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Operation Supervisor jobs at CSL Plasma - 439 jobs

  • Workforce & Capacity Optimization Lead

    Biolife Plasma Services 4.0company rating

    Waukegan, IL jobs

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About BioLife Plasma Services BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Limited, is an industry leader in the collection of high-quality plasma, which is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can't be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 250+ state-of-the-art plasma donation centers across the United States. Our employees are dedicated to enhancing the quality of life for patients and ensuring that the donation process is safe, straightforward, and rewarding for donors who wish to make a positive impact. When you work at BioLife, you'll feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. This position is currently classified as “hybrid” in accordance with Takeda's Hybrid and Remote Work policy. OBJECTIVES/PURPOSE Serve as a recognized expert in workforce optimization with deep expertise in scheduling and capacity planning and broad knowledge of related disciplines across US BioLife operations. Anticipate internal and external business challenges and regulatory considerations; recommend innovative process, technology, and policy improvements to enhance operational efficiency. Provide leadership and consultative guidance across BioLife regions, influencing workforce planning strategies and organizational priorities. Drive BioLife initiatives that optimizes resource utilization, improve scalability, and strengthen governance frameworks. ACCOUNTABILITIES Develop and execute enterprise-level workforce optimization strategies for BioLife, influencing broader Takeda business units and functions. Design and implement governance models, policies, and data-driven methodologies that ensure consistency, compliance, and operational flexibility across BioLife operations. Serve as a trusted advisor to senior leadership and cross-functional teams on workforce planning, capacity management, and emerging business or regulatory challenges. Lead BioLife projects and cross-functional teams to deliver scalable workforce solutions, including automation and process improvements. Own workforce data governance, ensuring data integrity, accessibility, and clear standards for reporting, analytics, and decision support. Analyze complex workforce and capacity datasets to identify trends, gaps, and optimization opportunities across BioLife operations. Develop predictive models and scenario analyses to forecast workforce needs, capacity constraints, and financial impacts using advanced analytics tools (e.g., Power BI, SQL, Python). Translate analytical findings into actionable strategies and initiatives that improve resource utilization, workforce flexibility, and operational scalability. Design and maintain dashboards, reporting frameworks, and KPIs to provide real-time visibility and monitor performance of workforce planning processes. Oversee direct labor budgeting and forecasting strategies, ensuring alignment with financial objectives, operational goals, and regulatory requirements. DIMENSIONS AND ASPECTS Technical/ Functional (Line) Expertise Recognized as an expert in workforce management and capacity planning with broad knowledge of related disciplines (HR, Finance, Operations, DD&T). Skilled in designing scalable frameworks and governance models for complex, matrixed environments. Decision-making and Autonomy Operates with autonomy; makes decisions impacting multiple functions and regions. Provides guidance in complex or unprecedented situations. Leadership Provide guidance and training across US BioLife Plasma Centers to advance workforce systems and capacity solutions. Leads cross-function teams and serves as a best-practice resource for workforce optimization. Influences senior leadership and drives adoption of innovative strategies. Interaction Partner closely with HR, Operations, Finance, DD&T, FPA, and BioLife leadership to ensure the alignment of shared workforce processes. Develop workforce planning strategies aligned with organizational goals and ensures effective stakeholder communication. Innovation Champions automation and advanced analytics to enhance workforce flexibility and efficiency. Implements innovative solutions to address organizational challenges and improve scalability. Complexity Operate in a matrixed environment, addressing diverse resource needs across BioLife centers and collaborating across functions. Manage cultural and logistical complexities inherent in workforce systems implementation within dynamic healthcare-focused settings. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS : Education Required: Bachelor's degree in business, Operations Management, Human Resources, or a related field. Preferred: Advanced degree (e.g., MBA or master's in business, Information Systems, or related field). Skills Expertise in workforce management frameworks, governance, and scalable scheduling strategies. Advanced proficiency in data engineering, report/dashboard creation, reporting administration. Power BI, Databricks, Python, SQL, Excel, etc. Advanced analytical and reporting skills for effective workforce planning and decision-making. Behavioral Competencies: Innovator with strong problem-solving skills and ability to drive adoption of new methodologies. Collaborator fostering alignment across departments and shared objectives. Strategic thinker with a systematic approach to addressing workforce planning challenges with ability to anticipate challenges and influence organizational direction. Adaptable leader capable of managing change and encouraging smooth adoption of new methodologies. High-impact communicator and collaborator across functions and regions. Innovator with strategic problem-solving skills to address workforce challenges effectively. Clear communicator who fosters cross-departmental alignment and productive partnerships. ADDITIONAL INFORMATION Travel required: 10% BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Bannockburn, IL U.S. Base Salary Range: $153,600.00 - $241,340.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBannockburn, ILWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes By applying, you consent to your information being transmitted by College Recruiter to the Employer, as data controller, through the Employer's data processor SonicJobs. See Biolife Plasma Services Terms & Conditions at us/legal/terms-and-conditions-of-use and Privacy Policy at legal/privacy-notice and SonicJobs Privacy Policy at us/privacy-policy and Terms of Use at us/terms-conditions
    $65k-120k yearly est. 1d ago
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  • Oncology L&D Lead for PV - Hybrid

    Takeda 4.7company rating

    Boston, MA jobs

    A leading pharmaceutical company in Boston is seeking an experienced Associate Director to lead training initiatives within the Oncology team. The role involves developing comprehensive training programs and collaborating with sales leaders to enhance team capabilities. Candidates should have a strong background in pharmaceutical sales, preferably in oncology, along with leadership and project management skills. This position offers a competitive salary and a hybrid work environment. #J-18808-Ljbffr
    $112k-207k yearly est. 16h ago
  • Country Operations Lead, Clinical Trials

    Astrazeneca 4.6company rating

    Boston, MA jobs

    A leading biopharmaceutical company in Boston seeks an Associate Director for Country Operations Management. The role requires a minimum of 8 years of experience in Development Operations, with strong leadership skills to drive team growth. Responsibilities include managing operational trial activities and ensuring compliance with local policies. The company offers a hybrid working model and comprehensive benefits, aiming to innovate in rare diseases and elevate patient care. #J-18808-Ljbffr
    $114k-149k yearly est. 2d ago
  • Strategic Operations Lead, US Market Access

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA jobs

    A global biotech company is seeking an Associate Director for Strategy and Operations in Boston. This role supports the US Market Access Leadership Team, driving strategic initiatives and operational execution. The ideal candidate will have over 8 years of experience, strong communication and collaboration skills, and a Bachelor's degree. The position offers a hybrid or on-site work model and competitive compensation ranging from $155,700 to $233,600 annually, with additional benefits such as educational support and paid time off. #J-18808-Ljbffr
    $155.7k-233.6k yearly 2d ago
  • Global Regulatory Strategy Lead - FDA Submissions

    Takeda 4.7company rating

    Boston, MA jobs

    A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience in regulatory affairs and offers opportunities for strategic leadership across multiple projects. Located in Boston, MA, the position is hybrid and provides a competitive salary range of $153,600 to $241,340. Ideal candidates will demonstrate strong communication skills and a solid understanding of drug development processes. #J-18808-Ljbffr
    $153.6k-241.3k yearly 16h ago
  • Strategic External Scientific Partnerships Lead

    Astrazeneca 4.6company rating

    Boston, MA jobs

    A leading biopharmaceutical company in Boston seeks an Associate Director for External Scientific Partnerships. This position drives strategic engagement with health professionals and organizations in the rare disease sector. Candidates should have a PhD or equivalent, alongside 3-5 years of relevant experience, strong leadership, negotiation, and project management skills. The role offers competitive pay, benefits, and a commitment to an inclusive workplace. #J-18808-Ljbffr
    $142k-233k yearly est. 1d ago
  • External Scientific Partnerships Lead - Rare Diseases (Equity Eligible)

    Astrazeneca GmbH 4.6company rating

    Boston, MA jobs

    A leading pharmaceutical company is seeking an Associate Director for External Scientific Partnerships to develop strategic initiatives with health professional societies. The ideal candidate should hold a PhD, PharmD, or equivalent and have 3-5 years of experience in the pharmaceutical field, particularly in rare disease. This role entails fostering key partnerships and engaging with thought leaders to advance medical strategies. Competitive compensation and benefits are offered, including an annual salary ranging from $150,202 to $225,304. #J-18808-Ljbffr
    $150.2k-225.3k yearly 1d ago
  • US Patient & Market Access Strategy Leader

    Takeda 4.7company rating

    Boston, MA jobs

    A global pharmaceutical company is seeking a Senior Vice President of Patient and Market Access to optimize access to innovative therapies. The role involves leading strategies for reimbursement, directing a team to achieve performance goals, and engaging with healthcare stakeholders. The ideal candidate brings 20+ years in the pharmaceutical industry, including extensive experience in Market Access and a deep understanding of the US healthcare system. A commitment to fostering an inclusive team environment is essential. #J-18808-Ljbffr
    $112k-207k yearly est. 4d ago
  • Strategic Partnerships Lead - Molecule Discovery & Licensing

    Eli Lilly and Company 4.6company rating

    San Francisco, CA jobs

    A global healthcare leader in San Francisco is seeking an Associate Director for their External Partnering team. This role focuses on driving molecule discovery and technology licensing, enhancing portfolio growth through new business opportunities. Candidates should possess deep knowledge in drug discovery, a minimum of 7 years experience in client services or sales within pharmaceutical environments, and strong relationship-building skills. Competitive salary range of $132,000 - $193,600 offered, alongside comprehensive benefits. #J-18808-Ljbffr
    $132k-193.6k yearly 3d ago
  • Strategic Leader, Targeted Drug Delivery & Receptor Biology

    Vertex Pharmaceuticals 4.6company rating

    San Diego, CA jobs

    A global biotechnology company is seeking a Principal Research Scientist in San Diego to focus on targeted drug delivery, particularly nucleic acid therapies. The ideal candidate will have expertise in receptor biology, collaborate with cross-functional teams, and contribute to innovative therapeutic programs. A Ph.D. or equivalent in biology or a related field is required, along with relevant experience of 4-10 years depending on the educational background. #J-18808-Ljbffr
    $114k-163k yearly est. 2d ago
  • Thought Leader Liaison, South Central

    EPM Scientific 3.9company rating

    Dallas, TX jobs

    Title: Associate Director, Thought Leader Liaison (Hematology) A small biotech company is seeking an experienced and strategic professional to join their hematology marketing team. The TLL will serve as a key field-based marketing leader, responsible for engaging Key Opinion Leaders and advocacy groups to support the growth of their innovative product portfolio. This role will also collaborate closely with field sales and internal stakeholders to gather market insights, build advocacy, and ensure alignment of marketing strategies with regional needs. Key Responsibilities: Identify, profile, and maintain long-term relationships with KOLs in assigned region Build advocacy for brands through on-label discussions and disease state education Identify and develop potential speakers for educational programs Drive pull-through of marketing strategy within field sales teams Coordinate activities with Sales, Marketing, and Market Access teams Support training initiatives during POAs and field rides Qualifications: 7+ years of pharmaceutical/biotech experience + minimum 3 years in oncology or hematology Prior experience in a TLL role or extensive KOL relationships with academic oncologists Strong leadership and cross-functional collaboration skills Ability to travel extensively (70%) Bachelor's degree in science or business-related discipline EPM Scientific is the only search firm dedicated to offering bench to bedside recruitment services with niche experts across every vertical of the development, approval, and launch cycle. Please note: Applicants who do not meet the above requirements will not be considered for this role.
    $53k-117k yearly est. 1d ago
  • Operations Supervisor

    GN Group 3.9company rating

    Shakopee, MN jobs

    The Operations Supervisor oversees and manages the day-to-day activities within the assigned Division Operations area. This role sets clear expectations, provides daily feedback to team members, and is responsible for maintaining and improving overall quality and KPIs through continuous improvement. Essential Functions (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) Support critical leadership functions for team including hiring, coaching, performance management, annual review, merit and engagement survey processes required to build a strong productive team Oversee, plan, and organize the department including responsibility for safety, organization, quality, compliance, turnaround time, efficiency, cost, and employee motivation daily Maintain accurate labor reporting of all hours within their area Work with divisional leadership to set area objectives including identifying the milestones, and executing the plan to include upward feedback Responsible for bank metrics in the area and department (Quality, SLA, Efficiency) and department or sub-department KPI's and daily communication of goals and priorities Manage business issues and complaints in your area for root cause and improvement Oversee team training, including cross training, and new employees Meet with each employee within area monthly to review performance, what's working, and what's not working Develop and mentor team technicians daily Identify and mentor future bench opportunities Support positive collaboration across teams, managing any necessary conflict proactively Initiate and support continuous improvement efforts to achieve business strategy and goals relative to profitability, cost control, and increased efficiency Prepare and participate in ISO, FDA, Internal Audits, and tours as required Utilize Entrepreneurial Operating System “EOS” tools to create and improve work process and workforce Write and deliver annual performance reviews with Leadership support and guidance Other duties as assigned Competencies (Knowledge and Skills needed for this position.) Work in a team environment Support the on-boarding/training of new team members Focuses on getting better every day Produce high quality work Willing to help other areas as needed Extensive knowledge of product line Lean Fundamentals & 5S Demonstrated knowledge and proficiency in the principles, procedures, and best practices related to manufacturing & fulfillment operations. Effective oral and written communication skills and group presentation skills. Ability to adapt to/work with a diverse workforce. Ability to work independently and as part of a team. Software proficiency including Excel, Word, and PowerPoint. Ability to identify opportunities for process improvements. Demonstrated organizational and administrative skills. Attention to detail, ability to prioritize and handle multiple tasks and projects concurrently. Ability to Lead, Manage, and hold team members accountable Desired Qualifications Required Education: High School Diploma/GED Preferred Education: Bachelor's degree Preferred Experience: 2+ Years of leadership experience 3 years of Order Management, Technical Support, Warehousing or Manufacturing experience. Experience working in a regulated environment (ISO 13485:2016, ISO 9001, FDA QSR) Leadership experience across multi-functional teams Experience with Lean tools & EOS Proficient in Microsoft Office Travel: Travel would be limited and then mainly local, if necessary, for learning opportunities. Direct reports: Hourly employees Indirect reports: n/a Job Location: Shakopee, Minnesota Working Environment: The position will be working in the Operations division - including warehouse and manufacturing areas. Physical Demands: Able to stand or sit for long periods of time. Able to lift 25 pounds by self and 50+ pounds with a team lift. (i.e. Sitting, standing, lifting, bending, reaching, etc.) Position Type and Expected Hours of Work: Day shift with possible weekends as needed. About Us GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts. What We Offer We value our employees and offer competitive wages and benefits including: - Generous Benefits including PTO and Paid Holidays - 401k with Company match - Paid Parental Leave & Transition Back to Work Benefits - Company HSA Contributions - Discounted GN Group products We encourage you to apply Even if you don't match all the above-mentioned skills, we will gladly receive your application if you think you have transferrable skills. We highly value a mindset, motivation, and energy, that aligns with our core values, to not only ensure growth for you, but for your team and the wider GN organization as well. We are committed to an inclusive recruitment process GN welcomes applicants from all backgrounds and applicants will receive equal consideration for employment. We make life sound better by developing intelligent sound solutions that transform lives through the power of sound, enabling you to hear more, do more & be more than you ever thought possible. Our integrated headset and communications solutions assist professionals in all types of businesses in being more productive. Our wireless headsets are designed to fit any lifestyle - from sports enthusiasts to commuters and office workers. GN operates in more than 90 countries across the world. Founded in 1869, GN has more than 7,000 employees today. Pay Transparency Notice: Depending on your work location, the target annual salary for this position can range from $79,000 to $85,000/yr. In addition, you may be eligible for a discretionary bonus. Compensation for roles at GN depend on a wide array of factors including but not limited to location, role, skill set, and level of experience. To remain competitive, GN offers a competitive benefits package, including annual bonuses, health insurance, a 401(k) plan, paid time off and paid holidays. GN participates in E-Verify. View the E-Verify poster here. View the Right to Work poster here. Disability Accommodation If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ****************************************. This email is provided for the purpose of supporting applicants who have a disability that prevents them from being able to apply online. Only emails received for this purpose will be returned. Emails left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
    $79k-85k yearly Auto-Apply 7d ago
  • Transformation Leader - External Manufacturing - Biologics

    Sanofi Group 4.3company rating

    Cambridge, MA jobs

    **Job Title:** Transformation Leader - External Manufacturing - Biologics **About the Job** Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. ****This is a hybrid role - 3 days a week onsite - required. **** **About Sanofi:** We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **Main Responsibilities:** **Support Transformation Delivery** + Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. + Localize change strategies to fit the GBU context, culture, and priorities. + Act as a key point of contact for all change-related activities in the GBU. **Drive Adoption & Engagement** + Ensure employees and managers understand the why, what, and how of transformation initiatives. + Develop and execute communication and training plans to maximize adoption. + Monitor adoption and embed new behaviors, processes, and tools into the GBU. **Stakeholder & Leadership Support** + Build strong relationships with GBU leaders to support them as change sponsors. + Provide coaching and guidance to managers and teams to reinforce change behaviors. + Act as a trusted advisor to GBU leadership on change readiness and risks. **Change Measurement & Reporting** + Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. + Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. + Capture lessons learned to continuously improve change implementation in the GBU. **About You** + Bachelor's degree in Business, Human Resources, Organizational Development, or related field. + 5+ years of experience in change management or organizational transformation. + Strong knowledge of CMO/CDMO manufacturing - Required. + Strong knowledge of change management frameworks + Demonstrated ability to work in complex, matrixed organizations. + Excellent communication, facilitation, and interpersonal skills. + Proven track record in supporting digital, operational, or organizational transformation programs. + Certification in Change Management or Project Management is a plus. **Key Competencies of a Transformation Leader** As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: **Vision & Strategy** + Strategic thinking: Ability to see the "big picture" and anticipate trends + Organizational alignment: Connect transformation to business objectives **Change Management** + Change management: Master methodologies + Resistance management: Identify and address barriers to change + Change communication: Adapt messages to different audiences **Operational Competencies** + Project/Program Management + Business acumen with ability to translate transformation into operational impact. + Problem-solving and analytical thinking. + Process optimization: Identify and implement improvements + Digital literacy: Understand emerging technologies (AI, automation, cloud) + Innovation: Promote experimentation and learning **Relational Competencies /Leadership & Influence** + **Cross-functional work: Orchestrate multi-functional teams** + Inspirational leadership: Mobilize and engage teams + Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. + Emotional intelligence: Understand and manage emotions during change change + Negotiation: Find compromises and create consensus **Soft Skills** + **Communication** : Strong communication and facilitation skills (Clarity, active listening, storytelling) + **Empathy** : Understand the human impact of change + **Resilience** and **adaptability** in dynamic environments. **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SG \#LI-GZ \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $147,000.00 - $212,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
    $147k-212.3k yearly 41d ago
  • Senior Manufacturing Lead - Temecula, CA

    Info. Services Inc. 4.2company rating

    Temecula, CA jobs

    Role: Senior Manufacturing Lead Duration: 6+ Months BGV will be done for the selected candidates. 1) Manufacturing experience in Medical Devices, especially disposable Cardio-Vascular products. 2) Six Sigma certified (Black Belt) 3) Experience in CTQs assessment and translating CTQ into manufacturing specifications 4) Experience in performing gap assessments between design outputs and manufacturing specifications 5) Design and develop manufacturing processes, tooling, and fixtures in order to meet production needs, while enhancing productivity and product quality 6) Process Validation - Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) 7) Experience in performing process characterization studies / Design of Experiments (DOE) to establish the process window / range for all the influencing process parameters 8) Experience in Test Method Validation (TMV) & Inspection Method Validation (IMV) 9) Utilization of tools like Gage R&R, Cp, Cpk, and Statistical Process Control (SPC) to improve manufacturing processes 10) Good experience in Lean manufacturing. Understanding of manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput. 11) Experience in Manufacturing process improvements / Manufacturing yield improvements to improve product quality 12) Good knowledge in Statistics & Minitab 13) Experience in Product Risk Management as per ISO14971 with good knowledge in executing PFMEA 14) Experience in handling CAPA (including field failure / root cause investigation), SCAR and NCMRs Six Sigma (Green belt), Medical Device, Manufacturing, Cardio-vascular, catheter, Process validation, Test Method validation, GD&T, Tolerance analysis, Jigs & Fixture design, Statistics, Minitab, Poka-Yoke, Process development, Process improvement, Value Stream mapping Mandatory Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks Poka-Yoke Expert - Process improvement Good - GD&T Good - Tolerance analysis Good - Test Method validation Good - Process validation Good - Cardio-vascular catheter manufacturing process Good Desired Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks Process development Good - Value Stream mapping Good - PFMEA Good - Please respond with your word resume and requested details: Full Name : Work Authorization: Contact Number : Email ID : Skype ID: Current location: Willing to relocate : Rate/hr : Additional Information All your information will be kept confidential according to EEO guidelines.
    $72k-111k yearly est. 2d ago
  • Supervisor Manufacturing

    Frontage Laboratories 3.9company rating

    Exton, PA jobs

    Manufacturing Manager Title: Manager, Manufacturing Operations Reports to : Vice President, PD & Manufacturing Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed. Roles & Responsibilities: Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing. Manage a team of manufacturing technologists, operators, and warehouse coordinators. Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution. Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required. Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs. Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM. Write, review and approve SOP's, qualification protocols, and other GMP documentation. Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients. Implements site initiatives in production operation as advised by site management. Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications. Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports. Responsible for compliance monitoring of area operations. Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues. Process and analyze manufacturing results, data and provide status updates to the management. Establish and maintain positive relationships with project stakeholders. Education, Experience & Skills Required: Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry. Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing. 5+ years of people management experience. Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations. Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable. Ability to perform frequent physical tasks with strength and mobility. Experience in microbiology and sterile manufacturing is a plus. Salary and Benefits : Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
    $60k-85k yearly est. Auto-Apply 5d ago
  • Transformation Leader - External Manufacturing - Biologics

    Sanofi 4.3company rating

    Framingham, MA jobs

    Job Title: Transformation Leader - External Manufacturing - Biologics About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a “local transformation enabler”: ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. **This is a hybrid role - 3 days a week onsite - required. ** About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Support Transformation Delivery Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. Localize change strategies to fit the GBU context, culture, and priorities. Act as a key point of contact for all change-related activities in the GBU. Drive Adoption & Engagement Ensure employees and managers understand the why, what, and how of transformation initiatives. Develop and execute communication and training plans to maximize adoption. Monitor adoption and embed new behaviors, processes, and tools into the GBU. Stakeholder & Leadership Support Build strong relationships with GBU leaders to support them as change sponsors. Provide coaching and guidance to managers and teams to reinforce change behaviors. Act as a trusted advisor to GBU leadership on change readiness and risks. Change Measurement & Reporting Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. Capture lessons learned to continuously improve change implementation in the GBU. About You Bachelor's degree in Business, Human Resources, Organizational Development, or related field. 5+ years of experience in change management or organizational transformation. Strong knowledge of CMO/CDMO manufacturing - Required. Strong knowledge of change management frameworks Demonstrated ability to work in complex, matrixed organizations. Excellent communication, facilitation, and interpersonal skills. Proven track record in supporting digital, operational, or organizational transformation programs. Certification in Change Management or Project Management is a plus. Key Competencies of a Transformation Leader As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: Vision & Strategy Strategic thinking: Ability to see the "big picture" and anticipate trends Organizational alignment: Connect transformation to business objectives Change Management Change management: Master methodologies Resistance management: Identify and address barriers to change Change communication: Adapt messages to different audiences Operational Competencies Project/Program Management Business acumen with ability to translate transformation into operational impact. Problem-solving and analytical thinking. Process optimization: Identify and implement improvements Digital literacy: Understand emerging technologies (AI, automation, cloud) Innovation: Promote experimentation and learning Relational Competencies /Leadership & Influence Cross-functional work: Orchestrate multi-functional teams Inspirational leadership: Mobilize and engage teams Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. Emotional intelligence: Understand and manage emotions during change change Negotiation: Find compromises and create consensus Soft Skills Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling) Empathy: Understand the human impact of change Resilience and adaptability in dynamic environments. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $147,000.00 - $212,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $147k-212.3k yearly Auto-Apply 32d ago
  • Manufacturing Supervisor

    Accupac 4.0company rating

    Lakewood, NJ jobs

    Job Description Job Title: Manufacturing Supervisor Hours: 2nd shift, Monday-Friday, 3:00pm-11:30pm Join Our Team: At Accupac, we are Makers. From formulation to manufacturing, we serve the most trusted brands in the beauty and personal care industries with a wide range of cosmetics, over-the-counter and medical devices across skincare, haircare, oral care, and healthcare products. But beyond that, we make a difference. We make a difference in the lives of our people, we make a difference in the community around us, we make a difference in the health of our planet for a better, brighter, more beautiful future for all. We value safety-minded, detail-driven leaders who thrive in a fast-paced manufacturing environment and bring strong organizational and people management skills to production operations. As a Manufacturing Supervisor, you'll oversee the preparation, mixing, and production of high-quality products while ensuring all compounding processes meet safety, efficiency, and compliance standards in accordance with cGMPs, regulatory requirements, and company policies. What We Offer: · Competitive Pay o Salary Range: $75,000.00 - $90,000.00 o Bonus: Exempt employees are eligible for a bonus in accordance with Accupac's Bonus Plan o The posted job may span more than one career level. The final offer, including level and pay, will be determined based on a variety of factors such as the candidate's relevant job and industry experience, education, knowledge, skills, geographic location, and abilities. Internal equity and alignment with market data will also be considered. We are committed to providing fair and competitive compensation based on each candidate's qualifications and fit for the role. · Employees are eligible for the following benefits: o Medical, Dental, and Vision insurance o Health Savings Account o Life Insurance with Optional Supplemental Plan o Pet Insurance o Short-Term Paid Disability o 401(k) Retirement Plan with Vested Company Match Contribution o Paid Time Off (PTO) o 10 Paid Holidays o Health Advocacy Programs · Career Growth What You'll Do: · Supervise and lead the compounding team in day-to-day operations, ensuring safe and efficient production · Train staff on SOPs, GMPs, safety protocols, and customer-specific procedures · Oversee mixing of raw materials according to formulation specifications and batch records · Ensure compliance with cGMP, FDA, and internal quality standards through regular inspections and audits · Maintain accurate and complete records of production, materials, and quality control checks · Schedule and assign work to meet daily and weekly manufacturing targets · Support troubleshooting of equipment and process issues, and implement corrective actions · Coordinate preventative maintenance and calibration of departmental equipment · Collaborate with internal teams including Quality, Project Management, and Maintenance · Assist in performance evaluations, disciplinary actions, and interviewing new team members · Participate in developing, reviewing, and editing departmental SOPs and procedures · Promote a culture of safety, accountability, and continuous improvement What We're Looking For: · High school diploma or GED required · Minimum 5 years of experience in manufacturing, with prior supervisory experience preferred · Strong knowledge of cGMPs, FDA regulations, and manufacturing best practices · Excellent communication and leadership skills with the ability to train, motivate, and supervise staff · Proficiency in basic math and computer software including Microsoft Office · Mechanical aptitude and ability to safely operate forklifts and pallet movers · Able to work different shifts or overtime to meet manufacturing needs Must meet physical requirements: lift/carry up to 50 lbs, perform repetitive tasks, stand/walk on concrete floors, work in dusty environments, and wear required PPE including respirators Ready to Apply? Join us at Accupac and become part of a company that values your skills and dedication. Click below to apply today! #INDOTHER2025
    $75k-90k yearly 31d ago
  • Manufacturing Supervisor

    Accupac 4.0company rating

    Lakewood, NJ jobs

    Job Title: Manufacturing Supervisor Hours: 2nd shift, Monday-Friday, 3:00pm-11:30pm Join Our Team: At Accupac, we are Makers. From formulation to manufacturing, we serve the most trusted brands in the beauty and personal care industries with a wide range of cosmetics, over-the-counter and medical devices across skincare, haircare, oral care, and healthcare products. But beyond that, we make a difference. We make a difference in the lives of our people, we make a difference in the community around us, we make a difference in the health of our planet for a better, brighter, more beautiful future for all. We value safety-minded, detail-driven leaders who thrive in a fast-paced manufacturing environment and bring strong organizational and people management skills to production operations. As a Manufacturing Supervisor, you'll oversee the preparation, mixing, and production of high-quality products while ensuring all compounding processes meet safety, efficiency, and compliance standards in accordance with cGMPs, regulatory requirements, and company policies. What We Offer: · Competitive Pay o Salary Range: $75,000.00 - $90,000.00 o Bonus: Exempt employees are eligible for a bonus in accordance with Accupac's Bonus Plan o The posted job may span more than one career level. The final offer, including level and pay, will be determined based on a variety of factors such as the candidate's relevant job and industry experience, education, knowledge, skills, geographic location, and abilities. Internal equity and alignment with market data will also be considered. We are committed to providing fair and competitive compensation based on each candidate's qualifications and fit for the role. · Employees are eligible for the following benefits: o Medical, Dental, and Vision insurance o Health Savings Account o Life Insurance with Optional Supplemental Plan o Pet Insurance o Short-Term Paid Disability o 401(k) Retirement Plan with Vested Company Match Contribution o Paid Time Off (PTO) o 10 Paid Holidays o Health Advocacy Programs · Career Growth What You'll Do: · Supervise and lead the compounding team in day-to-day operations, ensuring safe and efficient production · Train staff on SOPs, GMPs, safety protocols, and customer-specific procedures · Oversee mixing of raw materials according to formulation specifications and batch records · Ensure compliance with cGMP, FDA, and internal quality standards through regular inspections and audits · Maintain accurate and complete records of production, materials, and quality control checks · Schedule and assign work to meet daily and weekly manufacturing targets · Support troubleshooting of equipment and process issues, and implement corrective actions · Coordinate preventative maintenance and calibration of departmental equipment · Collaborate with internal teams including Quality, Project Management, and Maintenance · Assist in performance evaluations, disciplinary actions, and interviewing new team members · Participate in developing, reviewing, and editing departmental SOPs and procedures · Promote a culture of safety, accountability, and continuous improvement What We're Looking For: · High school diploma or GED required · Minimum 5 years of experience in manufacturing, with prior supervisory experience preferred · Strong knowledge of cGMPs, FDA regulations, and manufacturing best practices · Excellent communication and leadership skills with the ability to train, motivate, and supervise staff · Proficiency in basic math and computer software including Microsoft Office · Mechanical aptitude and ability to safely operate forklifts and pallet movers · Able to work different shifts or overtime to meet manufacturing needs Must meet physical requirements: lift/carry up to 50 lbs, perform repetitive tasks, stand/walk on concrete floors, work in dusty environments, and wear required PPE including respirators Ready to Apply? Join us at Accupac and become part of a company that values your skills and dedication. Click below to apply today! #INDOTHER2025
    $75k-90k yearly 59d ago
  • Manufacturing Supervisor 2nd Shift

    Capsugel Holdings Us 4.6company rating

    Tampa, FL jobs

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Lead Operator, GMP Manufacturing is responsible for direct oversight of staff operations on behalf of the Shift Supervisor of all GMP clinical manufacturing, GMP commercial manufacturing and packaging operations assigned. Lead Operator is responsible for ensuring that all projects assigned are executed in a compliant and efficient manner. Lead Operator is responsible for leading the personnel assigned to their unit. They are intimately involved with the technical aspects of all assigned projects per direct supervision and ensure that their unit works across the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals of Lonza. Key Accountabilities: Able to perform all tasks associated with Operators l, ll and lll. Help organize workflow for assigned unit and delegate tasks to team members. Communicate with direct supervision regarding goals, targets, deadlines and plans accordingly to accomplish tasks and bring projects to completion. Lead, train and advise personnel as applicable. Represent Management as “Designee” for process-related signatory duties. Peer review executed batch records for completeness and clarity. Perform and or assign equipment set-up and daily checks to support the manufacturing operation. Interact with client representatives as necessary to address project needs. Write, review and approve Standard Operating Procedures (SOPs), specifications, and other procedures as required. Participate in and recommend staff hiring. Provide recommendations for staff changes and improvement. Execute batch record instructions and oversight of team execution (including but not limited to: dispensing, operating equipment, testing, inspection, packaging as required, general support of the manufacturing operation in any capacity.) Work cross-functionally with supervision, QAU, PM, Technical Services (Mfg. Technical Specialists, Purchaser, Planner, Equipment & Instrumentation Engineer, Process Engineer, Validation Engineer), PDS, EHS, WH, etc. to achieve goals of the team and organization. Key Requirements: A high school diploma required. A minimum of 5 years of experience as a leader or in a management position is required. Pharma cGMP Experience is required. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
    $50k-68k yearly est. Auto-Apply 28d ago
  • Supervisor, Radiopharmaceutical Manufacturing (3rd Shift)

    Northstar Medical Radioisotopes 4.4company rating

    Beloit, WI jobs

    Join the best radiopharmaceutical company in the world! If you're looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. At the forefront of NorthStar's technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission-advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package. Position The Supervisor, Radiopharmaceutical Manufacturing will be responsible for leading daily production activities, ensuring compliance with all regulatory standards, safety standards, and company policies. This role is responsible for delivering all types of batches, including but not limited to clinical and commercial client batches per schedule and contract obligations. This position will lead and mentor a team, efficiently allocate resources, and continuously seek to enhance production processes to optimize operational efficiency. This position plays a key role in maintaining the integrity and safety of the manufacturing environment which is essential for the successful delivery of clinical and commercial radiopharmaceutical products. Responsibilities Manage the day-to-day activities and personnel to ensure efficient manufacturing of products to meet the master production schedule ensuring compliance with regulatory requirements, while maintaining high safety standards. Provide leadership, training, and support to the team. Responsible for the performance of team members and ensuring training requirements are achieved. Monitor and enforce strict quality assurance procedures and key operational metrics to meet the specifications of each product. Address and resolve any issues related to equipment, processes, or personnel in a timely and effective manner with proper communication and/or escalation as needed. Effectively communicate with essential manufacturing support groups to ensure clarity on product specifications, address any escalations promptly, and coordinate delivery schedules. Regularly update management on production status and any critical issues. Responsible to ensure complete and accurate records are maintained for Radiopharmaceutical Manufacturing (Batch Production Record) according to customer and/or Product Development orders. Assist leader in maintaining the department's budget, focusing on the efficient allocation and utilization of resources by monitoring monthly production expenditures. Collaborate with the manufacturing support teams to allocate resources effectively, supporting the technology transfer and process scale-ups in radiopharmaceutical manufacturing to meet business needs and product development goals. Qualifications Associate's Degree (AS) in a STEM discipline and minimum four (4) years of cGMP experience; or equivalent combination of education and experience. Minimum one (1) year of experience leading others required. Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9. Shift Information Third shift hours are Monday - Thursday 9pm - 7:30am (shift ends Friday morning). During this position's training period (approximately 60 days), the ability to work 1 st or 2 nd shift is required. Primary shift placement will occur upon completion of the training program. Additionally, this position supports production in a 24-hour manufacturing facility, Monday to Friday, occasional overtime and holidays required. Benefits Medical, dental, and vision insurance Healthcare Flex Spending Account (FSA) and Dependent Care FSA Company-paid short-term and long-term disability Company-paid life insurance & AD&D coverage Pet insurance 401(k) match Paid holidays and paid time off (PTO) Paid parental leave Bonus plan Equity Incentive Program Working Conditions This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include: Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors Noise levels range from quiet to loud, depending on the work area Specific vision abilities, including near vision, visual acuity, and color discrimination Personal Protective Equipment (PPE) is required and may include: Respirators, gloves, safety glasses, and full protective clothing Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings) Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to: Follow strict radiation safety procedures Participate in dosimetry monitoring and bioassay testing as part of the company protocol Inform leadership of any health conditions that may affect product integrity, by cleanroom standards Location NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford. Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you're drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation. NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
    $58k-77k yearly est. Auto-Apply 12d ago

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