NPD Quality Engineer II
Industrial engineer job at Terumo Medical
Req ID: 5357 Company: Terumo Medical Corporation Department: TIS Design Assurance/Quality Engineering The Design Quality Engineer (DQE) II will plan, coordinate, and manage the quality assurance (QA) activities associated with one or multiple New Product Development (NPD) and/or Sustaining Design Changes projects to ensure compliance to internal and external requirements during the development and commercialization of new products. This individual will provide overall Quality Assurance (QA) leadership and partner with the NPD organization in efficient, effective, and rapid development and commercialization of new products. This individual will manage the effective oversight of Design Quality activities, as well as participate as an active QA representative on project teams. The DQE II manages the daily operation of the Design quality aspects of one or multiple projects by ensuring timely completion of Design Quality Assurance deliverables that meet the company standards for quality. This individual provides NPD teams with clear, consistent, and timely feedback as it relates to compliance exposure and will provide innovative solutions to effectively resolve investigations and to meet the needs of customers, regulatory bodies, and Terumo business requirements.
As part of a project team, the DQE II will be responsible for developing sound Design History File deliverables, including, but not limited to, Quality Plans, Manufacturing Quality Plan, Design Verification protocols and reports, and conducting Design History File reviews at the end of each design control phase. In addition, the Principal, NPD QE will actively participate in design characterization, risk management activities, and design and process validation.
The salary range for this position is $75,120 - $104,500 based on experience plus an annual 8% target bonus.
**Job Details/Responsibilities**
+ Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.
+ Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned project activities.
+ Lead quality system development and implementation throughout product life cycle
+ Provide oversight for internal and external metrology, incoming inspection, acceptance criteria, disposition of non-conforming materials, and measurement system evaluations.
+ Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs.
+ Review and approve/reject technical transfer plans and reports from the design transfer perspective. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and evaluated.
+ Lead teams and ensure completion of Risk Management activities for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with limited guidance required.
+ Leads cross functional team on how to documents changes, using a risk-based approach for determining requirements.
+ Contribute to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other related products.
+ Develop and validate test methods.
+ Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
+ Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
+ Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with moderate complexity.
+ Review and approve product and process qualification and validation and other change control related documentation.
+ Active role in improving and drafting internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
+ Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
+ Performs analytical measurements and experiments to qualify or resolve product and process issues.
**Job Responsibilities (continued)**
+ Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.
+ Support field quality and analyze field returns to determine root cause.
+ Provide training and support for quality system processes and quality engineering practices.
+ Provide support as a Quality Assurance Team member to work with Engineering and Systems Teams to resolve issues related to Design Verification and Design Validation.
+ Clear understanding of Process Validation Principles and ability to support Process Qualification efforts (IQ, OQ, PQ etc.) for all classes of medical devices.
Internal contacts: All departments, including manufacturing, engineering, marketing/sales.
External contacts: Customers and vendor contacts as required.
**Knowledge, Skills and Abilities (KSA)**
+ Effective communication skills both verbal and written. Communicates effectively with internal teams and may present findings to small groups.
+ Strong organizational skills as well as time management skills essential for project work.
+ Self-motivating and able to balance multiple priorities and tight deadlines with limited supervision.
+ Excellent computer skills
+ Strong writing, mathematics, and statistics skills
+ Demonstrated working knowledge of key medical device related standards including 21 CFR 820 (Quality Systems Medical Devices), Design Controls, ISO 13485, and ISO 14791.
+ Basic experience using quality tools and statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) is desired.
**Qualifications/ Background Experiences**
+ BS in engineering, biomedical, life sciences, or similar discipline from an accredited university or college.
+ Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to new product development and/or manufacturing.
+ Minimum of 3 years of experience in an engineering and/or scientific environment
+ Minimum of 2 years of experience in a regulated industry (medical device industry preferred)
Supplier Industrialization Engineer
San Francisco, CA jobs
Nimble is a frontier robotics and AI company building the next era of autonomous logistics. We design, manufacture, and deploy intelligent robots that enable fast, efficient, and sustainable commerce at global scale. Our team is building generalized robot intelligence and developing the world's first generalist super-humanoid robots capable of performing all core warehouse workflows with superhuman performance.
We recently closed a $106M Series C at a $1B valuation, and we are continuing to grow our world-class team. Our long-term vision is to create the Autonomous Supply Chain-reinventing how goods move through factories, warehouses, and last-mile distribution using next-generation intelligent robotic systems.
Nimble was founded out of Stanford and Carnegie Mellon's top AI labs and is backed by the world's most prestigious investors. Our board includes iconic leaders in AI and robotics such as Marc Raibert (Founder of Boston Dynamics), Fei-Fei Li (Former Chief Scientist of AI at Google, Director of Stanford's AI lab), and Sebastian Thrun (Waymo, Founder of Google X, Kitty Hawk, and Udacity).
Join us and leave your mark on the future of robotics, AI, and global commerce.
Link: Introducing Nimble - Intelligent Fulfillment Robots at Scale
Why Join Nimble?
At Nimble, we are committed to building legendary products, a legendary team, and a legendary legacy. Join us and become part of an ambitious, humble, and resourceful culture where your work will leave a lasting impact on the future of robotics and commerce.
Nimble's Core Values:
Be relentlessly resourceful - Challenge conventions and overcome constraints.
Be legendary - Pursue excellence and craft work that inspires.
Be humble - Prioritize growth, learning, and the mission over ego.
Be dependable - Take ownership and deliver with integrity.
About the Role:
The Supplier Industrialization Engineer (SIE) will be responsible for ensuring that our suppliers are capable of delivering high-quality, scalable components that meet Nimble's rigorous standards. The SIE will partner closely with suppliers and internal teams to industrialize new parts, improve supplier capabilities, and drive continuous improvement across the supply base.
Key Responsibilities:
* Conduct supplier audits, quality assessments, and process inspections to ensure compliance with company standards.
* Develop and maintain processes to identify, contain, and resolve quality issues at supplier sites.
* Evaluate and approve supplier First Article Inspections (FAI) and Production Part Approval Processes (PPAP).
* Collaborate with suppliers to enhance manufacturing processes, improve capabilities, and support production ramp-up.
* Identify cost-effective solutions to improve supplier performance and reduce defects or delays.
* Provide technical guidance for implementing corrective actions and process improvements at suppliers.
* Ensure suppliers comply with international quality standards (ISO 9001, ISO 14001) and regulatory requirements.
* Monitor supplier adherence to environmental, safety, and operational standards.
* Serve as a liaison between suppliers and internal teams to resolve technical and operational challenges.
* Track and report supplier performance metrics, including on-time delivery, defect rates, and process efficiency.
* Conduct root cause analysis for supplier quality issues and implement corrective and preventive actions.
Qualifications:
* Bachelor's degree in Mechanical, Industrial, or Manufacturing Engineering (or equivalent experience). Masters preferred.
* 3+ years of experience in supplier quality, supplier development, or industrialization within manufacturing.
* Strong knowledge of manufacturing processes: machining, casting, injection molding, and electro-mechanical assembly.
* Hands-on experience with quality tools: PPAP, FMEA, SPC, 8D, etc.
* Willingness to travel globally to supplier sites (up to 30%)
$140,000 - $200,000 a year
Compensation for this position is made up base salary plus generous equity. The above range is the salary range.
Culture:
We embrace challenges and strive to make the impossible possible each day. We're not in this to do what's easy or to be mediocre. We want to create something legendary and leave our mark on the world. We're ambitious, we're gritty, we're humble and we're relentlessly resourceful in pursuit of our goals. If this sounds like you then you might be a great fit!
Press:
Link: Nimble Closes $106 Million Series C Funding Round, Scales Fully Autonomous Fulfillment with FedEx
Link: FedEx Announces Expansion of FedEx Fulfillment With Nimble Alliance
Nimble Robotics, Inc. is an equal opportunity employer. We make all employment decisions based solely on merit. We provide equal employment opportunity to all applicants and employees without discrimination on the basis of race, color, religion, national origin, ancestry, disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, sexual orientation, age, military or veteran status, or any other characteristic protected by applicable state, federal or local laws.
Nimble's Benefits
Paid Time Off
Enjoy the time you need to travel, rejuvenate, and connect with friends and family.
Health Insurance
Nimble provides medical, dental, and vision insurance through several premier plans and options to support you and your family.
Paid Parental Leave
Enjoy paid bonding time following a birth.
Commuter Benefits
Take the stress out of commuting with access to fully-paid parking spots.
Referral Bonus
Get a cash bonus for any friend or colleagues that you refer to us that we end up hiring.
401k
Contribute towards a 401k for retirement planning.
Equity
Be an owner in Nimble through our equity program
Industrial Engineer II
Roseville, CA jobs
The Industrial Engineer II is focused on eliminating wastefulness in production processes, and in developing ways to improve productivity, quality, and efficiency through the effective use of workers, machines, materials, and space information. The Industrial Engineer II will leverage a strong understanding of Lean Programs and drive continuous improvements working with cross-functional teams.
Specific Duties and Responsibilities• Review production schedules, engineering specifications, process flows, work instructions, and other information to understand methods and activities in manufacturing and services.• Drive efforts to analyze systems and determine how to manufacture parts or products with maximum efficiency and quality, with minimal supervision.• Work with manufacturing, quality, and R&D engineers to identify equipment and process improvement opportunities, and improvements in layout of workspaces.• Drive Time Study Analysis and identification of Value / Non-Value-added activities during these studies and subsequent presentation of findings, planning, and implementation of improvement plans.• Develop Systems, Processes and Procedures that enable the Industrial Engineering Group to function at a high level.• Develop, Support and be able to train Penumbra Employees on programs that support Lean Manufacturing Implementation.• Mentor and Train Industrial Engineers, help advance appropriate skill sets and understanding of Lean Manufacturing Concepts and Techniques.• Ensures facility efficiency and workplace safety, maintaining a safe and compliant work environment.• Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. • Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.• Ensure other members of the department follow the QMS, regulations, standards, and procedures.• Perform other work-related duties as assigned.
Position Qualifications Required• Bachelor's degree required in Industrial, Manufacturing, or Mechanical Engineering or a related discipline, with 2+ years of experience in the medical device or related industry, or an equivalent combination of education and experience• Creativity, critical thinking, problem solving, and analytical skills required• Excellent oral, written, and interpersonal communication skills with the ability to present findings and recommendations to diverse audiences• High degree of accuracy and attention to detail• Proficiency with standard office tools including Word, Excel, and PowerPoint• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
Position Qualifications Desired• Medical device, pharmaceutical, biotech, or other regulated industry experience desired• 2+ years of experience in a medical device industry role desired
Working Conditions• General office and cleanroom environments• Willingness and ability to work on site. May have business travel from 0% - 10%• Potential exposure to blood-borne pathogens• Requires some lifting and moving of up to 25 pounds• Must be able to move between buildings and floors.• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.• Must be able to read, prepare emails, and produce documents and spreadsheets. • Must be able to move within the office and access file cabinets or supplies, as needed.• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range: $90,000 to $120,000We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded.•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
Auto-ApplyIndustrial Engineer II
Roseville, CA jobs
The Industrial Engineer II is focused on eliminating wastefulness in production processes, and in developing ways to improve productivity, quality, and efficiency through the effective use of workers, machines, materials, and space information. The Industrial Engineer II will leverage a strong understanding of Lean Programs and drive continuous improvements working with cross-functional teams.
Specific Duties and Responsibilities
* Review production schedules, engineering specifications, process flows, work instructions, and other information to understand methods and activities in manufacturing and services.
* Drive efforts to analyze systems and determine how to manufacture parts or products with maximum efficiency and quality, with minimal supervision.
* Work with manufacturing, quality, and R&D engineers to identify equipment and process improvement opportunities, and improvements in layout of workspaces.
* Drive Time Study Analysis and identification of Value / Non-Value-added activities during these studies and subsequent presentation of findings, planning, and implementation of improvement plans.
* Develop Systems, Processes and Procedures that enable the Industrial Engineering Group to function at a high level.
* Develop, Support and be able to train Penumbra Employees on programs that support Lean Manufacturing Implementation.
* Mentor and Train Industrial Engineers, help advance appropriate skill sets and understanding of Lean Manufacturing Concepts and Techniques.
* Ensures facility efficiency and workplace safety, maintaining a safe and compliant work environment.
* Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
* Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
* Ensure other members of the department follow the QMS, regulations, standards, and procedures.
* Perform other work-related duties as assigned.
Position Qualifications Required
* Bachelor's degree required in Industrial, Manufacturing, or Mechanical Engineering or a related discipline, with 2+ years of experience in the medical device or related industry, or an equivalent combination of education and experience
* Creativity, critical thinking, problem solving, and analytical skills required
* Excellent oral, written, and interpersonal communication skills with the ability to present findings and recommendations to diverse audiences
* High degree of accuracy and attention to detail
* Proficiency with standard office tools including Word, Excel, and PowerPoint
* Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
Position Qualifications Desired
* Medical device, pharmaceutical, biotech, or other regulated industry experience desired
* 2+ years of experience in a medical device industry role desired
Working Conditions
* General office and cleanroom environments
* Willingness and ability to work on site. May have business travel from 0% - 10%
* Potential exposure to blood-borne pathogens
* Requires some lifting and moving of up to 25 pounds
* Must be able to move between buildings and floors.
* Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
* Must be able to read, prepare emails, and produce documents and spreadsheets.
* Must be able to move within the office and access file cabinets or supplies, as needed.
* Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range: $90,000 to $120,000
We offer a competitive compensation package plus a benefits and equity program, when applicable.
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Offer
* A collaborative teamwork environment where learning is constant, and performance is rewarded.
* The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
* A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
Industrial Engineer
Melville, NY jobs
, Inc. Founded in 1962, Air Techniques, Inc. set out to manufacture first-rate products for the dental industry. Over 63 years later, Air Techniques has grown from a small company into a successful corporation. At our New York headquarters, we design and build two main groups of products: utility room and digital imaging products. Our products are manufactured in a vertically integrated factory where compliance with the Food and Drug Administration Good Manufacturing Practices is paired with stringent Quality Standards. In-house engineering staff designs our products for the dental market. We are proud to maintain the ISO-13485 registration certification which reinforces our pledge to quality and customer satisfaction. At Air Techniques, we have earned our reputation in the dental industry through our commitment to quality and ensuring customer satisfaction. We are proud that Air Techniques represents superior quality to dealers and dentists worldwide.
Position Description
Our company is seeking an Industrial Engineer who will be working closely with Manufacturing, Engineering, Quality and Management to ensure the highest quality product is delivered to our customers. In addition, you will be tasked with driving process improvement throughout our various product lines to optimize workflow and throughput.
Essential Functions and Responsibilities:
Production layout and line balancing, utilizing lean manufacturing principles, processes and tools
Continuous Process Improvement consistent with business strategies and initiatives
Methods development for our electro-mechanical assembly
Review and calculate labor, material and other production costs to assist management in decision making
Work with Tool Room to develop and implement tooling solutions that increase efficiency and ease of manufacturing. Utilize automation where possible
Assures product quality by gathering key performance indicators and analyzing the data to drive improvement
Assist with troubleshooting and failure analysis for production devices and components
Active liaison between Operations and other departments
Active participant in company-wide quality audits
Management of diverse manufacturing-related projects
Performs other duties, as assigned
Work Experience Requirements:
2-5 years of hands-on, related experience in a manufacturing environment
Working knowledge of ERP systems
Working knowledge of Lean Manufacturing and Kanban principles
Core Skills Requirements:
Demonstrates people and communications skills
Ability to interface effectively at all levels of the organization
Education Requirements:
BS degree in Industrial or Manufacturing Engineering or related field
It is the policy of Air Techniques to provide equal employment opportunities to all qualified applicants without discrimination on the basis of race, creed, color, religion, national origin or ancestry, gender, citizenship, age, disability, marital status, veteran status, sexual preference, or any other characteristic protected by applicable federal, state, or local laws.
Auto-ApplyECO Process Development Research Associate II/III
Redwood City, CA jobs
Job DescriptionDescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a ECO Process Development Research Associate II/III. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. Codexis enzymes solve for real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesisâ„¢ platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. Codexis enzymes can drive improvements, such as higher yields, reduced energy usage and waste generation, improve efficiency in manufacturing and greater sensitivity in genomic and diagnostic applications.
To meet the goals we've set for ourselves, we look for individuals who are driven, eager to grow and ready to embrace meaningful challenges. We empower employees to be authentic, ambitious, agile and have the courage to take action where they can make a positive impact.
Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health.
About the Opportunity The Process Development Research Associate I will join the Process Development group which is part of the TechOps department. Successful candidates will be a part of a dynamic and enthusiastic team responsible for development, scale up and tech transfer of the ECO Synthesisâ„¢ platform. The individual will be working with a high performing team with day-to-day laboratory workflows and operations to help with design, optimization, and analysis of ECO Synthesisâ„¢ technology. The position is an on-site role located at our Redwood City facility full time.
If any of the below describes you, we would love to meet you!
Possess a passion for being part of the therapeutic community helping bring cutting edge treatments to patients in need.
Enjoys collaboration across different functional groups to get a holistic understanding of process development along with aligning data with internal stakeholders.
Enjoys problem solving by implementing engineering and analytical solutions.
In this role you will be responsible for:
Assist in the development and optimization of advanced analytical workflows, focusing on High-Performance Liquid Chromatography (HPLC).
Contribute to the development and enhancement of post-synthesis tangential flow filtration methods to ensure product quality.
Follow established protocols and procedures to conduct experiments, maintaining accurate and detailed records.
Collaborate with cross-functional teams to troubleshoot and resolve technical challenges.
Maintain laboratory equipment and ensure compliance with safety and quality standards.
The essential requirements of the job include:
Bachelor's degree in Life Sciences or Chemistry with 2+ years of experience, or a Master's degree.
Basic understanding of laboratory techniques.
Experience with High-Performance Liquid Chromatography (HPLC) is a plus.
Strong attention to detail and ability to follow protocols with supervision.
Additional experience that would be valuable for this role includes:
Excellent organizational and communication skills.
Ability to work effectively in a collaborative, team-oriented environment.
CODEXIS PAY TRANSPARENCY: The anticipated salary range for candidates who will work in Redwood City is $36.00 to $45.65/hour for an II and $89,000 to $121,000 for a III. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Codexis is a multi-state employer, and this salary range may not reflect positions that work in other states .
What can Codexis offer you?
Medical, Dental and Vision Insurance
Basic Life, AD&D, Short- and Long-Term Disability Insurance
401k with Company Match up to 4%
Company Equity
Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time
Annual Lifestyle Account for reimbursement of fitness programs, equipment and more
Employee Stock Purchase Program (ESPP)
Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)
Student Debt Program (Company Contribution to Loans)
Mental Health Wellness Program
Subsidized onsite lunch program
Onsite Gym Facilities
Paid Parental Leave
And More!
Process Development Associate (Co-Op Conversion Program)
Tarrytown, NY jobs
Regeneron's Preclinical Manufacturing & Process Development (PMPD) is seeking a Process Development Associate interested in process development and scale-up of biopharmaceuticals. In this role, you contribute to experiments that support manufacturing process development and research activities in a fast-paced laboratory setting. This role will be part of the PMPD Co-op conversion pilot program.
A Typical Day in the Role of Process Development Associate Might Look Like:
* Work as a contributing member of unit operations such as: Cell Culture & Media Development, Bioreactor Development, Analytics, Purification Development or Tech Transfer & Logistics in collaboration with multi-functional groups.
* Deliver written or oral communications as a representative of the PMPD group at a wide variety of internal projects.
* Collaborate with team members and supervisor to investigate new technologies.
* Contributes to continuous improvement efforts for growing efficiency and throughput within the group.
This Role Might Be For You If You Have:
* A strong initiative and drive to complete ambitious tasks and learn new technologies.
* Ability to work both independently and within a team environment on multiple projects simultaneously.
* Drive to contribute to lab equipment maintenance and safety to help create a safe, effective and efficient working environment.
* A curiosity about joining a collaborative team with a focus on continuous improvement.
This role requires a BS with 0 - 3 years of relevant experience. Excellent verbal and written communication skills, and record keeping abilities to accurately record, analyze, and document development data generated.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$70,300.00 - $110,100.00
Auto-ApplyProcess Development Associate, Bioreactor and Scale-Up Development (2 of 2)
Tarrytown, NY jobs
Regeneron's Bioreactor and Scale-Up Development Group within Preclinical Manufacturing and Process Development (PMPD) is looking for a motivated Process Development Associate to work as part of the late-stage development team to develop production processes of biologics in a non-GMP process development laboratory. In this role, they will perform studies at pilot scale to develop commercially enabling manufacturing processes.
A Typical Day in the Role of Process Development Associate Might Look Like:
* Support lab operations to cultivate mammalian cells producing biologics in bench and pilot-scale bioreactors, including sterilizing, sanitizing, and operating bioreactors, preparing buffers and feeds, and maintaining and onboarding laboratory equipment.
* Contribute to technology development projects to innovate process development and explore personal areas of interest.
* Evaluate and solve challenges associated with the scale-up of processes.
* Analyze seed train, production, and quality data to support process understanding and technology transfer, followed by authoring development reports, process transmittals, and documentation in electronic notebooks.
* Participate in Technology Transfer Start-Up Teams by transferring technology via written reports and providing virtual and on-site support during clinical production campaigns.
* Produce various non-clinical reagents to support Regeneron's Research and Development activities.
This Role Might Be For You If:
* You have strong initiative and strive to complete bold tasks and learn new technologies.
* You can work both independently and within a team environment on multiple projects simultaneously.
* You contribute to lab equipment maintenance and safety to help create a safe, effective and efficient working environment.
* You possess strong communication skills, including analytical, computer, and technical writing skills.
This role requires a BS or MS in Chemical Engineering or Bio-related Engineering with 0-2 years of experience in a laboratory setting. Experience with NOVA FLEX, Sartorius Biostat DCU Bench top Bioreactors, Biobrain Operate, Applikon bench top bioreactors, WAVE bioreactors, ABEC/Hyclone Single Use Bioreactors (50-500L), ABEC Stainless Steel Pilot Scale (40-500L) bioreactors, Medium Prep skid, CIP, Biosafety cabinets, incubators, autoclave, Perfusion Bioreactor, Continuous Processing, SynTQ, PI Historian, JMP, Benchling, Ignition, is a plus.
Please clearly state your GPA on your CV.
YouTube Video on PMPD Bioreactor Scale-Up & Development:
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YouTube Video on Diversity Equity & Inclusion in PMPD:
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YouTube Video on Career Development at Regeneron:
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#pmpd
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$70,300.00 - $110,100.00
Auto-ApplyProcess Development Associate - Pilot Scale Purification Development (PMPD)
Tarrytown, NY jobs
Regeneron's Preclinical Manufacturing & Process Development Group (PMPD) is seeking a Process Development Associate as a full time position to work in the Purification Development group. In this role, you will be responsible for the purification at pilot scale of a variety of clinical biologics, building systems to support the planning and execution of pilot scale work, and investigating technologies to support the scalability of pilot scale operations. The ideal candidate will be hardworking, efficient, flexible, and able to perform key responsibilities in a fast-paced, team environment. This is a lab based role focused on pilot scale operations, requiring a significant amount of physical activity.
A Typical Day in the Role Might Look Like:
* An associate or engineer who is experienced in the general operations of a laboratory and/or functional area. Begins to manage and organize data more independently - has some decision making capability and works under supervision (daily or near daily). Participates effectively as a member of a "team" within his/her laboratory or functional area. Communicates with all levels of the organization. Executes experiments alone and/or in collaboration alone with others. Performs routine technical tasks, begins to manage, organize, and interpret data more independently, and presents results to his/her supervisor. Receives general instruction for routine work; more detailed instruction is provided for new projects. The ability to design experiments with proper controls.
* Executes experiments/projects using established procedures. Performs basic data entry and analysis alone or in collaboration with others and recognizes unexpected results. Understands scientific method and experimental controls and works to perfect technique on the basics. Scientifically curious, enthusiastic, and proactively asks questions to learn or seek clarification
* Reads and understands scientific literature and technical documentation. Executes experimental plans to verify literature findings with direction and prepares comparison of internal data to literature for review with manager.
* Trains and becomes proficient in operations of job-relevant laboratory instrumentation and data systems. May have a role in knowledge/data management and be responsible for maintenance and service of lab/data resources. May assist in training new staff after demonstrating competency.
* Will support technology development and improvement initiatives
* May contribute to development of technology and automation to increase the throughput and speed of pilot scale operations.
* Builds relationships within subgroup to support shared goals and may train peers and indirectly lead, guide, and assist co-op students/interns. Proactively assists others in execution of experiments and knows when to ask for help from peers.
This Role Might Be For You If You :
* Enjoy a fast paced pilot scale laboratory setting where sound science and team work are the priorities.
* Contribute to lab equipment maintenance and safety to help create a safe, effective and efficient working environment.
* Anticipate and recognize potential problems with laboratory supplies / equipment and act to prevent and tackle problems.
* Can ensure training and/or compliance responsibilities are maintained.
* Has experience in small to large scale manufacturing.
The role requires A Bachelor's and/or Master's degree in either Chemical Engineering, Biochemical Engineering, or Biochemistry, and 1 - 5+ years' experience in the biotech or pharmaceutical industry. A strong fundamental understanding of various protein purification techniques is a plus. Experience with Downstream Development and with equipment like: Tangential flow filters, Normal flow filters, ultrafiltration/diafiltration skids, Akta chromatography systems, disc stack centrifuge, depth filtration, chromatographic columns, HPLC, UPLC, Empower, Unicorn, JMP, LIMS, PI Historian is a plus. Experience with raman spectroscopy and/or software programming is a plus.
#pmpd
Intro To PMPD Video:
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Intro To PMPD Purification Video:
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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$70,300.00 - $110,100.00
Auto-ApplyProcess Development Associate - Late Stage Purification Development (PMPD)
Tarrytown, NY jobs
Regeneron's Late-Stage Purification Development team within PMPD (Preclinical Manufacturing and Process Development) is seeking a full-time Process Development Associate. In this role, you will be responsible for the development and transfer of the harvest, affinity chromatography, and viral inactivation unit operations for recombinant proteins using Quality by Design principles.
A Typical Day in the Role Might Look Like:
* Designs and executes experiments at both bench and pilot-scale
* Analyzes data, draws conclusions from results, and proposes next steps
* Documents results in laboratory notebook and reports
* Communicates findings to functional area and department leadership
* Acts as purification development subject matter expert during manufacturing process transfer to ensure successful completion of GMP batches
* Works cross-functionally with the process development team to enable a robust, cohesive manufacturing process
* Supports technology development and improvement activities potentially including but not limited to: automation of pilot-scale unit operations, improving bench-scale process models, developing workflows for compilation and analysis of historical data, investigating new raw materials, equipment, and/or techniques to advance the harvest, affinity chromatography, and viral inactivation unit operations
* Trains peers and directly or indirectly manages, mentors, and assists co-op students and interns in conducting experiments, analyzing data, and documenting results.
* Contributes to lab equipment maintenance and general lab safety to help create a safe, effective, and efficient working environment
This Role Might Be For You If You:
* Have a solid understanding and practical experience in purifying monoclonal antibodies or other biopharmaceuticals
* Enjoy spending ~50-70% of time performing lab work at both bench and pilot-scale
* Have experience with process automation, specifically hardware, control logic, and/or HMI development
* Thrive in a team-based, collaborative environment
* Are well organized and able to manage multiple projects efficiently
* Are an effective communicator within all levels of an organization
* Are scientifically curious, creative, and have a problem-solver mentality
This role requires a Bachelor's degree in either Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field with 0 - 2 years of recombinant protein purification experience, including some but not limited to depth filtration, disc stack centrifugation, column chromatography, virus retentive filtration, ultrafiltration/diafiltration, buffer preparation. A strong fundamental understanding of various protein purification techniques and experience with Akta chromatography systems, HPLC, UPLC, Empower, Unicorn, JMP, LIMS, Python, Ignition, and PI Historian is a plus.
#pmpd
Intro To PMPD Video:
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Intro To PMPD Purification Video:
******************************************************************************************
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$70,300.00 - $110,100.00
Auto-ApplyProcess Development Associate, Bioreactor and Scale-Up Development (1 of 2)
Tarrytown, NY jobs
Regeneron's Bioreactor and Scale-Up Development Group within Preclinical Manufacturing and Process Development (PMPD) is looking for a motivated Process Development Associate to work as part of the late-stage development team to develop production processes of biologics in a non-GMP process development laboratory. In this role, they will perform studies at pilot scale to develop commercially enabling manufacturing processes.
A Typical Day in the Role of Process Development Associate Might Look Like:
* Support lab operations to cultivate mammalian cells producing biologics in bench and pilot-scale bioreactors, including sterilizing, sanitizing, and operating bioreactors, preparing buffers and feeds, and maintaining and onboarding laboratory equipment.
* Contribute to technology development projects to innovate process development and explore personal areas of interest.
* Evaluate and solve challenges associated with the scale-up of processes.
* Analyze seed train, production, and quality data to support process understanding and technology transfer, followed by authoring development reports, process transmittals, and documentation in electronic notebooks.
* Participate in Technology Transfer Start-Up Teams by transferring technology via written reports and providing virtual and on-site support during clinical production campaigns.
* Produce various non-clinical reagents to support Regeneron's Research and Development activities.
This Role Might Be For You If:
* You have strong initiative and strive to complete bold tasks and learn new technologies.
* You can work both independently and within a team environment on multiple projects simultaneously.
* You contribute to lab equipment maintenance and safety to help create a safe, effective and efficient working environment.
* You possess strong communication skills, including analytical, computer, and technical writing skills.
This role requires a BS or MS in Chemical Engineering or Bio-related Engineering with 0-3 years of experience in a laboratory setting. Experience with NOVA FLEX, Sartorius Biostat DCU Bench top Bioreactors, Biobrain Operate, Applikon bench top bioreactors, WAVE bioreactors, ABEC/Hyclone Single Use Bioreactors (50-500L), ABEC Stainless Steel Pilot Scale (40-500L) bioreactors, Medium Prep skid, CIP, Biosafety cabinets, incubators, autoclave, Perfusion Bioreactor, Continuous Processing, SynTQ, PI Historian, JMP, Benchling, Ignition, is a plus.
Please clearly state your GPA on your CV.
YouTube Video on PMPD Bioreactor Scale-Up & Development:
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YouTube Video on Career Development at Regeneron:
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#pmpd
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$70,300.00 - $110,100.00
Auto-ApplyProcess Development Associate
Thousand Oaks, CA jobs
Career CategoryScientificJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Associate
What you will do
Let's do this! Let's change the world!
In this vital role, you will serve as a member of Amgen's Late Stage Synthetics drug product team, learning and providing hands-on formulation and process expertise during the development of clinical and commercial formulations for Synthetics dosage forms.
Collaborate within Drug Product Technologies as a team member to support programs and initiatives.
Contribute to the design and execution of experiments and assist with the analysis and interpretation of data.
Organize and communicate information within the team to work toward the best possible formulations and processes.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with the following qualifications.
Basic Qualifications:
High school diploma / GED and 4 years of Scientific experience OR
Associate's degree and 2 years of Scientific experience OR
Bachelor's degree
Preferred Qualifications:
Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering or other related fields.
Strong problem-solving skills.
Ability to design and execute experiments and to interpret results.
Experience working with diverse team members.
Motivated self-starter with excellent oral and written communication and interpersonal skills.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
79,971.00 USD - 89,221.00 USD
Auto-ApplyProcess Development Associate - Pivotal Drug Substance
Thousand Oaks, CA jobs
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Process Development Associate - Pivotal Drug Substance**
**What you will do**
Let's do this! Let's change the world!
The Pivotal Drug Substance Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug substance manufacturing processes for all late-stage programs across the Amgen portfolio.
Located at our Cambridge, MA site, this lab based position will be responsible for support of the development, characterization, scale-up and support of upstream and downstream processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. This role is in an integrated group in which cell culture and purification scientists work together to advance Amgen's rich, exciting and dynamic pipeline. With Amgen's biology first approach, the position provides the unique opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and si RNAs.
The successful candidate will perform experiments at the bench scale, spanning the end- to end drug substance process, including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day- to day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to technology development. Finally, the candidate will also demonstrate the desire to expand and develop skills in both cell culture and purification, thereby further contributing to the integrated group.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 4 years of Scientific experience OR
+ Associate's degree and 2 years of Scientific experience OR
+ Bachelor's degree
**Preferred Qualifications:**
+ Bachelor's degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with a demonstrated record of excellence
+ Demonstrated ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment
+ Basic understanding of protein chromatography, filtration and cell culture principles; Hands-on experience with mammalian cell culture, and/or purification operations is a plus.
+ Motivated self starter with excellent interpersonal and organizational skills
+ Demonstrated success working with diverse team members in a dynamic, cross-functional environment
+ Familiarity with design of experiments and statistical analysis of data
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Sponsorship**
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Process Development Sr Associate
Thousand Oaks, CA jobs
Career CategoryScientificJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Sr Associate
What you will do
Let's do this! Let's change the world!
In this vital role you will be part of our Cleaning Characterization group, based in Amgen's Thousand Oaks, CA.
This group is responsible for the development of cleaning process design supporting new product introduction in Amgen internal manufacturing network for both drug substance and drug product. The cleaning characterization group perform bench scale studies to enable introduction of new molecules manufacturing in Amgen Manufacturing network. The group supports investigation of deviations/non conformances, writes technical cleaning evaluation reports, and supports plant inspections, including Prior Approval Inspections (PAIs).
Job Responsibilities:
Design and perform planned laboratory experiments in assessment of new product cleaning with existing cleaning process.
Help develop new methods, apparatus and procedures for bench-scale cleaning characterization work.
Write technical reports, assessments, and procedures.
Use characterization data to develop key operating parameters (KOPs), testing requirements and acceptance criteria for new product launches in manufacturing.
Work with Quality, Engineering and Cleaning Validation leads to implement Cleaning process requirements at full scale.
Write technical reports based on the bench scale studies supporting individual manufacturing site Cleaning validation program.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a motivated, curious and collaborative team-player with these qualifications.
Basic Qualifications:
High school diploma / GED and 6 years of Scientific experience OR
Associate's degree and 4 years of Scientific experience OR
Bachelor's degree and 2 years of Scientific experience OR
Master's degree
Preferred Qualifications:
Master's or Bachelor's degree in a scientific field with demonstrated ability in laboratory environment in life science industry.
Design and perform bench-scale experiments, and assessment of data/results.
Analytical methods: Total Organic Carbon (TOC), protein assays, gel electrophoresis, spectroscopic methods, Biological Binding Method (Bioassay, SPR or ELISA).
Characterization of cleaning process processes for biologicals.
Experience of writing technical reports based on laboratory studies.
Good knowledge of scientific principles, methodologies and practices.
Lab methods, including handling and dispensing chemicals, preparing buffers and operation of common lab equipment, such as pH and conductivity meters.
Strong interpersonal skills and ability to communicate with unique background teams.
Strong lab studies management(project management) skills to prioritize the lab studies based on changing priorities.
Good written and verbal communication skills.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
85,306.00 USD - 103,484.00 USD
Auto-ApplyProcess Development Associate - Pivotal Drug Substance
Thousand Oaks, CA jobs
Career CategoryScientificJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Associate - Pivotal Drug Substance
What you will do
Let's do this! Let's change the world!
The Pivotal Drug Substance Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug substance manufacturing processes for all late-stage programs across the Amgen portfolio.
Located at our Cambridge, MA site, this lab based position will be responsible for support of the development, characterization, scale-up and support of upstream and downstream processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. This role is in an integrated group in which cell culture and purification scientists work together to advance Amgen's rich, exciting and dynamic pipeline. With Amgen's biology first approach, the position provides the unique opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and si RNAs.
The successful candidate will perform experiments at the bench scale, spanning the end- to end drug substance process, including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day- to day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to technology development. Finally, the candidate will also demonstrate the desire to expand and develop skills in both cell culture and purification, thereby further contributing to the integrated group.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
High school diploma / GED and 4 years of Scientific experience OR
Associate's degree and 2 years of Scientific experience OR
Bachelor's degree
Preferred Qualifications:
Bachelor's degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with a demonstrated record of excellence
Demonstrated ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment
Basic understanding of protein chromatography, filtration and cell culture principles; Hands-on experience with mammalian cell culture, and/or purification operations is a plus.
Motivated self starter with excellent interpersonal and organizational skills
Demonstrated success working with diverse team members in a dynamic, cross-functional environment
Familiarity with design of experiments and statistical analysis of data
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
79,971.00 USD - 89,221.00 USD
Auto-ApplyProcess Development Sr Associate
Thousand Oaks, CA jobs
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Process Development Sr Associate**
**What you will do**
Let's do this! Let's change the world!
In this vital role you will be part of our Cleaning Characterization group, based in Amgen's Thousand Oaks, CA.
This group is responsible for the development of cleaning process design supporting new product introduction in Amgen internal manufacturing network for both drug substance and drug product. The cleaning characterization group perform bench scale studies to enable introduction of new molecules manufacturing in Amgen Manufacturing network. The group supports investigation of deviations/non conformances, writes technical cleaning evaluation reports, and supports plant inspections, including Prior Approval Inspections (PAIs).
**Job Responsibilities:**
+ Design and perform planned laboratory experiments in assessment of new product cleaning with existing cleaning process.
+ Help develop new methods, apparatus and procedures for bench-scale cleaning characterization work.
+ Write technical reports, assessments, and procedures.
+ Use characterization data to develop key operating parameters (KOPs), testing requirements and acceptance criteria for new product launches in manufacturing.
+ Work with Quality, Engineering and Cleaning Validation leads to implement Cleaning process requirements at full scale.
+ Write technical reports based on the bench scale studies supporting individual manufacturing site Cleaning validation program.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a motivated, curious and collaborative team-player with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 6 years of Scientific experience OR
+ Associate's degree and 4 years of Scientific experience OR
+ Bachelor's degree and 2 years of Scientific experience OR
+ Master's degree
**Preferred Qualifications:**
+ Master's or Bachelor's degree in a scientific field with demonstrated ability in laboratory environment in life science industry.
+ Design and perform bench-scale experiments, and assessment of data/results.
+ Analytical methods: Total Organic Carbon (TOC), protein assays, gel electrophoresis, spectroscopic methods, Biological Binding Method (Bioassay, SPR or ELISA).
+ Characterization of cleaning process processes for biologicals.
+ Experience of writing technical reports based on laboratory studies.
+ Good knowledge of scientific principles, methodologies and practices.
+ Lab methods, including handling and dispensing chemicals, preparing buffers and operation of common lab equipment, such as pH and conductivity meters.
+ Strong interpersonal skills and ability to communicate with unique background teams.
+ Strong lab studies management(project management) skills to prioritize the lab studies based on changing priorities.
+ Good written and verbal communication skills.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Process Development Sr. Associate - Drug Product Technology
Cambridge, MA jobs
Career CategoryOperationsJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Sr. Associate - Drug Product Technology
What you will do
Let's do this. Let's change the world. In this vital role you will join the Pre-Pivotal Drug Product, Synthetics Enabling Technologies (SET) team and support the characterization and development of small molecule drug candidates. This role is primarily laboratory-based and focuses on understanding physicochemical and biopharmaceutical properties that impact formulation design, stability, and oral bioavailability. The candidate will work closely with scientists on molecule assessment, solid-state characterization, and analytical teams to support early development programs.
Key Responsibilities include:
Conduct physicochemical profiling of small molecule drug candidates (e.g., solubility, pKa, logP/logD, hygroscopicity, dissolution, and chemical stability).
Assess developability risks by integrating experimental data on molecular properties.
Support material characterization to guide form selection and formulation strategy.
Perform solid-state analysis including X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), FT-IR, Raman spectroscopy, and solid-state NMR (as applicable).
Execute manual and automated high-throughput screening workflows. Prepare and characterize preclinical formulations (solutions, suspensions, solid dispersions, etc.) to enable in vivo studies.
Maintain accurate, detailed experimental records in electronic laboratory notebooks (ELN).
Document and interpret data to support regulatory filings and internal reports.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative individual with these qualifications.
Basic Qualifications:
High school diploma / GED and 6 years of Scientific experience OR
Associate's degree and 4 years of Scientific experience OR
Bachelor's degree and 2 years of Scientific experience OR
Master's degree
Preferred Qualifications:
B.S. in Chemistry, Chemical Engineering, Materials Science, Pharmaceutical Science, or a related scientific field, with at least two years of pharmaceutical/biotech industry experience.
Hands-on experience with solid-state and preformulation techniques.
Familiarity with data interpretation from XRPD, DSC, TGA, and spectroscopic methods.
Experience with high-throughput screening or automated liquid handling is desirable.
Strong attention to detail and commitment to data quality.
Effective communication and teamwork skills.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
85,306.00 USD - 103,484.00 USD
Auto-ApplyProcess Development Associate (Attribute Sciences)
Holly Springs, NC jobs
Career CategoryProcess DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Associate (Attribute Sciences)
What you will do
Let's do this. Let's change the world. This role is part of Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development.
In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen's FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting.
Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing.
Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements
Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing
Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR.
Execute methods, author reports and ensure safety and compliance for all activities.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR
Associate's degree and 2 years of Process Development / Chemistry or related experience OR
Bachelor's degree
Preferred Qualifications:
Degree in Chemistry or related area.
Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
Experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis), ELISA, DNA, Chromatography (SE and RP), PCR).
Experience in method transfers, method validation, and method troubleshooting.
Familiarity with United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
Effective oral and verbal communication skills.
Technical writing skills and attention to details in documents.
A self-starter and valuable teammate.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
79,971.00 USD - 89,221.00 USD
Auto-ApplyProcess Development Associate (Attribute Sciences)
Holly Springs, NC jobs
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Process Development Associate (Attribute Sciences)**
**What you will do**
Let's do this. Let's change the world. This role is part of Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development.
In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen's FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting.
+ Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing.
+ Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements
+ Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing
+ Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR.
+ Execute methods, author reports and ensure safety and compliance for all activities.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR
+ Associate's degree and 2 years of Process Development / Chemistry or related experience OR
+ Bachelor's degree
**Preferred Qualifications:**
+ Degree in Chemistry or related area.
+ Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
+ Experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis), ELISA, DNA, Chromatography (SE and RP), PCR).
+ Experience in method transfers, method validation, and method troubleshooting.
+ Familiarity with United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
+ Effective oral and verbal communication skills.
+ Technical writing skills and attention to details in documents.
+ A self-starter and valuable teammate.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Process Engineer
Morristown, IN jobs
Working at Freudenberg: We will wow your world!
Responsibilities:
Analyze existing manufacturing and operational processes to identify areas for improvement.
Design, develop, and implement process enhancements that improve quality, reduce waste, and increase throughput.
Collaborate with cross-functional teams including Operations, Quality, Maintenance, and Engineering to drive continuous improvement initiatives.
Develop and maintain process documentation including work instructions, process flow diagrams, and standard operating procedures.
Monitor process performance using KPIs and data analytics; recommend corrective actions as needed.
Support capital projects and equipment upgrades by providing process input and validation.
Lead root cause analysis and problem-solving efforts for process-related issues.
Ensure compliance with safety, environmental, and regulatory standards in all process changes.
Train and mentor operations staff on new processes and improvements.
Qualifications:
Bachelor's degree in Engineering (Mechanical, Industrial, Chemical, or related field).
3+ years of experience in process engineering or manufacturing environment.
Strong analytical and problem-solving skills.
Proficiency in process mapping, Lean, Six Sigma, or other continuous improvement methodologies.
Experience with data analysis tools and manufacturing software (e.g., ERP, MES).
Excellent communication and collaboration skills.
Ability to manage multiple projects and priorities in a fast-paced environment.
Communication & Collaboration: Communicates clearly and concisely, while engaging proactively with colleagues at all levels of the organization.
Value for Customers: Anticipates, understands and meets internal/external customers' needs and expectations. Develops solutions based on a customer centric approach.
Innovation: Drives and supports innovative ideas, while taking informed risks to seek and develop new or improved solutions.
Drive & Execution: Proactively identifies what needs to be done and takes action. Explores new ways and pursues new opportunities.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Freudenberg-NOK General Partnership
Auto-Apply