AGC Biologics
Manufacturing Project Specialist I-II
AGC Biologics, Boulder, Colorado, United States, 80301
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.
SummaryThe
Manufacturing Project Specialist, I-II.
performs GMP manufacturing operations safely, reliably and in compliance with stated processes; develops new technologies/equipment, and implements new systems, process improvements, equipment, and procedures.
Principal ResponsibilitiesSupport the implementation of new manufacturing processes in close collaboration with our MSAT and Process Development teams.Ensure manufacturing process optimization and continuous improvement.Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.Collaborate with engineering and validation teams to implement and qualify new equipment and controls.Follow-up on production campaigns including client communication, review and approval of batch records, troubleshooting, handling of deviations and CAPAs.Participate in customer meetings by providing manufacturing updates.Develop and update required documentation including:
Quality documents, such as Standard Operating Procedures (SOPS), Manufacturing Production Records (MPRs), work instructions, etc.User Requirement SpecificationsManufacturing Impact AssessmentsSystem deployment checklistsDeviation, risk assessments, change control and product change over reports
Review GMP documentation.Recognize and correct errors in bioprocess operations prior to failure.Recommend and execute projects and changes to bioprocess operations to reduce risk and increase efficiency.Assist with on-boarding and validating of new equipment and processes.Work with clients on process mapping and scale-up of manufacturing processes.Other duties as assigned.Knowledge, Skills & Abilities
Expertise in relevant math, science, and engineering disciplines.Proficient in assembling, disassembling, operating, and understanding complex equipment supporting viral vector and/or cell therapy manufacturing.Thorough knowledge of GMP regulations (ICH Q7A), equipment and technology as it applies to job function.Demonstrated ability to work independently, lead projects and multitask under aggressive timelines to support department and company objectives.Organizational and communication skills necessary to ensure daily work plan is executed.Excellent technical writing skills to create effective documents.Must be detail oriented, with the ability to complete written and verbally assigned tasks following specific procedures.Ability to interact collaboratively with peers and support groups.Education/Experience
BA/BS degree in a science related discipline preferred or combination of education and work experience.Level I: 2 - 4+ years' experience in Bioprocessing, Viral Vector or Cell Therapy operations.Level II: 5 or more years' experience in Bioprocessing, Viral Vector or Cell Therapy operations.Relevant industry experience:
Executing unit operations described in SOPs and MPRsCompleting required processing documentation including deviation reports, validation protocols, change control, product change over, risk assessments, etc.Aseptic process knowledge and Biosafety Level (BSL) 2/3 experience
Compensation Range$66,960 - $103,070Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
W
ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
SummaryThe
Manufacturing Project Specialist, I-II.
performs GMP manufacturing operations safely, reliably and in compliance with stated processes; develops new technologies/equipment, and implements new systems, process improvements, equipment, and procedures.
Principal ResponsibilitiesSupport the implementation of new manufacturing processes in close collaboration with our MSAT and Process Development teams.Ensure manufacturing process optimization and continuous improvement.Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.Collaborate with engineering and validation teams to implement and qualify new equipment and controls.Follow-up on production campaigns including client communication, review and approval of batch records, troubleshooting, handling of deviations and CAPAs.Participate in customer meetings by providing manufacturing updates.Develop and update required documentation including:
Quality documents, such as Standard Operating Procedures (SOPS), Manufacturing Production Records (MPRs), work instructions, etc.User Requirement SpecificationsManufacturing Impact AssessmentsSystem deployment checklistsDeviation, risk assessments, change control and product change over reports
Review GMP documentation.Recognize and correct errors in bioprocess operations prior to failure.Recommend and execute projects and changes to bioprocess operations to reduce risk and increase efficiency.Assist with on-boarding and validating of new equipment and processes.Work with clients on process mapping and scale-up of manufacturing processes.Other duties as assigned.Knowledge, Skills & Abilities
Expertise in relevant math, science, and engineering disciplines.Proficient in assembling, disassembling, operating, and understanding complex equipment supporting viral vector and/or cell therapy manufacturing.Thorough knowledge of GMP regulations (ICH Q7A), equipment and technology as it applies to job function.Demonstrated ability to work independently, lead projects and multitask under aggressive timelines to support department and company objectives.Organizational and communication skills necessary to ensure daily work plan is executed.Excellent technical writing skills to create effective documents.Must be detail oriented, with the ability to complete written and verbally assigned tasks following specific procedures.Ability to interact collaboratively with peers and support groups.Education/Experience
BA/BS degree in a science related discipline preferred or combination of education and work experience.Level I: 2 - 4+ years' experience in Bioprocessing, Viral Vector or Cell Therapy operations.Level II: 5 or more years' experience in Bioprocessing, Viral Vector or Cell Therapy operations.Relevant industry experience:
Executing unit operations described in SOPs and MPRsCompleting required processing documentation including deviation reports, validation protocols, change control, product change over, risk assessments, etc.Aseptic process knowledge and Biosafety Level (BSL) 2/3 experience
Compensation Range$66,960 - $103,070Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
W
ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.