Anika jobs - 55 jobs

The Human Resources Generalist is responsible for providing day-to-day support of Anika's human resources programs, policies, and objectives. Reporting to the Director of HR Operations & Shared Services, the position will interact closely with all members of the HR team to support a wide variety of areas including onboarding, recruitment, HRIS, employee relations, benefits administration, reporting, and maintenance of employee information. This role offers wide exposure to the full HR lifecycle and broader organizational activities. This is a key role on our HR Operations team to fully leverage our systems and tools for a modern and seamless end user experience across the employee lifecycle. As an HR power user, the position will have the opportunity to contribute ideas and help shape our ongoing process and technology strategy. Key Responsibilities Responsible for a multitude of HR operational activities including onboarding, offboarding, HRIS, benefit administration, leaves of absence, reporting, and day-to-day requests Provide a high level of customer service to assist the HR team and all levels of the organization in responding to business and HR needs Build collaborative relationships with HR, cross-functional departments, employees, and vendors Responsible for entering HRIS data flow including new hires, changes, terminations, LOA; collaborate with Payroll on related items Ensure all employee information in HRIS is accurate and up-to-date Produce day-to-day reporting including compliance needs Participate in review and testing of new HR system functionality Serve as power user in HR technologies, embrace new solutions Manage benefit administration and serve as primary point of contact for employees regarding various benefit programs and inquiries Maintain carrier feeds with vendors and resolve issues when they arise Support various recruitment activities as needed, including job postings, resume screening, interviewing, offer letters, references, and schedule coordination, etc. Support annual activities including benefit open enrollment, performance review and merit cycles, event planning, audits, etc. Manage and maintain service and recognition awards Maintain up-to-date HR information across internal and external platforms (employee handbook, company website, Intranet, etc.) Perform various operational support activities including file maintenance, scheduling, report generation, invoice reconciliation, and preparation of correspondence Maintain high level of confidentiality and handling of matters discreetly Participate in other HR projects as needed Qualifications Bachelor's degree in Business, Human Resources or related field 0-3 years' experience within Human Resources Technically savvy with the ability to adapt and learn new systems and solutions Strong organizational skills with the ability to prioritize, plan, organize, and manage a variety of tasks Strong customer service orientation Understands the importance of employee and company confidentiality Superb computer literacy with capability in Microsoft office suite and email Team player, proactive and enthusiastic individual with the ability to operate in a positive, helpful, and productive manner Preferred Experience, Knowledge and Skills HR / HRIS experience or other experience with HR or IT software Knowledge of general HR practices and employment regulations Demonstrated experience in a dynamic environment with the ability to multi-task and adjust to changing priorities Ability to work autonomously, effectively manage time, and meet deadlines with results Understands and appreciates diversity across cultures and people The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

The Production Planner will set and oversee the production plans to align with the sales forecast (demand plan) from the integrated business plan, while meeting business objectives of safety, quality, on-time delivery, competitive customer lead times, profitability, and inventory. The position works closely with the Supply Planning Manager, Manufacturing and Packaging Managers to ensure continuous and optimal production is achieved. The role encompasses understanding inventory management policies for finished goods supply, to raw material replenishment. The Production Planner will also be responsible for achieving set KPI's, whilst providing any root cause analytics, and other ad hoc reporting as needed. This position will interface with other cross functional teams from purchasing, quality, and warehousing to ensure production goals are met. Specific Responsibilities: Oversee the scheduling of production materials to ensure optimal production levels are maintained Support and if needed Lead daily/weekly production meetings. Respond to production issues and adjust planning schedule as required Communicate any major supply constraints that will disrupt manufacturing to Management. Initiate and support the release of Batch Records Initiate and manage planned deviations as needed Support any investigation of Non-conformances via Master Control, as needed. Analyze capacity and identify any potential bottlenecks in the production system and propose/implement solutions Monitor inventory levels of raw material and coordinate with Buyer/Planner to expediate orders Participate in the review of the company's inventory policy and make recommendations on adjustments to avoid risk of slow moving/obsolescent materials Track, measure, and report key metrics of performance versus plan Other projects and activities as required Job Complexity: The job requires the individual to work on problems of diverse scope requiring planning of complex operations. The position exercises broad judgment within generally defined practices and policies, and acts as advisor and trainer to resolve technical problems and meet schedules. Erroneous or mistimed decisions may cause critical delays or cost impact and may have an immediate effect on the company's success. The position interacts internally with peers and management and may interact with customers. Supervisory Responsibilities: None Travel: Ability to travel up to 10% Required Qualifications: Bachelor's degree in the life sciences or supply chain or relevant work experience +3 years of experience in production planning in a commercialized setting where manufacturing of bulk active ingredients as well as finished products is conducted A minimum of 1 year experience in an FDA regulated environment; GMP experience required Demonstrated experience with MRP/ERP systems (SAP preferred) Demonstrated ability to develop and maintain complex Excel spreadsheets Excellent professional communication skills Strong analytical and organizational skills Proactive problem definition and creative problem-solving skills Demonstrated teamwork and results orientation Provide high energy and a readiness to collaborate with internal resources Desired Experience, Knowledge, and Skills: APICS certification, CPIM, or CPM preferred Experience with injectable products is desirable The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

Salary Range:$45,000.00 To $55,000.00 Annually The Aseptic Manufacturing Technician has primary responsible for the activities and procedures required for the manufacture and filling of Aseptic products. The position works under close supervision and follows established procedures in the execution of daily activities. Specific Tactical Responsibilities: * Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedure (OPM) * Executes all procedures associated with aseptic fills (transfer, set-up, sanitization, autoclaving, process simulation, etc.,) * Adheres to written work instructions to perform solvent recovery, clean out of place, clean in place of complex equipment and components * Assists with troubleshooting and resolution of process related issues * Records data into Batch Records, log books and OPM's * Documents all work activities according to Good Documentation Practices * Reports procedural deviations and nonconformance to management * Maintains current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Job Complexity: The position works on assignments that are routine in nature where cGMP experience is required to perform work activities. The Aseptic Manufacturing Technician I normally receives detailed instruction on routine work and training on new assignments. Supervisory Responsibilities: None Required Qualifications: * High school diploma, GED or equivalent experience * 0 - 1+ years related experience in a manufacturing environment * Ability to work flexible hours to complete work activities * Must possess good written and verbal communication skills * Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas; ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes * Ability to lift, pull or push equipment requiring up to 25-50 lbs; ability to stand for 6 hours in a production suite * Ability to climb ladders and work platforms * Ability to work around chemicals (alcohols, acids & bases) * Ability to work flexible hours to complete work activities Desired Experience, Knowledge, and Skills: * Manufacturing experience in a medical device industry * Experience working in a clean room or using aseptic technique * Experience using commercial scale automated equipment * Ability to perform computerized transactions and maintain spreadsheets are a plus The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Medical Value and Health Information Technology (MVHIT) Manager - Health IT Liaison Manager East US What you will do Let's do this. Let's change the world. In this vital role you will secure coverage for our brands and to support patient access. In a dynamic healthcare environment, the organization recognizes the increasing importance of Integrated Delivery Networks (IDN) within the U.S. Healthcare system. As a result, the team is focused on developing and executing strategies for the IDN customer segments. This new position is a unique and highly visible opportunity to help build a path forward for our organization in terms of tapping into the constantly evolving IDN segment and Implementation Science. The MVIS will support and educate accounts using MAC-approved materials related to Electronic Health Records (EHR) supporting multiple therapeutic areas of interest to Amgen. This position will be responsible for directly managing prioritized accounts within their regional geography. They will advise the director and senior manage with the development of the strategy, messaging, tools, & resources to harness the organized potential of IDN's and/or health systems within the EHR space. Medical Value Health IT Liaison (MVHIT) will educate heath system in leveraging EHR-platforms to facilitate the evolution of care from a reactive episodic based care model. Relevant functionalities include clinical decision support consistent with evidence-based guidelines for identify (reporting tools), evaluating (alerts, order-sets) and engaging at-risk patients (e.g., patient portals and reminders) and/or health systems within the EHR space. This position will work closely within the Medical Value and Access team, MSLs and cross-functional partners to use population health strategies and value-based initiatives to support organizations whose goals are to deliver value through quality improvement, care management, and patient engagement. This is an enterprise role working across all prioritized Therapeutic Areas of Interest: Cardiology, Renal, and Metabolic (CRM), Oncology, Immunology, and Rare Disease. The main focus of this role is to educate these customers about health information technology (HIT) systems, including electronic health records (EHR), to enhance diagnosis, treatment, and patient management with tools that enable, for example, clinical workflows, patient stratification, and patient activation and outcomes at the point of care. Responsibilities * Work with cross-functional medical and commercial account teams to gather EHR customer insights and assess opportunities * Manage the customer accounts prioritization process for the MV Health IT Liaisons * Contribute to the development of scalable, EHR-enabled tools and resources in relation to key therapeutic areas * Deliver insights related to EHR objectives to key internal partners to help inform strategic decisions * Deliver education on EHR reporting and clinical decision support tools to support health system initiatives * Conduct regular meetings with customers to provide appropriate Health IT-related education * Create and complete key account plans for how to navigate the customer landscape plus complete key initiatives * Effectively assist through training and communication MSLs and KAMs on MVHIT and EHR programs and resources and provide support to field staff to address questions * Confidently engages customers in a field facing capacity using appropriate methods and MAC approved materials/messaging * Demonstrates effective use of CRM tool to run territory schedule and call documentation * Support cross-functional workstreams to support business initiatives as requested for identified accounts, contributing strategic insights on care management evolution, quality and care initiatives, and HIT implementation * Provide feedback and support on targeting strategies, Key Performance Indicators, and POAs * 50% travel may be required What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic liaison professional we seek is a leader with these qualifications. Basic Qualifications: * Doctorate degree OR * Master's degree and 3 years of Medical Capabilities experience OR * Bachelor's degree and 5 years of Medical Capabilities experience Preferred Qualifications: * Experience in pharmaceutical/biotech industry or hospital system * Understanding of or familiarity with EHR systems within IDNs * An understanding of the impact of healthcare market and legislative tends that impact Health Systems, Pharma, Payers * Experience in applying health information technology in in-patient and ambulatory settings * Strong eye for business, analytical skills, and critical thinking ability * Demonstrated customer-facing experience with a strong customer service mindset * Good understanding of IDNs and key partners * Hands-on experience with EHR products, such as Epic, Allscripts, eClinicalWorks, and Cerner * Experience with EHR reporting tools What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans * Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 122,813.00 USD - 161,137.00 USD

Additional Information All your information will be kept confidential according to EEO guidelines.

Salary Range:$60,000.00 To $80,000.00 Annually We are seeking a highly organized and detail-oriented Maintenance & Calibration Planner with proven experience in the pharmaceutical and medical device industry. This role is responsible for planning, scheduling, and optimizing both maintenance and calibration activities to ensure equipment reliability, regulatory compliance, and operational efficiency. A strong background in Computerized Maintenance Management Systems (CMMS)-particularly Blue Mountain RAM (BMRAM)-is essential. This position is primarily on-site at the Bedford, MA facility, with some flexibility for hybrid work depending on project needs and team coordination. Key Responsibilities * Develop and manage preventive and corrective maintenance schedules for GMP-critical and non-GMP assets. * Plan and coordinate calibration activities for instruments, sensors, and control systems in accordance with regulatory and internal standards. * Administer and maintain CMMS (preferably BMRAM), ensuring accurate asset data, calibration intervals, work order tracking, and documentation. * Ensure calibration records are complete, traceable, and compliant with FDA, ISO, and other applicable regulatory standards. * Collaborate with Quality, Manufacturing, and Engineering teams to align maintenance and calibration activities with production schedules and compliance requirements. * Generate and analyze metrics (e.g., PM and calibration completion rates, equipment downtime, backlog) to drive continuous improvement. * Support validation and qualification efforts for equipment and utilities, including calibration-related documentation. * Maintain spare parts and calibration standards inventory; coordinate procurement to replenish consumed inventory and maintain appropriate safety stock levels. * Lead planning for shutdowns, calibrations, and major equipment overhauls. * Train technicians and users on CMMS workflows, calibration procedures, and best practices. Qualifications * Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience). * 5+ years of maintenance and calibration planning experience in a regulated pharma or medical device environment. * Hands-on experience with CMMS platforms; Blue Mountain RAM (BMRAM) strongly preferred. * Familiarity with GMP, FDA 21 CFR Part 11, ISO 13485, and other regulatory frameworks. * Strong analytical, organizational, and communication skills. * Proficiency in Microsoft Office Suite and data visualization tools. Preferred Skills * Experience supporting audits and inspections (FDA, ISO, internal). * Knowledge of equipment qualification, calibration protocols, and validation lifecycle. * Lean or Six Sigma certification is a plus. * Ability to read and interpret engineering drawings, calibration certificates, and technical manuals. The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

Salary Range: $50,000.00 To $70,000.00 Annually Scope The Sr. Site Plumber will oversee plumbing operations and maintenance for a GMP manufacturing facility. This role ensures reliable operation of critical utility systems and supports manufacturing processes by performing and supervising plumbing-related tasks. The position requires strong technical expertise, leadership skills, strong troubleshooting skills, and the ability to work independently while guiding junior team members. Strategic Focus Areas * Ensure all plumbing systems operate at peak performance, efficiency, and reliability * Maintain compliance with internal safety protocols and external regulatory standards (e.g., IPC, NFPA, OSHA, GMP) * Lead continuous improvement initiatives related to plumbing infrastructure and related systems * Provide mentorship and training to junior technicians and apprentices * Support facility expansions and new equipment installations from an electrical standpoint Specific Tactical Responsibilities * Lead and perform preventative and corrective maintenance on plumbing systems and related utilities, including: * Potable water, process water (RODI/USP/WFI), plant steam, clean steam, alcohol handling systems (SDA, ethanol), fire protection, wastewater treatment, and compressed gas systems (air, N2, etc.). * Support installation, troubleshooting, and repair of facility and process equipment requiring plumbing expertise. * Interpret technical drawings, piping diagrams, and specifications for system maintenance and upgrades. * Train and mentor junior technicians; act as a subject matter expert for plumbing systems. * Respond to emergency service calls and resolve issues promptly while adhering to safety and compliance standards. * Knowledge and capability to work with hazardous and flammable materials using * Participate in cross-functional teams for investigations, root cause analysis, and continuous improvement initiatives. * Maintain accurate documentation of all maintenance activities in compliance with GDP and GMP requirements. * Engage in the organization's Reliability program and contribute to system improvements. * Participate in on-call rotation for off-hour emergencies and weekend walkthroughs. Job Complexity This role demands advanced technical proficiency in plumbing systems, the ability to interpret complex schematics and wiring diagrams, and sound judgment in high-risk environments. Supervisory Responsibilities * May provide guidance and oversight to junior electricians or contractors * No direct reports Required Qualifications * High School diploma or equivalent. * 5+ years of plumbing experience in a cGMP environment. * Journeyman or Master Plumber's License. * Ability to work independently and lead a team effectively. Desired Experience, Knowledge, and Skills * Experience in Biotech/Pharmaceutical manufacturing facilities. * Additional licensure in Wastewater, Refrigeration/Air Conditioning, or Electrical. * Additional relevant certifications HAZWOPER, OSHA 10/30, hoisting license, etc. * Familiarity with CMMS systems for tracking work orders. * Strong communication skills and ability to manage time effectively. The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

Career CategorySales & Marketing OperationsJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Associate - Payer Contracting (US - Remote) What you will do Let's do this. Let's change the world! Amgen has an exciting opportunity for an individual looking to make a significant impact on the organization. In this vital role the Senior Associate is integral to Amgen's financial performance and will lead contracting activities for Amgen's Managed Care Organization (MCO) customers. As a member of the US Value & Access team, Senior Associate will serve as Payer Contracting's point of contact for both internal and external partners for assigned Amgen's top regional MCO and Medicaid customers. This role reports to a Senior Manager of Payer Contracting. The Senior Associate will be an instrumental member of the customer team responsible for overseeing Amgen's customers and will be key in identifying and executing contract strategies to ensure Amgen's business needs are met. This role is integral in communicating account information to facilitate pricing and contracting decision-making by senior leadership. This individual will be the primary contract owner for the MCO client responsibilities and will assist in review of product pricing requests with internal executive committees. Additionally, this individual will partner with cross-functional teams to support product-specific pricing strategies, value-based contracts, contract performance, and contract completion needs. Manage the contract development process in conjunction with Amgen's account representative (Market Access), Coverage & Pricing, Legal, and other stakeholders Create term sheets and complete request for proposals (RFPs) as needed to provide pricing offers to MCO customers Act as business owner of the contract between Amgen and its customer, specifically owning the contracting strategy and completion of assigned top regional MCOs Implement MCO pricing and contracting strategies in alignment with brand/business approach Participate in the development and maintenance of MCO pricing and contracting strategies Maintain a comprehensive understanding of key MCO customer's financials, growth drivers, membership, mergers/acquisitions, end customers, etc. Inform the pricing analytics team of customer-specific information and trends that are critical to provide quarterly financial estimates for each customer Collaborate with Sales, Marketing, Finance, Market Access, customers, Legal, Operations, and other teams as necessary Review formularies and submission files to ensure customer compliance with the contract Support ad-hoc requests by senior leadership for product and/or customer related business analytics and strategy Other duties as assigned What we expect of you We are all different, yet we all use our unique contributions to serve patients. The contracting professional we seek is a collaborator with these qualifications. Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of commercial contracting, pricing, finance, accounting, and/or sales operations experience Or Associates degree and 6 years of commercial contracting, pricing, finance, accounting, and/or sales operations experience Or High school diploma / GED and 8 years of commercial contracting, pricing, finance, accounting, and/or sales operations experience Preferred Qualifications: Advanced degree (i.e. MBA, JD or equivalent degree) 2+ years of commercial contracting, pricing, finance, accounting, and/or sales operations experience in a biopharma or related business environment Experience solving complex business problems and running multiple projects concurrently Demonstrated track record of increasing responsibility and leadership experience Strong negotiation skills Previous experience providing and delivering information for decision making by executive management Ability to read and understand legal contract documents What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 88,558.00 USD - 117,130.00 USD

Career CategoryProcess DevelopmentJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director, Commercial Drug Products & Life Cycle Management What you will do Let's do this. Let's change the world. In this vital role you will be part of Amgen's Process Development organization, Drug Product Technologies unit that continuously strives to be a technical leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team leaders (DPTLs) play a central role in this process by serving as single point of accountability for individual drug product programs for technical activities specific to formulation, aseptic drug product process design and validation, integrated development of combination products, process improvements, life cycle changes, regulatory submissions, annual product reviews, etc. DPTLs are part of an integrated operations team and lead a technical team responsible for delivering drug product process transfers, process optimization, process trouble shooting, timely closure of non-conformance investigations and change control assessments to ensure supply of commercial drug products. We are seeking a director to lead an impactful team of DPTLs responsible for all commercial drug product programs in our portfolio. Provide scientific, technical and managerial leadership in support of commercial drug product and life cycle management activities. Lead a team of highly skilled scientists and engineers with advanced degrees and training and lead the strategic direction of the group to ensure contract book deliverables for the portfolio, aware of industry trends, future requirements and feedback from key partners. Provide technical leadership to influence and implement strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, biosimilars, and oral dosage forms. Maintain strong partnerships with product delivery team leaders in Operations, Therapeutic Area heads, all Process Development groups, Regulatory, Quality and with Clinical and Commercial manufacturing sites to positively influence Amgen practices and strategies to ensure success through the life cycle of current and future commercial products. Advance the organization's competence on GMP compliance, current regulatory trends and expectations. Actively direct and lead team capacity/resources, budget targets, timelines. Talent management responsibilities including hiring, leadership development, mentoring, training, and compliance to standard operating procedures, regulatory requirements, and quality systems in a GMP environment. Recruit and retain technical staff that can deliver in a highly matrixed and dynamic environment. Up to 25% travel to domestic and international sites. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of experience in engineering, science, or business management Or Masters degree and 8 years of experience in engineering, science, or business management Or Bachelors degree and 10 years of experience in engineering, science, or business management And In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: PhD from an accredited college or university in one of the following areas: Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area 10+ years of pharmaceutical development and management experience 10+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization Demonstrated knowledge of drug product commercialization and integrated combination product development Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites Strong knowledge about developing processes with single-use manufacturing equipment Implements with a sense of purpose and drives course corrections where appropriate Excellent written, verbal, and presentation skills - ability to distill, craft and present key messages relative to diverse audience requirements Knowledge of applicable global regulatory requirements. Experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters Strong problem solving, trouble shooting, and communication skills Ability to participate in global cross-functional teams and work effectively in a highly matrixed environment to lead change, efficiency, and strong cross functional relationships Hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems Superior knowledge of aseptic processing and manufacturing of injectable drugs in vials, syringes, cartridges, devices, disposables, and the associated GMP/Device documentation and regulatory filings Experience with biologics and oral dosage form manufacturing is critical Advanced understanding of primary containers (syringes, cartridges and vials), elastomer, polymer (injection and extrusion blow molding), formulation, technical modeling of complex systems, labeling and packaging, cold chain expertise Strong focus on coaching, motivating and providing career and scientific/technical advice to staff Strong networking skills to work across organizations to advance innovated processes, approaches and methodologies What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 199,180.00 USD - 225,807.00 USD

Summary of Responsibilities: The Senior Analytical Chemist leads the development, validation, and transfer of analytical methods for Anika products. This role involves complex problem-solving, mentoring junior staff, and ensuring compliance with regulatory standards. Strategic Focus Areas: Effectively collaborates with internal colleagues and external service providers to meet corporate objectives and drive business results. Demonstrates business and Quality Control knowledge. Specific Responsibilities: Method Development Design and develop robust analytical methods for raw materials, intermediates, and finished products. Optimize chromatographic and spectroscopic techniques (e.g., HPLC, GC, UV-Vis, FTIR). Evaluate method parameters such as specificity, linearity, accuracy, precision, and robustness. Method Validation Perform method validation in accordance with regulatory guidelines (e.g., ICH Q2(R1), USP, FDA). Prepare and execute validation protocols and reports. Conduct statistical analysis of validation data to ensure method reliability. Instrument Operation and Maintenance Operate and maintain analytical instruments (e.g., HPLC, GC, LC-MS, ICP-MS). Troubleshoot instrument issues and coordinate with vendors for repairs or calibration. Documentation and Compliance Maintain accurate and complete laboratory records in compliance with GMP standards. Write and review SOPs, protocols, and technical reports. Ensure compliance with internal quality systems and external regulatory requirements. Sample Analysis Analyze samples for stability studies, release testing, and in-process controls. Interpret and report analytical data with attention to detail and scientific integrity. Cross-functional Collaboration Work closely with formulation, process development, research and development, and quality assurance teams. Support technology transfer of analytical methods to manufacturing or QC labs. Continuous Improvement Evaluate and implement new technologies or techniques to improve analytical capabilities. Support implementation of lean practices, digital tools, or automation to enhance lab productivity Participate in laboratory audits and contribute to CAPA (Corrective and Preventive Actions). Contribute to other projects as assigned Job Complexity: The position works on problems of medium to complex scope. The position exercises judgment within defined practices and procedures to determine appropriate action. The position must be able to manage multiple priorities and projects. Supervisory Responsibilities: None Required Qualifications: MS or PhD in Chemistry, Biology, Pharmaceutical Sciences, or equivalent experience. 5+ years of experience in analytical method development and validation. Expertise in HPLC, GC, UV-Vis, FTIR, and other analytical techniques. Demonstrated experience with cGMP regulations Strong understanding of regulatory requirements and quality systems. Excellent technical writing, documentation and communication skills. Excellent time management skills in meeting with committed deliverables and timeline Ability to work flexible hours to complete work activities Desired Experience, Knowledge, and Skills: Experience in a result driven, team environment Constantly strives to exceed goals, requirements, accomplishments and expectations The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

Summary of Primary Responsibilities: The QC Incoming Inspector completes all activities required to approve raw materials for use in product manufacture. The position also performs inspection activities during in-process manufacturing. Specific Responsibilities: Perform quality line clears and in process inspections during the inspection and packing processes according to specific SOP requirements Issue lot numbers and control labels for incoming raw materials; perform inspections per internal procedures and specifications Release approved raw materials for use in manufacturing process to include completion of associated documents, notice of approval form (bin card) and relabeling of inventory Review MPS of other incoming inspectors for approval and release. Monitor and perform annual retain inspection; coordinate required retesting with QC; complete required documentation Perform OOS investigations and participate in MRB as required for rejected materials Perform as SME for the function and provide training as required to new employees, contractors and other QA personnel Perform biennial review for designated procedures and MPS as needed Documents; author and complete DCR as required Document all work activities according to Good Documentation Practices Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Participate in other projects as assigned Job Complexity: The position works on assignments that are routine in nature and receives detailed instruction on all work. Supervisory Responsibilities: None Required Qualifications: Associates degree in the life science or relevant work experience 0 - 1 year of experience in a cGMP facility or previous experience in a QA/QC role within the industry; internship experience considered Experience using Microsoft Office or an ERP system Desired Experience, Knowledge, and Skills: Bachelor's degree preferred Experience working in a clean room environment Excellent communication and documentation skills The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

Salary Range:$90,000.00 To $120,000.00 Annually Summary of Primary Responsibilities: This position is responsible for providing support for manufacturing support for commercial products through review and approval of Process Change Controls, CAPAs and Deviations. Support new product development as needed. Performs Internal audits as assigned. Participates in customer and regulatory audits as part of the Audit Team; maintain the Design History Files (DHF), Design Master Records (DMR); track implementation of internal and external audits observations for on time closure. Works closely with Operations, Manufacturing Engineering and Research & Development to ensure manufacturing of effective and high-level product quality, while ensuring implementation of efficient corrective and preventive action plans. Works with other business units' quality functions to identify areas where compliance input and escalation is required to ensure consistency in the application of criteria across Anika. Specific Responsibilities: * Review and approve CAPAs, Change Controls. Manage Internal and External Audit programs and maintain associated tracking logs. Has capability to manage these programs within the Electronic Quality Management system upon implementation. * Evaluates and improve the above programs to ensure compliance with regulatory requirements. * Performs internal audits as assigned and track implementation of audits observations for on time closure. * Leads investigations, performs root cause analysis, prepares detailed investigation reports and implements corrective actions as needed. * Performs QA review of new and revised procedures, technical protocols, validations and reports as assigned. * Participates as assigned in the development of customer requirements and design inputs; works with team to ensure that customer requirements (user needs) can be validated and design requirements can be verified * Facilitates the Risk Management Process in accordance with the latest version of ISO 14971; ensures integration of risk management outputs with design, process and regulatory requirements * Designs and maintains procedures and systems for process and quality data collection * Conducts and/or supports process capability evaluations and determines critical process control points and appropriate control limits. * Support equipment and process validation methods to ensure they are properly validated prior to implementation and critical equipment is periodically re-validated * Conducts gap analyses of in-house practices versus relevant regulations, standards and industry practices; develops plans and implements corrective actions to ensure continued compliance. * Act as the SME trainer of other QA personnel. * Performs other related duties as assigned Job Complexity: Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting method and techniques for obtaining solutions. Requires thorough knowledge of FDA, ISO, and other regulatory guidelines related to the manufacturing of medical devices. Supervisor Responsibilities: No direct reports. Has responsibility to oversee diverse teams in the implementation of projects. Experience, Knowledge and Skills Required: * Bachelor's Degree in engineering or equivalent experience * Prior experience with review and approval of process change controls, CAPAs, Internal/External Audits. * Strong knowledge of statistical process control methods and techniques. * Working knowledge and demonstrated application of ISO 14971 Risk Management for Medical Devices * Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices. * Knowledge of the FDA 21CFR, EU, TGA (Australia), ANVISA (Brazil) * Working knowledge of cGMPs, QSRs, MDDs, MDR * Familiarity with the principles of Design Control * Working knowledge of Electronic Quality Management System. * Working knowledge of Six Sigma a plus * Strong writing and presentation skills The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

Summary of Primary Responsibilities: This position is responsible for leading the Facilities department in accordance with current Good Manufacturing Practices (cGMP), ISO requirements, and industry best practices. Reporting to the Director of Engineering, this position provides the results-oriented leadership and creativity required to build a world-class organization and establish robust and efficient systems. The Facilities group is responsible for the Maintenance and Calibration of all physical assets including process equipment, utilities, and site infrastructure as well as managing Capital Projects. As the company's head of Facilities, the incumbent will manage a multi-million-dollar budget and engage in proactive relationships with local, state, and federal authorities. Responsibilities: Provide daily leadership and direction to Facilities team ensuring highest levels of equipment and utility uptime and maintenance of company infrastructure. Develop, maintain, and continuously improve the preventative maintenance and calibration management programs in compliance with regulatory requirements and industry best practices. Identify and negotiate with outside contractors to perform specialized repairs and maintenance, maintaining strong relationships with all essential vendors. Develop, implement and monitor budgets; report potential budget issues and take corrective action to stay within budgets. Design and plan facility upgrades; acts as Project Lead and coordinates all parties to meet construction deadlines and budgetary requirements. Develop and maintain relationship with building landlord; resolve issues and concerns between the parties. Demonstrate excellence in care for not only cGMP aspects of the site, but also ensuring that snow removal, landscaping, salting, office appearance, and general facilities are both presentable and maintained to provide a safe working environment. Develop and maintain solid working relationships with federal, state and local authorities; represents and advocates Anika's positions with these agencies. In collaboration with Engineering, support the Facilities team with technical and engineering expertise and solutions to provide a high level of service to Production. Ensure timely completion of assigned CAPAs, Safety CAPAs, NCs, PDs, Change Controls, etc. and any other quality or exception management workflows. Provide strategy and leadership with regard to CMMS System (BMRAM) administration, including New Assets, PMs, CALs, GWRs, spare parts control, etc. Perform other work-related duties as assigned. Job Complexity: The position manages a high level of complexity and focuses on issues of both tactical and strategic significance. Manages, develops and advises subordinates. Develops and administers budgets, schedules and performance requirements. Frequent interactions with external officials, external vendors, internal project teams and departments. Supervisory Responsibilities: Supervise internal professionals within the facilities department, including employees within the maintenance and trades. Responsible for supervision of contractors on site. Experience, Knowledge, and Skills Required: Bachelor's degree in engineering or life sciences or equivalent experience 5+ years of experience in pharmaceuticals or medical devices 3+ years in management / supervisor / leadership positions with direct personnel supervision is required for this role. Minimum of 5 years of cGMP facility design, construction, and/or maintenance and a track record of managing successful capital improvement projects. Strong leader and manager of teams with the ability to create high performance teams and develop employees to their full potential in a fast-paced environment. Excellent analytical and problem-solving skills coupled with strong presentation skills. Excellent communication skills, both verbal and written. High degree of integrity and professionalism with the ability to reach out and establish relationships across a global organization. The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

Summary of Primary Responsibilities: Responsible for all microbiological and some analytical testing of production materials under GMP conditions. Responsible for process and equipment validation (autoclave and depyrognenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation.) Specific Responsibilities: Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples Perform company's purified water and DI water bioburden, endotoxin and TOC testing as per USP requirements Complete all required documentation according to SOP Verify work of technicians and assist in training Review environmental condition of classified areas, maintain database for environmental results of clean room environment and summarize data for annual environmental report Provide training on environmental compliance issues Development and validation of new or improved microbiological methods Writing and/or approving validation protocols, coordinating and/or performing validation and writing and/or approving validation reports Establishing databases for microbiological and validation data Performs Internal Audits as scheduled Other duties and projects as assigned Job Complexity: Works on complex problems requiring in-depth analysis and evaluations of factors, and on assignments that are required to be performed according to defined procedures and practices. Exercises considerable judgment and initiative within broadly defined practices and policies in selecting methods and techniques. Normally receives no instruction on routine work, general instructions on new assignments. Supervisory Responsibilities: None. Experience, Knowledge, and Skills: Requires BS in microbiology, biology or related science or equivalent experience. 1+ years experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), bacteriostasis and growth promotion assay Experience with GMP, GLP, and FDA regulations and ISO requirements Experience in environmental monitoring of clean room, aseptic media fill evaluation Excellent verbal and written communication skills Proven ability to meet deadlines for testing and reporting Proficient in the use of Microsoft Office Suite including PowerPoint

The Procurement Leader plays a key role in the Global Supply Chain team. The Scope of responsibility spans all materials both direct and indirect, services, and any other support needed across all Anika sites. This role requires the ability to multitask and delegate as necessary. It is responsible for summarizing NPI make v buy recommendations in collaboration with the cross functional teams. Ensure new raw material (material masters) and outside service purchases are setup with appropriate raw material lead times, safety stocks, standard costs as well as replenishment parameters and are planning proper demand in MRP. Key Responsibilities: Manage procurement of raw materials, finished goods, as well as outside service providers in alignment with the Demand, Supply, and Manufacturing site needs and lead-times. Accountable and responsible for the management of direct and indirect spend categories for Anika franchises. Work collaboratively with the cross functional teams to minimize cost and maximize customer service. Train, develop and lead their team. Establishes procurement KPI's for both direct and indirect spend categories and tracks monthly performance to goal. Optimize procurement practices to minimize backorders and service interruptions, while ensuring E&O is not increased Work with R&D, Engineering, Manufacturing and Legal on all NPI as POC for Supply Agreements Identifies preferred suppliers for both direct and indirect spend categories. Working with R&D, Quality and Regulatory defines sourcing strategy matrix for core spend categories. Facilitate alternate, redundant suppliers for critical materials as defined and agree to by Ops leadership teams. Execute other BCP activities when redundant supply is not available. Monitor Global Social, Economic and Political climates to proactively mitigate additional risk to supply. Develop/Update Supplier Code of Conduct with inclusion of ESG concepts as strategies evolve. Identify proactive opportunities for improvement within area of control as well as supporting processes. Implements lean inventory management principles where applicable. Function as additional support to Contract Manufactures for risk mitigation, problem solving, future business opportunities. Lead the establishment of the supplier Quarterly Business Review process (QBR's) with key suppliers to review key metrics including On Time Delivery, Quality , Cost and Service levels. Supervisory Responsibilities: This role will have leadership responsibility across multiple sites and regions as determined by the Operations Leadership team. Required Qualifications: Bachelor's Degree in or equivalent level of relevant experience 7+ years Supply Chain, Planning and Procurement experience. Proven success managing teams both onsite and remote, international purchasing experience preferred. Team leadership experience. Global Supply Chain experience. SAP experience required. Desired Experience, Knowledge, and Skills: Ability to coach, direct, and oversee associates both onsite and in a remote environment. Knowledgeable of best practices in Procurement and Supply Agreement management Excellent communication and follow up skills to manage expectations and resolve conflicts with stakeholders. Strong numerical problem-solving skills. Ability to boil down vast amount of data to the relevant points. Ability to collaborate with cross functional teams on an international basis. Proficiency with Excel and PowerPoint a must. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to manage complex projects with many inputs and variables. The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Engineer: Mathematical Modeling and Simulation Cambridge, MA What you will do Let's do this. Let's change the world. Amgen's Combination Product Operations Digital and Data Strategies group is a process development team that develops and deploys innovative advanced simulation technologies towards improved process understanding, robustness and monitoring, and prediction and optimization of the manufacturing of combination products. In this vital role you will support the team by incorporating physics and empirical techniques to develop rigorous finite element models (FEM) and numerical models of drug delivery devices (in-silico modeling assets) and improving the way Amgen manages and uses in-silico models to enhance decision making within the organization. The candidate will apply engineering principles to develop efficient and trustworthy models addressing a wide variety of challenging problems associated with advanced material modelling, device design, characterization, verification, validation, manufacturing and tolerance analysis. The ideal candidate enjoys tackling challenges and excels at developing functional in-silico models of combination products that enable insights for root cause investigation and design robustness supporting lifecycle management activities and complaint reduction. Responsibilities: * Implementing explicit and implicit FEM structural models. Ensuring that the approach and simplifications used to build these models is efficiently representing the physical system. * Applying engineering principles like kinematic, structural, and tolerance analysis combined with material characterization and testing to create in-silico models able to capture the behavior of the device during use, assembly and transport. * Continuous improvement of in-silico models, managing the lifecycle of the model and improving methods and workstreams to guarantee efficiency and trustworthiness of the models. * Demonstrating critical and analytical thinking skills to explore new opportunities in in-silico and data-driven computational models. Modeling real-world scenarios with the adequate level of detail and help inform the decision making in a reduced time frame. * Simulate complaints and real-world issues within lifecycle of combination products. Being able to apply an analytical approach to create models that accurately represent the real world scenarios and helps identify the root cause analysis of any complaint. * Providing positive leadership and delivering work in a fast-paced, multi-project, cross-functional environment. Delivering predictions and insight on time to solve challenging production and customer problems.. * Model ownership, responsible for developing and managing backlog of in-silico product projects. Being able to concisely communicate on the modelling scope, limitations and assumptions to stakeholders with a technical and not technical background. Mentor also other simulation experts in the best use of simulation technologies. It is expected that the Senior Engineer - Modeling and Simulation will not only lead and collaborate heavily with internal team members, but also document and communicate the underlying technical basis of the models for the benefit of and use by the broader engineering and scientific community responsible for design and manufacture of drug delivery devices. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications. Basic Qualifications: Doctorate degree OR Master's degree and 2 years of Engineering experience OR Bachelor's degree and 4 years of Engineering experience OR Associate's degree and 8 years of Engineering experience Or High school diploma / GED and 10 years of Engineering experience Preferred Qualifications: * Finite element model experience with a commercial platform like SIMULIA, ANSYS, ALTAIR or COMSOL. * Experience in explicit FEM modelling and non-linear structural models; contact modelling, large deformations, plasticity, and hyperelasticity. * Knowledge of statistic and robustness analysis principles, being able to create models capturing the inherent variability in the process and device dimensions. * Skilled in programming in Python, and/or MATLAB for engineering purposes. Scripting using commercial software codes like abaqus user subroutines, Tcl/Tk to automate model creation and post/processing. * Experience with combination products and device regulatory requirements, medical device development and design controls, and knowledge of process controls. * Excellent communication, presentation, and technical documentation skills are highly desired. * Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise. * Ability to manage multiple competing priorities simultaneously and work in highly collaborative, cross-functional environments. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans * Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline External/Internal postings: Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 123,098.00 USD - 149,145.00 USD

Career CategoryScientificJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Senior Scientist - Attribute Sciences What you will do Let's do this! Let's change the world! This is an exciting opportunity to join the Amgen Biologics Pivotal Attribute Sciences team based in Cambridge, Massachusetts. In this role you will: Lead late-stage protein structural elucidation and forced degradation studies using LC/MS workflows including reduced peptide mapping, disulfide mapping, and intact mass analysis; effectively communicate results to support regulatory filings. Maintain, troubleshoot, and optimize high-resolution mass spectrometry methods; partner with instrument vendors and application specialists as needed to ensure reliable performance, consistent data quality, and high instrument uptime. Develop, optimize, and qualify LC/MS and complementary LC-UV protein characterization methods to identify and monitor critical quality attributes; coordinate with program leads to identify and implement control strategies. Lead training, qualification, and method transfer from our process development labs to our global quality network. Interpret analytical results, author and review technical protocols/reports, and contribute to analytical CMC sections in regulatory filing documents including IND and BLAs. Design automation-ready MS workflows including sample preparation, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency. Build robust, inspection-ready LC/MS data analysis and reporting workflows (templates, QC checks, method trending) and ensure traceability and data integrity for CMC deliverables. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Bachelor's degree and 5 years of Scientific experience OR Master's degree and 3 years of Scientific experience OR Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] Preferred Qualifications: Strong written and verbal communication skills, ability to support data-driven decision making with diverse internal and external stakeholders. 5+ years of experience in industrial analytical laboratories supporting characterization of protein therapeutics, including partnering with QC and/or CMOs on method execution. Deep LC/MS expertise in bottom‑up peptide mapping (including disulfide mapping) and intact mass analysis for biologics, with strong fundamentals in sample preparation, artifact control, and MS/MS data interpretation. Hands-on experience with Thermo Orbitrap platforms (e.g., Q-Exactive, Exploris, Tribrids), including routine maintenance, calibration, and independent troubleshooting of common failure modes (sensitivity loss, spray instability, mass accuracy drift, carryover/contamination). Experience with Chromeleon and Biopharma Finder is a plus. Strong RP‑UHPLC expertise (reversed‑phase method development and troubleshooting) to support peptide mapping/intact workflows (gradient optimization, column selection, carryover mitigation, pressure/peak‑shape troubleshooting). Hands-on experience with laboratory automation including liquid handlers, pipetting robots, and automation software. Familiarity with United States Pharmacopeia (USP), International Conference on Harmonization (ICH), and Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation. Experience in authoring and reviewing regulatory submissions, especially module 3 (Quality) common technical documents for IND/BLA submissions. What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 136,692.00 USD - 164,965.00 USD

Career CategorySales & Marketing OperationsJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Dermatology Thought Leader Liaison Sr. Manager, Northeast Live What you will do Let's do this. Let's change the world! This critical role will focus on maintaining and building relationships with external Opinion Leaders and large medical centers in Dermatology. The Northeast Thought Leader Liaison (TLL) Sr. Manager will report into the Director of Professional Relations with a dotted line to the East Regional Sales Director. They will join the National team of Dermatology Thought Leader Liaisons in the inflammation Business Unit. The TLL will be a critical member of the Otezla Brand Marketing Team and will coordinate closely with the Otezla field sales team. The TLL will be responsible for the following, but not limited to: OL Development and Management Identify, cultivate, and maintain professional relationships with established and up-and-coming regional Opinion Leaders in Dermatology Work cross functionally to drive and develop aligned external engagement strategies across multiple cross functional teams including medical, training, marketing, and sales Manage OL Speaker bureau relationships including supporting speaker training, compliance, and product theater speaker management Manage regional speaker bureau, including providing speaker recommendations Identify and manage relationships with key national Dermatology Accounts and Psoriasis Centers Conference Management Attend and manage brand activity at key regional and national Dermatology conferences, including managing product theaters, and other ancillary brand activities Manage overall regional sponsorship budget, including working with organizations to secure sponsorships, and owning regional congress plan Coordinate executive meetings with OLs at national conferences Complete all necessary conference and speaker contract requirements in a timely manner Coordinate with marketing to ensure all congress materials are delivered on time Coordinate with sales and marketing Coordinate closely with the sales team to ensure alignment with conference OL engagement plan as well as other OL/account engagement Provide customer and market insights back to the marketing team and provide input into P2P development, advisory boards, and strategy Partner with the HCP Marketing team to develop advisory board strategy, content, advisory recommendations, and attend advisory boards as appropriate Provide insights summary from key congresses to the marketing team Additional Information: Significant business travel, by air or car, is regularly required (Greater than 50%) Willingness to work evenings and select weekends is required Located near a hub airport is recommended Role covers the Northeast United States; NY, MD, MA, WV, OH, MI, CT, PA, ME, RI Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The marketing professional we seek is a collaborative partner with these qualifications. Basic Qualifications: Doctorate degree and 2 years of marketing or sales experience Or Master's degree and 4 years of marketing or sales experience Or Bachelor's degree and 6 years of marketing or sales experience Or Associates degree and 10 years of marketing or sales experience Or High school diploma / GED and 12 years of marketing or sales experience Preferred Qualifications: 5+ years of experience working in Dermatology in sales or marketing roles Prior experience in thought leader engagement, regional marketing, sales, or sales leadership Strong relationship building skills, with proven ability to build and maintain lasting relationships with OLs Ability to exercise strong decision-making skills and live up to the highest ethical standards. Excellent written and verbal communication skills Ability to build productive partnerships and collaborate effectively in a matrix organization. Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com. Salary Range 188,046.00 USD - 219,737.00 USD

Salary Range:$150,000.00 To $180,000.00 Annually The Senior Process Engineer leads diverse process improvement initiatives and process development projects for medical devices and drug products. Acting as a technical lead on multi-disciplinary teams, this role designs, purchases, validates, and implements equipment and systems that support cGMP-compliant manufacturing. The engineer applies strong analytical skills to solve complex problems, optimize processes, and ensure timely, effective decisions that align with corporate goals. Key Responsibilities Process Development & Improvement * Lead the design and specification of equipment and systems in alignment with cGMP and other relevant standards. * Identify opportunities for cost reduction and process efficiency improvements through standardization and automation. * Develop and manage projects consistent with department and corporate objectives. * Collaborate with suppliers to evaluate, select, and validate cost-effective raw materials that meet industry standards. * Use methodologies such as Six Sigma and Lean to implement process improvements. Commissioning, Validation & Compliance * Collaborate with validation teams to ensure equipment and processes meet commissioning and qualification requirements. * Develop and maintain: User Requirement Specifications (URS), and Functional Design Specifications (FDS). * Support FAT/SAT activities and documentation for process equipment and systems. * Test equipment and materials; develop and validate processes to support regulatory approval and new product introduction. * Support the development of equipment qualification (IOQ, PQ) and process validation (PV) protocols. * Perform process/product risk assessments and prepare reports according to company procedures. Documentation & Compliance * Draft operating procedures for new equipment and processes; work with Document Control to finalize and implement through the document mastering process. * Develop and edit material master part specifications and artwork specifications to meet requirements. * Lead the initiation, investigation, implementation and closure of NCRs and CAPA relating to processes and process equipment. Cross-Functional Collaboration * Interact with multiple internal departments and external vendors to coordinate multidisciplinary tasks. * Lead and participate in project teams, ensuring alignment with regulatory and operational requirements utilizing project management tools such as MS Project. * Develop strong partnerships with validation, facilities, manufacturing, R&D, QA, RA, IT enabling efficient and high value deliverables from all company functions. Safety and Technical Support * Promote safety awareness and ensure proper use of protective equipment in all engineering activities and ensure compliance with EHS standards. * Provide technical support to metrology and calibration teams to deploy assets with effective process ranges and calibration job plans. * Support manufacturing and facilities with equipment troubleshooting, at times off-hours, to reduce maintenance time and increase process reliability. Qualifications & Experience Education: Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related field. Experience: * 5-8 years in a cGMP-regulated environment. * Experience with medical device manufacturing and packaging equipment/processes. * Demonstrated expertise in material, equipment, and process validation per medical device and pharmaceutical industry standards. Desired Skills: * Master's degree in Chemical or Mechanical Engineering or related field. * Excellent equipment and process troubleshooting skills. * Strong communication skills (written and verbal), including ability to present to large groups and management. * Familiarity with FDA, ISO 13485, and EU MDR compliance for medical devices. * Proficiency with statistical analysis software and techniques. * Experience with processes such as formulation and filling for viscous solutions, aseptic manufacturing, or fiber extrusion and carding * Experience with terminal sterilization (steam, gamma, VHP and EtO). * Ability to manage time effectively, prioritize workload, and deliver results autonomously. * Strong personal values: honesty, integrity, people development, and drive for results. * Experience with automation platforms such as Rockwell Automation, Ignition, Siemens, Wonderware and Modicon. * Experience supporting scale-up and tech transfer from R&D to manufacturing. * Familiarity with ERP and MES systems. The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. Submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.