Manufacturing associate jobs in Grafton, MA - 497 jobs

Pay: Up to $34/hour base (differentials for weekends and overnights) Shift: We are hiring for both day and 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)

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. Responsibilities Perform cGMP manufacturing operations according to documented procedures or batch records Operate automated manufacturing equipment and record relevant in-process data. Complete production and testing records following Good Documentation Practices (GDP) Handle, assemble, and visually inspect products, including use of a microscope, automated inspection systems, or other optical systems. Contribute to root cause analysis (RCA) and help contribute to manufacturing investigations Support manufacturing related R&D efforts as needed Perform other assigned duties related to manufacturing, quality control, and/or facility operations. Qualifications 2 + years' relevant experience working in regulated environments in medical device or biopharmaceutical industries; experience working in a clean room is preferred High school diploma minimal, associate's degree or trade certifications preferred Good written and verbal communication skills, attention to detail, and a demonstrated ability to work effectively within a team Ability to stand or sit for a full shift on a manufacturing line Entrepreneurial spirit and drive to positively impact global human health At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ****************** .

Job Title: Manufacturing Technical Operations Duration: 12 months of contract - with chance to extend Pay Rate: $50.00 - $59.00 hourly on W (Tues- Sat/ 1st:(9-6) JOB SUMMARY This senior-level staff member on the MTO is responsible for complete ownership of quality records including, but not limited to Deviations, CAPAs, Change Controls, Risk Assessments and Analytical and Quality Control Investigations supporting cell manufacturing at our Boston site. This includes all aspects of record ownership, triages, investigation, CAPA and change controls. The person in this role will drive cross-functional root cause analysis meetings and promote compliance best-practices to ensure timely and thorough completion. This includes all aspects of MTOs operational compliance support with emphasis on tracking and executing CGT initiatives, implementing MTO best practices and ensuring exceptional internal and external department collaboration and communication. This role will be pivotal for distributing and acting on metrics as well as supporting MTO intake and prioritization. This role is an on-site position based in our Boston location. This role requires a high-level of schedule flexibility to support our cell manufacturing clinical hours of operation and timelines. This senior-staff members work Tuesday through Saturday, time to be determined. KEY RESPONSIBILITIES: Triage manufacturing issues in real-time on manufacturing floor. Use root cause analysis tools to lead and write investigations quality events in the cell manufacturing, quality control, material operations and facility operations functional areas. Identify and collaborate with SMEs for triage, determine immediate actions and containment, document initial impact assessments. Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions. Own, drive and manage CMC CAPAs and change controls from initiation, assessment and planning, execution, and closure. Own deviations, CAPA, Effectiveness Check (EC) and Risk Assessment records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved. Promote MTO and QA- aligned compliance best practices to further establish operational and quality event record center of excellence teams. Other duties and projects as assigned to meet departmental requirements and clinical timelines. QUALIFICATIONS: 6+ years progressive experience in pharmaceutical development and manufacturing. BS in engineering, science or related discipline. Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs. Experienced with technical writing and performing event investigations in a GMP-compliant environment. Experience gowning manufacturing floor in Grade B environments. Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit ******************* to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status

At indi GO Technologies (Tradename: “GO”), we are changing the electric vehicle paradigm with our own class of ultra-efficient electric vehicles for ride hailing and last-mile delivery use cases. The indi GO line of purpose-built EVs provides the smoothest, roomiest, and most affordable ride using patented SmartWheel technology. Our technology combines premium suspension, a spacious cabin, and low cost-per-mile performance to enable truly sustainable transportation. We are seeking an experienced Manufacturing Operations specialist to help establish and scale-up our manufacturing capabilities. This role will help manage manufacturing facility infrastructure, implement production processes, perform manufacturing project management, and participate in the implementation of manufacturing practices to deliver world-class efficiency, quality, and cost control. Responsibilities: Manufacturing facility setup, layout optimization, and equipment commissioning. Function as part of a high-performing production team. Implement manufacturing best practices and continuous improvement initiatives. Collaborate with product and engineering to integrate manufacturing considerations early in product design. Develop and manage schedules to meet volume ramp-up targets. Track key manufacturing KPIs for efficiency, quality, and cost. Help ensure health, safety, and environmental compliance across operations. Requirements: Bachelor's degree in manufacturing, mechanical, or industrial engineering; Master's preferred. 5+ years in manufacturing operations Experience scaling manufacturing from prototype to volume production. Knowledge of lean manufacturing, Six Sigma, or similar process optimization methodologies. Experience in automotive or complex electromechanical assembly highly preferred. Strong leadership, problem-solving, and organizational skills. Qualified candidates working from our EV facility and HQ in Woburn, MA (20 minutes from downtown Boston) are preferred and will be prioritized. Note that only experienced and qualified candidates should apply, and also state whether they can either work full time in Woburn MA or are open to relocation to the NorthEast area. We are looking for like-minded individuals on our movement to truly impact sustainability. Join us on our mission to change the EV paradigm! indi GO Technologies offers competitive salaries, stock options, flexible hours, and a 401K plan. We support a diverse team, knowing that innovation truly thrives with a variety of backgrounds and experiences. Job Title and Compensation The salary range for this position is between $117,000 and $132,000, based on full-time employment. Actual salaries are based on several factors unique to each candidate, including but not limited to skill set, experience, certifications, and work location. Our open positions are based on job competencies that are specific to each role. If you are offered a position, the job title may be different from what is advertised to align with the role's competencies and your specific background, experience, and interview results. indi GO Technologies is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, gender, gender expression, gender identity, genetic information or characteristics, physical or mental disability, marital/domestic partner status, age, military/veteran status, medical condition, or any other characteristic protected by law.

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 $35.00 per hour to $42.00 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: ***********************************************

Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our: focus on science and innovation, we aim to offer a lifetime of clearer vision commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases. We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This person will report directly to the Manufacturing Manager within the manufacturing group to perform specific production builds in our GMP cleanroom environment. This position requires someone to have excellent hand/eye coordination as they will be working with our extremely small products. This position is located at our Northbridge, MA site. This role will require an eye exam. Excellent Compensation Package, including Equity and Comprehensive Benefits upon hire. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual responsibilities Execute necessary builds adhering to governmental guidelines, good manufacturing practices (GMP's) and company procedures. Schedule and plan daily manufacturing builds & duties in a team environment. Ensure that work environment is maintained clean, safe and organized. Maintain and complete manufacturing documents and quality records for manufacturing products. Maintain the accuracy and movement of raw materials used in manufacturing, including job kitting and cycle counting. Maintain daily cleaning activities and logs for manufacturing areas and equipment. Analyze root causes of production issues and develop corrective actions. Guide other Associates in their assigned duties when needed. Work with all departments at EyePoint. Other tasks as assigned. Qualifications Primary skills and knowledge required include, but are not limited to the following: Manufacturing and Laboratory Safety experience Previous experience working with medical device and microscope assembly work. Previous experience using semi-automated systems would be a plus. Level of Education Required: High School Diploma or equivalent Number of Years of Experience in the Function and in the Industry: Two plus years of experience working in a GMP environment preferably in the pharmaceutical/biopharmaceutical or medical device industry, but not required. Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. This position is classified as non-exempt and is eligible for overtime pay in accordance with federal and state wage and hour laws. The target salary range for this position is listed below. #LI-Onsite Min USD $67,000.00/Yr. Max USD $84,333.00/Yr.

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team . Position Summary: ultradedicated - Your biggest challenges yield rare possibilities The Manufacturing Associate II will be a suite based position within the Gene Therapy Manufacturing facility. The position is a suite/clean room based position where the Associate II position will be an on the floor technician assigned to the Upstream Manufacturing area. Expertise will include all cell thaw and culture activities through the various scale of bioreactors up to 2000L and harvest operations. Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic. This is a shift based position from 7am to 7pm on a Pitman rotation. Responsibilities: 1. Quality Systems · Be able to operate efficiently the Veeva Vault system for all quality documentation. · Ensure that high standards of cGMP are adhered to at all times. · Carry out the manufacturing review of the completed batch records in a timely manner per established targets. · Assist in Lot Disposition activities as required, including deviation follow ups, comment resolution in a timely manner to adhere to lot release timing 2. Documentation · Create, write and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks. · Support the completion of change control forms and Deviations, plus subsequent implementation of changes and follow up actions. · Ensure that high standards of cGMP documentation completion are adhered to at all times and documentation is left in a reviewable condition at all times. 3. Plant and Process · Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process. · Ongoing maintenance of own training, ensuring full training has taken place to support the execution of production activities. · Identify and drive any continuous Improvements to the process/equipment. 4. Batch Ownership · Identification of immediate actions/escalation needed to mitigate risk to product, employee safety or schedule as appropriate. · Initiation of MFG related Quality Incidents as required. · Support/ Drive through to completion any projects as required. 5. Miscellaneous · Ensure high standards of housekeeping are adhered to at all times. · Participate in internal/regulatory audits as required. · Ensure effective liaison and communication with other departments, maintaining good relations at all times. · Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite. Requirements: 1. High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience. 2. 2+ years experience in a Biologics Manufacturing setting 3. Experience with viral vectors would be beneficial for this role Physical Demands/Work Environment/Safety Considerations: · Stand for extended periods of time with periodic stooping / bending / kneeling · Able to lift, push, pull up to 50lbs. · Climb ladders and stairs of various heights. · Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment. · Certain tasks may require the use of a respirator; medical clearance will be required in advance. · Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment. · Working in temperature-controlled environments (cold rooms). #LI-CT1 #LI-Onsite The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment. Pay Range $78,300 - $96,700 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at ********************************. See our CCPA Employee and Applicant Privacy Notice . See our . It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to : ******************************** .

Day Shift openings 8:00am- 8:00pm 12hr rotating shifts 2 weekends a month Operate equipment to meet daily production requirements while meeting all quality expectations and safety standards. Inspect production and package product. Follow daily schedules, SWI's, and SOP's to produce devices or components that comply with customer specifications. Key Accountabilities/Essential Functions: Complete Tasks within assigned work center in accordance with Product specific work instructions. Required to read, comprehend controlled work instructions in order to identify manufacturing documentation and work instructions as required. Responsible for visual inspection of product for defects as identified in the work instructions. Segregate and document rejected or scrap product within assigned work center(s) utilizing SMC's Red Bin Procedure. Maintain a safe and organized work space. Maintain compliance with all required documentation utilizing proper GDP. Must be able to learn and understand ‘Lock Out Tag Out' procedure as an affected employee. Regular attendance and professionalism. Other Position Duties: Notify Cell Lead or Shift Supervisor when problems interrupt work flow and output. Notify the Cell Lead or QC when a defect is found. Verify that equipment is operating properly. Notify Cell Lead or Shift Supervisor when it is not. Abide by all applicable clean room procedures and guidelines. Adhere to all safety practices. Follow standard work and cGMP guidelines. Other duties as assigned. Qualifications: Level I Associate: High School diploma or equivalent required. The ability to read, write, speak, and comprehend English. Ability to work well with others in a team environment and independently is essential. Self motivated. Good written, verbal, and presentation skills. Keen Attention to Detail High Manual Dexterity Preferred Level II Associate: Same qualifications as above Manufacturing Experience of Greater than 6 Months Required Level III Associate: Same qualifications as above Manufacturing Experience of Greater than 6 Months Required Manufacturing Experience in a Clean Room Environment Preferred Able to proficiently assist cell leads with the training and oversight of operations being completed by newer associates. Physical Requirements: Bend, squat, climb, grasp, reach, lift or otherwise move frequently for extended periods. Lift, move or otherwise transfer up to 50 lbs. frequently, or more occasionally Walk, stand or otherwise move about continuously Exposure to machine shop physical hazards including chemicals which may require respiratory protection Typically sits, grasps items and performs keyboarding for occasional operation of a computer At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments. All applicants must be authorized to work in the US #IND #LI-KS1

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. Duties and Responsibilities Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities). Strong knowledge and understanding of manufacturing process and equipment to perform various production steps Ability to train employees Subject matter expert operating production equipment, as needed Monitor and record record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines; perform mathematical calculations related to production processes Initiate new documents for procedures; may make minor revisions to existing documents Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution Order, receive and distribute supplies into production area as needed 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 Convey information to external stake holders (auditors, global colleagues, etc.); oversee support for groups that support manufacturing (such as external cleaners, etc.) Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.) Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers; lead team meetings and facilitate multidepartment discussions Provide knowledge in areas of training process improvements Such additional responsibilities as the Company may also assign Qualifications With high school diploma: Normally requires 6+ years of related experience required or an Associate's Degree in Life Sciences/Engineering field. Biotech Certificate preferred With Bachelor's degree: Normally requires 4+ years of related experience Demonstrated knowledge of CGMP manufacturing Knowledge of laboratory and pharmaceutical production equipment 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 meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule 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 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

Work Schedule Flex 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, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials, Working at heights When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Job Description Join Thermo Fisher Scientific and participate in important work that has a tangible impact on the world. As a Manufacturing Associate II, you will play a pivotal role in supporting groundbreaking scientific achievements and advancements. This is an outstanding opportunity to join a committed team that is committed to excellence and innovation. Location / Division / Shift Location: United States Division: Manufacturing Shift: Day Shift, 12-hour rotation (Days - 2/2/3 Rotation) Summary As a Manufacturing Associate II, you will report to the shift supervisor and work closely with colleagues to carry out manufacturing operations in alignment with cGMP standards. You will receive training in various departments, guaranteeing the flawless execution of all tasks. Your contributions will play a meaningful role in the achieve world-class our premier bioprocessing operations, and you are encouraged to uphold strict adherence to corporate standards and procedures. Responsibilities Demonstrate safe work habits and strictly adhere to safety procedures Participate in Tier 1 meetings and support team preparedness Maintain GMP Kanban in support of manufacturing operations Support continuous improvement processes and tech transfer activities Spend at least 80-90% of time on the manufacturing floor Collaborate with related functional areas to achieve production goals Identify and implement efficiency improvements Education/Experience High School Diploma or equivalent experience is required 1+ year of experience in a GMP environment required Proven knowledge of cGMP Ability to grow in a fast-paced, multidimensional environment with multiple priorities Knowledge/Skill/Abilities Sharp attention to detail and competence in following procedures Maintain sterile credentials and operate in a cleanroom setting Collaborate effectively within and across the teams Apply knowledge of Good Manufacturing processes and pharmaceutical equipment Physical requirements Gown aseptically and/or sterile gown as needed Vision specifications: near sight, far sight, color sight, side vision, depth perception, and capability to adjust focus Able to sit and stand for prolonged durations Occasionally lift, stand, walk, use hands to handle or feel, reach with hands and arms, and stoop, kneel, or crouch, lift, pull, push up to 50 lbs. Ability to work 7am-7pm on rotating days in a 24/7 operation, including weekends and holidays Compensation and Benefits The hourly pay range estimated for this position based in Massachusetts is $19.64-$32.73. 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: *****************************************************

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.

Join us in revolutionizing the world of currency manufacturing and anti-counterfeit security! Crane Currency is now hiring Manufacturing Associate on All Shifts for our Nashua, NH site. If you have experience in machine operation or manufacturing, this is your chance to join Crane and master a key part of our production process. You'll play a hands-on role in creating products that people use every day-just look inside your wallet to see the impact of your work. How you will make an impact: As a Manufacturing Associate at Crane Currency, you operate press machinery safely, eliminate defective materials, and use test equipment to meet specifications. You maintain accurate records, follow troubleshooting and safety procedures, and handle materials securely. Your duties include inspecting goods, documenting data, packaging products, and potentially training others or learning new equipment. This role supports efficient operations and customer satisfaction. What's in it for you: * Attractive Pay & Career Growth: Enjoy a competitive pay rate with meaningful opportunities for career advancement and professional development. * Generous Shift Differentials: Benefit from generous shift differentials, including 15% for 2nd shift and 20% for 3rd shift. * Impactful Work: Play a crucial role in manufacturing currency security features for the US and countries worldwide. * Certification & Networking: Gain the ability to become a certified operator, network with industry experts, and work with advanced technologies. * Innovative & Stable Organization: Join a growing and innovative organization with a proud history dating back to the early 1800s, within a stable industry. Please note: This role lets you begin your career with us, subject to security clearance. Initially, you'll work via our agency partner. After clearance, training, and meeting performance standards, you may be offered a permanent position at Crane Currency. Key Attributes and Qualifications: * Experience in technical manufacturing or Machine Operating position (ex. CNC, Press, Extrusion, etc.) * Strong mechanical aptitude and dexterity. * Ability to learn the minimum computer skills required to control the associated operation monitoring functions on both the PLC and Inspection system computers. * High school diploma or equivalent. * Adaptable, Reliable and a Team Player. * Must be a U.S. Citizen with an ability to demonstrate and maintain suitability for employment in a position of Public Trust consistent with our US Government contract requirements. Shift Schedule: * 1st shift: 6AM - 2PM (Mon - Fri) * 2nd shift: 2PM - 10PM (Mon - Fri) * 3rd Shift: 10PM - 6AM (Mon - Fri) What drives our team: We are a passionate team of 1,200 creators and problem solvers, united by our purpose, we give people confidence every day in moments that matter. This comes to life through our Shared Values: * People Matter * Do the Right Thing * Trusted Partner * Innovate for Growth * Always Improving Learn more about our values and culture: ************************************************************* You can also check us out at: ********************************************************************* Who we are: Crane Currency is a premier industrial technology company and a pioneer in currency manufacturing and advanced micro-optics technology for securing physical products. Yes, chances are you have our product in your wallet right now! Our sophisticated equipment and software leverage proprietary core capabilities with detection and sensing technologies. Around the world, our customers trust us to anticipate their needs with innovative, reliable, and high-quality currency & authentication solutions and services-just as they have for generations. Where we are: Your role is in Nashua, New Hampshire, a 40-mile drive from the vibrant heart of Boston. Check out what makes Nashua a great place to live and work here: ************************************************************************************ Crane Currency is a drug free workplace. SUITABILITY AND BACKGROUND INVESTIGATION REQUIREMENTS: The final offer of employment will be subject to the applicant's successful completion of a background investigation and favorable adjudication. Failure to successfully meet these requirements will be grounds for disqualification in the hiring process. The background investigation process conducted by Crane and our U.S. Government Agency customers is very thorough. Therefore, it is imperative that applicants exercise candor and honesty when answering background questionnaires, especially as it relates to arrest, employment, education, finances, illegal drug use, and/or other criminal history. Falsification discovered in security documents or during the background investigation process may result in an immediate negative suitability determination. Crane NXT is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, or national origin or any other characteristic protected under applicable federal, state, or local law. #CCY #ONSI #LI-MB1 #NHJobs #ManufacturingJobs #HiringNow #NewHampshireCareers #ManufacturingCareers #JoinOurTeam #JobOpportunities #CareerGrowth #pressoperator #NHManufacturing #WorkInNH #JobSearch #CareerStart #ManufacturingIndustry #NowHiring #JobOpening #CareerOpportunities #ManufacturingTalent #NHEmployment #PressOperator #HiringNow #NashuaJobs #ManufacturingJobs #CraneCurrency #JobOpening #RelocationAssistance #MachineryJobs #SkilledTrades #JobOpportunity #printing #printingpress #Flexographic y #JobOpening #RelocationAssistance #MachineryJobs #SkilledTrades #JobOpportunity

Job DescriptionBenefits: Bonus based on performance Dental insurance Health insurance Paid time off Training & development Full-time position available in manufacturing/factory setting. Parts are very small with most being smaller than a dime. Seeking individuals supporting assembly process. Primary activities include: - Measurement using drop gauge - Small component assembly - Some microscope work for quality control/inspection Successful candidate will have the following: - Strong attention to detail - Reliable attendance - Team player and positive attitude - Good manual dexterity - Ability/willingness to work for long periods of time Job Types: Full-time Benefits: Paid time off Medical & Dental available Schedule: Monday - Thurs: 7:30AM-3:30PM (8 hrs) Friday: 7:30AM-2:00PM (6.5 hrs) Work Location: Pelham, NH (100% in-person)

Associate Director, Cell & Gene Therapies External Manufacturing Operations - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (based in US, New England) The primary focus of the Associate Director, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located either at the cell and gene therapy CMO's site and/or be able to travel up to 50% of their time to those sites as a "Person-in-Plant" to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. Key Responsibilities: * Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs) * Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management); be Vertex's "eyes and ears" at the CMO for right-first-time execution of commercial operations. * Proactively "connect the dots" on emerging trends and issues and lead/influence cross functional teams to drive resolutions and minimize impact to compliance and delivery of safe and reliable supply * Maintain on-site presence at CMO facilities for extended periods (including off hours/weekends) to oversee (i) critical program activities, (ii) clinical and commercial batch manufacturing until the CMO is sustainably executing operations, and (iii) Health Authority inspections. * Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. * Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities including but not limited to (i) contract management (including tracking KPIs and metrics e.g. for batch release, inventory targets and schedule attainment), (ii) forecast communication and schedule alignment, (iii) supplier governance (including Vertex Quality/other audits) and (iii) finance (e.g. issuance of POs and reconciliation/validation of invoices; tracking of spend vs budget). * Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing. * Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization. * Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements. * Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain, CMC, and Quality leadership. * Collaborate with CMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments. * Lead continuous improvement initiatives to affect timely resolution of supply issues. * Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders. Minimum Requirements: * Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role working with or in cGMP facilities within the biotechnology industry. * Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations. * Strong technical background in aseptic manufacturing operations. * Solid project management skills and experience managing complex projects. * Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience. * Strong leadership and an innate ability to collaborate and build relationships is critical. * Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change * Flexibility to work shift hours required to cover critical process steps * Ability to travel, national and international, up to 50% * Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces and electronic quality systems Desired Additional Skills: * Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. * Solid experience in equipment and facility qualification and validation for ATMP CMO's * Cleanroom qualification (Grade A/B) history Environment: * Office and cleanroom - must be able to comply with cleanroom gowning requirements at CMO * Must be able to remain in a stationary position 50% during cleanroom processing activities * Must be comfortable moving about inside the cleanroom to oversee process tasks * Compressed gasses and LN2 are commonly used in manufacturing operations * Human tissue (e.g. apheresis) and cellular materials are commonly used Pay Range: $160,000 - $240,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Associate Manufacturing I- Night Shift Live What you will do Let's do this. Let's change the world. In this role, you will join a team of impactful manufacturing execution associates that leverage adaptability, agility, teamwork, and curiosity. The Manufacturing Associate I 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. The on-boarding phase for this role will last 2-6 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7pm -7am with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay. There are multiple openings for this position, but the following list offers some insight into basic expectations for our manufacturing associates. 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. Qualifications Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Associate Manufacturing professional we seek is a committed individual 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, 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 Additional Information Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. 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. Amgen offers a Total Rewards Plan comprising 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 including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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. 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. All your information will be kept confidential according to EEO guidelines.

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 $35.00 per hour to $42.00 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: ***********************************************

Operate equipment to meet daily production requirements while meeting all quality expectations and safety standards. Inspect production and package product. Follow daily schedules, SWI's, and SOP's to produce devices or components that comply with customer specifications. Key Accountabilities/Essential Functions: Complete Tasks within assigned work center in accordance with Product specific work instructions. Required to read, comprehend controlled work instructions in order to identify manufacturing documentation and work instructions as required. Responsible for visual inspection of product for defects as identified in the work instructions. Segregate and document rejected or scrap product within assigned work center(s) utilizing SMC's Red Bin Procedure. Maintain a safe and organized work space. Maintain compliance with all required documentation utilizing proper GDP. Must be able to learn and understand ‘Lock Out Tag Out' procedure as an affected employee. Regular attendance and professionalism. Other Position Duties: Notify Cell Lead or Shift Supervisor when problems interrupt work flow and output. Notify the Cell Lead or QC when a defect is found. Verify that equipment is operating properly. Notify Cell Lead or Shift Supervisor when it is not. Abide by all applicable clean room procedures and guidelines. Adhere to all safety practices. Follow standard work and cGMP guidelines. Other duties as assigned. Qualifications: Level I Associate: High School diploma or equivalent required. The ability to read, write, speak, and comprehend English. Ability to work well with others in a team environment and independently is essential. Self motivated. Good written, verbal, and presentation skills. Keen Attention to Detail High Manual Dexterity Preferred Level II Associate: Same qualifications as above Manufacturing Experience of Greater than 6 Months Required Level III Associate: Same qualifications as above Manufacturing Experience of Greater than 6 Months Required Manufacturing Experience in a Clean Room Environment Preferred Able to proficiently assist cell leads with the training and oversight of operations being completed by newer associates. Physical Requirements: Bend, squat, climb, grasp, reach, lift or otherwise move frequently for extended periods. Lift, move or otherwise transfer up to 50 lbs. frequently, or more occasionally Walk, stand or otherwise move about continuously Exposure to machine shop physical hazards including chemicals which may require respiratory protection Typically sits, grasps items and performs keyboarding for occasional operation of a computer #IND #LI-KS1

Associate Director, Cell & Gene Therapies External Manufacturing Operations - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (based in US, New England) The primary focus of the Associate Director, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located either at the cell and gene therapy CMO's site and/or be able to travel up to 50% of their time to those sites as a “Person-in-Plant” to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. Key Responsibilities: Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs) Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management); be Vertex's “eyes and ears” at the CMO for right-first-time execution of commercial operations. Proactively “connect the dots” on emerging trends and issues and lead/influence cross functional teams to drive resolutions and minimize impact to compliance and delivery of safe and reliable supply Maintain on-site presence at CMO facilities for extended periods (including off hours/weekends) to oversee (i) critical program activities, (ii) clinical and commercial batch manufacturing until the CMO is sustainably executing operations, and (iii) Health Authority inspections. Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities including but not limited to (i) contract management (including tracking KPIs and metrics e.g. for batch release, inventory targets and schedule attainment), (ii) forecast communication and schedule alignment, (iii) supplier governance (including Vertex Quality/other audits) and (iii) finance (e.g. issuance of POs and reconciliation/validation of invoices; tracking of spend vs budget). Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing. Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization. Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements. Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain, CMC, and Quality leadership. Collaborate with CMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments. Lead continuous improvement initiatives to affect timely resolution of supply issues. Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders. Minimum Requirements: Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role working with or in cGMP facilities within the biotechnology industry. Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations. Strong technical background in aseptic manufacturing operations. Solid project management skills and experience managing complex projects. Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience. Strong leadership and an innate ability to collaborate and build relationships is critical. Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change Flexibility to work shift hours required to cover critical process steps Ability to travel, national and international, up to 50% Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces and electronic quality systems Desired Additional Skills: Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. Solid experience in equipment and facility qualification and validation for ATMP CMO's Cleanroom qualification (Grade A/B) history Environment: Office and cleanroom - must be able to comply with cleanroom gowning requirements at CMO Must be able to remain in a stationary position 50% during cleanroom processing activities Must be comfortable moving about inside the cleanroom to oversee process tasks Compressed gasses and LN2 are commonly used in manufacturing operations Human tissue (e.g. apheresis) and cellular materials are commonly used Pay Range: $160,000 - $240,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Job Description Live What you will do Let's do this. Let's change the world. In this role, you will join a team of impactful manufacturing execution associates that leverage adaptability, agility, teamwork, and curiosity. The Manufacturing Associate I 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. The on-boarding phase for this role will last 2-6 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7am -7 with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay. There are multiple openings for this position, but the following list offers some insight into basic expectations for our manufacturing associates. 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. Qualifications Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Associate Manufacturing professional we seek is a committed individual 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, 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 Additional Information Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. 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. Amgen offers a Total Rewards Plan comprising 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 including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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. 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. All your information will be kept confidential according to EEO guidelines.