing associates.
  • Leads initiative to assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.
  • Acts as qualified trainer for SOPs and procedures in functional area.

Qualifications

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 5 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
  • A minimum of 1-3 years of leadership experience is preferred.
  • Advanced ability working with single-use chromatography and UF/DF systems, ultracentrifuges, and aseptic operations.
  • Advanced knowledge of cGMP regulations.
  • Proven ability to troubleshoot and resolve equipment and processing issues.
  • Advanced efficiency working in a Biological Safety Cabinet (BSC).
  • Demonstrated ability working with single-use mixers, sterile tube welders, sterile tube sealers, turbidimeters, and integrity testers.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Exhibits extreme attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows eagerness to learn and problem-solve.
  • Innovative and efficient when solving problems with a strong focus on continuous improvement.
  • Possesses sound technical aptitude to learn and operate production equipment.
  • Ability to teach, lead and mentor co-workers.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Able to accommodate a flexible work schedule to support business demands.
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.
April 22, 2022

Vector Drug Product Bioprocessing Associate I

Summary

The Vector Drug Product Bioprocessing I Associate will be responsible for performing routine cGMP aseptic filling of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. The incumbent will be responsible for operating aseptic fillers and isolators and performing production support activities while maintaining compliance to cGMP standards. In addition, operators will perform visual inspection of finished product.Operators will be expected to assist in other areas when Drug Product fills are not occurring.

We are looking for individuals that are willing to work within a team, are hard-working, and highly motivated. This position requires multi-tasking and excellent peer-to-peer communication skills.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment to perform aseptic filling, inspection, labeling, and packaging of Drug Product.
  • Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Assist in the resolution of manufacturing deviations/non-conformances.
  • Assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.

Qualifications

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A range of 0-2 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
  • General knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • General knowledge of aseptic filling equipment and isolators.
  • Ability to work well independently and as part of a team.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows willingness to learn and problem-solve.
  • Willingness to learn and operate production equipment.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A range of 0-2 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.
April 21, 2022

Vector Downstream Bioprocessing I Associate THIRD SHIFT

Summary

The Vector Downstream Bioprocessing I Associatewill be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the genetherapy asset at the Center for Breakthrough Medicines.The incumbent will be responsible foroperatingdownstream equipmentfor adherent and suspension systemsand performingproductionsupportactivitieswhile maintaining compliance to cGMP standards.

We are looking for individualsthatare willing to work withina team,arehard-working, and highly motivated.This position requires multi-tasking and excellentpeer-to-peercommunicationskills.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment tooperatechromatography systems, ÄKTA chromatography controllers, UF/DF systems, ultracentrifuges, and perform sterile filtrations.
  • Assist in maintaining thecGMP status of the manufacturing facilitytoalways ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Assist in the resolution of manufacturing deviations/non-conformances.
  • Assist in validation activitiesrelated tothe qualification of themanufacturing process, facilitysuites, andprocessequipment.

Qualifications

N/A

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A range of 0-2 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
  • General knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • General knowledge of purification equipment.
  • Ability to work well independently and as part of a team.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows willingness to learn and problem-solve.
  • Willingness to learn and operate production equipment.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.

Travel

N/A

April 19, 2022

Vector Downstream Bioprocessing I Associate SECOND SHIFT

Summary

The Vector Downstream Bioprocessing I Associatewill be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the genetherapy asset at the Center for Breakthrough Medicines.The incumbent will be responsible foroperatingdownstream equipmentfor adherent and suspension systemsand performingproductionsupportactivitieswhile maintaining compliance to cGMP standards.

We are looking for individualsthatare willing to work withina team,arehard-working, and highly motivated.This position requires multi-tasking and excellentpeer-to-peercommunicationskills.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment tooperatechromatography systems, ÄKTA chromatography controllers, UF/DF systems, ultracentrifuges, and perform sterile filtrations.
  • Assist in maintaining thecGMP status of the manufacturing facilitytoalways ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Assist in the resolution of manufacturing deviations/non-conformances.
  • Assist in validation activitiesrelated tothe qualification of themanufacturing process, facilitysuites, andprocessequipment.

Qualifications

N/A

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A range of 0-2 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
  • General knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • General knowledge of purification equipment.
  • Ability to work well independently and as part of a team.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows willingness to learn and problem-solve.
  • Willingness to learn and operate production equipment.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.

Travel

N/A

Vector Upstream Bioprocessing I Associate SECOND SHIFT

Summary

The Vector Upstream Bioprocessing I Associatewill be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the genetherapy asset at the Center for Breakthrough Medicines.The incumbent will be responsible foroperatingupstream equipmentfor adherent and suspension systemsand performingproductionsupportactivitieswhile maintaining compliance to cGMP standards.

We are looking for individualsthatare willing to work withina team,arehard-working, and highly motivated.This position requires multi-tasking and excellentpeer-to-peercommunicationskills.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment toperformcell culturescale-up and operatesingle use bioreactors.
  • Assist in maintaining thecGMP status of the manufacturing facilitytoalways ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Assist in the resolution of manufacturing deviations/non-conformances.
  • Assist in validation activitiesrelated tothe qualification of themanufacturing process, facilitysuites, andprocessequipment.

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A range of 0-2 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
  • General knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • General knowledge of cell expansion vessels.
  • Ability to work well independently and as part of a team.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows willingness to learn and problem-solve.
  • Willingness to learn and operate production equipment.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.
April 13, 2022

Cell Therapy Bioengineering Associate I

Summary

The Cell Therapy Bioengineering Associate will be responsible for performing routine processes for the manufacture of human blood derived cell therapies in a controlled, cGMP cleanroom environment of a multi-product facility. The incumbent will be responsible for operating equipment for autologous and allogeneic cell therapy processes and performing lab support activities while maintaining compliance to cGMP standards. The successful candidate will play a key role in establishing internal standards for onboarding and training of new cell therapy team members while establishing best practices that will become standards of procedure for the cell therapy organization. We are looking for an individual that has experience working within a team, is hard-working, self-motivated, results-driven, and solution-oriented. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a higher-level associate.

Responsibilities

• Work cross-functionally in a hands-on capacity utilizing aseptic technique to perform cell culture processes through cell culture, harvest, and cryopreservation and lab support activities within a cleanroom environment. • Ensure work is completed in compliance with controlled documentation (SOPs, batch records, forms, etc.) and all applicable guidelines, safety policies and procedures are followed. • Become fully trained and qualified in all aspects of assigned processes. • Maintain manufacturing facility in a cGMP status and ensure a continued state of inspection readiness. • Adhere to the schedule ensuring manufacturing logistics are maintained on time. • Develop a functional level of technical knowledge of cell therapy processes. • Record process data and information in a clear/concise format according to proper GDPs. • Develop a functional level of comfort working with basic lab equipment, specific Cell Therapy process equipment, and manufacturing logistics systems. • Author and revise documents for equipment and processes, when applicable. • Assist in tech transfer activities related to new product introduction to the manufacturing facility. • Assist in the resolution of manufacturing deviations of process and equipment problems

Education & Experience

Bachelor’s degree in biological science(s) field or related engineering is preferred but not required. • A minimum of 0-2 years of experience in cGMP biological manufacturing. Cell therapy manufacturing is highly preferred. • Basic understanding of cell culture, cryopreservation, and aseptic processing/technique. • Strong written and verbal communication skills, with excellent teamwork aptitudes. • General knowledge of cGMP and FDA regulations. • Basic mathematical skills and technical writing capabilities. • Familiarity with MS Office applications.

Physical Demands

• Ability to carry up to 55 pounds. • Ability to stand for long periods of time while wearing PPE. • Ability to work weekends/off-shift hours, when applicable. This position has the possibility to evolve into a second shift or off-shift position.

March 24, 2022

Cell Therapy Bioengineering Associate II

Summary

The Cell Therapy Bioengineering Associate will be responsible for performing routine processes for the manufacture of human blood derived cell therapies in a controlled, cGMP cleanroom environment of a multi-product facility. The incumbent will be responsible for operating equipment for autologous and allogeneic cell therapy processes and performing lab support activities while maintaining compliance to cGMP standards. The successful candidate will play a key role in establishing internal standards for onboarding and training of new cell therapy team members while establishing best practices that will become standards of procedure for the cell therapy organization. We are looking for an individual that has experience working within a team, is hard-working, self-motivated, results-driven, and solution-oriented. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills.This position has the potential to evolve into a higher-level associate.

Responsibilities

Work cross-functionally in a hands-on capacity utilizing aseptic technique to perform cell culture processes through cell culture, harvest, and cryopreservation and lab support activities within a cleanroom environment. • Ensure work is completed in compliance with controlled documentation (SOPs, batch records, forms, etc.) and all applicable guidelines, safety policies and procedures are followed. • Become fully trained and qualified in all aspects of assigned processes. • Maintain manufacturing facility in a cGMP status and ensure a continued state of inspection readiness. • Adhere to the schedule ensuring manufacturing logistics are maintained on time. • Establish a broad level of technical knowledge of cell therapy processes. • Record process data and information in a clear/concise format according to proper GDPs. • Establish a broad level of comfort working with basic lab equipment, specific Cell Therapy process equipment, and manufacturing logistics systems. • Author and revise documents for equipment and processes, when applicable. • Perform tech transfer activities related to new product introduction to the manufacturing facility. • Assist in the resolution of manufacturing deviations of process and equipment problems

Demonstrate a positive attitude within the team and proven ability to complete assignments on time.

Education & Experience

Bachelor’s degree in biological science(s) field or related engineering is preferred but not required. • A minimum of 1-3 years of experience in cGMP biological manufacturing. Cell therapy manufacturing is highly preferred. • General understanding of cell culture, cryopreservation, and aseptic processing/technique. • Strong written and verbal communication skills, with excellent teamwork aptitudes. • General knowledge of cGMP and FDA regulations. • Basic mathematical skills and technical writing capabilities.

MS Office Experience

Physical Demands

Ability to carry up to 55 pounds. • Ability to stand for long periods of time while wearing PPE. • Ability to work weekends/off-shift hours, when applicable. This position has the possibility to evolve into a second shift or off-shift position.

Vector Upstream Bioprocessing Lead Associate

Summary

The Vector Upstream Bioprocessing LeadAssociatewillserve as arole model to leada diverse teamtowards achievingon-time delivery ofmanufacturing operations by performingroutine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the genetherapy asset at the Center for Breakthrough Medicines. The incumbent willembrace and promote right-first-timeculture whileoperatingupstream equipmentfor adherent and suspension systemsand performing production support activities while maintaining compliancetocGMP standards.

We are looking for individualsthathave experience as a goal andsolution-oriented team player, arehard-working, highly motivated,andeager to contribute to building a manufacturing operation. The individual will alsohave a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functionalteam andshowcommitment to the highest safety and quality standards.This position requires multi-tasking,interdepartmental coordination,and excellentpeer-to-peercommunicationskills. This positionhas the potentialtoevolve into a supervisor role.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment toperformcell culturescale-up and operatesingle use bioreactors.
  • Leadand motivateoperational staff on a daily basis bypromotinga culture. ofinclusiveness,safety, continuous improvement,training objectives, and compliance.
  • Assist in maintaining thecGMP status of the manufacturing facilitytoalways ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Proactively assist in the resolution of manufacturing deviations/non-conformances and troubleshooting ofprocess andequipmentproblems.
  • Provides timely technical input to support ongoing operations.
  • Assistwith on-the-floor reviewofbatch records in real time.
  • Assist in the development oftraining materialtosupport the initial and ongoing training of manufacturing personnel.
  • Identify opportunities for improvements in process, safety, quality, and cost.
  • Lead trainingofnewBioprocessing associates.
  • Leads initiative to assist in validation activitiesrelated tothe qualification of themanufacturing process, facilitysuites, andprocessequipment.
  • Acts as qualified trainer for SOPs and procedures in functional area.

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 5 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
  • A minimum of 1-3 years of leadership experience is preferred.
  • Experience working with single-use bioreactors, aseptic operations, cell culture, and seed scale-up.
  • Advanced knowledge of cGMP regulations.
  • Proven ability to troubleshoot and resolve equipment and processing issues.
  • Advanced efficiency working in a Biological Safety Cabinet (BSC).
  • Demonstrated ability working with incubators, pipettes, and micropipettes.
  • Demonstrated ability working with sterile tube welders, sterile tube sealers, and cell counting machines.
  • Experience working with of cell expansion vessels such as T-flasks or shake flasks.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Exhibits extreme attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows eagerness to learn and problem-solve.
  • Innovative and efficient when solving problems with a strong focus on continuous improvement.
  • Possesses sound technical aptitude to learn and operate production equipment.
  • Advanced experience working with single-use bioreactors, aseptic operations, and seed scale-up is highly preferred.
  • Ability to teach, lead and mentor co-workers.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Able to accommodate a flexible work scheduleto support business demands.
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.
January 10, 2022

Vector Upstream Bioprocessing III Associate

Summary

The Vector Upstream Bioprocessing IIIAssociatewill be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the genetherapy asset at the Center for Breakthrough Medicines.The incumbent will be responsible foroperatingupstream equipmentfor adherent and suspension systemsand performingproductionsupportactivitieswhile maintaining compliance to cGMP standards. This position willparticipate in theonboarding and training ofthe inaugural manufacturing staff for the stand upofa new organization.

We are looking for individualsthathave experience working withina team,arehard-working, highly motivated,andsolution oriented.This position requires multi-tasking,interdepartmental coordination,and excellentpeer-to-peercommunicationskills.Thisposition hasthe potentialtoevolve into a lead role.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment toperformcell culturescale-up and operatesingle use bioreactors.
  • Assist in maintaining thecGMP status of the manufacturing facilitytoalways ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Assist in the resolution of manufacturing deviations/non-conformances and troubleshooting ofprocess andequipmentproblems.
  • Assists with the training of Bioprocessing associates.
  • Assist in validation activitiesrelated tothe qualification of themanufacturing process, facilitysuites, andprocessequipment.

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 3 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
  • Strong knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.
  • Experience working with single-use bioreactors, aseptic operations, cell culture, and seed scale-up is highly preferred.
  • Demonstrated ability to troubleshoot and resolve equipment and processing issues.
  • Strong knowledge of process validation practices for biopharmaceutical products.
  • Proven efficiency working in a Biological Safety Cabinet (BSC).
  • Experience working with incubators, pipettes, and micropipettes.
  • Experience working with sterile tube welders, sterile tube sealers, and cell counting machines.
  • Experience working with of cell expansion vessels such as T-flasks or shake flasks.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows eagerness to learn and problem-solve.
  • Innovative and efficient when solving problems with a focus on continuous improvement.
  • Possesses technical aptitude to learn and operate production equipment.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.