Production Operator (2nd Shift)
Manufacturing associate job in Boston, MA
Production Operator (2nd Shift) Rockland, MA Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life, so it's equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a variety of people, global locations, technologies and products, 3M is a place where you can collaborate with other curious, creative 3Mers.
This position provides an opportunity to transition from other private, public, government or military experience to a 3M career.
The Impact You'll Make in this Role
As a Production Operator, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative people around the world. Here, you will make an impact by:
Observing all safety procedures, maintain a clean and safe work area
Applying quality instructions & specifications
Monitoring the production or packing operation to ensure quality objectives are met
Loading/unloading material into & from equipment
Working as a team member through sharing information, problem solving & assisting others
Your Skills and Expertise
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:
Possess a High School Diploma/GED or higher (completed and verified prior to start) from an accredited institution
***Applicants meeting the basic qualifications above may be required to take and pass 3M elected testing as a part of the selection process***
Additional qualifications that could help you succeed even further in this role include:
Minimum one (1) year of plant and/or manufacturing experience in a public, private, government, or military environment
Post-high school education
Basic computer knowledge
Pay & Benefits
Pay starting at $22.62/hour
New hires start with 3 weeks paid vacation
Health, vision and dental start day one
Employee stock discount
401K Match of 5%
Our plant operates 24/7 so we have multiple shifts available, including days, evenings, overnights, weekends, 8 hour shifts, 12 hour shifts, etc. Note - If you are selected for an overnight, evening or weekend shift, you may be brought onto a different shift initially for training purposes before starting on your actual shift.
Work location:
Onsite - 30 Commerce Rd, Rockland, MA 02370
Travel: N/A
Relocation Assistance: N/A
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
3M offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.
Chat with Max
For assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting assistant on 3M.com/careers.
The starting rate of pay for this position is $22.62 per hour. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: .
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All US-based 3M full time employees will need to sign an employee agreement as a condition of employment with 3M. This agreement lays out key terms on using 3M Confidential Information and Trade Secrets. It also has provisions discussing conflicts of interest and how inventions are assigned. Employees that are Job Grade 7 or equivalent and above may also have obligations to not compete against 3M or solicit its employees or customers, both during their employment, and for a period after they leave 3M.
Learn more about 3M's creative solutions to the world's problems at ********** or on Instagram, Facebook, and LinkedIn @3M.
Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.
Safety is a core value at 3M. All employees are expected to contribute to a strong Environmental Health and Safety (EHS) culture by following safety policies, identifying hazards, and engaging in continuous improvement.
Pay & Benefits Overview:
3M does not discriminate in hiring or employment on the basis of race, color, sex, national origin, religion, age, disability, veteran status, or any other characteristic protected by applicable law.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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GMP Manufacturing Associate
Manufacturing associate job in Norwood, MA
Pay: Up to $34/hour (differentials for weekend)
Shift: We are hiring for nights.
Role: (Contract) Manufacturing Associate I
Duration: Six-month contract (with possible extension)
Required Experience:
Bachelor's Degree in a related field
OR Associate's Degree with 2+ years of experience
OR 4+ years of related GMP experience
We are seeking a Manufacturing Associate I to join a cohesive team at a state-of-the-art GMP Manufacturing site in Norwood, MA. In this role, you will play a key part in producing mRNA-based medicines for clinical trials. If you're detail-oriented, thrive in a fast-paced environment, and want to contribute to innovative healthcare solutions, this is the opportunity for you!
Responsibilities
Operate manufacturing equipment and execute processes to produce mRNA medicines
Use disposable technologies, automation systems, and Manufacturing Execution Systems (MES)
Work closely with Quality Assurance (QA) to ensure rapid product release
Follow Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs)
Document equipment operations and process steps clearly and accurately
Monitor production processes to ensure compliance with quality standards
Support investigations into any deviations or issues that arise during production
Maintain a clean, safe, and compliant work environment (including gowning procedures)
Practice safe work habits and follow site safety guidelines
Look for opportunities to improve operational efficiency
Qualifications
Biotech
Laboratory/Sciences
GMP
Experience
Experienced
4 year(s)
Manufacturing Technician
Manufacturing associate job in Westborough, MA
Manufacturing Test Technician
6 months contract (with possibility of extension)
Westborough, MA (onsite)
Pay Range: $25/h - $35/h on W2, DOE
We are looking for a technician for 6 months that can come in and support an Engineer developing a manufacturing test process for a Mechatronics machine that inducts and labels packages.
This test solution will be focused on Control Panels, conveyance, printers, dimensioners, weigh scale, delta robot labeler and vision systems. This is an electromechanical product with high PLC and IO content.
The tech will aid the engineer to create and integrate the test solutions that will eventually be shipped to a contract manufacturer. This is a hands-on role. The expectation is the tech can be self-motivated and translate direction from the Engineer into actions and deliverables. The tech will support setting up the systems and the environment to test products and integrate the test solutions.
The technician will need to be able to travel to local suppliers for custom test panels or other solutions to perform acceptance testing per the direction of the lead engineer.
Required:
Basic mechanical aptitude for test system installation and assembly.
Proficiency in electrical wiring, routing, and connections.
Experience in electrical system troubleshooting and debugging.
Ability to follow Standard Operating Procedures (SOPs) for system startup.
Capable of executing test plans and procedures with minimal supervision.
Knowledge of reading schematics and wiring diagrams.
Experience in creating Bills of Materials (BOM) from technical documentation.
Understanding of proper packaging and shipping procedures.
Valid driver's license and ability to travel locally to vendor locations.
Attention to detail and strong documentation skills.
Ability to work independently and follow written/verbal instructions.
Experience with quality control and testing procedures.
Must be comfortable with hands-on technical work.
Education/Experience:
Technical degree or equivalent experience in electronics/mechanical field.
2+ years of experience in a similar technical role preferred.
Certification in electronics or related field is a plus.
Top 3 skills required:
Proficiency in electrical wiring, routing, and connections.
Experience in creating Bills of Materials (BOM) from technical documentation.
Basic mechanical aptitude for test system installation and assembly.
Russell Tobin offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.
Manufacturing Technician
Manufacturing associate job in Auburn, MA
Our manufacturing client company is hiring a qualified Manufacturing Technician to join their team on a temp to possible perm basis! Fully onsite, Auburn MA area
Shifts: Monday - Friday, Tuesday - Saturday, and Sunday - Thursday, all 7:30AM - 4PM, not offering Friday - Monday 4 - 10 shift.
Essential Job Duties:
You will be responsible for performing routine tasks. You'll help maintain quality control measures and support inventory management by keeping accurate records. In addition, you will be expected to keep your workspaces and machinery clean, sanitized, and organized to maintain operational efficiency.
The ideal candidate will have a keen eye for detail and the ability to focus on sensitive and complex tasks.
Strong verbal and written communication skills, flexibility, and adaptability are essential to succeed in this role. You must be able to stand for extended periods, lift up to 50 lbs occasionally, and perform manual tasks requiring fine motor skills.
Safety is a priority, and you will be required to maintain balance while using ladders or performing tasks such as stooping, kneeling, or reaching.
Must Haves:
-Reliable
-Experience from restaurants, manufacturing, or other repetitive work
-Comfortable in a fast-paced environment
-Detail-oriented
Packaging Operator
Manufacturing associate job in Fall River, MA
About the Company
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.
About the Role
The purpose of this role is to assist in packaging manufactured metered dose inhalation (MDI) products in a pharmaceutical manufacturing company.
Responsibilities
Understanding basics of mechanical machinery and principles of control systems.
Operating pharmaceutical packaging equipment with minimum rejection and maximum output maintaining quality standard within standard norms.
Cleaning machines and area as per batch to batch and product to product change over.
Performing operations and preventative maintenance of machines.
Identifying and assisting in the corrective actions of packaging related issues.
Correcting status labelling at all stages of packing line with signature.
Ensuring that appropriate equipment calibrations are performed, and records are maintained.
Ensuring line clearance before initiating packaging activities in each area.
Wearing appropriate PPE as stated in the SOP before initiating process.
Working individually and in collaboration with others as part of a team.
Executing procedures to complete tasks in a safe and efficient manner.
Completing documents on time, ensuring accuracy and completeness.
Adhering to all cGMPs, compliance/regulatory mandates and quality requirements.
Complying with company policies and procedures.
Performing duties through the proper safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
Performing other related duties as assigned.
Qualifications
High school diploma or equivalent is required.
Accredited college certificate or university degree is preferred.
Minimum of one (1) year experience in packaging operations preferred.
Proficient in the English language (Speaking/Reading/Writing) to understand work instructions and document results.
Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment highly preferred.
Basic understanding of mechanical machinery and the operating principles of control systems.
Ability to follow both verbal and written instructions.
Demonstrated ability to work in both independent and team environments.
Good knowledge of Health & Safety procedures, including, OSHA.
Strong mathematical and organizational skills.
Required Skills
Minimum of one (1) year of experience working in a pharmaceutical, nutraceutical, cosmetic or other cGMP environment.
Hands-on experience with current Good Manufacturing Practices (cGMP) and following Standard Operating Procedures (SOPs).
Experience in wearing and working with Personal Protective Equipment (PPE).
Preferred Skills
Good Documentation skills (writing and reading batch records).
Good knowledge of Health & Safety procedures, including OSHA.
Pay range and compensation package
Salary: USD 39000 - 41000
Compensation Details: Salary Maximum: $19/hr - $20/hr
Equal Opportunity Statement
We are committed to diversity and inclusivity.
KFC Team Member - Early Pay Access!
Manufacturing associate job in North Stonington, CT
Team Member
**We offer early wage access through Tapcheck so you can cash out on your wages before payday!**
At KFC, we feed the world. But we do more than fill people up. We fulfill their lives. Our meals matter; when we serve them with southern hospitality, we make our customers' day. So, our jobs are more than a paycheck-they're about being independent, having fun, and making new friends.
As a Team Member, you could be the smiling face that greets and serves customers. Or you could be the cook that prepares our world-famous chicken (and tell your friends you know the “secret” - just kiddin'). Whatever job you do, you know what you do matters - to your team and to your customers.
The good news is that your training will teach you everything you need to know to succeed on the job.
But there are a few skills you should have from the get-go:
You're a fun and friendly person who values customers and takes absolute pride in everything you do.
You like talking - a lot - even to strangers (despite what your Mom told you). This is important because you're not able to text message customers.
You've got attitude - the right kind of course - and understand the need to be on time, all the time. With loads of energy, you understand that work is easier - and more fun - working as a team.
And you're at least 16 years old.
Pay range for this position is $15.00 - $17.25/hr
Keep in mind, this is just basic information. You'll find out more after you apply. Independently owned, franchised, or licensed locations may have different requirements.
Manufacturing Associate, LNP
Manufacturing associate job in Framingham, MA
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
Reporting to the Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of LNP therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing formulated LNP Manufacturing within a GMP environment.
Responsibilities
Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations
Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting.
Transfer raw material inside cleanroom suite using sanitizing reagents or equipment.
Participates in technology transfer from Process Development to the Manufacturing group.
Assist in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups.
Ensures all materials and equipment are identified and available in time for manufacturing operations.
Execute standard work per manufacturing schedule
Participate in Quality investigations and resolutions.
Ensure cGMP compliance through consistent execution.
Other duties and projects as assigned to meet departmental requirements.
Minimum Qualifications
Certificate, associate's degree or higher in biological sciences or related fields and 2-5 years of relevant Manufacturing experience or related fields
Available to work a flexible schedule as needed.
Ability to don cleanroom garments and work within a classified environment (Grade B and C)
Knowledge of GMP and industry standards
T-Mix and TFF experience preferred
Fluency in Windows and Microsoft Office applications
Attentive to detail and accuracy
Ability to effectively communicate and collaborate with internal stakeholders is essential
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion
Ability to lift 40 pounds
Ability to stand for 6 hours in a clean room environment
Self-driven, independently motivated, data driven and excellent problem-solving ability
Competencies
Collaborative - Openness, One Team
Undaunted - Fearless, Can-do attitude
Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
Entrepreneurial Spirit - Proactive. Ownership mindset.
Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.
Manufacturing Associate: Base pay range of $40.00 per hour to $44.00 per hour + bonus, equity and benefits.
The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: ***********************************************
Auto-ApplyAssociate III Downstream Manufacturing - 12hr. Rotation Schedule (2/2/3)
Manufacturing associate job in Plainville, MA
Work Schedule
12 hr shift/days
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Operating equipment is used to manufacture products. Weighs, measures and checks raw materials to ensure that batches manufactured contain proper ingredients in proper quantities. Fully trained and proficient at manufacturing drug product injectables in a cleanroom environment and following GMP standards. Autonomously run equipment, pumps, and automated systems and collaborate with team members to ensure it's right the first time and on schedule. Perform operations in Support Services, Upstream, Downstream, and Fill/Finish workstreams following SOPs and Batch records and recommending improvements.
Work Hours:
This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include holidays. This role is a 1st shift, 7am-7pm shift (2/2/3 Rotation).
Responsibilities
Optimally complete work instructions while following procedures and cGMP regulations. Applications of acquired job skills and company policies and procedures to complete assigned task
Fully trained on all unit operations associated with the department. Works on assignments that are semi-routine in nature but receives instruction on new processes that are accepted practices
Follows established procedures on routine work, requires instructions only on new assignments.
Stays up to date on required job training.
Maintains inventory records of raw materials used in batch manufacturing. Keeps accurate and up-to-date batch records and data sheets on batches in process.
Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements as required
Assist with manufacturing batch records reconciliation.
Complete assigned work tasks on time.
Adhere to SOP's, Batch Records, and Wok Instructions by living the Quality values every day and holds peers across the site accountable as well.
Support the on-time closure of Nonconformance's/ CAPAs.
Assist in the completion and identification of PPI initiatives and continuous improvements.
Identify and communicate items requiring customer concern; complete post critical issue decisions.
Accurately records and analyzes batches against standards all processing data gathered from instruments, etc. to ensure operating standards are met.
Make approved adjustments as appropriate to maintain process parameters within designated limits.
Maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations.
Ensure chemicals are properly stored and labeled.
90% of time spent on the floor
Education/Experience/Equivalency Requirements:
High School Diploma or Equivalent
Minimum of 2 years' experience in manufacturing/operations
Knowledge, Skills and Abilities:
Ability to perform aseptic operations. Surface level problem solving skills.
Ability to anticipate system response.
Understand cleanroom concepts.
Ability to follow directions & procedures and work in team environment.
Strong attention to detail and aim to accomplish the job timely, accurately and safely the first time is required, as well as the ability to work closely and effectively in a team environment.
Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.
Physical Requirements:
Employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk or hear. The employee is required to walk and stoop or kneel/crouch up to 50% of the time. The employee is required to ascend/ descend ladders, and push, pull, or lift a maximum of 50 lbs. Employee may be asked to sit continuously for a maximum of 6 hours. Specific vision abilities required by this job include close vision and ability to adjust focus with tasks.
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our distributed team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
For more information, please visit ********************* Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Compensation and Benefits
The hourly pay range estimated for this position based in Massachusetts is $23.02-$38.36.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
Auto-ApplyManufacturing Associate I
Manufacturing associate job in Watertown Town, MA
Job DescriptionPosition Title: Manufacturing Associate I Reports to: Director, Manufacturing Status: Regular, Full-Time, Exempt Company Summary: Stratus Therapeutics is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells. We have breakthrough potential to provide patients with rapid and broad access to HLA-compatible transgene-free blood stem cell therapies.
Stratus Therapeutics is committed to advancing science and enhancing the health and well-being of patients. This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform.
Position Summary: Stratus Therapeutics is seeking a motivated Manufacturing Associate/Sr. Manufacturing Associate to support routine GMP Manufacturing operations. This includes day-to-day operational tasks including but not limited to Cell Culture in a clean room environment, GMP Materials Logistics, and Environmental Monitoring within Stratus GMP manufacturing space. This is an on-site role, primarily in Watertown, MA with occasional work in Cambridge MA. Some travel between sites is required.
Specific responsibilities include, but are not limited to:
Perform, verify, and support GMP Cell Culture manufacturing activities in a cleanroom environment
Complete applicable GMP Manufacturing Batch Records, Forms, and associated documentation
Support GMP materials release and labeling
Transfer materials into the GMP cleanroom suites following proper wipe down procedures.
Follow Personnel, Material, and Waste flow procedures related to GMP manufacturing of Cell Therapy products
Restock cleanroom manufacturing areas as needed.
Perform environmental monitoring sampling when needed.
Support deviation investigations and CAPA activities
Other related duties as needed
Qualifications include:
Associates degree is required (in a science-related discipline preferred) BA/BS degree preferred
0- 2 years of professional work experience in a cell based therapeutic product is preferred
Strong interpersonal skills & attention to detail
Strong commitment to teamwork, collaboration, and professionalism
Proficiency in working with MS Office Suite
Able to handle a dynamic workload, multi-task, and perform effectively under tight deadlines
Must be able to lift 30 lbs.
AAP/EEO Statement
Stratus Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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Manufacturing Associate (Entry Level and Experience)
Manufacturing associate job in New Bedford, MA
Job Description
Precix is seeking dedicated individuals for the role of Manufacturing Associate, both entry-level and experienced, to join our team and contribute to our mission of being a manufacturing leader in sealing solutions. At Precix, we pride ourselves on our commitment to quality, innovation, and continuous improvement, allowing us to consistently exceed our customers' expectations. Our collaborative approach leverages extensive engineering expertise and a creative mindset to design solutions that perform exceptionally well, even in extreme conditions. We foster a culture rooted in integrity, transparency, and diversity, valuing the contributions of our employees and forging strong relationships with our customers and suppliers. As a Manufacturing Associate, you will play a vital role in our production process and help create the high-quality sealing solutions that our customers rely on. If you are looking to develop your skills in a dynamic environment that prioritizes teamwork and growth, we invite you to be part of the Precix team and help us make a meaningful impact in the world.
Responsibilities
Assist in the manufacturing process by operating machinery and equipment according to company standards.
Conduct quality checks on products to ensure they meet Precix's high-quality standards.
Maintain a clean and organized work environment to promote safety and efficiency.
Collaborate with team members to ensure smooth workflow and meet production deadlines.
Follow production schedules and adjust work as needed to achieve goals.
Participate in training and development programs to enhance skills and advance career.
Report any issues or discrepancies in the production process to supervisors promptly.
Requirements
High school diploma or equivalent; some technical training or experience in manufacturing is a plus.
Ability to work effectively in a team-oriented environment.
Good communication skills and the ability to understand instructions clearly.
Strong attention to detail and a commitment to quality work.
Willingness to learn and adapt to new processes and equipment.
Basic problem-solving skills and a proactive approach to work.
Ability to stand for extended periods, lift heavy objects, and perform physically demanding tasks.
Benefits
Health Care Plan (Medical, Dental & Vision)
Life Insurance (Basic, Voluntary & AD&D)
Family Leave (Maternity, Paternity)
Short Term & Long Term Disability
Training & Development
Employee Assistance Program - Counseling
Paid Time Off
Associate Manufacturing Nights - West Greenwich, RI
Manufacturing associate job in West Greenwich, RI
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers
. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
What you will do
Let's do this. Let's change the world. In this vital role you will perform operations in the Manufacturing area, specifically Inoculation/Seeds. Operations will be performed according to Standard Operating Procedures (SOPs).
Responsibilities include:
Perform and monitor critical processes, execute routine validation protocols,
Regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
Perform basic troubleshooting and assist in the review of documentation for assigned functions.
Participate on cross-functional teams and represent the Inoc/Seeds group.
May also have the responsibility of owning NC/CAPA's and Change Control records.
Identify, recommend, and implement improvements related to routine functions
In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (C Shift). This includes extra benefits such as receiving an added 15% shift differential, and also getting premium pay for any Sundays worked. The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).
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 self-starter with these qualifications.
Additional Qualifications/Responsibilities
What you will do
Let's do this. Let's change the world. In this vital role you will perform operations in the Manufacturing area, specifically Inoculation/Seeds. Operations will be performed according to Standard Operating Procedures (SOPs).
Responsibilities include:
Perform and monitor critical processes, execute routine validation protocols,
Regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
Perform basic troubleshooting and assist in the review of documentation for assigned functions.
Participate on cross-functional teams and represent the Inoc/Seeds group.
May also have the responsibility of owning NC/CAPA's and Change Control records.
Identify, recommend, and implement improvements related to routine functions
In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (C Shift). This includes extra benefits such as receiving an added 15% shift differential, and also getting premium pay for any Sundays worked. The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).
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 self-starter with these qualifications.
Manufacturing Associate II/III
Manufacturing associate job in Cumberland, RI
Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within Greater Boston's vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform,
Encapsulated Cell Technology (ECT),
designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, by leveraging ECT's innovative approach providing sustained, targeted treatment directly to the eye.
Auto-ApplyManufacturing Associate II/III
Manufacturing associate job in Cumberland, RI
Job Description
Neurotech Pharmaceuticals, Inc. is a private biotech company located in Cumberland, RI and Needham, MA, within the realm of Greater Boston's vast biotechnology landscape. Since our inception more than 20 years ago, our focus has been on developing and commercializing transformative therapies for chronic eye diseases. The core platform technology, Encapsulated Cell Therapy (ECT), is a first-in-class drug delivery platform designed to slow the progression of chronic eye diseases. Neurotech's first commercial product, ENCELTOTM (revakinagene taroretcel-lwey), is approved in the United States for the treatment of adults with idiopathic Macular Telangiectasia Type 2 (MacTel). Encapsulated cell-based gene therapy is designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases.
We are currently seeking to add a Manufacturing Associate who will play a vital role in day-to-day, hands-on cGMP manufacturing operations. The Manufacturing Associate will be an independent thinker to monitor and troubleshoot critical processes and regularly draft and revise documents such as Batch Records and SOPs. S/he will also provide peer review of technical reports such as deviations, CAPAs and Change Controls. In addition, the Manufacturing Associate will identify, recommend and implement improvements related to routine floor operations.
Job Requirements
Perform basic to complex aseptic operations within an ISO 5 environment according to Batch Records and SOPs.
Document all activities in Batch Records, Logbooks, Forms, etc. using Good Documentation Practices.
Follow verbal and written procedures in operating production equipment and to monitor/perform process steps, while being able to identify subtle variances or escalating events that are non-routine in nature.
Perform in-process testing and other tasks as assigned that ensure sustainable right-first-time performance.
Lead project(s) from creation of tasks through execution and closure.
Create batch records and SOPs for newly defined processes
Assist with manufacturing material management.
Assist with and Own quality systems.
May be required to prepare, sanitize, and disinfect equipment to prevent microbial contamination
Education and Experience
Bachelor's degree in Science with a minimum of 2 years' experience with aseptic upstream biologic production or aseptic fill/finish processes in a GMP environment or
High School Diploma/Associate's with a minimum of 4 years' experience with aseptic upstream biologic production or aseptic fill/finish processes in a GMP environment.
Knowledge, Skills, and Abilities
Must have cGMP manufacturing experience with the ability to interpret and apply GMP knowledge
Must have Cell Culture Experience and technical understanding of adherent cell culture processes
Must be detail oriented with organization and planning skills
Must be proficient in Microsoft Office (Word, Outlook, Excel, Powerpoint)
Ability to demonstrate technical writing capability
Experience with and Basic troubleshooting skills on Manufacturing and lab equipment
Support Quality and Validation activities/documentation as needed
Must possess a positive attitude and willingness to perform hands-on daily operations
Must be able to work independently day to day and collaboratively on project team
Experience with manufacturing automated systems and electronic batch reporting a plus.
Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Manufacturing Associates (General Labor / Machine Operators)
Manufacturing associate job in Norwich, CT
Job DescriptionNOW HIRING - IMMEDIATE OPENINGS! Manufacturing Associates (General Labor / Machine Operators)
Norwich, CT
Hiring Full-Time Associates
Join a busy and rapidly growing manufacturing team in Norwich! We're looking for strong Machine Operators and motivated Laborers who are ready to work in a fast-paced manufacturing environment. If you're dependable, driven, and eager to learn, this is a great opportunity to grow with a stable company.
About the JobWork as part of a hands-on production team to help meet daily goals. These roles involve physical activity, movement throughout the plant, and supporting various areas of production.
What You'll Do
Operate or assist with operating production machinery
Move, load, and handle materials safely and efficiently
Maintain a clean and organized work area
Support your team to meet and exceed production targets
What We're Looking For
Strong work ethic and reliable attendance
Motivated individuals who want to work in a manufacturing environment
Ability to stand, lift to 50 lbs, and move throughout the facility
Positive attitude and teamwork skills
Prior manufacturing or machine operating experience is a plus (pay depends on experience)
Steel-toe footwear required
Schedule & Pay
Pay: Depending on experience (starting at $18.00/hr +)
Shift: Monday-Friday | 6:00 AM - 4:30 PM
Weekly pay
Overtime available
Apply TodayWe're hiring quickly - multiple openings available NOW! Start earning right away and build your career with a solid manufacturing team in Norwich, CT.
A.R. Mazzotta is an equal opportunity employer. It is the policy of A.R. Mazzotta to employ, recruit, hire, train and promote individuals without regard to race, color, religious creed, sex, national origin, age, marital status, present or past history of mental disability, intellectual disability, learning disability, or physical disability, religion, political affiliation or belief, pregnancy, ancestry, veteran status, sexual orientation, gender identity or expression or any other status protected by federal, state, or local laws.
#E2
Manufacturing Associates (General Labor / Machine Operators)
Manufacturing associate job in Norwich, CT
NOW HIRING - IMMEDIATE OPENINGS! Manufacturing Associates (General Labor / Machine Operators)
Norwich, CT
Hiring Full-Time Associates
Join a busy and rapidly growing manufacturing team in Norwich! We're looking for strong Machine Operators and motivated Laborers who are ready to work in a fast-paced manufacturing environment. If you're dependable, driven, and eager to learn, this is a great opportunity to grow with a stable company.
About the JobWork as part of a hands-on production team to help meet daily goals. These roles involve physical activity, movement throughout the plant, and supporting various areas of production.
What You'll Do
Operate or assist with operating production machinery
Move, load, and handle materials safely and efficiently
Maintain a clean and organized work area
Support your team to meet and exceed production targets
What We're Looking For
Strong work ethic and reliable attendance
Motivated individuals who want to work in a manufacturing environment
Ability to stand, lift to 50 lbs, and move throughout the facility
Positive attitude and teamwork skills
Prior manufacturing or machine operating experience is a plus (pay depends on experience)
Steel-toe footwear required
Schedule & Pay
Pay: Depending on experience (starting at $18.00/hr +)
Shift: Monday-Friday | 6:00 AM - 4:30 PM
Weekly pay
Overtime available
Apply TodayWe're hiring quickly - multiple openings available NOW! Start earning right away and build your career with a solid manufacturing team in Norwich, CT.
A.R. Mazzotta is an equal opportunity employer. It is the policy of A.R. Mazzotta to employ, recruit, hire, train and promote individuals without regard to race, color, religious creed, sex, national origin, age, marital status, present or past history of mental disability, intellectual disability, learning disability, or physical disability, religion, political affiliation or belief, pregnancy, ancestry, veteran status, sexual orientation, gender identity or expression or any other status protected by federal, state, or local laws.
#E2
Associate Manufacturing-Nights
Manufacturing associate job in West Greenwich, RI
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.
Associate Manufacturing - Nights
What you will do
Let's do this. Let's change the world. In this vital role you will perform operations in the Manufacturing area, specifically Inoculation/Seeds. Operations will be performed according to Standard Operating Procedures (SOPs).
Responsibilities include:
* Perform and monitor critical processes, complete routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
* Perform basic troubleshooting and assist in the review of documentation for assigned functions.
* Participate on cross-functional teams and represent the Inoc/Seeds group.
* May be responsible for NC/CAPA's and Change Control records.
* Identify, recommend, and implement improvements related to routine functions.
In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (D Shift). This includes extra benefits such as receiving an added 15% shift differential, and also getting premium pay for any Sundays worked. The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).
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 self-starter with these qualifications.
Basic Qualifications:
* High school/GED + 2 years of manufacturing or operations work experience OR
* Associate's + 6 months of manufacturing or operations work experience OR
* Bachelor's
Preferred Qualifications:
* Knowledge of small scale bioreactors, wave bioreactors, and aseptic processing.
* CFR and Regulatory knowledge
* Mechanical ability/expertise
* Knowledge of WIP lab equipment and computers, with LIMS access
* Basic statistical mathematical skills
* Ability to interpret and apply GMP knowledge
* Understanding of analytical methods for manufacturing area
* Ability to demonstrate technical writing capability with Trackwise access
* Able to demonstrate project management skills and presentation skills
* Independently collaborate with outside resources
* Ability to understand, apply and evaluate basic chemistry, biology and physical principles
* Basic troubleshooting skills on bioreactors
* Experience with Delta V, RD's
* Experience with lab equipment/testing
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
73,359.00 USD - 85,625.00 USD
Lead Upstream Manufacturing Associate
Manufacturing associate job in Milford, MA
Advancing medicine to save lives. Together.
Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.
Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions - together with our clients.
Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.
As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.
This role will follow an overnight Pitman schedule, 5pm-5am.
Key Experience/ Responsibilities for Lead Upstream Manufacturing Associate
Subject Matter Expert in cGMP upstream manufacturing; especially with Mammalian Cell Culture, Roller Bottles, Rocker Bioreactors, Fed batch and Profusion Bioreactors, Cell Harvest Clarification, Viral Inactivation, Buffer and Media preparation
A thorough understanding of cell culture key performance indicators, cell counts, seeding densities, confluence, and the science behind the upstream production of mAb's
Specific equipment/systems that we are using include Cellmate roller bottle robot, 20L/50L wave bioreactor, Cytiva 200L & 500L single use bioreactor, TCU's, BSC's, roller racks, incubators and disposable technology systems; must have a thorough understanding of the equipment and controls as this role will be the front-line troubleshooting and correction role for the shift
Must have experience with initiating, developing and revising SOP's and Batch records for upstream processes
Thoroughly familiar with the identification of actions and results that are outside procedures and limits which require escalation through events and deviations; responsibilities include leading and completing investigations of root causes and formally documenting/writing deviations for such events in upstream
Subject matter expert for materials and the ordering of materials in time to meet the schedule; participates in inventory cycle counts and resolution/ corrective actions for discrepancies
Assures that SAP transactions for process orders are executed on time and works with supply chain to resolve any discrepancies
Schedules daily activities for coworkers on shift, tracks completion of activities and reports on progress to manufacturing supervisor
Assures that executed batch records are reviewed thoroughly and all entries are correct before turning over to QA for approval; works to resolve batch record entry issues before they are reviewed by QA
Assures activities in the suite are conducted safely and in accordance with Safety procedures
Ways of Working - Leadership Capabilities
Collaborates with and provides open, honest, technically accurate information to support teams (Eng, Fac, PS, QA, QC, SC) during scheduling meetings, event/deviation investigations and process/ equipment troubleshooting
This position is the lead Qualified Trainer for new employees or for developing new competencies in existing/ transferred personnel; must be experienced with training models and focused on building competencies and behaviors to elevate the performance of team members
Monitors team culture provides clarity to misinformation and legacy attitudes and behaviors
Elevates issues early, presents issues with options for quick and compliant resolution
Provides feedback and SME support for training department process improvements
Provides feedback to supervisor/ manager on employees' performance on the shift
Leads some team meetings and may facilitate multi-department discussions
Supports a positive work environment that promotes inclusion and diversity
Standard Manufacturing Duties and Responsibilities for Associates
The Key Experience and Ways of working distinguish the Lead Upstream Manufacturing Associate from the Manufacturing Associate roles. However, the Lead Associate is on the floor, operating the equipment and completing batch records alongside the manufacturing associates. The following manufacturing responsibilities are also performed
Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities):
Perform, Monitor, Review, and record batch parameters, including computer data entry; complete relevant paperwork following GDP/GMP guidelines; perform mathematical calculations related to production processes
Pushing buffer containers ranging from 50L to 200L
Sitting for periods of 2 to 3 hours
Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids and columns, analytical equipment
Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.)
Such additional responsibilities as the Company may also assign
Proficient in BSC operations and aseptic technique
Qualifications
With high school diploma: Normally requires 8+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred
With Bachelor's degree: Normally requires 6+ years of related experience
Able to read and follow detailed written instructions and have good verbal/written communication skills
Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms
Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
Good computer skills, knowledge of Microsoft Word, Excel
Good interpersonal skills and be able to work effectively and efficiently in a team environment
Ability to work in a clean room environment and comply with hygiene standards and use of special garments; additionally, personal protective equipment must be worn due to safety requirements.
Proficient in BSC operations and aseptic technique
Working Conditions
Normal office working conditions: computer, phone, files, fax, copier
Personal Protective Equipment must be worn as required
May require lifting amounts of 25 lbs
Manufacturing operations tasks requires operator to regularly remain on feet for shift
Physical Requirements
PPE as required
May require lifting amounts of 25 lbs
Manufacturing operations tasks requires operator to regularly remain on feet for shift
Auto-ApplyLead Bioprocessing Associate, Manufacturing
Manufacturing associate job in Worcester, MA
Job Title - Lead Bioprocessing Associate, MFG
The primary responsibility of this role will be to support and deliver on process and equipment operation activities during manufacturing operations. The Lead Bioprocessing Associate will be a key member of the Worcester Manufacturing team. They will work independently and in a team environment to contribute to the operation and overall successful start-up and transition to GMP operations. This includes, but is not limited to, movement and cleaning/disinfection of materials and equipment, operating manufacturing systems for engineering/validation testing and/or manufacture of commercial GMP products, documenting GMP data via written and electronic systems, developing and adhering to standard operating procedures and developing and delivering training for operation of manufacturing systems and processes. A key responsibility of this role will be to coach and mentor Technicians (Bioprocessing Associates). Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of cGMP requirements.
Responsibilities
Responsible for execution of daily cGMP manufacturing operations and/or operations tasks required for facility start up.
Collaborates with manufacturing team members to organize and align daily tasks within the shift/team.
Participates in the organization daily activities and work with Bioprocessing Associates in executing those activities in a safe, compliant, and efficient manner to maintain production schedules.
Act as designee for the Supervisor in their absence. Duties in this situation would include but are not limited to attending and leading meetings, time off coverage, use escalation process, act as a point of contact for Bioprocessing Associates.
Understands and executes aseptic operational techniques, as well as facility start-up tasks.
Perform all core production tasks in Upstream manufacturing, Downstream manufacturing, media/buffer solution preparation, or manufacturing support areas, as well as all ancillary tasks.
Lead and actively participate in shift handovers. Liaise with manufacturing leadership regarding issues which may arise from the production area, including highlighting process bottlenecks.
Act as SME on all applicable manufacturing equipment and procedures, participating in audits/inspections as needed.
Write, review and update Standard Operating Procedures (SOPs), On the Job Training (OJTs), Production Batch Records (PBRs), Logbooks, Training Competencies and Work Instructions.
Carry out all production operations in the assigned area as directed by the relevant SOPs, PBRs and Manufacturing Execution Systems (MES).
Perform initial troubleshooting of issues identified during routine operations. Adhering to Right First Time (RFT) principals at all times.
Create and lead training for SOPs, process execution and equipment operation. Support the development of training matrices and ensure compliance with training requirements.
Support deviation investigations through interactions with quality assurance and investigators to document immediate actions taken and root cause analysis.
Actively participate in facility, equipment start-up and validation activities.
Provide input on equipment installation, operation and troubleshooting to support introduction of new products and processes.
Work with cross functional teams to facilitate the development and validation of the Biologics manufacturing facility.
Lead Bioprocessing Associate will also develop and demonstrate individual skills as subject matter experts and are required to display technical leadership by acting as ‘Champion' to drive improvements and excellence within specific aspects of the manufacturing operation.
Assist in driving and maintaining a safety orientated Culture, cGMP/GDP compliant work environment at all times.
Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.
Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Method 1, 2 etc.) to optimize efficiency and drive the culture of Continuous Improvement (CI) and Zero Defects.
Support equipment design and risk assessments as per requirements.
Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule delivery, EHS metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training.
Provide assistance and/or support for maintenance, engineering, quality or other colleagues, as requested.
Due to the start-up nature of the project, there will be an expectation for flexibility and an ability to take on varied tasks at short notice not covered extensively within this job description.
Conduct all activities that are in accordance with Company policies & SOPs, WuXi Biologics values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. Advise management of non-conformance issues.
Identify process and method gaps and highlight opportunities for continuous improvement (CI).
Shift work is required. The shift pattern may be varied according to business requirements and may require off-shift, weekend or holiday work.
Identify and manage equipment training gaps and requirements.
Perform all duties in accordance with GMP requirements, SOPs and established controlled documents and systems.
Will be flexible to take on additional tasks and responsibilities at the discretion of leadership.
Will act as a role model for the Manufacturing function and also the wider organization in adherence to the WuXi Biologics corporate core values and PROUD culture.
Qualifications
HS Diploma or equivalent required. Advanced education in a biotechnology certificate program or BS/BA in science related field or combination of relevant Experience & Education preferred.
3-4 years cGMP commercial operations experience with 2+ years direct experience in biologics drug substance manufacturing.
Requires understanding of scientific principles, operational aspects of production equipment and automation control
Demonstrated experience of working in a cGMP environment is essential
Strong demonstrated knowledge in biologics manufacturing is essential
Comprehensive knowledge and experience of relevant cGMP, safety and environmental regulations within the biopharmaceutical industry
Previous experience acting as supervisor or designee is preferred
Demonstrated experience as an SME in a biopharmaceutical operation is preferred
Experience in coordinating shift activities and escalation of issues to ensure all manufacturing processes are adhered to is preferred
Demonstrated experience with project management and execution is an advantage
Good level of knowledge and execution of validation protocols is an advantage
Experience in Lean, 6 Sigma tools in standard work and 5S are an advantage
Demonstrated career progression is desirable
Behavioral Competencies
Self-motivated with excellent communication and interpersonal skills
High level of adaptability, working in a fast-paced environment and champion of change
Ability to positively influence and work well with others
Show leadership and support to junior team members
Ability to troubleshoot, with strong analytical skills
Comfortable making risk-based decisions
Results driven and a proven record of being a high achiever
Physical Requirements
Must be able to work in an office environment with minimal noise conditions
Must be able to work in Lab setting with Biohazards / Various Chemicals
Must be able to wear appropriate PPE
Must be able to work in environment with variable noise levels
Ability to Stand / Sit / Walk for long periods of time
Ability to Lift / Push / Pull 25 lbs routinely
Ability to crouch, bend, twist, and reach
Clarity of vision and have the ability to identify and distinguish colors
Must be able to perform activities with repetitive motions
Ability to climb Ladders / Stairs / Scaffolding
Ability to work in variable temperatures from high to freezing
The anticipated base pay range for this position is $40-50hr
WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
Manufacturing Associate, LNP
Manufacturing associate job in Framingham, MA
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
Reporting to the Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of LNP therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing formulated LNP Manufacturing within a GMP environment.
Responsibilities
* Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations
* Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting.
* Transfer raw material inside cleanroom suite using sanitizing reagents or equipment.
* Participates in technology transfer from Process Development to the Manufacturing group.
* Assist in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups.
* Ensures all materials and equipment are identified and available in time for manufacturing operations.
* Execute standard work per manufacturing schedule
* Participate in Quality investigations and resolutions.
* Ensure cGMP compliance through consistent execution.
* Other duties and projects as assigned to meet departmental requirements.
Minimum Qualifications
* Certificate, associate's degree or higher in biological sciences or related fields and 2-5 years of relevant Manufacturing experience or related fields
* Available to work a flexible schedule as needed.
* Ability to don cleanroom garments and work within a classified environment (Grade B and C)
* Knowledge of GMP and industry standards
* T-Mix and TFF experience preferred
* Fluency in Windows and Microsoft Office applications
* Attentive to detail and accuracy
* Ability to effectively communicate and collaborate with internal stakeholders is essential
* Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion
* Ability to lift 40 pounds
* Ability to stand for 6 hours in a clean room environment
* Self-driven, independently motivated, data driven and excellent problem-solving ability
Competencies
* Collaborative - Openness, One Team
* Undaunted - Fearless, Can-do attitude
* Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
* Entrepreneurial Spirit - Proactive. Ownership mindset.
Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.
Manufacturing Associate: Base pay range of $40.00 per hour to $44.00 per hour + bonus, equity and benefits.
The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: ***********************************************
Associate Manufacturing - Nights (Downstream)
Manufacturing associate job in West Greenwich, RI
Career CategoryOperationsJob 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.
Associate Manufacturing - Nights (C shift)
What you will do
Let's do this. Let's change the world. In this vital role you will join a team of impactful manufacturing associates that leverage adaptability, agility, teamwork, and curiosity. The Manufacturing Associate at Amgen supports the production process by operating equipment, maintaining production records, and adhering to safety and quality standards. They contribute to the overall efficiency of the manufacturing process.
Responsibilities Include:
Under general supervision, Associate will perform operations in the manufacturing area.
Operations will be performed according to Standard Operating Procedures (SOP's)
Associate will perform and monitor critical processes, complete routine validation protocols and regularly draft and revise documents such as Manufacturing Procedures, SOP's and technical reports.
Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions.
May participate on cross-functional teams and represent the manufacturing teams.
Associate may also have the responsibility of owning deviations/CAPA's.
In addition, Associate may identify, recommend and implement improvements related to routine functions. In this vital role you will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).
In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (C Shift). This includes extra benefits such as receiving an added 15% shift differential, and also getting premium pay for any Sundays worked. The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).
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 great teammate with these qualifications.
Basic Qualifications:
High school/GED + 2 years of manufacturing or operations work experience OR
Associate's + 6 months of manufacturing or operations work experience OR
Bachelor's Degree in a related field
Preferred Qualifications:
Bachelor's degree in Science or Engineering
Knowledge of large-scale biotechnology operations such as purification, chromatography, TFF cell culture, aseptic processing, etc.
Knowledge of Single-use Systems
CFR and Regulatory knowledge
Mechanical ability/expertise
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Demonstrated technical writing capability
Able to demonstrate project management skills and presentation skills
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
Basic troubleshooting skills on production equipment
Experience with Delta V
Experience with lab equipment/testing
What you can expect from 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.
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.
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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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Salary Range
73,359.00 USD - 85,625.00 USD
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