Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
Join our dynamic team as a Manufacturing Associate, Downstream! In this role, you'll be a crucial part of our multi-product manufacturing facility, working in strict compliance with cGMP and Standard Operating Procedures. Your responsibilities will encompass various tasks, including production, meticulous documentation, report writing, materials procurement, and equipment scheduling. You'll be instrumental in ensuring the timely production and release of top-quality products. At our company, we value core principles such as Integrity, Adaptability, Innovation, Teamwork, and Passion, all united by a shared mission to enhance patients' lives through the consistent delivery of high-quality biopharmaceuticals. If you're ready to make a meaningful impact, apply now and be part of our journey!
* Ensuring the timely setup of equipment and materials for each production run.
* Planning and preparing all necessary resources for various processes and activities.
* Operating and diligently maintaining BioProcess chromatography skids.
* Proficiently handling the packing, unpacking, and cleaning of production-scale chromatography columns.
* Executing antibody and enzyme purification techniques using Affinity chromatography, Size Exclusion chromatography, Ion Exchange chromatography, Hydrophobic Interaction, and Tangential Flow Filtration (TFF).
* Conducting pH and conductivity meter calibration and testing.
* Managing product filtration processes, including sterile filtration, ultrafiltration, and viral filtration.
* Demonstrating exceptional aseptic techniques with precise, deliberate movements.
* Participating in product filling, including aseptic processing and media fill qualifications.
* Upholding the cleanliness and maintenance of cleanroom facilities and equipment.
* Monitoring and controlling raw material inventory levels.
* Ensuring compliance with Good Manufacturing Practices (GMP) documentation standards.
* Taking the initiative to revise and initiate Batch Production Records, Standard Operation Procedures, study protocols, and reports.
* Leading and managing independent projects as assigned, contributing to the overall success of the manufacturing team.
* Skillfully preparing media and buffer solutions critical for production processes.
* Conducting manual cleaning of small parts and equipment to maintain hygiene and efficiency.
* Performing thorough filter integrity testing using specialized equipment like the Sartocheck 3/4 Filter Integrity Tester.
* Operating and ensuring the proper maintenance of the ARS Frontier Autoclave.
Minimum Qualifications:
* 2+ years of experience with large-scale liquid chromatography columns or similar equipment.
* 1+ years of related experience in the life sciences industry.
* Proficiency in working within a GMP production environment with aseptic techniques.
* Capability to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment.
Preferred Qualifications:
* Bachelor's or associate degree (A.A.) with a preference for biology or chemistry emphasis.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. Must have the ability to be flexible working overtime, weekends and/or holidays when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $20.53-$27.34 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
We understand the importance of attracting and retaining top talent. The expected base pay range for this position is ($20.53-$27.34 hourly) plus bonus and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$20.5-27.3 hourly Auto-Apply 30d ago
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Supervisor, Manufacturing Downstream (Flex)
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.
* Schedule, plan and coordinate production activities.
* Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required.
* cGMP documentation.
* Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).
* Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.
* Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.
* Coordinate manufacturing, validation, and maintenance activities with supporting departments.
* Oversee the setup of new manufacturing processes and critical equipment.
* Identify the technical, procedural and equipment issues that hinder production and compliance.
* Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.
* Assist in the transfer of technology from Process Development to GMP Manufacturing.
* Assist with technical and compliance investigations, inspections and audits.
* Report all unsafe activities to department manager, EHS and/or Human Resources.
* Participate in proactive team efforts to achieve departmental and company goals.
* Manage direct reports and escalate issues to manager as needed.
* Perform other duties as assigned
Minimum Qualifications:
* Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education.
* A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations.
Preferred Qualifications:
* Bachelor's degree in life sciences or related field.
Position Type/Expected Hours of Work:
This role is a full-time position with a Sunday through Wednesday or a Wednesday through Saturday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 5:00pm to 4:00am. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$75k-95k yearly Auto-Apply 57d ago
Specialist (OTF), Quality Assurance
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: Join Avid as a Quality Assurance Specialist (OTF) and be a critical part of ensuring top-notch quality for our products and services. As the QA Specialist within the Quality Assurance On-the-Floor (OTF) team, you will be responsible for providing quality oversight for clinical and commercial cell therapy operations, ensuring adherence to current Good Manufacturing Practices (CGMP), Good Documentation Practice (GDP), and Data Integrity/ALCOA+ principles, supporting right-first-time execution on the production floor.Collaborate with manufacturing departments, enforce GMP requirements and QA policies, maintain a state of inspection readiness, and participate in designing and implementing department and cross-functional initiatives. You'll be part of a dynamic team committed to delivering high-quality products and services to our customers, in a fast-paced and innovative environment. If you're detail-oriented, highly organized, and looking for a challenging opportunity to grow and develop your skills, apply now to be a part of our team.
Provide quality oversight of production floor to ensure manufacturing operations adhere to GMP and GDP requirements, including data integrity.
Observe manufacturing operations and identify departures from clean room behaviors, aseptic techniques, and applicable procedures through process observations.
Perform real-time review of executed batch records and manufacturing test forms to ensure compliance with procedures.
Collaborate with Manufacturing teams to resolve discrepancies on-the-floor.
Ensure timely escalation of any discrepancies to management.
Provide support during regulatory inspections and other audits; maintain a state of inspection readiness.
Perform other duties as assigned by Quality Assurance management.
Minimum Qualifications:
Bachelor's degree (preferably in the Life Sciences).
2+ years of experience in the biopharmaceutical industry.
Knowledge of CGMPs or equivalent regulations.
Ability to interpret quality standards for implementation.
Skills to independently evaluate situations and propose potential solutions.
Position Type/Expected Hours of Work: This role is a full-time position operating on a Wednesday to Saturday or Sunday through Wednesday shift on a 4x10 (4 days x 10 hours) schedule, with operating hours from 7:00am to 6:00pm. During the initial training period, working days and hours will be Monday through Friday, 8:00am to 5:00pm. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $27.00 to $36.77 hourly annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$27-36.8 hourly Auto-Apply 44d ago
Manager, Data Analytics
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Manager, Data Analytics is responsible for overseeing master data management and integrity, ERP system functionality, system optimization, QMS documentation and metrics reporting. This role combines hands-on analytical expertise with leadership responsibilities, ensuring accurate planning, reporting and team development. The Data Analytics Manager will serve as a key liaison between cross-functional teams including Manufacturing, Quality, and Warehouse Operations.
Supervise and mentor a team of analysts responsible for ERP data management, QMS documentation, and reporting.
Serve as a Dynamics D365 super-user, ensuring accurate BOM setup, item master data, and system configuration.
Collaborate with Manufacturing, Quality, and Warehouse teams to ensure timely release and availability of materials.
Develop and monitor Supply Chain KPIs and metrics to drive continuous improvement and cost reduction.
Oversee training documentation and onboarding processes for ERP users.
Troubleshoot ERP issues related to material masters, recipes, and process orders.
Support cycle count and physical inventory processes, including gap analysis and classification adjustments.
Recommend and implement process improvements and system enhancements.
Ensure compliance with cGMP and regulatory requirements in all supply chain operations.
Assist end-users in developing reports to assist in data analysis and business decisions.
Responsible for assisting in the implementation of newly defined ERP related initiative including modifications or enhancements.
Communicates and works with ERP system users, vendors and management to determine appropriate system configuration and set-up.
Utilize system data to review stocking levels and inventory turns to recommend adjustments to reorder points.
Other duties may be assigned.
Supervisory Responsibilities:
Direct supervision of analysts.
Provide coaching, performance feedback, and development opportunities.
Ensure team alignment with departmental goals and operational excellence.
Minimum Qualifications:
Bachelor's degree in supply chain, business, life sciences, or related field.
Minimum 6 years of experience in supply chain operations, with at least 2 years in a supervisory or lead role.
Experience in pharmaceutical or biotech industry preferred.
Proficiency in ERP systems (preferably Dynamics D365 or Oracle).
Strong understanding of MRP, BOM, and production scheduling principles.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal abilities.
Ability to manage multiple priorities and meet deadlines.
Proficient in Microsoft Office Suite (Excel, Word, Outlook).
Knowledge of cGMP and Good Documentation Practices.
Leadership and team-building capabilities.
Position Type/Expected Hours of Work:This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime when necessary. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $81,000 - $103,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$81k-103k yearly Auto-Apply 60d+ ago
Research Associate, Process Development Upstream
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Research Associate in Process Development - Upstream will develop and optimize scalable cell culture processes and contribute to transferring the process to Avid Manufacturing. In addition, the Research Associate will maintain production equipment and will research and implement new methods and technologies to enhance process operations.
Responsible for mammalian cell culture process development and optimization including but not limited to recombinant protein production, cell adaptation to suspension or serum-free conditions, media/feed screening comparing growth and productivity in various media, growing and maintaining cells in shake flasks, wave and stirred tank bioreactors. Responsibilities also include seed train development, production bioreactor inoculation, maintenance, sampling, and feeding, and cell culture harvest/clarification.
Work with many different kinds of mammalian cell lines (CHO-GS, CHO-DG44, CHO-M, CHO-S, NSO, HEK, etc) utilizing aseptic techniques, and apply a good understanding of the effect of general metabolic pathways (nutrient usage, expression system, etc.) physical (morphology, pH, osmolality, etc.) as well as mechanical (agitation speeds, oxygen and pH control, etc.) parameters on cell growth and recombinant protein production.
Preparation of various cell culture media and feed formulations from scratch.
Operate, troubleshoot, and maintain cell culture equipment such as bioreactors and analyzers.
Scale up and tech transfer cell culture and harvest processes to the Manufacturing department.
Analyze growth, production, and nutrient usage data, create data spreadsheets and graphs in Excel or JMP, document data and findings for traceability and regulatory requirements, write technical and summary reports, generate slide decks, and lastly, communicate findings and participate in scientific discussions within the group and with clients.
Work with minimal supervision on projects of routine or low to moderate complexity.
Research and implement new methods and technologies to enhance operations.
Perform other duties as assigned.
Minimum Qualifications:
B.S. degree in a Biological Science
Minimum of 1-2 years of relevant industry experience with demonstrated working knowledge of scientific principles.
Position Type/Expected Hours of Work: This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Supervisor. Any scientific member can expect to work overtime, including during the weekends and holidays. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $65,800 - $80,000 annually, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$65.8k-80k yearly Auto-Apply 60d+ ago
Data Reviewer, Quality Control
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Data Reviewer, Quality Control's main responsibility will be to review Quality Control analytical data.
In this role you will:
* Conduct a comprehensive and critical evaluation on QC data in Empower and SoftMax Pro software including but not limited to contents, results, data accuracy, and scientific relevance, format and adherence to cGMPs.
* Perform a thorough review of raw data, including electronic raw data and documentations to ensure compliance with applicable specifications and/or protocols.
* Conduct GMP review of laboratory notebooks, logbooks, and associate forms.
* Conduct GMP review of electronic raw data to ensure compliance with data integrity policies.
* Support OOS/OOT investigations.
* Support internal and external audit.
* Support QC method validation review, as needed.
* Perform review of procedural and method revisions, where necessary.
* Perform other duties as assigned to support Quality activities.
Minimum Qualifications:
* Bachelor's degree, preferably in a life sciences field (such as biology, microbiology, biochemistry, chemistry).
* 4+ years' work experience in a GMP/biopharmaceutical/pharmaceutical manufacturing environment.
* Experience with Empower and SoftMax Pro software.
* Knowledge of cGMPs, pharmacopeia and compendial requirements.
* Experience in and knowledge of 21 CFR data integrity requirements.
* Familiarity with analytical testing methods and validation including laboratory instrumentation.
* Strong verbal and written communication skills.
* Familiarity with laboratory computerized systems such as Empower and LIMS.
* Proficient with Microsoft applications.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Supervisor. Must be available to work holidays, weekends, or extended hours if needed.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $26.73-$35.62 hourly, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$26.7-35.6 hourly Auto-Apply 52d ago
Scientist, Process Development Early Phase
Avid Bioservices 4.2
Avid Bioservices job in Costa Mesa, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
Join us as a Scientist, Process Development Early Phase, where you'll harness scientific and engineering concepts to drive biologics production with mammalian and other cells. Your role extends beyond the lab bench, encompassing support for cell culture and other technologies, participation in process scale-up, optimization, technology transfer, and validation efforts. You'll be an integral part of both client and internal programs, conducting impactful technical investigations while staying at the forefront of state-of-the-art principles and theories across various scientific disciplines, all while contributing to scientific literature. Make your mark in the world of cutting-edge science and innovation.
* Cultivate mammalian and other cell lines for biologics production using various bioreactor systems and cell culture techniques, ensuring strict aseptic conditions.
* Support activities related to cell line development, including evaluation of cell performance and implementation of strategies to optimize productivity and stability.
* Contribute to formulation development experiments, assisting in the design and execution of studies to assess product stability, compatibility, and delivery.
* Conceive and execute well-designed experiments, meticulously analyze results, and derive meaningful insights.
* Actively engage in supporting both client and internal programs, contributing your expertise to drive successful outcomes.
* Excel in troubleshooting upstream process issues, proactively brainstorming innovative solutions to overcome upstream challenges.
* Demonstrate proficiency in operating and troubleshooting essential process equipment, while also pioneering methods and procedures for novel assignments.
* Maintain comprehensive documentation of data and findings to ensure traceability and regulatory compliance, while regularly updating management on project status and progress.
* Exhibit strong technical writing skills, creating detailed technical protocols, Process Development reports, guides, SOPs, and other essential documents.
* Prioritize safety by adhering to all policies, practices, and procedures, promptly reporting any unsafe activities, actively participating in collaborative team efforts to achieve departmental and company goals, and flexibly performing additional duties as assigned.
* Provide valuable guidance and mentorship to Associate Scientists and Laboratory Assistants, fostering their growth and development.
* Other tasks as assigned.
Minimum Qualifications:
* Bachelor's degree in biology, Biochemistry, Immunology, Virology, or an equivalent scientific field, or a combination of education and experience that demonstrates the necessary knowledge and skills.
* 3+ years of relevant and hands-on experience in protein, or large molecule production.
* Hands-on experience with various mammalian and other cell lines, adherent and suspension cultures, all executed with stringent aseptic techniques.
* Proficiency in working with bioreactors for suspension cultures, showcasing practical expertise in this area.
* Proficiency in working with multi-layer vessels for adherent cultures, demonstrating hands-on experience.
* Familiarity with microcarriers is desired and will be considered an asset.
* Understanding of regulatory requirements and cGMP compliance in bioprocess development.
Position Type/Expected Hours of Work:
This role is a full-time position. Days of work are Monday through Friday. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $101,300 to $125,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$101.3k-125k yearly Auto-Apply 60d+ ago
Calibration Technician
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Calibration Technician will perform calibrations and complete associated documentation across a wide variety of equipment that requires a variety of standards.
* Calibrations - perform calibrations on a scheduled and non-scheduled basis, on a wide variety of equipment, including, but not limited to, pipettes, balances, gauges, and chart recorders.
* Calibration scheduling - Maintain a schedule/calendar for all necessary calibrations, both equipment and standards.
* Software - Experience with calibration software, Blue Mountain or equivalent.
* Vendors - Maintain all vendor information and documentation relevant to both the continued vendor qualifications and the calibration, maintenance and repair of company standards.
* Record keeping - maintain thorough and complete records for all calibrated items, both equipment and standards, that can be utilized for both a complete device history and traceability back to the NIST standards.
* Maintenance - Ability to perform repair maintenance on equipment as required, completing and maintaining the calibrations.
* Standards - the understanding of and ability to use all types of calibration standards, basic mechanical, pneumatic, electronic and electrical, and sophisticated test equipment.
* Facilitate - Provide knowledge and assistance in ensuring company compliance with current regulations, cGMP requirements, customer requirements, and company objectives.
* Training - Maintaining current memberships in appropriate organizations or associations, or receiving training either via conference or internet, to maintain current understanding of regulations, standards and industry trends in order to provide continuous improvement to the calibration systems.
* Documentation - Prepare calibration instructions and procedures that utilize the principles of measurement science, technical analysis, accuracy and precision specifications.
* Technical advisor - Provide technical expertise and assistance in, quality investigations, root cause analysis, corrective and preventative actions, and calibration requirements in new projects or procedures.
* Inspections - Represent the calibration system and be prepared to explain qualifications, systems, methods and results during audits and inspections.
* Continuous Improvement - Analyze, assess and continuously improve calibration practices, procedures and results.
* Confer with vendors, contractors, and other departments.
* Comply with all safety policies, practices and procedures.
* Participate in proactive team efforts to achieve departmental and company goals.
* Determine methods and procedures on new assignments and may provide guidance to other nonexempt personnel.
* Rely on experience and judgment to plan and accomplish goals.
* Perform a variety of complicated tasks.
* Perform other duties as assigned.
Minimum Qualifications:
* Bachelor's Degree or equivalent experience/training required. Technical degree preferred.
* 5+ years' experience as an instrumentation technician in a cGMP environment preferred.
* Experience with calibration software, Blue Mountain or equivalent.
* Demonstrated ability to determine the appropriate calibration methods for various types of systems, instruments, and loops.
* Experience with operating and implementing calibration management systems (Cal-Man, Blue Mountain, etc..) a plus.
* Ability to maintain a GMP compliant record keeping system.
* Experience in an ISO controlled environment.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $31.77 to $42.35 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$31.8-42.4 hourly Auto-Apply 60d+ ago
Technician, Environmental Monitoring
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role: The Technician, Environmental Monitoring, will perform environmental monitoring and routine utility testing within a GMP biopharmaceutical manufacturing organization.
Perform environmental monitoring (non-viable particulates, air viables, surface, temperatures) in cleanroom environments within the Manufacturing area.
Perform environmental monitoring for aseptic filling processes.
Operate monitoring equipment that includes Met One Laser Particle Counter, Viable Air Sampler, Conductivity meter, pH meter, TOC analyzer.
Monitor temperatures of Manufacturing and Microbiological QC temperature storage units.
Perform Preventative Maintenance verification of RCS Air Sampler.
Read EM plates/strips and document results on relevant forms.
Collect Purified Water samples throughout the manufacturing facility and perform TOC and conductivity testing of samples.
Input trending data for EM and water samples.
Perform Cleaning Verification of cleaned production equipment.
Perform Area Release per protocol for campaigned manufacturing areas.
Responsible for notification and re-testing of alert and action OOL's.
Perform other duties as assigned.
Minimum Qualifications:
Associate's degree (A.A.) or equivalent from two-year college or technical school; or minimum two years' experience and/or training; or equivalent combination of education and experience.
Preferred Qualifications:
Knowledge or experience in a GMP environment.
Position Type/Expected Hours of Work: This role is a full-time position with working days of Monday through Friday, unless otherwise stated by Supervisor. Must have the ability to work overtime, weekends and/or holidays when necessary. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $20.52-$27.35 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. We understand the importance of attracting and retaining top talent. The expected base pay range for this position is ($42,700-$56,900) plus bonus and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$20.5-27.4 hourly Auto-Apply 60d+ ago
Contract Specialist
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
As a Contract Specialist, you will play a pivotal role in managing the full lifecycle of contracts that drive our business forward. You'll review a wide range of agreements-including master services, supply, confidentiality, and vendor contracts-ensuring alignment with strategic goals and regulatory standards. Collaborating cross-functionally with Legal, Business Development, Finance, and Operations, you'll help shape contract terms that support compliance and operational excellence. Your expertise will support teams in interpreting complex contract language and resolving issues efficiently. This is a high-impact position ideal for a detail-oriented professional who thrives in a fast-paced, collaborative environment and is passionate about driving clarity, compliance, and value through contract management.
* Manage the full lifecycle of contracts and agreements.
* Review a variety of contracts including master services agreements, supply agreements, confidentiality agreements and vendor contracts.
* Collaborate with internal stakeholders including Legal, Business Development, Finance and Operations to ensure contract terms align with business and compliance objectives.
* Maintain and manage a centralized contract repository, ensuring timely tracking of key milestones, obligations, and renewals.
* Support cross-functional teams in interpreting contract terms and resolving contractual issues.
* Ensure all contracts comply with applicable laws, industry regulations (e.g., FDA, cGMP), and internal policies.
* Assist in the development and continuous improvement of contract templates and workflow processes.
* Participate in internal training and knowledge-sharing initiatives to promote contract literacy across departments.
Minimum Qualifications:
* Minimum of 3 years of experience in contract management, preferably within the life sciences, pharmaceutical, or CDMO industry.
* Strong understanding of contract law, commercial terms, and regulatory frameworks relevant to drug development and manufacturing.
* Excellent communication, negotiation, and interpersonal skills with a collaborative approach to problem-solving.
* Highly organized with strong attention to detail and the ability to manage multiple priorities.
* Proficiency in contract management systems and Microsoft Office Suite.
Preferred Qualifications:
* Paralegal certification is a plus.
* Familiarity with FDA regulations, cGMP standards, and industry-specific quality and compliance requirements.
* Experience working in a matrixed organization with cross-functional teams.
* Ability to draft and negotiate contracts.
* Ability to foster positive relationships with internal stakeholders and external partners.
Position Type/Expected Hours of Work:
This role is a full-time position. Days of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $65,800 to $87,700 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$65.8k-87.7k yearly Auto-Apply 60d+ ago
Project Manager
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
Join forces with our dynamic project management team and ignite your passion for driving impactful client projects! As a Project Manager, you'll lead the coordination and planning of cross-functional activities for designated projects, ensuring they not only meet but exceed their objectives within set timelines and budget constraints.
Your journey with us will involve diving deep into client relationships, seamlessly onboarding projects, crafting efficient processes, facilitating smooth technology transfers, and orchestrating GMP operations within the thrilling realm of Drug Substance and Viral Vector space.
If you're ready to roll up your sleeves and be a driving force behind transformative projects, then seize this opportunity to make your mark in a team that thrives on innovation and collaboration!
* Manage early stage and/or late-stage biologics projects to drive deliverables and maintain budget.
* Support the project management team implementation of standardized templates, project governance, project process flow, and resource allocation tools and techniques.
* Supports the planning/preparation/facilitation of internal and client facing meetings (technology transfer, process development, manufacturing, and quality).
* Supports project readiness activities related to biologics projects including early-stage and late-stage covering process validation and commercialization (timeline generation, documentation tracking, schedule adherence, functional resource planning, risk assessment, and budgeting).
* Supports project interface with operations/outside contractor/supply chain for GMP production readiness, schedules and facilitate sub-team (as assigned) meetings.
* Provides Project Management support to all assigned projects including oversight of project charter, project plan/timeline, risk management and risk elevation, project monitoring, and project closure.
* Responsible for effective meeting facilitation, maintenance of meeting minutes, and action item generation, follow-up, and elevation for all assigned projects.
* Supports the high-level management of corporate initiatives.
* Back up for Sr. Project Management activities.
* Other tasks may be assigned as needed.
Minimum Qualifications:
* Bachelor's degree in a scientific discipline.
* 3+ years of experience in biotechnology or pharmaceuticals with specific project management capacity.
* Project Management certification is advantageous.
* Proficiency in MS Project is essential.
* Strong attention to detail and ability to multitask effectively.
* Familiarity with the drug development process.
* Excellent written and oral communication skills.
* Occasional overnight travel by land and/or air may be required to attend seminars, conferences, or client meetings.
Position Type/Expected Hours of Work:
This role is a full-time position. Days of work are Monday through Friday.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $87,400 to $116,600 annually, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$87.4k-116.6k yearly Auto-Apply 52d ago
Engineer, IT Systems Compliance
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Engineer, IT Systems Compliance is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that have been newly installed, upgraded, replaced and/or modified in the cGMP Manufacturing Facility as well as its related manufacturing support areas, which may include Facilities/ Engineering, Quality Assurance, Supply Chain, and Quality Control.
* Review and help author User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems and processes
* Generate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols, engineering studies and final reports that comply with corporate and regulatory requirements.
* Coordinate and oversee validation protocol execution or validation activities with cross-functional departments.
* Evaluate and analyze qualification data collected during projects, while verifying acceptability of the data and compliance with the approved protocol.
* Ensure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed by the Validation Committee
* Provide input and assist on the development of validation policies and procedures.
* Effectively interact and provide validation guidance to other departments.
* Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectation.
* Provide input and assist in change control assessment and Part 11 assessment for validated systems.
* Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflects validated conditions.
* Assist department manager on other types of projects/managerial responsibilities as needed
Minimum Qualifications:
* BA/BS in science (such as Biology, Microbiology, Biochemistry, Chemistry), Engineering (such as Electrical, Electronics, Computer Science) or other equivalent technology related field.
* Minimum of 3 years' work experience in biopharmaceutical/pharmaceutical manufacturing environment of which 1 year is directly involved in validations.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8am to 5pm PST, unless otherwise stated by Supervisor.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $82,000- $104,400 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$82k-104.4k yearly Auto-Apply 45d ago
Sr. Microbiologist, Quality Control
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
As a Sr. Microbiologist, Quality Control, you will lead the way in ensuring compliance with environmental regulations and Good Manufacturing Practices (GMP) by performing microbiological testing in a biopharmaceutical manufacturing organization. You will utilize state-of-the-art technology to monitor air, water, and surfaces for potential contaminants, inoculate microbial cultures for growth promotion testing, and perform bioburden testing. You will also review and trend data, generate charts, and maintain inventory of supplies. Your work will contribute to the production of life-saving biopharmaceuticals, making a positive impact on public health and the environment.
* Perform bioburden testing of water and in-process samples per USP, EP requirements, and gram staining of recovered microorganisms.
* Read EM plates and document results on relevant forms.
* Perform growth promotion testing.
* Perform Trending in LIMS (MODA or Labware).
* Maintain inventory of department supplies and place purchase orders.
* Inoculate microbial cultures for growth promotion testing.
* Prepare cultures to send out for identification when needed.
* Support investigations for EM out-of-limit results, including notification and re-testing of alert and action OOLs.
* Perform data review of environmental monitoring and assist in the preparation of environmental monitoring data trending reports.
* Monitor temperatures of Manufacturing and Microbiological QC refrigerators, freezers, cryo-freezers, and cold-room area.
* Other tasks as assigned.
Minimum Qualifications:
* B.S. in Microbiology or related field with a minimum of 4-5 years of experience in a GMP facility working in a Microbiology lab; or master's degree in microbiology or related field with a minimum of 1-3 years of experience.
* Experience in performing the following tasks on a routine basis:
* Bioburden testing of water systems, raw materials, in-process materials/components, and finished product.
* Gram staining and experience with colony morphology.
* Aseptic microbiological techniques used in the microbiology lab to prevent contamination and cross-contamination.
* Trend Report and/or Protocol writing.
* Support Investigations to determine root cause and corrective action.
* Growth promotion testing.
* Knowledge of aseptic techniques and behavior.
* Must have knowledge of cGMP and should have necessary skills working in controlled environments.
* Experience with LIMS (preferable Labware and or MODA)
* Working knowledge of USP, EP, and Annex 1.
Position Type/Expected Hours of Work:
This role is a full-time position with a Sunday through Wednesday schedule, working 10 hours each day (4 days x 10 hours), with operating hours typically from 7:00am to 6:00pm.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $65,800 to $75,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$65.8k-75k yearly Auto-Apply 30d ago
Associate Engineer, MSAT (Downstream)
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Associate Engineer, MSAT (Downstream)'s primary responsibilities are to support the successful transfer and execution of new downstream processes into manufacturing. This requires an understanding of manufacturing downstream equipment and techniques to set up the manufacturing downstream operations for success. The Associate Engineer, MSAT (Downstream) should be capable of contributing to technical discussions on MSAT projects. The Associate Engineer, MSAT (Downstream) will drive process improvement to increase efficiency and decrease risk.
* Develop and cultivate positive client and internal Avid group (PD, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.) partnerships.
* Capable of contributing to a project from start to finish with supervision in support of the MSAT technical Subject Matter Expert (SME).
* Ability to communicate with client on process status and collaborate to resolve issues on the floor.
* Provide technical expertise to support process tech transfers, troubleshoot process issues, and implement process improvements.
* Author Manufacturing Batch Production Records, Technical Reports, Standard Operating Procedures, User Requirement Specifications, Design Specifications, and Process Validation Protocols.
* Contribute to proper scale-up assessments to translate executed PD-scale process into manufacturing scale.
* Assist in proper equipment/facility fit and gap assessments for new processes or process changes to ensure proper execution.
* Author new product introduction protocols.
* Monitor process health through process monitoring.
* Assist in authoring technical risk assessments to identify gaps, incorporate new materials, and/or identify areas of improvement.
* Provide technical training to Manufacturing Downstream Operators.
* Assist in CAPA (Corrective Action Preventive Action) investigations and recommend dispositions. Conduct systematic investigations of root causes, problems, or identified risks.
* Research and identify new material and/or equipment for continuous improvement.
* Evaluate and assess the impacts of process, material, and equipment changes to product quality attributes.
* Prepare analysis and reports of proposed changes that are based on sound scientific and engineering principles.
* Ability to perform statistical analysis of data to form conclusions and recommendations.
* Performs other duties as assigned.
Minimum Qualifications:
* Bachelor's degree in scientific or engineering (chemical or biomedical) discipline
* Minimum of 1 year of downstream biologic manufacturing or process downstream development.
* Quality assurance knowledge.
* Hands-on experience with depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.
* Hands-on experience with downstream process equipment including, but not limited to AKTA ready column chromatography skids, large-scale filtration skids, Unicorn software.
* Track record for analyzing and resolving complex manufacturing and production issues using sound scientific principles.
* Batch production record, technical risk assessment, and/or technical protocol/study generation and review.
Preferred Qualifications:
* Master's degree in scientific or engineering (chemical or biomedical) discipline.
* Technical transfer, scale-up, and mass transfer of downstream processes.
* JMP statistical software.
Position Type/Expected Hours of Work:
This role is a full-time position operating Monday through Friday. The employee must also, if instructed, be able to work overtime, holidays and/or weekends when needed.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $65,00-$87,700 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
We understand the importance of attracting and retaining top talent. The expected base pay range for this position is ($65,800-$87,700) annually plus bonus, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$65.8k-87.7k yearly Auto-Apply 60d+ ago
Analyst (In Process) Quality Control
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Quality Control In-Process Analyst will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment for the Quality Control In-Process team.
* Perform basic compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results.
* Formulate buffers and reagents for the purpose of performing test methods.
* Write and revise test methods and procedures.
* Perform aseptic sampling, endotoxin, pH, conductivity, osmolality, A280 and endotoxin by LAL.
* Perform water testing and raw material sampling and testing.
* Perform QC testing for lot release, stability, development/validation projects, and investigations.
* Other functions include writing study protocols and reports.
* Work with other departments in developing, revising and implementing QC procedures and policies.
* Should be aware of company cGMPs as well as industry regulations that apply to all job functions.
* Perform sample pick up and sample locating without supervision and with strict adherence to written protocols.
* Other duties as assigned.
Minimum Qualifications:
* BS degree in Biochemistry, Chemistry, Biology or a related field.
* 2 years of biotech industry experience working in a QC or analytical lab.
* Must have experience with analytical testing, writing reports, GMPs, and regulatory audits.
* Experience with most, if not all the methodologies listed above.
* Experience with basic maintenance and troubleshooting of analytical instrumentation is highly desirable.
Position Type/Expected Hours of Work:
* This is a full-time position operating Wednesday to Saturday on a 4x10(4 days x 10 hours) schedule.
* Will have an adaptable schedule to accommodate operational and scheduling demands.
* Availability needed for overtime and weekend shifts as necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $26.73 to $35.63 hourly, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$26.7-35.6 hourly Auto-Apply 52d ago
Engineer, GxP Systems
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Support Engineer, GxP is responsible for the technical design, planning, implementation, and support of enterprise systems and laboratory equipment to ensure that these are operating at optimum levels. You will serve as the technical expert in systems administration for specialized manufacturing, development, and quality control systems and recommend the redesign, configuration, recovery, and continuity plans of the operational and information technology and applications for these systems. You will analyze the feasibility of system requirements and develop system specifications and will support project leadership and management in the identification, development, and adoption of technology and processes to deliver quality reliable solutions in the support of our core manufacturing and quality control operations.
Maintain system administration documentation for various laboratory instruments, enterprise systems, and manufacturing equipment.
Support the generation and/or modification of test methods for various laboratory equipment.
Provide technical and documentation support for the change management process on the supported systems and equipment.
Perform equipment testing as needed. Trais technical staff in the operation of developed and/or acquired software and hardware.
Provide tools, procedures, and training sessions for Operations, Support and Systems Development staff who assist in support efforts.
Provide guidance or work instructions to internal and external users.
Perform troubleshooting and support problem-solving efforts with vendors.
Support security policies and procedures to protect systems from unauthorized or unintended use and/or abuse.
Coordinate and support project efforts to maximize benefits and minimize impact to departments and operations.
Other tasks as assigned.
Minimum Qualifications:
Bachelor's degree in Life Sciences, Computer Science, or related disciplines. Relevant experience may substitute for the degree requirement on a year for year basis.
1+ years' work experience in technical writing, complex systems design, and support.
Experience using a combination of the following software: Spectramax Softmax Pro, HPLCS, BioTek plate readers, Beckman 32Karat, Empower 3, EndoscanV, Applied Biosystems, Beckman Vi-Cell BLU, Sartorius Sartochecks, iCE Protein Simple, Sievers TOC, Cary SoloVPE, Cytiva Unicorn, Thermo DeltaV, Sartorius MFCS, Bio-Rad Image Lab Densitometer, Acronis, Veeam, Beckman Spectraphotometer.
Ability to establish and maintain cooperation, understanding, trust, and credibility.
Ability to plan, organize, and document complex system design activities and to configure systems to be consistent with organization's policies/procedures
Ability to communicate technical/complex information verbally and in writing.
Ability to perform tasks timely and efficiently and respond to emergency situations effectively as needed.
Position Type/Expected Hours of Work: This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Supervisor. Must be available to work holidays, weekends, or extended hours if needed. This position includes participation in an on-call rotation to provide support outside of regular business hours.Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $72,000 to $90,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$72k-90k yearly Auto-Apply 43d ago
Data Reviewer, Quality Control
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Data Reviewer, Quality Control's main responsibility will be to review Quality Control analytical data. In this role you will:
Conduct a comprehensive and critical evaluation on QC data in Empower and SoftMax Pro software including but not limited to contents, results, data accuracy, and scientific relevance, format and adherence to cGMPs.
Perform a thorough review of raw data, including electronic raw data and documentations to ensure compliance with applicable specifications and/or protocols.
Conduct GMP review of laboratory notebooks, logbooks, and associate forms.
Conduct GMP review of electronic raw data to ensure compliance with data integrity policies.
Support OOS/OOT investigations.
Support internal and external audit.
Support QC method validation review, as needed.
Perform review of procedural and method revisions, where necessary.
Perform other duties as assigned to support Quality activities.
Minimum Qualifications:
Bachelor's degree, preferably in a life sciences field (such as biology, microbiology, biochemistry, chemistry).
4+ years' work experience in a GMP/biopharmaceutical/pharmaceutical manufacturing environment.
Experience with Empower and SoftMax Pro software.
Knowledge of cGMPs, pharmacopeia and compendial requirements.
Experience in and knowledge of 21 CFR data integrity requirements.
Familiarity with analytical testing methods and validation including laboratory instrumentation.
Strong verbal and written communication skills.
Familiarity with laboratory computerized systems such as Empower and LIMS.
Proficient with Microsoft applications.
Position Type/Expected Hours of Work: This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Supervisor. Must be available to work holidays, weekends, or extended hours if needed. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $26.73-$35.62 hourly, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$26.7-35.6 hourly Auto-Apply 51d ago
Supervisor, Manufacturing Downstream (Flex)
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.
Schedule, plan and coordinate production activities.
Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required.
cGMP documentation.
Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).
Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.
Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.
Coordinate manufacturing, validation, and maintenance activities with supporting departments.
Oversee the setup of new manufacturing processes and critical equipment.
Identify the technical, procedural and equipment issues that hinder production and compliance.
Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.
Assist in the transfer of technology from Process Development to GMP Manufacturing.
Assist with technical and compliance investigations, inspections and audits.
Report all unsafe activities to department manager, EHS and/or Human Resources.
Participate in proactive team efforts to achieve departmental and company goals.
Manage direct reports and escalate issues to manager as needed.
Perform other duties as assigned
Minimum Qualifications:
Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education.
A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations.
Preferred Qualifications:
Bachelor's degree in life sciences or related field.
Position Type/Expected Hours of Work:This role is a full-time position with a Sunday through Wednesday or a Wednesday through Saturday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 5:00pm to 4:00am. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$75k-95k yearly Auto-Apply 56d ago
Contract Specialist
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: As a Contract Specialist, you will play a pivotal role in managing the full lifecycle of contracts that drive our business forward. You'll review a wide range of agreements-including master services, supply, confidentiality, and vendor contracts-ensuring alignment with strategic goals and regulatory standards. Collaborating cross-functionally with Legal, Business Development, Finance, and Operations, you'll help shape contract terms that support compliance and operational excellence. Your expertise will support teams in interpreting complex contract language and resolving issues efficiently. This is a high-impact position ideal for a detail-oriented professional who thrives in a fast-paced, collaborative environment and is passionate about driving clarity, compliance, and value through contract management.
Manage the full lifecycle of contracts and agreements.
Review a variety of contracts including master services agreements, supply agreements, confidentiality agreements and vendor contracts.
Collaborate with internal stakeholders including Legal, Business Development, Finance and Operations to ensure contract terms align with business and compliance objectives.
Maintain and manage a centralized contract repository, ensuring timely tracking of key milestones, obligations, and renewals.
Support cross-functional teams in interpreting contract terms and resolving contractual issues.
Ensure all contracts comply with applicable laws, industry regulations (e.g., FDA, cGMP), and internal policies.
Assist in the development and continuous improvement of contract templates and workflow processes.
Participate in internal training and knowledge-sharing initiatives to promote contract literacy across departments.
Minimum Qualifications:
Minimum of 3 years of experience in contract management, preferably within the life sciences, pharmaceutical, or CDMO industry.
Strong understanding of contract law, commercial terms, and regulatory frameworks relevant to drug development and manufacturing.
Excellent communication, negotiation, and interpersonal skills with a collaborative approach to problem-solving.
Highly organized with strong attention to detail and the ability to manage multiple priorities.
Proficiency in contract management systems and Microsoft Office Suite.
Preferred Qualifications:
Paralegal certification is a plus.
Familiarity with FDA regulations, cGMP standards, and industry-specific quality and compliance requirements.
Experience working in a matrixed organization with cross-functional teams.
Ability to draft and negotiate contracts.
Ability to foster positive relationships with internal stakeholders and external partners.
Position Type/Expected Hours of Work:This role is a full-time position. Days of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $65,800 to $87,700 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
$65.8k-87.7k yearly Auto-Apply 60d+ ago
Project Manager
Avid Bioservices 4.2
Avid Bioservices job in Tustin, CA
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role: Join forces with our dynamic project management team and ignite your passion for driving impactful client projects! As a Project Manager, you'll lead the coordination and planning of cross-functional activities for designated projects, ensuring they not only meet but exceed their objectives within set timelines and budget constraints. Your journey with us will involve diving deep into client relationships, seamlessly onboarding projects, crafting efficient processes, facilitating smooth technology transfers, and orchestrating GMP operations within the thrilling realm of Drug Substance and Viral Vector space. If you're ready to roll up your sleeves and be a driving force behind transformative projects, then seize this opportunity to make your mark in a team that thrives on innovation and collaboration!
Manage early stage and/or late-stage biologics projects to drive deliverables and maintain budget.
Support the project management team implementation of standardized templates, project governance, project process flow, and resource allocation tools and techniques.
Supports the planning/preparation/facilitation of internal and client facing meetings (technology transfer, process development, manufacturing, and quality).
Supports project readiness activities related to biologics projects including early-stage and late-stage covering process validation and commercialization (timeline generation, documentation tracking, schedule adherence, functional resource planning, risk assessment, and budgeting).
Supports project interface with operations/outside contractor/supply chain for GMP production readiness, schedules and facilitate sub-team (as assigned) meetings.
Provides Project Management support to all assigned projects including oversight of project charter, project plan/timeline, risk management and risk elevation, project monitoring, and project closure.
Responsible for effective meeting facilitation, maintenance of meeting minutes, and action item generation, follow-up, and elevation for all assigned projects.
Supports the high-level management of corporate initiatives.
Back up for Sr. Project Management activities.
Other tasks may be assigned as needed.
Minimum Qualifications:
Bachelor's degree in a scientific discipline.
3+ years of experience in biotechnology or pharmaceuticals with specific project management capacity.
Project Management certification is advantageous.
Proficiency in MS Project is essential.
Strong attention to detail and ability to multitask effectively.
Familiarity with the drug development process.
Excellent written and oral communication skills.
Occasional overnight travel by land and/or air may be required to attend seminars, conferences, or client meetings.
Position Type/Expected Hours of Work: This role is a full-time position. Days of work are Monday through Friday. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $87,400 to $116,600 annually, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.