Manufacturing Associate 2 - 2A Shift: Sun-Tues, every other Sat, Can work anytime from 4pm-6am
Dexcom 4.7
Manufacturing associate job at Dexcom
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Where you come in:
You will be responsible for the overall operation of potentially large-scale manufacturing machinery including actions such as feeding materials for processing, adjusting settings, performing minor repairs, and pulling finished product from the line.
Operates hand tools, or production equipment.
Assembles products or sub-assemblies according to verbal or written instructions, or by following drawings or diagrams.
Follows GMP guidelines.
Work at this level requires following standardized methods and under immediate supervision on assignments that are semi-routine in nature.
Follows pre-established guidelines and procedures with minimal choice as to method of performance of the work.
Has contact with employees at other levels within the company. Information exchanged is generally non-complex.
Sets up and operates a variety of automatic or semi-automatic machines including robotic assembly equipment used in the production of the company's product.
Can work 2A Shift: Sun-Tues, every other Sat | Can work anytime from 4pm-6am
What makes you successful:
Moderate understanding of general job aspects and some understanding of the detailed aspects of the job.
Applies acquired job and company knowledge of policies and procedures to complete semi-routine tasks.
Normally follows established procedures on routine work, requires instructions only on new assignments.
Works under close supervision.
What you'll get:
A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
0-5%
Experience and Education
Typically requires a minimum of 2-4 years of related experience and a High School diploma/certificate or equivalent.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$17.40 - $29.03
$17.4-29 hourly Auto-Apply 60d+ ago
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Manufacturing Associate III
Endologix 4.7
Irvine, CA jobs
Join our high-impact manufacturing team as a ManufacturingAssociate III at Endologix! WHO WE ARE: Endologix LLC is a California-based global medical device company dedicated to improving patients' lives through innovative therapies for the interventional treatment of vascular disease. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician training-supported by industry-leading clinical evidence. At Endologix, we're driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health.
What sets us apart is not just our technology, but our culture. At Endologix, we foster a collaborative, mission-driven environment where every team member plays a vital role in advancing patient care. We value integrity, tenacity, and innovation-and we support our people with the tools, trust, and training they need to grow and continuously learn. If you're passionate about making a meaningful impact in healthcare, you'll find purpose and belonging here.
ABOUT THE ROLE:
We're looking for a talented ManufacturingAssociate III to join our high-impact manufacturing team. In this role, you'll be responsible for the efficient and accurate assembly of high-quality medical devices in compliance with approved Manufacturing Process Instructions (MPIs), Standard Operating Procedures (SOPs), and quality standards. This role requires a strong understanding of medical device manufacturing processes and a commitment to continuous improvement. The Associate III serves as a technical resource on the production floor, assisting in troubleshooting line issues, identifying root causes, and recommending corrective actions. In addition, this individual actively contributes to process improvement initiatives, supports training of junior team members, and collaborates cross-functionally with Engineering, Quality, and other support functions to ensure smooth production flow and compliance with regulatory requirements.
Responsibilities
WHAT YOU'LL DO:
* Assemble medical device products using small hand tools, calibrated instruments, microscopes, measurement devices, and test fixtures.
* Ensure full compliance with Endologix policies, procedures, and quality standards, including safety regulations, environmental protocols, and required stretching exercises.
* Maintain cleanroom and controlled environment integrity through proper attire and adherence to controlled environment practices.
* Perform in-process quality checks and promptly report any safety, quality, or process-related concerns.
* Identify and escalate unacceptable materials and sub-assemblies to Engineering and/or the Supervisor.
* Ensure complete compliance with Endologix Quality and Regulatory policies and Core Values.
* Take ownership of product quality by strictly following manufacturing instructions and completing quality records accurately.
* Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
* Collaborate with supervisors, engineers, and technicians to troubleshoot line issues and implement process improvements.
* Understand and use production terminology and demonstrate awareness of common manufacturing defects and their impact.
* Exhibit flexibility by performing effectively across multiple assembly stations with minimal errors.
* Participate actively in Lean Manufacturing and 5S initiatives to enhance efficiency and workplace organization.
* Demonstrate knowledge of Lean principles and apply them to daily operations.
* Proactively engage cross-functional resources to resolve production issues.
* Read and interpret engineering drawings, specifications, and method sheets accurately.
* Enter data into electronic systems as required for documentation and tracking.
* Serve as a certified trainer for manufacturing processes; train and mentor other production employees.
* Provide coaching and guidance to peers on standard operating procedures and assembly techniques.
* Support supervisors as needed, including participating in leadership tasks and line coordination.
* Perform other duties as assigned by supervisor.
Qualifications
WHAT YOU'LL BRING:
Education:
* High school diploma or equivalent required; associate or technical degree preferred.
Experience:
* 3-5 years of experience in a regulated manufacturing environment, preferably in the medical device industry.
* Experience working within a clean room environment.
* Lean & 5S experience desired.
Skills/Competencies:
* Strong attention to detail and ability to follow complex instructions and procedures.
* Demonstrated ability to troubleshoot line issues and work independently with minimal supervision.
* Effective communication skills and the ability to collaborate within a team environment.
* Familiarity with lean manufacturing principles and continuous improvement methodologies is a plus.
HOW YOU'LL SHOW UP:
All In: Bring full commitment to everything you do. Support one another, hold yourself accountable, and take ownership of your work. Move with urgency, deliver on your promises, and lead with boldness and passion.
Act with Integrity: Prioritize ethics and transparency in every decision. Earn trust by being honest, respectful, and dependable - working diligently to uphold the confidence of your colleagues, customers, and communities.
Tenacious: Meet challenges head-on with resilience and resolve. Stay focused, push through obstacles, and consistently look for solutions, not excuses.
Pioneering: Challenge the status quo and embrace innovation. Develop new ideas, test bold solutions, and pave the way for others - driving progress through curiosity and creativity.
WHAT WE OFFER:
At Endologix, we know that great work starts with great people - and people do their best when they feel valued and supported. That's why we offer competitive pay, solid benefits, career growth, a culture that genuinely cares, and the flexibility you need to thrive both at work and at home. But more than that, we offer purpose. You'll be part of a team that's making a real impact on patients' lives. When you join us, you're not just taking a job, you're building a meaningful career with a team that's invested in your success.
The compensation package includes:
* Hourly rate of $25.00/hr-$30.00/hr
* Discretionary bonus
* Equity participation as approved by Board of Directors (4-year vesting schedule)
* Comprehensive health, dental, and vision insurance plans
* Generous PTO and holiday schedule
* 401(k) retirement plan with company match
Plus:
* Employee wellness initiatives and mental health support
* Collaborative and inclusive company culture focused on impact and innovation
* Opportunities for career growth and internal mobility
OUR COMMITMENT TO DIVERSITY & INCUSION:
Endologix LLC. is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
$25-30 hourly Auto-Apply 60d+ ago
Manufacturing Associate 1 - Days 1A and 1B
Dexcom 4.7
Manufacturing associate job at Dexcom
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Where You Come In :
You will be responsible for the overall operation of potentially large‑scale manufacturing machinery, including feeding materials for processing, adjusting settings, performing minor repairs, and pulling finished products from the line.
You operate hand tools or production equipment.
You assemble products or sub‑assemblies according to verbal or written instructions, or by following drawings or diagrams.
You follow GMP guidelines.
You work at this level by following standardized methods and under immediate supervision on assignments that are semi‑routine in nature.
You follow pre‑established guidelines and procedures with minimal choice as to the method of performance of the work.
You have contact with employees at other levels within the company, where information exchanged is generally non‑complex.
You set up and operate a variety of automatic or semi‑automatic machines, including robotic assembly equipment, used in the production of the company's products.
What Makes You Successful :
You have a moderate understanding of general job aspects and some understanding of the more detailed aspects of the role.
You apply acquired job and company knowledge, including policies and procedures, to complete semi‑routine tasks effectively.
You normally follow established procedures for routine work and require instructions only for new assignments.
You work under close supervision while ensuring tasks are completed accurately and in accordance with expectations.
What You'll Get :
A front‑row seat to life‑changing CGM technology and the opportunity to learn about our brave #DexcomWarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in‑house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry‑leading organization committed to our employees, customers, and the communities we serve.
Experience and Education :
You typically have 0-2 years of related experience and a High School diploma/certificate or equivalent.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$16.82 - $25.28
$16.8-25.3 hourly Auto-Apply 20d ago
Associate, Manufacturing Operations
Abeona Therapeutics Inc. 4.0
Cleveland, OH jobs
About Abeona Our Values: Patient First | Innovation | Integrity | Determination | Trust Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.
Company Description
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN (prademagene zamikeracel) is the first autologous cell-based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN. Abeona's portfolio includes adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions.
Position Overview
Abeona is looking for a ManufacturingAssociate to join our team in Cleveland, OH. The successful candidate will be responsible for Manufacturing initiatives supporting multiple product pipelines. The candidate will be an integral part of a fast-paced group responsible for the manufacture of retroviral vector, autologous gene-corrected cell therapies, and clinical AAV gene therapies. Responsibilities will include executing protocols and manufacturing clinical material across multiple products as well as supporting process optimization work and document generation. The ideal candidate will have experience in production of biologics in a controlled cGXP setting. Strong aseptic and cell culture technique as well as collaborative work in a team is an integral part of this position.
Schedule:
The current manufacturing team schedule is Monday to Friday, with occasional weekend shifts. The manufacturing team will be transitioning into a 4-day work week with 10-hour shifts in the near future. These days will be Sunday - Wednesday and Wednesday to Sunday.
Essential Duties and Responsibilities
* Produce cell therapies in cGMP facility in conjunction with manufacturing production records (MPRs).
* Execute studies in support of process optimization and validation.
* Author, review, and provide technical support for manufacturing SOPs and MPRs.
* Identify, suggest, and manage projects in parallel with manufacturing activities to reach set goals.
* Ability to collaborate with others while maintaining a strong capability in independent, critical thought.
* Strong organizational skills required.
* Must be able to work as part of a team.
* Contribute to activities that support safety and/or lab infrastructure.
Qualifications
* BS or equivalent in scientific discipline and min of 2-4 years related lab experience or MS or equivalent with 1-2 years of experience.
* General biological lab experience.
* Experience with mammalian and/or insect cell culture technology.
* Familiarity with aseptic technique, cell culture, and cell counters is strongly preferred.
* Previous GXP experience.
* Experience with production processes for cell therapies and/or viral vectors or vaccines is highly preferred.
* A strong background in the fundamentals and scale-up of production of biologic molecules strongly preferred.
Additional Desired Skills and Abilities:
* Advanced communication and organizational skills.
* Advanced interpersonal skills and the ability to work with individuals across all organizational levels.
* Attention to detail and accuracy.
* Detailed record keeping and data documentation.
* Demonstrated project management skills.
* Ability to read, analyze, and interpret technical procedures, publications, intellectual property and/or government documents.
* Working knowledge of GLP, GDP, GCP and GMP regulations and their ISO counterparts and ICH Guidelines.
* High level of proficiency with Microsoft Office programs.
* Less than 10% travel. Any travel will be reimbursed in accordance with company policy
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Hand-eye coordination and manual dexterity sufficient to operate office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting of up to 50 pounds is required.
Benefits
Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes:
* Medical insurance coverage (multiple options to meet our employees' and their families' needs)
* Dental and vision coverage
* 401k match plan
* Lifestyle spending account
* Compensation (annual): $70,000 - $$73,700 (please note that this range includes annual salary and the maximum anticipated annual bonus)
Visa Sponsorship Not Currently Available
IMPORTANT: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
$70k-73.7k yearly 6d ago
Associate, Manufacturing Operations
Abeona Therapeutics 4.0
Cleveland, OH jobs
About Abeona
Our Values: Patient First | Innovation | Integrity | Determination | Trust
Join us in making
cure
the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.
Company Description
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first autologous cell-based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN™. Abeona's portfolio includes adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions.
Position Overview
Abeona is looking for a ManufacturingAssociate to join our team in Cleveland, OH. The successful candidate will be responsible for Manufacturing initiatives supporting multiple product pipelines. The candidate will be an integral part of a fast-paced group responsible for the manufacture of retroviral vector, autologous gene-corrected cell therapies, and clinical AAV gene therapies. Responsibilities will include executing protocols and manufacturing clinical material across multiple products as well as supporting process optimization work and document generation. The ideal candidate will have experience in production of biologics in a controlled cGXP setting. Strong aseptic and cell culture technique as well as collaborative work in a team is an integral part of this position.
Schedule:
The current manufacturing team schedule is Monday to Friday, with occasional weekend shifts. The manufacturing team will be transitioning into a 4-day work week with 10-hour shifts in the near future. These days will be Sunday - Wednesday and Wednesday to Sunday.
Essential Duties and Responsibilities
Produce cell therapies in cGMP facility in conjunction with manufacturing production records (MPRs).
Execute studies in support of process optimization and validation.
Author, review, and provide technical support for manufacturing SOPs and MPRs.
Identify, suggest, and manage projects in parallel with manufacturing activities to reach set goals.
Ability to collaborate with others while maintaining a strong capability in independent, critical thought.
Strong organizational skills required.
Must be able to work as part of a team.
Contribute to activities that support safety and/or lab infrastructure.
Qualifications
BS or equivalent in scientific discipline and min of 2-4 years related lab experience or MS or equivalent with 1-2 years of experience.
General biological lab experience.
Experience with mammalian and/or insect cell culture technology.
Familiarity with aseptic technique, cell culture, and cell counters is strongly preferred.
Previous GXP experience.
Experience with production processes for cell therapies and/or viral vectors or vaccines is highly preferred.
A strong background in the fundamentals and scale-up of production of biologic molecules strongly preferred.
Additional Desired Skills and Abilities:
Advanced communication and organizational skills.
Advanced interpersonal skills and the ability to work with individuals across all organizational levels.
Attention to detail and accuracy.
Detailed record keeping and data documentation.
Demonstrated project management skills.
Ability to read, analyze, and interpret technical procedures, publications, intellectual property and/or government documents.
Working knowledge of GLP, GDP, GCP and GMP regulations and their ISO counterparts and ICH Guidelines.
High level of proficiency with Microsoft Office programs.
Less than 10% travel. Any travel will be reimbursed in accordance with company policy
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Hand-eye coordination and manual dexterity sufficient to operate office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting of up to 50 pounds is required.
Benefits
Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes:
Medical insurance coverage (multiple options to meet our employees' and their families' needs)
Dental and vision coverage
401k match plan
Lifestyle spending account
Compensation (annual): $70,000 - $$73,700 (please note that this range includes annual salary and the maximum anticipated annual bonus)
Visa Sponsorship Not Currently Available
IMPORTANT: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
$70k-73.7k yearly 6d ago
Associate, Manufacturing Operations
Abeona Therapeutics Inc. 4.0
Cleveland, OH jobs
Job Description
About Abeona
Our Values: Patient First | Innovation | Integrity | Determination | Trust
Join us in making
cure
the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.
Company Description
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first autologous cell-based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN™. Abeona's portfolio includes adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions.
Position Overview
Abeona is looking for a ManufacturingAssociate to join our team in Cleveland, OH. The successful candidate will be responsible for Manufacturing initiatives supporting multiple product pipelines. The candidate will be an integral part of a fast-paced group responsible for the manufacture of retroviral vector, autologous gene-corrected cell therapies, and clinical AAV gene therapies. Responsibilities will include executing protocols and manufacturing clinical material across multiple products as well as supporting process optimization work and document generation. The ideal candidate will have experience in production of biologics in a controlled cGXP setting. Strong aseptic and cell culture technique as well as collaborative work in a team is an integral part of this position.
Schedule:
The current manufacturing team schedule is Monday to Friday, with occasional weekend shifts. The manufacturing team will be transitioning into a 4-day work week with 10-hour shifts in the near future. These days will be Sunday - Wednesday and Wednesday to Sunday.
Essential Duties and Responsibilities
Produce cell therapies in cGMP facility in conjunction with manufacturing production records (MPRs).
Execute studies in support of process optimization and validation.
Author, review, and provide technical support for manufacturing SOPs and MPRs.
Identify, suggest, and manage projects in parallel with manufacturing activities to reach set goals.
Ability to collaborate with others while maintaining a strong capability in independent, critical thought.
Strong organizational skills required.
Must be able to work as part of a team.
Contribute to activities that support safety and/or lab infrastructure.
Qualifications
BS or equivalent in scientific discipline and min of 2-4 years related lab experience or MS or equivalent with 1-2 years of experience.
General biological lab experience.
Experience with mammalian and/or insect cell culture technology.
Familiarity with aseptic technique, cell culture, and cell counters is strongly preferred.
Previous GXP experience.
Experience with production processes for cell therapies and/or viral vectors or vaccines is highly preferred.
A strong background in the fundamentals and scale-up of production of biologic molecules strongly preferred.
Additional Desired Skills and Abilities:
Advanced communication and organizational skills.
Advanced interpersonal skills and the ability to work with individuals across all organizational levels.
Attention to detail and accuracy.
Detailed record keeping and data documentation.
Demonstrated project management skills.
Ability to read, analyze, and interpret technical procedures, publications, intellectual property and/or government documents.
Working knowledge of GLP, GDP, GCP and GMP regulations and their ISO counterparts and ICH Guidelines.
High level of proficiency with Microsoft Office programs.
Less than 10% travel. Any travel will be reimbursed in accordance with company policy
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Hand-eye coordination and manual dexterity sufficient to operate office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting of up to 50 pounds is required.
Benefits
Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes:
Medical insurance coverage (multiple options to meet our employees' and their families' needs)
Dental and vision coverage
401k match plan
Lifestyle spending account
Compensation (annual): $70,000 - $$73,700 (please note that this range includes annual salary and the maximum anticipated annual bonus)
Visa Sponsorship Not Currently Available
IMPORTANT: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
$70k-73.7k yearly 6d ago
Manufacturing Associate - IgG Production
Twist Bioscience 4.4
Portland, OR jobs
We are looking for motivated, enthusiastic individuals to join our Twist Bioscience Operations team in Wilsonville, OR. The ManufacturingAssociate, IgG Production, will produce various IgG antibody products, focusing on molecular and cellular biology, as well as running analytic techniques in the high-throughput/highly-automated lab according to established SOPs, along with working with sensitive equipment and following good manufacturing practices. Candidates must also be a team player, neat and highly organized, able to work in a cleanroom environment and foster safe work practices.
The ManufacturingAssociate will perform basic reagent handling, chemistry and molecular biology workflows in a highly automated, high-throughput manner and will be responsible for the manufacture and analysis of a variety of custom DNA based intermediates and products across Twist Bioscience's proprietary process workflow to meet the Twist production forecast and timelines.
The ideal candidate will be driven and will do what it takes to keep manufacturing on track in a fast paced start-up environment. The ManufacturingAssociate will be responsible for the production of custom gene based products and/or various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule.
Roles and Responsibilities include but are not limited to:
Manufacture high quality custom products in a high throughput MFG lab according to established SOPs.
Operate laboratory equipment and liquid handling robots such as Hamilton Stars, bioanalyzers, centrifuges, sealers, thermocyclers, spectrometers, Illumina Next-Gen sequencers etc.)
Effectively use molecular and cell biology processes and techniques, especially PCR, DNA quantitation, purification and cloning.
Maintain thorough, accurate and detailed documentation of all work performed using existing document templates and software applications.
Update and write work instructions and documentation.
Work independently and in a safe manner.
Pay great attention to details and perform consistent work without excessive supervision.
Help Leads and Supervisors with troubleshooting and the handling of process deviations.
Package and/or organize products for shipping.
Work according to Good Manufacturing and ISO practices. Learn, adopt and promote lean manufacturing concepts.
Complete all the daily assigned tasks to keep the manufacturing schedule on track and report back to Lead and Supervisor.
What You'll Bring to the Team
Relevant experience that can indicate success in a high throughput, fast pace laboratory manufacturing environment.
Associates or Bachelors degree in Biology, chemistry or related field is desirable.
Familiarity or prior experience in a manufacturing and/or a laboratory environment is highly desirable.
Good written and verbal skills are critical.
Good computer skills (Excel, Word, Atlassian etc) and the ability to quickly learn new software applications.
Ability to pay great attention to details.
Working Conditions
The work will be performed in a very dynamic laboratory team environment.
It is a controlled laboratory environment.
Must be able to stand for long periods of time while performing duties.
Must be able to work safely with chemicals and hazardous materials.
Must be able to lift up to 20 lbs.
Must be able to work outside of regular work hours/ work a flexible shift as needed
Please indicate shift preferences in your application.
Possible Shifts:
1.5A: Sunday-Tuesday, Alt Wednesday (2:00pm-2:30am)
1.5B: Alt Wednesday, Thursday-Saturday (2:00pm-2:30am)
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.
#LI-MS1
#LI-MS1
$39k-47k yearly est. Auto-Apply 52d ago
Manufacturing Associate
Twist Bioscience 4.4
Portland, OR jobs
We are looking for motivated, enthusiastic individuals to join our Twist Bioscience Operations team in Wilsonville, OR. The ManufacturingAssociate will produce various DNA and plasmid products, focusing on molecular and cellular biology, as well as running analytic techniques in the high-throughput/highly-automated lab according to established SOPs, along with working with sensitive equipment and following good manufacturing practices. Candidates must also be a team player, neat and highly organized, able to work in a cleanroom environment and foster safe work practices.
Please indicate shift preferences in your application.
Possible Shifts:
1A: Sunday-Tuesday, Alt Wednesday (7:00am-7:30pm)
1B: Alt Wednesday, Thursday-Saturday (7:00am-7:30pm)
2A: Alt Saturday, Sunday - Tuesday (7:00pm-7:30am)
2B: Wednesday - Friday, Alt Saturday (7:00pm-7:30am)
The ManufacturingAssociate will perform basic reagent handling, chemistry and molecular biology workflows in a highly automated, high-throughput manner and will be responsible for the manufacture and analysis of a variety of custom DNA based intermediates and products across Twist Bioscience's proprietary process workflow to meet the Twist production forecast and timelines. The ideal candidate will be driven and will do what it takes to keep manufacturing on track in a fast paced start-up environment. The ManufacturingAssociate will be responsible for the production of custom gene based products and/or various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule.
Roles and Responsibilities include but are not limited to:
Manufacture high quality custom products in a high throughput MFG lab according to established SOPs.
Operate laboratory equipment and liquid handling robots such as Hamilton Stars, bioanalyzers, centrifuges, sealers, thermocyclers, spectrometers, Illumina Next-Gen sequencers etc.)
Effectively use molecular and cell biology processes and techniques, especially PCR, DNA quantitation, purification and cloning.
Maintain thorough, accurate and detailed documentation of all work performed using existing document templates and software applications.
Update and write work instructions and documentation.
Work independently and in a safe manner.
Pay great attention to details and perform consistent work without excessive supervision.
Help Leads and Supervisors with troubleshooting and the handling of process deviations.
Package and/or organize products for shipping.
Work according to Good Manufacturing and ISO practices. Learn, adopt and promote lean manufacturing concepts.
Complete all the daily assigned tasks to keep the manufacturing schedule on track and report back to Lead and Supervisor.
What You'll Bring to the Team
Relevant experience that can indicate success in a high throughput, fast paced laboratory manufacturing environment.
Associates or Bachelors degree in Biology, chemistry or related field is desirable.
Familiarity or prior experience in a manufacturing and/or a laboratory environment is highly desirable.
Good written and verbal skills are critical.
Good computer skills (Excel, Word, Atlassian etc) and the ability to quickly learn new software applications.
Ability to pay great attention to details.
Working Conditions
The work will be performed in a very dynamic laboratory team environment.
It is a controlled laboratory environment.
Must be able to stand for long periods of time while performing duties.
Must be able to work safely with chemicals and hazardous materials.
Must be able to lift up to 20 lbs.
Must be able to work outside of regular work hours/ work a flexible shift as needed
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.
#LI-MS1
$39k-47k yearly est. Auto-Apply 60d+ ago
Manufacturing Associate II
Arcellx Inc. 4.0
Redwood City, CA jobs
Who We Are Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.
What Matters to Us
Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.
Arcellx Core Values
* Start with Authenticity: We foster an inclusive environment where each person can bring their authentic self to w
* Think 'we' before 'me': We prioritize collective success, collaborating and supporting one another to achieve our shared goals.
* Embrace the challenge: We deliver exceptional results by working with shared determination and a commitment to doing what's right.
How You'll Make a Difference
As a ManufacturingAssociate II, your mission is to deliver to patients every time! Our potentially life-saving treatments would not exist without the work of our manufacturing team. Your work will have a tremendous impact on our ability to deliver our transformative cell therapy to the patients who need it most.
The "Fine Print" - What You'll Do
* Key Responsibilities
* Accurately follow manufacturing batch records (MBRs) and standard operating procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs)
* Execute end-to-end cell therapy manufacturing operations including:
* Operation of manufacturing equipment for batch production
* Media preparation, reagent handling, buffer preparation
* Aseptic processing in controlled cleanroom environments
* Document all activities in accordance with Good Documentation Practices (GDPs)
* Support deviation investigations, CAPA execution, and change control activities
* Complete all training activities required to maintain quality compliance.
* Maintain strict compliance with regulatory and internal quality standards
* Perform routine maintenance activities required for a GMP environment
Skills and Experience We Look For
* Bachelor's degree in relevant scientific field and 2+ years of industry experience in manufacturing (cell therapy, biologics, or aseptic manufacturing environment)
* Familiarity with mammalian cell culture and aseptic techniques
* Ability to operate within a clean room environment for long duration
* Understanding of GMP principles and cleanroom operations
* Excellent organizational and prioritization skills
* Exceptional collaboration, communication, and interpersonal skills
* Flexibility to work weekends, holidays, or shift schedules as required
Rewards at Arcellx
Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.
The estimated base salary range for this position is $80,000 - $120,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.
Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.
Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to ****************
#LI-Onsite
$33k-43k yearly est. 57d ago
Manufacturing Associate II
Arcellx 4.0
Redwood City, CA jobs
Who We Are
Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.
What Matters to Us
Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.
Arcellx Core Values
Start with Authenticity:
We foster an inclusive environment where each person can bring their authentic self to w
Think ‘we' before ‘me'
: We prioritize collective success, collaborating and supporting one another to achieve our shared goals.
Embrace the challenge
: We deliver exceptional results by working with shared determination and a commitment to doing what's right.
How You'll Make a Difference
As a ManufacturingAssociate II, your mission is to deliver to patients every time! Our potentially life-saving treatments would not exist without the work of our manufacturing team. Your work will have a tremendous impact on our ability to deliver our transformative cell therapy to the patients who need it most.
The “Fine Print” - What You'll Do
Key Responsibilities
Accurately follow manufacturing batch records (MBRs) and standard operating procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs)
Execute end-to-end cell therapy manufacturing operations including:
Operation of manufacturing equipment for batch production
Media preparation, reagent handling, buffer preparation
Aseptic processing in controlled cleanroom environments
Document all activities in accordance with Good Documentation Practices (GDPs)
Support deviation investigations, CAPA execution, and change control activities
Complete all training activities required to maintain quality compliance.
Maintain strict compliance with regulatory and internal quality standards
Perform routine maintenance activities required for a GMP environment
Skills and Experience We Look For
Bachelor's degree in relevant scientific field and 2+ years of industry experience in manufacturing (cell therapy, biologics, or aseptic manufacturing environment)
Familiarity with mammalian cell culture and aseptic techniques
Ability to operate within a clean room environment for long duration
Understanding of GMP principles and cleanroom operations
Excellent organizational and prioritization skills
Exceptional collaboration, communication, and interpersonal skills
Flexibility to work weekends, holidays, or shift schedules as required
Rewards at Arcellx
Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.
The estimated base salary range for this position is $80,000 - $120,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.
Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.
Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to ****************
#LI-Onsite
$33k-43k yearly est. Auto-Apply 60d+ ago
Manufacturing Associate Downstream (Early Phase)
Avid Bioservices 4.2
Costa Mesa, CA jobs
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 ManufacturingAssociate, 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 44d ago
Manufacturing Associate Upstream (Early Phase)
Avid Bioservices 4.2
Costa Mesa, CA jobs
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 ManufacturingAssociate Upstream performs multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility, including, but not limited to production, documentation, writing reports, requesting, and purchasing materials, and scheduling equipment services and calibrations. The ManufacturingAssociate will play an integral role in ensuring the production and on-time release of quality products. The ManufacturingAssociate will conduct him/herself in a manner representing the core values (Integrity, Adaptability, Innovation, Teamwork, and Passion) of the company with the common purpose of improving patients' lives by consistently delivering high-quality biopharmaceutical products. Lead and conduct investigations as they pertain to facilities (or other areas of operations involving equipment or utilities) to determine roots causes and corrective/preventative actions.
Perform daily monitoring of equipment.
Operate and maintain cell culture bioreactors (Wave and 100L - 2000L disposable STR/SUB) in batch, fed-batch, and perfusion modes.
Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 15L spinner flasks performed in a BSC).
Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, balance, scale, MFCS, Rees, and Delta V.
Harvest operations - pod filtration, 3M filtration, and TFF system.
Schedule vendor service appointments for equipment.
Purchase necessary equipment and associated materials that are needed or low in supply.
Help create and actively support 5S, Area Improvement, and Safety Team initiatives to ensure a Continuous Improvement culture throughout the department.
Operate Sartocheck filter integrity testers.
Maintain cleanroom facility and equipment.
cGMP Documentation.
Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms.
Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling.
Identify, escalate, and report deviations (IRs/DRs/CAPAs).
Set up critical new manufacturing processes and equipment.
Troubleshoot equipment and process issues in collaboration with Facilities (FAC), Manufacturing Sciences and Technology (MSAT), and Validation (VAL) departments.
Ensure that equipment and material are available as required for each production run.
Identify the technical, procedural, and equipment issues that hinder production and compliance. Inform support departments and manager as needed.
Assist in the transfer of technology from PD and MSAT to cGMP Manufacturing.
Assist with periodic technical and compliance investigations, inspections, and audits.
Report all unsafe activities to manager and/or Human Resources.
Participate in proactive team efforts to achieve departmental and company goals.
Communicate with team members, supervisors, and members of other departments, as appropriate, to assure prompt resolution of problems.
Prepare media and buffer.
Perform aseptic filling.
Other duties may be assigned.
Minimum Qualifications:
2+ years of related experience and/or training; or equivalent combination of education and experience.
2+ years of industry experience working with mammalian cell culture.
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 $20.52-$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. 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 22d ago
Manufacturing Associate Upstream
Avid Bioservices 4.2
Tustin, CA jobs
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 ManufacturingAssociate Upstream performs multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility, including, but not limited to production, documentation, writing reports, requesting, and purchasing materials, and scheduling equipment services and calibrations. The ManufacturingAssociate will play an integral role in ensuring the production and on-time release of quality products. The ManufacturingAssociate will conduct him/herself in a manner representing the core values (Integrity, Adaptability, Innovation, Teamwork, and Passion) of the company with the common purpose of improving patients' lives by consistently delivering high-quality biopharmaceutical products. Lead and conduct investigations as they pertain to facilities (or other areas of operations involving equipment or utilities) to determine roots causes and corrective/preventative actions.
* Perform daily monitoring of equipment.
* Operate and maintain cell culture bioreactors (Wave and 100L - 2000L disposable STR/SUB) in batch, fed-batch, and perfusion modes.
* Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 15L spinner flasks performed in a BSC).
* Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, balance, scale, MFCS, Rees, and Delta V.
* Harvest operations - pod filtration, 3M filtration, and TFF system.
* Schedule vendor service appointments for equipment.
* Purchase necessary equipment and associated materials that are needed or low in supply.
* Help create and actively support 5S, Area Improvement, and Safety Team initiatives to ensure a Continuous Improvement culture throughout the department.
* Operate Sartocheck filter integrity testers.
* Maintain cleanroom facility and equipment.
* cGMP Documentation.
* Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms.
* Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling.
* Identify, escalate, and report deviations (IRs/DRs/CAPAs).
* Set up critical new manufacturing processes and equipment.
* Troubleshoot equipment and process issues in collaboration with Facilities (FAC), Manufacturing Sciences and Technology (MSAT), and Validation (VAL) departments.
* Ensure that equipment and material are available as required for each production run.
* Identify the technical, procedural, and equipment issues that hinder production and compliance. Inform support departments and manager as needed.
* Assist in the transfer of technology from PD and MSAT to cGMP Manufacturing.
* Assist with periodic technical and compliance investigations, inspections, and audits.
* Report all unsafe activities to manager and/or Human Resources.
* Participate in proactive team efforts to achieve departmental and company goals.
* Communicate with team members, supervisors, and members of other departments, as appropriate, to assure prompt resolution of problems.
* Prepare media and buffer.
* Perform aseptic filling.
* Other duties may be assigned.
Minimum Qualifications:
* 2+ years of related experience and/or training; or equivalent combination of education and experience.
* 2+ years of industry experience working with mammalian cell culture.
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 operating Monday through Friday on a 5x8 (5 days x 8 hours) schedule, with operating hours from 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 $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.
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
Manufacturing Associate Upstream
Avid Bioservices 4.2
Tustin, CA jobs
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 ManufacturingAssociate Upstream performs multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility, including, but not limited to production, documentation, writing reports, requesting, and purchasing materials, and scheduling equipment services and calibrations. The ManufacturingAssociate will play an integral role in ensuring the production and on-time release of quality products. The ManufacturingAssociate will conduct him/herself in a manner representing the core values (Integrity, Adaptability, Innovation, Teamwork, and Passion) of the company with the common purpose of improving patients' lives by consistently delivering high-quality biopharmaceutical products. Lead and conduct investigations as they pertain to facilities (or other areas of operations involving equipment or utilities) to determine roots causes and corrective/preventative actions.
Perform daily monitoring of equipment.
Operate and maintain cell culture bioreactors (Wave and 100L - 2000L disposable STR/SUB) in batch, fed-batch, and perfusion modes.
Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 15L spinner flasks performed in a BSC).
Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, balance, scale, MFCS, Rees, and Delta V.
Harvest operations - pod filtration, 3M filtration, and TFF system.
Schedule vendor service appointments for equipment.
Purchase necessary equipment and associated materials that are needed or low in supply.
Help create and actively support 5S, Area Improvement, and Safety Team initiatives to ensure a Continuous Improvement culture throughout the department.
Operate Sartocheck filter integrity testers.
Maintain cleanroom facility and equipment.
cGMP Documentation.
Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms.
Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling.
Identify, escalate, and report deviations (IRs/DRs/CAPAs).
Set up critical new manufacturing processes and equipment.
Troubleshoot equipment and process issues in collaboration with Facilities (FAC), Manufacturing Sciences and Technology (MSAT), and Validation (VAL) departments.
Ensure that equipment and material are available as required for each production run.
Identify the technical, procedural, and equipment issues that hinder production and compliance. Inform support departments and manager as needed.
Assist in the transfer of technology from PD and MSAT to cGMP Manufacturing.
Assist with periodic technical and compliance investigations, inspections, and audits.
Report all unsafe activities to manager and/or Human Resources.
Participate in proactive team efforts to achieve departmental and company goals.
Communicate with team members, supervisors, and members of other departments, as appropriate, to assure prompt resolution of problems.
Prepare media and buffer.
Perform aseptic filling.
Other duties may be assigned.
Minimum Qualifications:
2+ years of related experience and/or training; or equivalent combination of education and experience.
2+ years of industry experience working with mammalian cell culture.
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 operating Monday through Friday on a 5x8 (5 days x 8 hours) schedule, with operating hours from 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 $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. 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
(CW) Manufacturing Associate (TEMPORARY)
Biomarin Pharmaceutical Inc. 4.6
Novato, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
CONTRACT *Shift schedule is Sundays to Tuesdays alternating Saturdays. Hours is 6pm to 7 am. *
Duties
PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).
TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.
QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.
WORK ENVIRONMENT/PHYSICAL DEMANDS
* Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
* Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
* May require work around loud equipment. • The use of personal protective equipment will be required.
* Requires various shift based work and off hours.
Skills
* Strong communication skills-verbal and written
* Ability to work in a team environment which includes good conflict resolution and collaboration
* Displays good initiative to identify areas for improvement and implement solutions
Education
* Bachelor's degree in science related area or engineering
* Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
$15-30 hourly 16d ago
(CW) Manufacturing Associate (TEMPORARY)
Biomarin Pharmaceutical Inc. 4.6
Novato, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
CONTRACT ROLE-Sunday - Tuesday/Wednesday Shift from 6am - 7pm (Alternate every other Wednesday)
Duties
PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).
TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.
QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.
WORK ENVIRONMENT/PHYSICAL DEMANDS
* Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
* Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
* May require work around loud equipment. • The use of personal protective equipment will be required.
* Requires various shift based work and off hours.
Skills
* Strong communication skills-verbal and written
* Ability to work in a team environment which includes good conflict resolution and collaboration
* Displays good initiative to identify areas for improvement and implement solutions
Education
* Bachelor's degree in science related area or engineering
* Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
$15-30 hourly 16d ago
Manufacturing Associate - IgG Production
Twist Bioscience Corporation 4.4
Wilsonville, OR jobs
We are looking for motivated, enthusiastic individuals to join our Twist Bioscience Operations team in Wilsonville, OR. The ManufacturingAssociate, IgG Production, will produce various IgG antibody products, focusing on molecular and cellular biology, as well as running analytic techniques in the high-throughput/highly-automated lab according to established SOPs, along with working with sensitive equipment and following good manufacturing practices. Candidates must also be a team player, neat and highly organized, able to work in a cleanroom environment and foster safe work practices.
The ManufacturingAssociate will perform basic reagent handling, chemistry and molecular biology workflows in a highly automated, high-throughput manner and will be responsible for the manufacture and analysis of a variety of custom DNA based intermediates and products across Twist Bioscience's proprietary process workflow to meet the Twist production forecast and timelines.
The ideal candidate will be driven and will do what it takes to keep manufacturing on track in a fast paced start-up environment. The ManufacturingAssociate will be responsible for the production of custom gene based products and/or various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule.
Roles and Responsibilities include but are not limited to:
* Manufacture high quality custom products in a high throughput MFG lab according to established SOPs.
* Operate laboratory equipment and liquid handling robots such as Hamilton Stars, bioanalyzers, centrifuges, sealers, thermocyclers, spectrometers, Illumina Next-Gen sequencers etc.)
* Effectively use molecular and cell biology processes and techniques, especially PCR, DNA quantitation, purification and cloning.
* Maintain thorough, accurate and detailed documentation of all work performed using existing document templates and software applications.
* Update and write work instructions and documentation.
* Work independently and in a safe manner.
* Pay great attention to details and perform consistent work without excessive supervision.
* Help Leads and Supervisors with troubleshooting and the handling of process deviations.
* Package and/or organize products for shipping.
* Work according to Good Manufacturing and ISO practices. Learn, adopt and promote lean manufacturing concepts.
* Complete all the daily assigned tasks to keep the manufacturing schedule on track and report back to Lead and Supervisor.
What You'll Bring to the Team
* Relevant experience that can indicate success in a high throughput, fast pace laboratory manufacturing environment.
* Associates or Bachelors degree in Biology, chemistry or related field is desirable.
* Familiarity or prior experience in a manufacturing and/or a laboratory environment is highly desirable.
* Good written and verbal skills are critical.
* Good computer skills (Excel, Word, Atlassian etc) and the ability to quickly learn new software applications.
* Ability to pay great attention to details.
Working Conditions
* The work will be performed in a very dynamic laboratory team environment.
* It is a controlled laboratory environment.
* Must be able to stand for long periods of time while performing duties.
* Must be able to work safely with chemicals and hazardous materials.
* Must be able to lift up to 20 lbs.
* Must be able to work outside of regular work hours/ work a flexible shift as needed
Please indicate shift preferences in your application.
Possible Shifts:
1.5A: Sunday-Tuesday, Alt Wednesday (2:00pm-2:30am)
1.5B: Alt Wednesday, Thursday-Saturday (2:00pm-2:30am)
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as "writing" DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.
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$39k-47k yearly est. Auto-Apply 60d+ ago
(CW) Manufacturing Associate
Biomarin Pharmaceutical 4.6
Novato, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
CONTRACT ROLE-Sunday - Tuesday/Wednesday Shift from 6am - 7pm (Alternate every other Wednesday) ****
Duties
PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).
TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.
QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.
WORK ENVIRONMENT/PHYSICAL DEMANDS
• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
• May require work around loud equipment. • The use of personal protective equipment will be required.
• Requires various shift based work and off hours.
Skills
• Strong communication skills-verbal and written
• Ability to work in a team environment which includes good conflict resolution and collaboration
• Displays good initiative to identify areas for improvement and implement solutions
Education
-Bachelor's degree in science related area or engineering
-Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
$36k-43k yearly est. Auto-Apply 15d ago
(CW) Manufacturing Associate
Biomarin Pharmaceutical 4.6
Novato, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
*CONTRACT ***Shift - Sunday -Tuesday w/alternating Saturdays 1800-0700****
Duties:
PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).
TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.
QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.
WORK ENVIRONMENT/PHYSICAL DEMANDS
• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
• May require work around loud equipment. • The use of personal protective equipment will be required.
• Requires various shift based work and off hours.
Skills
• Strong communication skills-verbal and written
• Ability to work in a team environment which includes good conflict resolution and collaboration
• Displays good initiative to identify areas for improvement and implement solutions
Education
-Bachelor's degree in science related area or engineering
-Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
$36k-43k yearly est. Auto-Apply 7d ago
(CW) Manufacturing Associate (TEMPORARY)
Biomarin Pharmaceutical Inc. 4.6
Novato, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
* CONTRACT *Shift - Sunday -Tuesday w/alternating Saturdays 1800-0700
Duties:
PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).
TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.
QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.
WORK ENVIRONMENT/PHYSICAL DEMANDS
* Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
* Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
* May require work around loud equipment. • The use of personal protective equipment will be required.
* Requires various shift based work and off hours.
Skills
* Strong communication skills-verbal and written
* Ability to work in a team environment which includes good conflict resolution and collaboration
* Displays good initiative to identify areas for improvement and implement solutions
Education
* Bachelor's degree in science related area or engineering
* Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
In the U.S, the salary range for this position is $ null to $ null per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $null to $null. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: