Vericel Corp jobs - 38 jobs

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Schedule: This position is in-office from Monday - Friday at our Cambridge and Burlington, MA locations. POSITION SUMMARY The Buyer/Planner I role is responsible for ensuring an uninterrupted supply of materials essential for the functioning of assigned product lines and areas. DUTIES AND RESPONSIBILITIES Essential Functions: Review purchase requisitions to ensure that they meet the organization's compliance. Create Purchase Orders; maintain accurate open PO lines to define inbound quantities and due dates from suppliers. Managed returned goods to suppliers. Confirm that modifications and changes to existing orders are properly documented and processed. Track status of back orders and inventory aging report. Partner with internal customers when needed to expedite purchase requisitions or identify solutions for supply chain disruptions which may include the sourcing of alternative providers. Resolve pricing and/or invoicing discrepancies with suppliers. Plans the replenishment of materials to support the production schedule, while controlling inventory turns and materials shortages. Conducts material planning and inventory management for assigned raw materials. Maintains accurate data regarding Bill of Materials associated with all raw materials. Act as liaison with suppliers and Vericel finance during annual standard cost updates. Requests quotes from suppliers, performs new supplier sourcing and evaluation. Adheres to appropriate Standard Operating Procedures for business planning unit to ensure compliance with SOPs, ISO 9000, and cGMP procedures, MRB, Sarbanes-Oxley Controls, and corrective action goals. Other job duties are required. QUALIFICATIONS, EDUCATION AND EXPERIENCE B.S. degree (or equivalent experience) and 0-2 years of work experience or A.A./A.S and 2+ years of relevant experience or GED, High school diploma or equivalent with and 4+ years of relevant experience. • Experience working on cross functional teams. Strong written and verbal communication skills. Proficiency in all Microsoft Office Familiar with Purchasing and Quality Systems. Preferred Qualifications: Experience in Life Sciences. Familiar with cGMP processes. Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies. WORKING CONDITIONS AND PHYSICAL DEMANDS May be required to stand for long periods of time while performing physical duties. Must be able to lift, carry, push and pull up to 50 lbs. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The annual salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $56,000 - $70,000. This position is eligible for bonus and equity. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Regulatory Compliance: (15%) Stays current with federal, state, local and company-specific rules, regulations, and practices. Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety. Ensures that SOP's are current and that staff perform routine tasks according to SOP through direct observation. Plasma Collection Center Quality Assurance Oversight: (80%) Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements. Tracks deviations and trending in operating procedures and policies through established mechanisms. Reports errors, deficiencies, discrepancies and observations to center management and the Regional Quality Manager. May stop operations or shipments when donor or product safety is or may be compromised. Identifies potential SOP revisions as needed to support continuous improvement. Works in collaboration with center manager and management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of audit observations. Tracks responses to and evaluates effectiveness of corrective actions for errors. Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program. Coordinates management review meetings and participates in center staff meetings. Employee Recruitment and Retention: (5%) Responsible for providing feedback and developing employees in the quality department. Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases. Fosters teamwork. Works collaboratively with staff, peers, and management to achieve business goals. Communicates continuously and resolves conflicts proactively. Provides timely feedback on performance and initiates disciplinary action when necessary. Participates in the evaluation and review of center staff. Ensures high levels of customer service and satisfaction. Meets and strives to exceed customer expectations. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Minimum of one-year relevant work experience, or an equivalent combination of education and experience. Relevant work experience within medical or regulated field, highly desirable. Previous work experience within the plasma collection industry is strongly preferred. Computer skills in word processing, excel, data analysis and databases highly desirable. Demonstrated understanding of quality assurance in an FDA-regulated environment. Demonstrated understanding of plasma center operations. Effective organizational, technical and problem-solving skills. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Refers to Group/Regional Lead for guidance on complex, high-impact or urgent decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Consults and coordinates directly with the Center Manager on quality concerns within the plasma center. Advises and coordinates will all other center roles to effectively problem solve, mitigate risk, ensure safety of staff and donors, and provide an exceptional customer experience. Attend staff meetings and other team meetings as required. Attention to detail and ability to work independently Effective coaching and counseling skills. Innovation May participate in the management of projects and new initiatives within the center or across centers. Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Complexity Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Production environment oversight. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required. Desired: Associates or Bachelor's degree highly desirable. ADDITIONAL INFORMATION FLSA Classification (US) - Exempt Other duties and responsibilities as assigned. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Worcester U.S. Base Salary Range: $73,600.00 - $101,200.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Worcester Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes 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.

Department Name: Commercial Manager: Director of Sales Humacyte, Inc. (Nasdaq: HUMA) is bringing to market a once-in-a-generation scientific technology platform. Bioengineered, readily available and universally implantable, our product is focused on improving the lives of patients and transforming the practice of medicine. Located in Durham, N.C., the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company's innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of Acellular Tissue Engineered Vessel (ATEV™), to target multiple vascular applications including vascular trauma repair, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery and a treatment for type 1 diabetes. We are looking for the best of the best candidates to come and join our expanding team. We have a diverse group of passionate, collaborative, and innovative individuals with access to a truly cutting-edge platform technology. As we grow, we are continuously looking for courageous new talent to help us launch and create new markets for our products. Come to Humacyte for the awesome technology, stay because our people make an outstanding team and corporate culture. If you're ready to put your thumbprint on changing the future of regenerative medicine, Humacyte may have an exciting career for you. Position Background: We are seeking an experienced Surgical Sales Executive - Northeast who will play a pivotal role driving the awareness and adoption of Humaycte's portfolio of products while delivering excellence in execution, maximizing revenue and achieving assigned growth targets. This is an incredible opportunity for someone who is passionate about making a difference in the healthcare community, bringing first-in-class regenerative medicine products to the marketplace that save and improve the lives of patients worldwide and will transform the practice of medicine. We are looking for candidates with a proven track record of success building strong relationships with key customers and changing clinician behavior while exceeding quota, taking disruptive technology from no share to full share in a high growth clinically differentiated market. Candidates must have strong clinician acumen, superior selling skills and be strong in business planning. This role will report to the Sales Director and will be a remote role. If you possess the following and want to make a meaningful impact while having lots of fun, we invite you to explore this opportunity. Major Accountabilities: Demonstrate results orientation and excellence in execution by transforming activities into results. Create, maintain and present a business plan that is specific, timely, actionable and leads to goal attainment and quota achievement Analytically assess your business and use data to spot trends, drive informed decisions to effectively grow your market, manage your opportunity pipeline and accurately forecast Ensure you accurately articulate the science. Demonstrate superior product, procedural, disease state, competitive and market understanding. Ensure fluency in all product indications and claims with strong clinical and technical acumen Be proficient in understanding and articulating healthcare economics, reimbursement, coding and coverage. Effectively utilize company resources to support customer inquiries and discussions Effectively navigate the value analysis process to affect clinical practice. Demonstrate knowledge of GPOs and IDNs as well as the healthcare contracting process Responsible for key customer development and continuous expansion of network of clinical champions with a commitment to customer satisfaction and retention Ensure effective targeting while demonstrating superior selling skills with a hunter mentality, getting in front of the right clinicians in the right accounts. Successfully navigate the sales process to establish new accounts and new users to grow market share and exceed individual objectives Effectively utilize company resources to maintain accurate and timely account and surgeon profiles Demonstrates change agility, flexibility and adversity quotient. Thrives in a fast-paced dynamic environment. Excels in selling conceptionally Partner with Medical Affairs to deliver high impact medical education programs, also in conjunction with MSLs Demonstrate effective organization, time and resource management through planning and prioritization in a dynamic, fast-paced environment. Contribute to our winning culture based on trust and accountability, holding self and team members to a high standard of excellence View challenges as opportunities and demonstrate proficiency in problem solving Strong emotional intelligence with excellent written and verbal communication skills and active listening skills Submit all expense reports in a timely manner according to company policy Complete all required training in a timely manner according to company policy Attend key medical conferences and symposiums General Competencies: (For All Humacyte Positions) Able to communicate effectively in English, both verbally and in writing Excellent communication and interpersonal skills Possess a positive roll-up-the-sleeves attitude and optimistic outlook Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others Excellent organizational and time management skills with ability to set own priorities in a timely manner High degree of flexibility and adaptability Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook Must be able to work as needed to meet tight deadlines and at peak periods Self-motivated and organized critical thinker with solid interpersonal and business communication skills Demonstrated ability to work in a cross functional team Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements Always observe safety precautions and regulations in all areas where duties are performed Responsible for reporting all safety hazards and potential unsafe working conditions Ensures Humacyte or other required trainings/certifications are up to date Represents the organization in a positive and professional manner Reports to work on time and as scheduled Qualifications: Degree in life sciences or biomedical engineering preferred 5+ years of experience as a Sales Representative delivering consistent results in quota achievement Self-starter with a hunter mentality experienced in selling high growth, premium priced, disruptive technology Hospital/OR sales experience required. Vascular surgery, trauma surgery and/or life sciences market experience are strongly preferred Startup or new product launch experience preferred Ability to implement clinical data and scientific foundation into sales strategies required Exhibits strong teamwork, drive, emotional intelligence, resilience, passion, integrity, courage and work ethic while being highly accountable Knowledge of Salesforce.com or other CRM systems is highly desired Establish and maintain all credentials (Vendormate, etc) to enter and work in the hospital per facility requirements Perks: (For All Humacyte Positions) Stock Options 401k Plan with 4% Match and no Vesting Schedule Medical, Vision and Dental Plans Company Paid Long Term/Short Term Disability Company Paid Life Insurance 23 Days Paid Time Off (PTO) 10 Company Designated Holidays + 2 Floating Holidays Paid Parental Leave Policies **Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. You will report to the Center Manager and oversee the general management of employees assigned to the production areas. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. How you will contribute: You will oversee employee performance and scheduling You will lead Inventory Control efforts and lead in operational efforts You will work with donors to resolve concerns You will analyze opportunities specific to non-conforming events You will perform all tasks for Medical History, Phlebotomy, and Sample Processing areas. You will foster teamwork, communicate and resolve conflicts. What you bring to Takeda: High school diploma or equivalent Cardiopulmonary Resuscitation (CPR) and AED certification Frequent bending and reaching Ability to walk and stand for entire shift, frequent lifting to 32 pounds and occasional lifting to 50 pounds Fine motor coordination, depth perception, and ability to monitor equipment from a distance Because of potential exposure to bloodborne pathogens, pro-longed glove wear is required What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Attleboro U.S. Hourly Wage Range: $25.70 - $35.33 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Attleboro Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt No 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.

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: The Associate I, Cell Therapy Manufacturing is responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Schedule: This role will be required to work on-site Sun-Wed or Wed-Sat. Position Scope: Perform manufacturing procedures inside a manufacturing clean room in accordance with established SOPs, cGMPs, and safety regulations. Qualified to perform aseptic manipulations of cell culture operations. Document all operations in Electronic Batch Records and log sheets according to cGMPs and established SOPs. Maintain manufacturing-controlled areas in an inspection ready state. Perform clean room equipment sanitization. Record equipment and facility metrology data to ensure the equipment operates within specifications. Report out of specification readings to production management. Able to work independently upon completion of training. Be receptive to feedback and guidance from manager and other more experienced staff. Ability to organize, plan and manage time to effectively complete daily tasks. The ability to cooperate with others in a team environment will be critical to success. Practice safe work habits and adhere to Vericel's safety procedures and guidelines. Able to make cell-culture decisions based on cell observations and guidelines in written procedures. Assist in reviewing and revising production documents (SOP's and electronic records). Fully trained in at least one unit operation in both product lines. Ability to identify and report deviations and contribute to deviation investigations. In addition to being fully qualified in MACI or Epicel, cross train and qualify in at least one core competency e.g. 3T3, Media Prep, GP, TrackWise, Veeva. Achieve Qualified Trainer status. Other duties as assigned. Qualifications: Bachelor's degree (Life Sciences or related field) with 0 - 2 years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or Biotechnology certificate with 1 - 2+ years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or HS diploma/GED with 4 - 6+ years of cGMP experience. Excellent communication skills, written and verbal. Experience with Microsoft Office suite. Experience in small scale tissue culture processing (preferred). Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO (preferred). Ability to sit for long periods of time while performing cell culture operations. Ability to lift, carry, push and pull up to 50 lbs. Ability to work 1 weekend day and rotating holiday coverage. Ability to gown and gain entry to manufacturing areas. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $23.08 to $27.40 per hour. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

The Senior Mechanical Engineer, is a self-starter who can play a key contributor role in our hardware development team. In this role you will plan, analyze and implement the designs and improvements to the mechanical systems in Ivenix products to achieve product performance goals and business objectives. Salary Range: $145,000 - $160,000 * Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level) * Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. * Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. This position is onsite 3 days per week Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future. Responsibilities * This Engineer will design and develop components and subassemblies used in durable and consumable equipment designed by Ivenix. Display standard engineering principles to resolve difficult problems, from conception to final design with team input. Design complex electro-mechanical mechanisms. Define, and demonstrate design meets engineering performance goals. * Independently define components, material specifications, and process techniques to ensure proper functionality and long-term performance. Optimize designs for low-cost, high quality, high reliability and high-volume assembly. * Generates GD&T drawings identifying critical dimensions according to tolerance stack up analysis and manufacturing process capabilities. * Performs and leads DFMEA according to product / system functional analysis, and updates designs (3D and 2D) and solutions accordingly. * Establish engineering design documentation including Design files, technical records and engineering changes. * Identify risks and resolve issues that may negatively impact project schedules and identify solutions to improve project schedules. Investigate new technologies and best practices. Guide the conceptualization of new methodologies and processes into implementation. * Prototype, debug, troubleshoot, and/or rework devices while maintaining quality technical documentation. Build and test prototypes to verify design function * Establishes and performs DoE to assess and characterize new solutions and designs. * Design and develop processes, tools or fixtures for assembling and testing products. * Perform and document failure analysis of returned product * Work with manufacturing departments to ensure final design is properly executed in the creation of mechanical products All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities Requirements The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * BS or MS Degree in Mechanical Engineering or Biomedical Engineering * 8+ years of experience as a mechanical design engineer on product development teams * Direct experience developing within a regulated environment (Medical, Aerospace, Military) * Experience designing complex electro-mechanical assemblies in SolidWorks or other CAD system. * Experience in selecting appropriate materials and fabrication methods based on engineering requirements. * Experience using PDM to manage database and drawing revisions in accordance with FDA requirements * Design for Manufacturing (DFM) or New Product Introduction experience * Experience with system integration challenges such as thermal management of electronics, injection molded part design, and design for reliability. * Attention to details, natural inclination to be methodical and hands-on in a R&D lab environment. * Task management skills with ability to prioritize multiple assignments. * Strong problem solving and analytical skills. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. Phlebotomist About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: * You will greet donors as they enter and exit the donor floor. * You will perform venipuncture of donors and programming of plasmapheresis machine. * You will monitor donors during the donation process and manage donor reactions. * You will perform all tasks required for the setup, verification, operation, and troubleshooting of plasmapheresis equipment within scope of training. * You will install, prime, and disconnect disposable sets on the plasmapheresis machines * You will stock supplies, break down empty cartons and assist with proper disposal. * You will take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system. * You will perform finger sticks, test sample, and record other donor measures to include hematocrit, total protein, and weight. * You will enter donor information into the Donor Information System (DIS). * You will coordinate donors to donor floor and compensate donors using the Debit Card system. * You will support the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes through use of company approved procedures including 5S, Value Stream Mapping and Kaizen. What you bring to Takeda: * High school diploma or equivalent * Ability to walk and/or stand for the entire work shift * Will work evenings, weekends, and holidays * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. * Fine motor coordination, depth perception, and ability to hear equipment from a distance * Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear * 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - West Springfield U.S. Starting Hourly Wage: $19.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - West Springfield Worker Type Employee Worker Sub-Type Regular Time Type Part time Job Exempt No 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.

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: The Director of Regulatory Affairs, Advertising & Promotion will own and drive regulatory leadership and oversight for advertising, promotional, and non-promotional activities supporting cell therapy, biologics, combination products and medical devices. This individual will be responsible for ensuring that all promotional materials and communications are scientifically accurate, compliant with FDA and other global regulatory standards, and aligned with company objectives. The role requires strong expertise in regulatory requirements for advanced therapies and combination products, the ability to chair and guide promotional review processes, and proven leadership in cross-functional and regulatory authority interactions. Schedule: This position is in-office from Monday - Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays. Position Scope: Enable the business by providing regulatory guidance and oversight for U.S. and global advertising and promotional activities supporting cell therapy, biologics, combination products and medical devices. Leverage strong written/verbal communication skills to review and approve all promotional, non-promotional, and scientific materials to ensure accuracy, fair balance, and compliance with applicable regulations. Partner and build strong relationships cross-functionally with Medical, Legal, Quality, and Commercial to ensure promotional content is scientifically rigorous and compliant. Chair high-volume Medical, Legal, Regulatory (MLR) meetings for Vericel's brands sharing the regulatory perspective with the goal of enabling business and mitigating risk. Serve as primary contact and SME with FDA OPDP/APLB and other health authorities. Maintain deep expertise in FDA regulations, guidance documents, and enforcement actions pertaining to advertising and promotion; monitor regulatory developments and communicate changes and implications to internal stakeholders. Ensure the promotional review process is efficient, consistent, and aligned with regulatory expectations, with the goal of supporting business agility while minimizing compliance risk. Develop, implement, and continuously improve processes, SOPs, and best practices for the review and approval of advertising and promotional materials, including integrating new AI technologies. Provide training and education to internal teams on requirements for prescription product promotion. Partner with and advise product development and brand teams on advertising and promotional considerations during product development, launch planning, and lifecycle management. Participate in or lead regulatory project team and labeling meetings, providing strategic input on promotional implications of proposed labeling, new claims, and campaign concepts. Qualifications: Bachelor of Science in a scientific discipline; Master's degree preferred. 10+ years direct Regulatory Affairs experience with at least 5+ years of experience in regulatory review of promotional materials for prescription drug or biologic products. Proven track record in managing promotion review committees (e.g. PRC) or other regulatory governance forums. Deep knowledge of FDA / OPDP / APLB regulations; global experience with promotional guidance and enforcement trends in advertising and promotion preferred. Experience in negotiations and/or formal interactions with regulatory authorities (OPDP/APLB or equivalent) preferred. Demonstrated ability to collaborate and influence cross-functionally (Medical, Legal, Commercial, Quality) and drive alignment under regulatory constraints. Strong team player that has a customer service approach and is solution oriented. Attention to detail, strong written and verbal communication skills and the ability to work individually, within a multidisciplinary team. Experience authoring and implementing SOPs, review processes, training materials for promotional compliance. Proven success in managing large, complex, time-sensitive projects in a regulated environment. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $188,000 to $235,000 annually. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute * You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). * You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. * You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. * You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. * You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. * You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: * High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements * Currently licensed or certified in the state where responsibilities will be assigned: Registered Nurse (RN), Nurse Practitioner (NP) or Physician Assistant (PA) * Current Cardiopulmonary Resuscitation (CPR) and AED certification * Fulfill state requirements (in state of licensure) for basic IV therapy * Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist * Two years in a clinical or hospital setting More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Medford U.S. Hourly Wage Range: $38.64 - $53.13 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Medford Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt No 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.

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: The Quality Control Analyst I is responsible for performing routine testing of raw materials, in-process, drug product (DP) and stability samples within the QC laboratory in accordance with SOPs for product release and validation. Schedule: This position is in-office Sunday - Thursday. Position Scope: Perform routine QC testing for raw materials, in-process, DP, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, plate reader, etc. in accordance with SOPs and cGMP guidelines. Perform cell culture microbial and/or molecular assays. Perform routine Environmental Monitoring and utilities testing. Perform microbial limits, Bioburden testing, and identifying and trending microorganisms. Lab support including but not limited to glass washing, autoclaving, etc. Assist in the review of QC data and provide summaries to management as needed. Report out-of-specification or out-of-trend results in a timely manner to ensure appropriate actions are taken. Performance of QC general laboratory equipment calibration and maintenance, laboratory housekeeping and preparation of the laboratory for audits. Participate in transfer methods from support groups to the QC laboratory. Coordinate departmental systems (i.e. inventory, documentation, equipment maintenance). Communicate inter-departmentally and with outside contacts to solve technical issues. Exercise sound judgment and decision making when problem solving. Author and conduct periodic review to QC documents, including SOPs, protocols and forms as needed. Initiate deviations and lab investigations as needed. Practice safe work habits and adheres to Vericel's safety procedures and guidelines. Other duties as assigned. Qualifications: BS plus 0-2 years' industry experience in cGMP lab environment, or AS, 2-4 years' industry experience. HS Diploma, 4+ years' industry experience in cGMP lab environment, or equivalent. Basic working knowledge of cGMP regulations and/or lab experience Preferred Qualifications: 1 year of experience in a cGMP lab environment. Proficient in Outlook, MS Word, Excel and lab based data management systems (LIMs). Experience with microbiological testing or environmental monitoring. Experience in biotech, pharmaceutical or other regulated industry. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $32.21 to $38.46 per hour. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: * You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. * You will screen new and repeat donors and take and record donor vital signs and finger stick results. * You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. * You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. * You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: * High school diploma or equivalent * Ability to walk and/or stand for the entire work shift * Will work evenings, weekends, and holidays * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. * Fine motor coordination, depth perception, and ability to hear equipment from a distance * Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear * 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - West Springfield U.S. Starting Hourly Wage: $18.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - West Springfield Worker Type Employee Worker Sub-Type Regular Time Type Part time Job Exempt No 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.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. Now offering daily pay to our hourly team members! BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Responsible for all Sample Processing job skills, including, preparing plasma units for freezing, preparing samples of plasma for testing, and preparing plasma units and samples for shipment. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Provide exceptional customer service to internal and external customers (5%) Perform all required duties in the area of Sample Processing (including, but not limited to): (95%) Prepare units for frozen storage. Collect and store samples from plasma units for testing. Perform routine maintenance on the freezer including monitoring freezer and refrigerator temperatures and removing ice buildup. Prepare frozen plasma units and samples for shipping following established protocol. Organize plasma boxes/documents for scheduled shipments and assist in loading shipments. Manage supplies, assist management team with inventory control procedures, break down empty cartons and assist with proper disposal. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records. Ability to multi-task and work as a team player. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Attend staff meetings and other team meetings as required. Good verbal communication and customer service skills. Innovation Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Complexity Production environment requiring the ability to walk and stand for the entire work shift. Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee. Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs. Must be able to occasionally work in a cold environment ranging from -20 C (-4 F) to -40 C (-40F). Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance. Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear DUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required Desired: Experience in a laboratory, hospital, or other regulated environment is a plus ADDITIONAL INFORMATION FLSA Classification (US) - Non-Exempt Other duties and responsibilities as assigned. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - West Springfield U.S. Starting Hourly Wage: $18.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - West Springfield Worker Type Employee Worker Sub-Type Regular Time Type Part time Job Exempt No 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.

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: The Materials Associate I is responsible for shipping and receiving activities that include storage and transport of materials from suppliers, vendors and third-party warehouse to production areas. Schedule: As a company that thrives on teamwork and collaboration, this role will be required to work on-site 5 days a week. There are 2 Materials Associate I positions available. (1) Sunday - Thursday 8:00 - 4:30 and (2) Tuesday - Saturday 8:00 - 4:30. Position Scope: Performs Manufacturing Support activities in accordance with established SOPs, cGMPs, and safety regulations. Receives and distributes all Quality Controlled inspected and non-Quality Control inventoried material and general goods received at the Vericel site. Loads and unloads delivery vehicles and assembles stock onto pallets, warehouse trucks, racks, bins, shelves, refrigerators, and freezers. Opens cartons, bundles, and other containers and able to convey stock onto pallets, warehouse trucks, racks, bins, shelves refrigerators and freezers. Stores, transfers, and distributes material in accordance with specific material requirements. Maintains LN2 and CO2 systems including weekly manual fills of Liquid Nitrogen Cryovials Storage Dewars. Assists with data entry of In-Transit requests for material from Third Party off-site storage location. Maintains inventory control in ERP system by performing system transactions at time of material receipt, storage, and distribution. Performs routine inventory cycle counts. Participates in scheduled annual physical inventory activities. Assists with Surgeon Training Kits order requests including preparation and sanitization of reusable material. Prepares Vericel Biopsy Kit assemblies. Performs Biopsy Accessioning activities (Receipt and Inspection) processes. Assists with preparation of inventory sales order fulfillment and end of day closing activities. Works with Materials Management and Accounting as needed to investigate and resolve receiving issues and coordination of material returns. Maintenance of material staging areas. Interacts with various groups (QA, R&D, QC, Materials Management, Sales and Marketing, Facilities & Engineering, Finance, Third Party Logistics, and Customer Care) on material requests and shipping and receiving activates. Performs additional activities as required to support manufacturing operation demands. Qualifications GED, High school diploma or equivalent with a minimum of 1 years of experience working in a cGMP environment in the biotech or pharmaceutical industry. Ability to comply with regulatory compliance within Vericel. Experience in high volume and fast-paced materials and manufacturing support environment. Excellent communication skills, written and verbal. Experience operating motorized and non-motorized material handling equipment. Organizational planning skills and the ability to collaborate with others in a team environment. Experience with MS Office. Knowledge of ERP inventory system Working Conditions & Physical Demands May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements. May be required to stand for long periods of time while performing physical duties. May be required to lift, push or pull up to 40 lbs. Must operate motorized and non-motorized material handling equipment. Must be willing to work weekends, holidays and work overtime as required to meet production demands. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $19.00 to $23.08 per hour. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements Currently licensed or certified in the state where responsibilities will be assigned: LPN or LVN Current Cardiopulmonary Resuscitation (CPR) and AED certification Fulfill state requirements (in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include medical/dental, paid time off and retirement benefits, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Medford U.S. Hourly Wage Range: $28.85 - $39.66 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Medford Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt No 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.

We're growing - and we're looking for a Talent Acquisition Manager who will help us build the exceptional teams that bring our mission to life. Vericel, a leader in advanced cell therapies for sports medicine and severe burn care, is seeking a strategic and hands-on Talent Acquisition Manager to strengthen our ability to attract and retain top talent. This individual will play a critical role in shaping Vericel's hiring strategy, advancing our employer brand, directly filling positions, and equipping hiring managers with the skills and tools to make great hiring decisions. You'll be both a strategic partner and a roll-up-your-sleeves recruiter who drives results, builds scalable talent programs, and helps Vericel continue to grow its exceptional team and culture. This position is in-office from Monday - Thursday at our Burlington, MA location, with flexibility to work remotely on Fridays. Key Responsibilities Talent Strategy & Execution * Partner with business and functional leaders, as well as respective HR Business Partners, to understand workforce needs and build proactive recruiting strategies aligned with Vericel's growth plans. * Directly responsible for full cycle recruiting from entry through leadership positions across technical, manufacturing, quality, commercial and corporate functions. * Develop and maintain strong pipelines of mission-driven candidates who align with Vericel's values and patient-focused purpose. Employer Branding & Candidate Experience * Strengthen Vericel's reputation as an employer of choice by developing and executing an employer branding strategy that reflects our purpose, culture, and scientific excellence. * Design and execute creative sourcing strategies to attract top talent aligned with Vericel's mission and values. * Build and enhance Vericel's employer brand by showcasing our people, culture, and impact through social media, career events, and digital storytelling. * Ensure a seamless and engaging candidate experience from first touch through onboarding. Manager Enablement & Hiring Excellence * Design and deliver training programs that equip hiring managers and hiring teams with the skills to conduct effective interviews and make evidence-based hiring decisions. * Develop and maintain practical hiring tools, templates, and interview guides that standardize best practices across the organization. * Coach leaders on competency-based interviewing and candidate evaluation techniques to strengthen selection quality. * Leverage recruiting technology and analytics to track progress, share insights, and continuously improve hiring outcomes. * Create and manage dashboards to track recruiting metrics, such as time-to-fill, pipeline, and hiring manager satisfaction. * Build innovative tools and processes that simplify hiring and enhance collaboration between HR, hiring teams, and leadership. ________________________________________ Qualifications * High sense of urgency, strong follow-through, and a passion for delivering exceptional results * Strong consultative and relationship-building skills with hiring managers and candidates * Experience managing a high volume of requisitions and meeting aggressive hiring goals * Bachelor's degree with 5+ years of progressive recruiting experience * Proven success hiring for critical and specialized roles in a fast-paced, growth-oriented environment (biotech, pharma, or life sciences preferred) * Demonstrated ability to build and execute employer branding initiatives * Experience designing and delivering interview and selection training for managers * Strong proficiency with ATS systems and recruiting analytics tools * Excellent communication, relationship-building, and influencing skills * Strong bias for action, accountability, and continuous improvement The annual salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $125,000 - $150,000. This position is eligible for bonus and equity. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Highly experienced engineering position, under minimal or no direct supervision guides the designing, building and maintaining software used in medical devices and engineering projects related to medical technology. Applies standard engineering practices to resolve problems of high complexity. May assist and mentor experienced engineers Salary Range: $150,000-$155,000 * Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level) * Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. * Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future. Responsibilities This engineer guides the conceptualization of new methodologies while Identifying improvements for processes and best practices of software development. Generates innovative solutions to complex problems using multiple disciplines and technical principles. Advise senior management regarding appropriate action. Analyzes, plans, designs, executes, and documents high complex software applications and/or processes within established medical product design controls. Designs and develops software adhering to product requirements, definitions and/or program goals. Applies standard techniques in solving complex problems, performing root cause and failure analysis. Extensive latitude for independent judgment to resolve issues and contribute to the team's development. Displays advanced understanding of theories/practices utilized by own discipline and other disciplines outside the primary area of expertise to identify coverage of risks, requirements, architectural components, functions, and performance. Works with senior leadership to improve software engineering process efficiency. Works with internal and external staff to conduct design, redesign, prototype, and other software engineering activities. Resolves as well as leads others to resolve software defects. Performs code reviews to confirm software implemented to approved designs, specifications and meet quality standards. Assists with Project timing, tracking progress to program schedule. Mentors and guides junior staff, routinely provides advice and assistance to team members regarding routine and unique problems. May supervise or direct Sr engineers and lower-level engineers on assigned projects. Authors and reviews software specifications compliant with design control process. Develops and maintains technical records and detailed documentation for internal and external. Requirements * Bachelor's degree in Engineering is required, Information Technology or related field is preferred. * 8+ years of experience in software engineering, troubleshooting, and solving problems. * Experience in the software development life-cycle methodology and software product implementation. Experience of medical device development processes and FDA regulations a plus. * Demonstrated experience in designing and implementing performant system software solutions using a variety of technologies. * Advanced experience in using Object Oriented design patterns in multi-tiered and multi-layered architectures. * Advanced Experience with C#, .Net Framework / .Net Core, Entity Framework, SQL Server, Windows Services and Web Services is required. * Experience with HTTP, SOAP, and REST protocols. Experience in internet networking design architecture for real-time communications is a plus. * Experience with cloud services such as Azure, AWS, GCP is desired. * Experience with microservices and Kubernetes is desired. * Experience working with virtual and cloud environments is required. Experience with VMWare is desired. * Experience with various types of automated testing such as Unit, Integration, System, Performance, Load/Stress, Regression is desired. * Ability to diagnose and solve complex problems involving multiple technologies. * Knowledgeable in source control management and configuration. Experience with Git/Bitbucket desired. * Ability to work as a collaborative team member. * Advanced in problem solving, analytical, troubleshooting, and debugging skills. * Strong attention to details, natural inclination to be methodical. * Excellent in written and verbal communication skills Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: * Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. * Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. * Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. * Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. * Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. * Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: * Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. * 3-5 years of experience leading medium to large teams (20+ direct reports) * Up to 90-100% travel during the Trainee Program * Ability to walk and/or stand for the entire work shift * Willingness to travel and work at various BioLife locations across the country * Ability to work evenings, weekends, and holidays * Have a valid driver's license for the entire duration of the program * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. * Fine motor coordination, depth perception, and ability to hear equipment from a distance * Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: * Associates or Bachelor's Degree * Experience working with SOPs, GDP, GMP, CLIA, and the FDA * Experience working in a highly regulated or high-volume retail environment * Excellent interpersonal, organizational, technical, and leadership skills About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Virtual U.S. Base Salary Range: $80,000.00 - $110,000.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - VirtualUSA - MA - Attleboro, USA - MA - Medford, USA - MA - Worcester Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes 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.

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: Reporting to the Chief Compliance Officer, the Compliance Manager is responsible for the day-to-day leadership, operations, and program management of the Vericel Compliance program, which includes but is not limited to monitoring, training, development of policies and procedures, communications, third party due diligence, investigations, and risk assessment auditing and reporting. This individual is the main point-of-contact and compliance lead for the commercial and medical organizations within Vericel, as well as a primary contact for all parts of the business with respect to day-to-day contracting needs and other operational matters of a legal nature. The ideal candidate will have previous Artificial Intelligence experience to leverage expertise to build an efficient and scalable compliance program. Schedule: This position is in-office from Monday - Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays. Position Scope: Build an effective and scalable compliance program, leveraging experience and AI expertise. Serve as the legal representative in connection with the Company's Medical, Legal and Regulatory (MLR) review process. Utilize in-depth knowledge of the requirements of the Anti-Kickback Statute as they apply to commercial activities, the on-label promotion of the Company's commercial products, as well as other laws, guidance and industry codes governing key biotechnology compliance areas. Serve as a trusted compliance advisor to the commercial and medical organizations. Establish effective working relationships and build credibility within the Company, especially at senior management and operational leadership levels, implementing a culture of trust, integrity, transparency, and openness. Develop and deliver engaging compliance training and communications tailored to the needs of the business (including monitoring online and live training campaigns). Support the annual needs assessments for HCP engagements, ensuring compliance with all regulatory bodies. Manage the Company's compliance with Open Payments reporting obligations. Responsible for constructing procedures governing internal investigations as well as for the conduct of such investigations. Develop and execute monitoring plans to monitor in-person and transactional business activities. Support Vericel's data privacy and protection efforts. Provide support on other matters requested by Legal Management, including with respect to litigation matters, and contracting responsibilities, as needed. Assist in long-term strategic planning for the compliance program in response to effectiveness measures, continuous evolution activities and industry-leading best practices for effective compliance programs. Remain abreast of industry best practices and changing standards. Qualifications: Bachelor's degree and experience in Healthcare and Corporate Compliance is required. 5-8+ years of experience in corporate compliance in the medical device, pharmaceutical or biotech industry at companies with a marketed, commercial product. Successful AI application to design efficient compliance review processes. Knowledge of Health Care Compliance programs and policies, the AdvaMed code of conduct, state and federal open payments laws, Federal health care programs, and FDA requirements required. Deep understanding of healthcare compliance laws, regulations, and industry codes of practice governing medical device and biopharmaceutical industry business practice, including but not limited to commercial, medical affairs, market access, and clinical development activities. Proficiency in Microsoft Office Suite, Veeva Vault, and contract management systems. Highly familiar with the current U.S. life science marketplace, including substantive knowledge of applicable U.S. laws relating to healthcare and pharmaceuticals, auditing, experience developing and implementing new policies, practices and related systems (i.e., CRM, Aggregate Spend). Exceptional written and verbal communication skills and interpersonal skills, with high degree of emotional intelligence. Proven ability to work cooperatively toward the most effective solutions in a dynamic, fast-paced, multidisciplinary environment including the ability to exercise sound business judgment, know when to seek the input of others, and work independently when efficiency is required. Commitment to integrity and ethical conduct; ability to handle confidential and proprietary information with discretion, and experience working in a high-growth public company environment. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $142,000 to $181,000 annually. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Schedule: This position is in-office from Monday - Friday at our Cambridge and Burlington, MA locations. POSITION SUMMARY The Buyer/Planner I role is responsible for ensuring an uninterrupted supply of materials essential for the functioning of assigned product lines and areas. DUTIES AND RESPONSIBILITIES Essential Functions: * Review purchase requisitions to ensure that they meet the organization's compliance. * Create Purchase Orders; maintain accurate open PO lines to define inbound quantities and due dates from suppliers. * Managed returned goods to suppliers. * Confirm that modifications and changes to existing orders are properly documented and processed. * Track status of back orders and inventory aging report. * Partner with internal customers when needed to expedite purchase requisitions or identify solutions for supply chain disruptions which may include the sourcing of alternative providers. * Resolve pricing and/or invoicing discrepancies with suppliers. * Plans the replenishment of materials to support the production schedule, while controlling inventory turns and materials shortages. * Conducts material planning and inventory management for assigned raw materials. * Maintains accurate data regarding Bill of Materials associated with all raw materials. * Act as liaison with suppliers and Vericel finance during annual standard cost updates. * Requests quotes from suppliers, performs new supplier sourcing and evaluation. * Adheres to appropriate Standard Operating Procedures for business planning unit to ensure compliance with SOPs, ISO 9000, and cGMP procedures, MRB, Sarbanes-Oxley Controls, and corrective action goals. * Other job duties are required. QUALIFICATIONS, EDUCATION AND EXPERIENCE * B.S. degree (or equivalent experience) and 0-2 years of work experience or A.A./A.S and 2+ years of relevant experience or GED, High school diploma or equivalent with and 4+ years of relevant experience. • Experience working on cross functional teams. * Strong written and verbal communication skills. * Proficiency in all Microsoft Office * Familiar with Purchasing and Quality Systems. Preferred Qualifications: * Experience in Life Sciences. * Familiar with cGMP processes. * Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies. WORKING CONDITIONS AND PHYSICAL DEMANDS * May be required to stand for long periods of time while performing physical duties. * Must be able to lift, carry, push and pull up to 50 lbs. * Why Vericel? * Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. * Career Growth: Be a part of a growing organization with opportunities to expand your impact. * Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The annual salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $56,000 - $70,000. This position is eligible for bonus and equity. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.