Manufacturing Manager jobs at Amgen

Career CategoryManufacturingJob 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. Manufacturing Senior Associate What you will do Let's do this. Let's change the world. In this role you will be managing and leading all aspects of a device assembly & packaging line. Responsibility includes maintaining production in full cGMP compliance. Assist with supervising and developing technicians while overseeing production equipment to ensure production schedules are completed. Lead manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting. Maintain machine uptime, perform any fault clearing and clear stoppages on automated equipment. Ensure all safety and compliance procedures are followed at all times. Escalate appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk. Provide training to manufacturing staff on process and equipment. Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor. Collaborate with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner. Support Deviation Triage and Corrective and Preventive Actions (CAPA) processes Write, review & revise controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc) Apply process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations. Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant. Participate in the design, development, and implementation of processes in support of the manufacturing floor. Participate in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification and Validation. Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek will possess these qualifications. Basic Qualifications: High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience Or Associate's + 2 years biotech or pharmaceutical manufacturing, process development or quality experience Or Bachelor's + 6 months biotech or pharmaceutical manufacturing, process development or quality experience work experience Or Master's Preferred Qualifications: Degree in Chemical Engineering, Industrial Engineering or Life Sciences Technical understanding of pharmaceutical/biotech packaging equipment and processes Experience with Current Good Manufacturing Practices (cGMP) Ability to be flexible and manage change Experience participating in and leading cross-functional teams Experience in managing multiple, competing priorities in a fast-paced environment Strong scientific, technical interactions with partner organizations such as PD and F&E. Experience in GMP Tech Support roles, GMP operations, process development or scheduling. Experience with Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification Ability to organize, analyze, and interpret technical data that is impacting operations Background in lean manufacturing methodologies and operational excellence Expertise in electronic systems used in manufacturing (MES, LIMS, Maximo, CCMS, SAP, etc.) 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. 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 88,378.00 USD - 106,188.00 USD

RTI Surgical is now Evergen! This rebrand reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. About Evergen: Evergen (formally RTI Surgical) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen's commitment to advancing regenerative medicine here: ************************ JOB RESPONSIBILITIES Provides strategic leadership for the regulatory function, setting the vision and goals for the department and leading a high-performance team of professionals Executes and manages technical and scientific regulatory activities independently as a decision-maker on regulatory issues and assures that deadlines are met Directs staff, including consultants, to assure timely and accurate preparation of domestic and international regulatory submissions Authors or reviews key portions of technical files/dossiers, FDA premarket submissions such as 510(k) and IDE, Canadian devices licenses, and other international product registrations Negotiates and interacts with regulatory authorities during the development and review process to ensure successful submission approval Serves as primary contact for regulatory agencies in matters related to product submissions and registrations Identifies emerging issues and anticipates regulatory obstacles throughout the product lifecycle and develops solutions in collaboration with members of regulatory and cross functional teams Oversees regulatory maintenance of product marketing registrations, approvals, and clearances Manages the development process (e.g., design, development, approval, implementation, control, revision, and translation) of product labeling (e.g., package labels, ancillary labels, package insert, and surgical technique) to assure accuracy, consistency, and compliance with applicable regulatory requirements, as well as company and customer requirements Negotiates labeling-related requests from internal stakeholders and business partners based on manufacturing capabilities and regulatory requirements Reviews and approves advertising and promotional items to ensure regulatory compliance and ensures external communications meet regulations Participates in audits and inspections by regulatory authorities and certification or accreditation bodies Communicates with customers as needed on regulatory related matters with a high level of customer service Maintains knowledge of the global competitive landscape, regulatory environment, regulations, guidance, and provides updates to peers and project teams Contributes to the development and maintenance of Regulatory Affairs working practices and procedures Other duties as assigned Education Bachelor's degree in science, engineering or relevant technical discipline Experience 10+ years of regulatory experience in a tissue, biologics or medical device with knowledge of FDA, ISO, AATB and MDR labeling, and quality system requirements 7+ years of leadership experience Certification AATB CTBS preferred RAC certifications preferred Skills Excellent verbal and written communication Microsoft Office Suite Enterprise Resource Planning (ERP) software Budget Management Project Management Process Improvement Methodologies Strategic Planning Travel 10% SAFETY Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.) Working Environment Onsite: Office environment with assigned workstation Remote positions only. Home office environment with minimum distractions. #LI-Remote

Balanced Body is an energetic, environmentally sensitive company that is growing! Balanced Body leads the world in providing Pilates equipment and education. We are looking for a strategic, results-driven Director of Operations to join our dynamic team and oversee the operational excellence of our business. The Director of Operations will be responsible for overseeing all aspects of the supply chain, manufacturing, warehousing, logistics, and maintenance. This leadership role requires a strategic thinker who can optimize production processes, ensure product quality, manage day to day operational efficiency and lead cross functional teams. The Director of Operations will work closely with other senior leadership to align operations with business goals and deliver exceptional value to customers. Requirements Essential Duties of position include: Manufacturing Operations: Oversight of manufacturing activities, including planning, processes to achieve efficiency, quality and resource allocation. Strategic planning with production teams and champion methodologies like Lean Six Sigma to drive productivity and quality. Supply Chain Management: Oversight of procurement department, suppliers and managing inventory. Provide strategic direction for global supply chain to improve efficiency, value and reduce costs. Oversight and support on contract negotiating with suppliers and managing relationships with vendors. Monitor market conditions and proactively address potential risks with global supply chain. Warehouse and Logistics Management: Oversight of warehouse and logistics activities. Develop and implement strategic operations to support multiple locations including 3PL's globally. Analyze and track KPI's to identify areas for improvement. Optimize warehouse layout, process and systems ensuring safety compliance. Expertise in warehouse management procedures and best practices. Provide leadership to department managers. Promote a productive work environment with high performing teams. Provide support for operational staffing, scheduling and development. Strategically collaborate with cross-functional teams like Sales, Marketing, Finance to ensure smooth operations align with company goals. Lead the SIOP cycle which involves data analytics, process improvement and lead the process of finalizing the consensus demand forecast and execution plans to maximize On-Time Delivery (OTD). Foster a culture of accountability, and continuous improvement. Develop and implement effective operational strategies to improve productivity, cost-effectiveness and quality. Lead efforts to streamline production workflows, reduce lead times, and manage resources effectively. Plan, monitor, and enhance key metrics for day-to-day operations to ensure efficient and timely completion of tasks. Collaboration with Senior Leadership in the development of performance goals and long-term operational plans. Experience implementing and tracking smart goals. Establish and enforce accountability for core Key Performance Indicators (KPIs) related to Safety, Quality, Cost, Delivery, People, and overall Operational Excellence. Drive high-level decision-making by developing operational policies, executing strategic capital investment decisions, and optimizing facility layouts for maximum efficiency. Review financial information to make informed decisions and enhance profitability. Develop long-term operational strategies and align them with broader business objectives. Manage risks effectively and implement measures to mitigate potential threats. Other duties as assigned. Skills and Qualifications 10+ years in a senior leadership role, preferably in a manufacturing environment. Bachelor's degree in business administration or related field. Strong working knowledge of data analysis and performance metrics. Proven ability to implement process improvement initiatives. Work Location: on-site in Sacramento, CA 95828 Salary: $175,000 - $250,000 + Bonuses. Negotiable based on experience. The Company Balanced Body is the world's largest designer and manufacturer of Pilates equipment, as well as a provider of high-quality Pilates and other mind-body instructor training and continuing education. We currently do business in over 100 countries, with world-renowned customer service and a serious commitment to environmentally friendly business practices. If you want to work with a company with a passion for changing lives in small and large ways, let us hear from you. We offer competitive compensation and excellent benefits including: Medical, Dental, Vision 401(k) plan & Match! Life, AD&D and Long-Term Disability Insurance Balanced Body is an equal opportunity employer dedicated to workforce diversity. NO AGENCY CALLS! Salary Description $175,000 -$240,000 + Bonuses. Negotiable DOE

Balanced Body is an energetic, environmentally sensitive company that is growing! Balanced Body leads the world in providing Pilates equipment and education. We are looking for a strategic, results-driven Director of Operations to join our dynamic team and oversee the operational excellence of our business. The Director of Operations will be responsible for overseeing all aspects of the supply chain, manufacturing, warehousing, logistics, and maintenance. This leadership role requires a strategic thinker who can optimize production processes, ensure product quality, manage day to day operational efficiency and lead cross functional teams. The Director of Operations will work closely with other senior leadership to align operations with business goals and deliver exceptional value to customers. Requirements Essential Duties of position include: * Manufacturing Operations: Oversight of manufacturing activities, including planning, processes to achieve efficiency, quality and resource allocation. Strategic planning with production teams and champion methodologies like Lean Six Sigma to drive productivity and quality. * Supply Chain Management: Oversight of procurement department, suppliers and managing inventory. Provide strategic direction for global supply chain to improve efficiency, value and reduce costs. Oversight and support on contract negotiating with suppliers and managing relationships with vendors. Monitor market conditions and proactively address potential risks with global supply chain. * Warehouse and Logistics Management: Oversight of warehouse and logistics activities. Develop and implement strategic operations to support multiple locations including 3PL's globally. Analyze and track KPI's to identify areas for improvement. Optimize warehouse layout, process and systems ensuring safety compliance. Expertise in warehouse management procedures and best practices. * Provide leadership to department managers. Promote a productive work environment with high performing teams. * Provide support for operational staffing, scheduling and development. * Strategically collaborate with cross-functional teams like Sales, Marketing, Finance to ensure smooth operations align with company goals. Lead the SIOP cycle which involves data analytics, process improvement and lead the process of finalizing the consensus demand forecast and execution plans to maximize On-Time Delivery (OTD). * Foster a culture of accountability, and continuous improvement. * Develop and implement effective operational strategies to improve productivity, cost-effectiveness and quality. * Lead efforts to streamline production workflows, reduce lead times, and manage resources effectively. * Plan, monitor, and enhance key metrics for day-to-day operations to ensure efficient and timely completion of tasks. * Collaboration with Senior Leadership in the development of performance goals and long-term operational plans. Experience implementing and tracking smart goals. * Establish and enforce accountability for core Key Performance Indicators (KPIs) related to Safety, Quality, Cost, Delivery, People, and overall Operational Excellence. * Drive high-level decision-making by developing operational policies, executing strategic capital investment decisions, and optimizing facility layouts for maximum efficiency. * Review financial information to make informed decisions and enhance profitability. * Develop long-term operational strategies and align them with broader business objectives. * Manage risks effectively and implement measures to mitigate potential threats. * Other duties as assigned. Skills and Qualifications * 10+ years in a senior leadership role, preferably in a manufacturing environment. * Bachelor's degree in business administration or related field. * Strong working knowledge of data analysis and performance metrics. * Proven ability to implement process improvement initiatives. Work Location: on-site in Sacramento, CA 95828 Salary: $175,000 - $250,000 + Bonuses. Negotiable based on experience. The Company Balanced Body is the world's largest designer and manufacturer of Pilates equipment, as well as a provider of high-quality Pilates and other mind-body instructor training and continuing education. We currently do business in over 100 countries, with world-renowned customer service and a serious commitment to environmentally friendly business practices. If you want to work with a company with a passion for changing lives in small and large ways, let us hear from you. We offer competitive compensation and excellent benefits including: * Medical, Dental, Vision * 401(k) plan & Match! * Life, AD&D and Long-Term Disability Insurance Balanced Body is an equal opportunity employer dedicated to workforce diversity. NO AGENCY CALLS! Salary Description $175,000 -$240,000 + Bonuses. Negotiable DOE

Full-time Description Balanced Body is an energetic, environmentally sensitive company that is growing! Balanced Body leads the world in providing Pilates equipment and education. We are looking for a strategic, results-driven Director of Operations to join our dynamic team and oversee the operational excellence of our business. The Director of Operations will be responsible for overseeing all aspects of the supply chain at Balanced Body including manufacturing, procurement, warehousing, logistics, and maintenance. This leadership role requires a strategic thinker who can optimize production processes, ensure product quality, manage day to day operational efficiency and lead cross functional teams. The Director of Operations will work closely with other senior leadership to align operations with business goals and deliver exceptional value to customers. Requirements Essential Duties of position include: Supply Chain Management: Oversight of procurement, warehousing, logistics, and maintenance. Oversight of suppliers and managing inventory. Manufacturing Operations Management: oversight of manufacturing planning, organizing, processes to achieve efficiency and quality. Provide leadership to department managers. Promote a productive work environment with high performing teams. Provide support for operational staffing, scheduling and development. Foster a culture of accountability, and continuous improvement. Develop and implement effective operational strategies to improve productivity, cost-effectiveness and quality. Lead efforts to streamline production workflows, reduce lead times, and manage resources effectively. Plan, monitor, and enhance key metrics for day-to-day operations to ensure efficient and timely completion of tasks. Collaboration with Senior Leadership in the development of performance goals and long-term operational plans. Experience implementing and tracking smart goals. Experience with KPI's related to Safety, Quality, Cost, Delivery, People, and Operational Excellence. Decision Making: Developing operational policies, making capital investment decisions, and optimizing facility layouts. Reviewing financial information to make informed decisions and enhance profitability. Developing long-term operational strategies and aligning them with the broader business objectives. Managing risks effectively and implementing measures to mitigate potential threats. Other duties as assigned. Qualifications: Bachelor's degree in Operations Management, Supply Chain Management, Business Administration (preferably with specialization in operations), or a related field. 10+ years' experience in operational management, preferably within Manufacturing. Minimum 7 years in a management or leadership capacity Proven experience in leading large teams, optimizing the manufacturing process, and managing all supply chain functions. Excellent leadership abilities, people skills, and in-depth knowledge of diverse business functions and principles Strong understanding of Lean Manufacturing, Six Sigma, quality control systems and procedures and continuous improvement principles. Working knowledge of CRM and ERP Software (including MRP) Exceptional problem solving, organization, and communication skills Ability to work effectively in a fast-paced, deadline driven environment. Extensive experience managing budgets and controlling expenses for operations Strong understanding of regulatory requirements and environmental and safety regulations. Work Location: on-site in Sacramento, CA 95828 Salary: $150,000 - $220,000 The Company Balanced Body is the world's largest designer and manufacturer of Pilates equipment, as well as a provider of high-quality Pilates and other mind-body instructor training and continuing education. We currently do business in over 100 countries, with world-renowned customer service and a serious commitment to environmentally friendly business practices. If you want to work with a company with a passion for changing lives in small and large ways, let us hear from you. We offer competitive compensation and excellent benefits including: Medical, Dental, Vision 401(k) plan & Match! Life, AD&D and Long-Term Disability Insurance Balanced Body is an equal opportunity employer dedicated to workforce diversity. NO AGENCY CALLS! Salary Description $150,000 -$220,000

Job SummaryThis position oversees management of all areas of Manufacturing operations to produce products and direct activities so that approved products are manufactured on-schedule within the quality standards and cost objectives. This position reports directly to the Plant Manager. Directly manages approximately 7 Production Manager(s) and/or Senior Manager(s) for the formulation, filling, and component preparation departments that support the terminal sterilization lines including terminal sterilizers and aseptic fill lines including lyophilizers. Indirectly manages approximately 400 Direct Labor Production Employees and Manufacturing Engineers.Responsibilities POSITION RESPONSIBILITIES Establishes and controls the processes and procedures for compounding, aseptic and terminal sterilization filling, component preparation, capping, and lyophilization. Assist company officers and senior staff members in the development and formulation of long and short-range planning, policies, programs, and objectives. Develop the manufacturing plan and establish procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards. Achieve optimum employee levels with the least amount of overhead and raw material costs to meet annual budget. Formulate and recommend manufacturing policies and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation. Direct and monitor department managers and supervisors to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures. Act as a liaison between department management/subordinate levels, as well as executive/Supervisor levels to inform personnel of communications, decisions, policies, and all matters that affect their performance and results. Hire, train, develop, and evaluate staff. Take corrective action as necessary on a timely basis and in accordance with company policy. Ensure compliance with current federal and local regulations. Consult with Human Resources Department as appropriate. Identify, recommend, and implement changes to improve productivity, reduce defects and reduce cost and scrap, monitor scrap and rework data. Direct the establishment, implementation and maintenance of production standards. Direct and coordinate efforts to improve Right First Time execution, reduce deviations and manage the prioritization of the deviation writers to close deviations needed for on time batch release. Direct and coordinate various programs essential to manufacturing procedures (e.g., training, safety, housekeeping, cost reduction, worker involvement, security, etc.) Initiate and coordinate major projects (e.g., plant layout changes, installation of capital equipment, major repairs, etc.) Work effectively and relate well with others. Exhibiting a professional manner in dealing with others while working to maintain constructive working relationships Keep current on information and technology affecting functional areas to increase innovation and ensure compliance Participate in the preparation and presentation of site related business metrics and performance metrics, such as Line OEE achievement and production output, to upper level management. Support regulatory inspections and company audits as the Subject Matter Expert for the assigned departments under your control and engage direct reports as needed for support. Perform miscellaneous duties and projects as assigned and required. As part of Top Management, you have the overall responsibility and accountability for all aspects of the Health, Safety, Environment, Energy, and Quality Management Systems, including the following: taking overall responsibility and accountability for the prevention of work-related injuries and ill health, the protection of the environment, as well as the provision of safe, harmless, and healthy workplaces, ensuring that the Health, Safety, Environment, Energy, and Quality Management Systems' policies and related objectives are established and are compatible with the strategic direction of the organization Salary Range: $190,000 - $225,000 • Position is eligible to participate in a bonus plan with a target of 16% of the base salary • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. POSITION REQUIREMENTS Bachelors of Science degree in related field or equivalent education and experience. 10 years of experience in pharmaceutical manufacturing in a cGMP environment required with 5 years of progressive levels of managerial experience and broad span of organizational control. Terminal sterilization and lyophilization experience preferred. Excellent analytical and technical skills. Excellent written and verbal communication skills. Must be able to communicate and interact with all levels of the organization and manage in a dynamic environment to meet plant and company objectives. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

The Director of Manufacturing balances the urgency of daily shift operations with the pursuit of long-term goals while ensuring the highest standards of quality and compliance. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff members to achieve overall organizational objectives. The individual must have the ability to coordinate work between functions to ensure alignment with overall department vision and promote urgency, ownership, and accountability across the organization. Duties and Responsibilities Manage the execution of shift manufacturing to meet quality, client, and financial objectives as well as supporting technical transfer of clinical production activities across shifts Oversee the finite scheduling of aseptic formulation and filling operations to ensure timely batch preparation and filling in alignment with production plans, quality standards, and manufacturing priorities Partner with Quality and Operational Excellence manufacturing management team to ensure consistent product quality; drive efforts to create a right-first time (RFT) culture, reduce and eliminate human errors, manage deviations to ensure true root cause is identified and on time closure is achieved and continuously improve operational performance Proactively identify, assess, and mitigate operational, quality, and organizational risks, escalating key risks and issues Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.) while maintaining high standards of quality, compliance, and safety through leadership by example Implement and drive continuous improvement initiatives across manufacturing operations, leveraging data-driven insights and Operation Excellence methodologies Develop, implement, and maintain KPIs aligned with site objectives to measure and monitor manufacturing performance across key areas including productivity, yield, utilization, cycle times, compliance, and cost efficiency Regularly review and refine KPI metrics to reflect changes in business needs and operational priorities Provide management reporting through use of department metrics aligned with site objectives and balanced scorecard Balance team and individual responsibilities and exhibit objectivity and openness to others' views Facilitate effective communication between clients and internal stakeholders to ensure alignment of site objectives Work to maintain a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations Other duties as assigned Regulatory Responsibilities Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.) Ensure compliance with all local, state, federal, FDA, OSHA, cGMP or other applicable regulations Supervisory Responsibilities Balance team and individual responsibilities Exhibit objectivity and openness to others' views Give and welcome feedback Contribute to building a positive team spirit Put success of team above own interests Build morale and group commitments to goals and objectives Support everyone's efforts to succeed Experience Eight (8) to ten (10) years of supervisory/leadership experience in a GMP manufacturing environment with specific involvement with Operations, Quality and Compliance Management Direct parenteral manufacturing/quality experience preferred Experience in a Lean, Six Sigma or similar Operational Excellence system Education Bachelor's degree from an accredited college or university with a major in Science, Engineering or is preferred An equivalent combination of education and experience may be considered Knowledge, Skills & Abilities Excellent teamwork Ability to communicate clearly and cooperate with other staff members to achieve overall organizational objectives Ability to coordinate work between functions to ensure alignment with overall department vision Ability to promote urgency, ownership, and accountability across the organization Skilled in relational databases and ability to use computerized software to support management reporting including word processing, spreadsheets, charts/graphs and presentations Knowledge of FDA regulations, GMP/GLP/GCP, CFR 210, 211, 610, Part 11, and Parenteral Manufacturing Guidance (FDA/EU Annexes), Lean Manufacturing, Six-Sigma Ability to set and achieve challenging goals Ability to demonstrate persistence and overcome obstacles Ability to measure self against standards of excellence Ability to take calculated risks to accomplish goals Physical Requirements Ability to meet gowning requirements for cleanroom activities Able to lift up to approximately 15-50 pounds frequently and up to 50 lbs. occasionally Frequent standing and walking throughout the facility Use of both hands and arms in repetitive motion Fine and gross motor skills Satisfactory audio-visual acuity

The Director of Manufacturing balances the urgency of daily shift operations with the pursuit of long-term goals while ensuring the highest standards of quality and compliance. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff members to achieve overall organizational objectives. The individual must have the ability to coordinate work between functions to ensure alignment with overall department vision and promote urgency, ownership, and accountability across the organization. Duties and Responsibilities Manage the execution of shift manufacturing to meet quality, client, and financial objectives as well as supporting technical transfer of clinical production activities across shifts Oversee the finite scheduling of aseptic formulation and filling operations to ensure timely batch preparation and filling in alignment with production plans, quality standards, and manufacturing priorities Partner with Quality and Operational Excellence manufacturing management team to ensure consistent product quality; drive efforts to create a right-first time (RFT) culture, reduce and eliminate human errors, manage deviations to ensure true root cause is identified and on time closure is achieved and continuously improve operational performance Proactively identify, assess, and mitigate operational, quality, and organizational risks, escalating key risks and issues Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.) while maintaining high standards of quality, compliance, and safety through leadership by example Implement and drive continuous improvement initiatives across manufacturing operations, leveraging data-driven insights and Operation Excellence methodologies Develop, implement, and maintain KPIs aligned with site objectives to measure and monitor manufacturing performance across key areas including productivity, yield, utilization, cycle times, compliance, and cost efficiency Regularly review and refine KPI metrics to reflect changes in business needs and operational priorities Provide management reporting through use of department metrics aligned with site objectives and balanced scorecard Balance team and individual responsibilities and exhibit objectivity and openness to others' views Facilitate effective communication between clients and internal stakeholders to ensure alignment of site objectives Work to maintain a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations Other duties as assigned Regulatory Responsibilities Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.) Ensure compliance with all local, state, federal, FDA, OSHA, cGMP or other applicable regulations Supervisory Responsibilities Balance team and individual responsibilities Exhibit objectivity and openness to others' views Give and welcome feedback Contribute to building a positive team spirit Put success of team above own interests Build morale and group commitments to goals and objectives Support everyone's efforts to succeed Experience Eight (8) to ten (10) years of supervisory/leadership experience in a GMP manufacturing environment with specific involvement with Operations, Quality and Compliance Management Direct parenteral manufacturing/quality experience preferred Experience in a Lean, Six Sigma or similar Operational Excellence system Education Bachelor's degree from an accredited college or university with a major in Science, Engineering or is preferred An equivalent combination of education and experience may be considered Knowledge, Skills & Abilities Excellent teamwork Ability to communicate clearly and cooperate with other staff members to achieve overall organizational objectives Ability to coordinate work between functions to ensure alignment with overall department vision Ability to promote urgency, ownership, and accountability across the organization Skilled in relational databases and ability to use computerized software to support management reporting including word processing, spreadsheets, charts/graphs and presentations Knowledge of FDA regulations, GMP/GLP/GCP, CFR 210, 211, 610, Part 11, and Parenteral Manufacturing Guidance (FDA/EU Annexes), Lean Manufacturing, Six-Sigma Ability to set and achieve challenging goals Ability to demonstrate persistence and overcome obstacles Ability to measure self against standards of excellence Ability to take calculated risks to accomplish goals Physical Requirements Ability to meet gowning requirements for cleanroom activities Able to lift up to approximately 15-50 pounds frequently and up to 50 lbs. occasionally Frequent standing and walking throughout the facility Use of both hands and arms in repetitive motion Fine and gross motor skills Satisfactory audio-visual acuity

Why join Hologic: You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance your manufacturing operation skills and knowledge to further your career. At Hologic, our employees have a unique sense of pride and fulfillment in their work because we are a force for good. As an innovative global medical technology company, we specialize in women's health and wellbeing and create products that detect and diagnose disease earlier and with more certainty than ever before. Our employees in Newark, Delaware support the production of the “Coolest Thing Made in Delaware,” a recent honor awarded to us by the Delaware State Chamber of Commerce for our 3Dimensions Mammography System that helps find breast cancer. What to expect: The Supervisor, Manufacturing directs the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Prioritizes production schedules based on product introduction, equipment efficiency, and materials supply. Plans and administers procedures and budgets. Makes budgetary recommendations and at higher levels, controls capital expenditures and direct/indirect labor. Develops schedules and manpower requirements for assigned areas. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. Receives assignments in the form of objectives with goals and the process by which to meet goals. Directs subordinates to complete assignments using established guidelines, procedures, and policies. Administers company policies that directly affect subordinate employees. Management reviews work to measure meeting of objectives. Provides immediate supervision/acts as advisor to a unit or group of employees, and may become actively involved, as required, to meet schedules and resolve problems. Works on issues where analysis of situation or data requires review of relevant factors. Follows established practices and procedures in analyzing situations and may exercises judgement within defined policies to determine appropriate action. Monitors daily operations of a unit or sub-unit. Requires full knowledge of own area of functional responsibility. What we expect: Accountable for department oversight. Will work collaboratively with Group Leads and manufacturing associates to improve team engagement, product quality and cost efficiency. Responsible for reviewing, evaluating, and implementing changes and specification requirements. Take appropriate actions to ensure product manufacturing volumes are align with the planning provided. Actively participate in building the forecast and budget Drive systematic improvements through analysis of KPIs and other performance data. Interface with manufacturing engineering, equipment engineering, management to improve cycle time, tool availability, process, and product yield. Transfer process know-how to manufacturing by creating SOPs and training production operators. Partner with other functional teams to continuously improve and develop manufacturing capability to support both existing and future production. Participate in NPI projects and drive successful introduction of new products and production concepts from design phase to volume production. Promote compliance-based culture, ensure timely and effective investigation and root cause identification and resolution of manufacturing non-conformances and corrective preventative action plans (CAPA) Work with department manager to develop and drive implementation of lean manufacturing across the organization. Establish a strong network across various organizations such as Supply Chain, R&D, Sourcing, Finance, etc to drive end-to-end cross functional improvements of the business. Recruit, lead and develop the personnel in the department. Education & Experience: Preferred Minimum Non-Technical Degree: AA/AS Degree, possibly BA/BS Preferred Minimum Non-Technical Degree: 5+ Years Experience with manufacturing scheduling and working in a lean manufacturing environment. Experience with high precision mechanical, electrical industrial products. Must be self-motivated with capability to work in a fast-paced environment. Skills Strong attention to detail with analytical and problem-solving skills Proven leadership behavior with demonstrated ability to attract, lead and develop talent. Ability to anticipate and resolve conflicts while leveraging unique team talents to enhance engagement. Demonstrated ability to attract, lead and develop talent. Working knowledge of SPC (statistical process control) principles Working knowledge of industrial engineering Problem solving The annualized base salary range for this role is $75,600 to $120,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.. Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-PR1 Must follow all applicable FDA regulations and ISO requirements. Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)

Why join Hologic: You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance your manufacturing operation skills and knowledge to further your career. What to expect: Directs the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Prioritizes production schedules based on product introduction, equipment efficiency, and materials supply. Plans and administers procedures and budgets. Makes budgetary recommendations and at higher levels, controls capital expenditures and direct/indirect labor. Develops schedules and manpower requirements for assigned areas. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. Receives assignments in the form of objectives with goals and the process by which to meet goals. Directs subordinates to complete assignments using established guidelines, procedures, and policies. Administers company policies that directly affect subordinate employees. Management reviews work to measure meeting of objectives. Provides immediate supervision/acts as advisor to a unit or group of employees, and may become actively involved, as required, to meet schedules and resolve problems. Works on issues where analysis of situation or data requires review of relevant factors. Follows established practices and procedures in analyzing situations and may exercises judgement within defined policies to determine appropriate action. Monitors daily operations of a unit or sub-unit. Requires full knowledge of own area of functional responsibility. What we expect: Accountable for department oversight. Will work collaboratively with Group Leads and manufacturing associates to improve team engagement, product quality and cost efficiency. Responsible for reviewing, evaluating, and implementing changes and specification requirements. Take appropriate actions to ensure product manufacturing volumes are align with the planning provided. Actively participate in building the forecast and budget Drive systematic improvements through analysis of KPIs and other performance data. Interface with manufacturing engineering, equipment engineering, management to improve cycle time, tool availability, process, and product yield. Transfer process know-how to manufacturing by creating SOPs and training production operators. Partner with other functional teams to continuously improve and develop manufacturing capability to support both existing and future production. Participate in NPI projects and drive successful introduction of new products and production concepts from design phase to volume production. Promote compliance-based culture, ensure timely and effective investigation and root cause identification and resolution of manufacturing non-conformances and corrective preventative action plans (CAPA) Work with department manager to develop and drive implementation of lean manufacturing across the organization. Establish a strong network across various organizations such as Supply Chain, R&D, Sourcing, Finance, etc to drive end-to-end cross functional improvements of the business. Recruit, lead and develop the personnel in the department. Education & Experience: Preferred Minimum Non-Technical Degree: AA/AS Degree, possibly BA/BS Preferred Minimum Non-Technical Degree: 5+ Years Experience with manufacturing scheduling and working in a lean manufacturing environment. Experience with high precision mechanical, electrical industrial products. Must be self-motivated with capability to work in a fast-paced environment. The annualized base salary range for this role is $75,600 to $110,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.. Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-PR1 Must follow all applicable FDA regulations and ISO requirements. Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)

About Us: Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better. A Brief Overview As the Director, Manufacturing Operations, you'll be the driving force behind strategic supplier partnerships, ensuring high-quality products are manufactured and delivered on time, every time. You'll lead cross-functional teams, manage complex programs, and champion initiatives that boost efficiency, reduce costs, and maximize product impact across its lifecycle. With a sharp focus on compliance, innovation, and collaboration, you'll play a pivotal role in shaping supply operations and bringing market-ready solutions to life. Key Responsibilities: Planning &Scheduling Identify and direct key activities so that approved products are manufactured and released on schedule, within quality standards and budget objectives, per plan. Develop and ensure updated back up plans exist to meet production targets during equipment downtime or vendor caused issues. Oversight Actively manage the Master Supply Agreements and oversight to contract operations Process Improvement Promote application of lean initiatives and new technology to products, processes and equipment. Partner with sustaining engineering to identify improvements in manufacturing equipment/process to improve productivity and quality of current and future products while expecting cost reductions. Business Monitoring Ensure area and personnel MBOs, budgets, KPIs, manning levels, and other business monitoring tools are developed and achieved on an annual basis. New Product/Process Support Attend and participate on product development teams for new products and processes that will require manufacturing time and manufacturing resources. Plan, budget, and implement initiatives for manufacturing of new products or with new processes. Minimum Requirements Bachelor's Degree in Engineering, Business, or equivalent. Required Industrial Engineering background or training. Trained in and has applied Lean and Six Sigma (Green or Black belt) principles. Advanced training in personnel management. Extensive hands-on experience and supervision of manufacturing department, engineering, or quality (10+ years). Required Preferred Qualifications Previous experience managing contract production. Preferred Masters Degree. Preferred Technical & Functional Skills Knowledge Skills and Abilities Demonstrated personnel / proven record of project leadership and management skills; adherence to KPIs. Strong interpersonal skills, mechanical aptitude, and proven ability to implement lean principles. Demonstrated aptitude and ability to successfully manage production plans while meeting scheduled program/project deadlines; must be able to work both independently and with a teams and accurate planning skills and ability to implement under budget constraints. While not required, the ability to speak and/or understand German would be beneficial. Working knowledge of FDA, OSHA, ISO, and other bodies regulating requirements for manufacturing, production, and warehouse areas. Strong technical skills to fully understand and solve manufacturing related issues that occur in daily activities and projects/programs. Understanding of SAP system and operation, BOMs, Routers, COGs, etc. Proficient use of Microsoft Programs (ex: Word, Excel, PowerPoint, Project); Sharepoint; Jaber; Ariba; Axxerion, SAP, and other production related software. Ability to interact and work well with personnel at all levels of the organization and ability to direct staff to most effectively use their time and skills. Strong skills in training staff and/.or working with personnel needing to train staff on job functions and responsibilities. Benefits: Comprehensive Medical, Dental, and Vision plans 20 days of Paid Time Off 15 paid holidays Paid Sick Leave Paid Parental Leave 401(k) Employee bonuses And more! Your benefits and PTO start the date you're hired with no waiting period.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your role at Baxter 3rd Shift: 11pm-7:30am You will be responsible for implementing and supervising daily activities in a specific production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. May monitor and control labor. Your team Baxter is focused on saving and sustaining lives by finding solutions to sophisticated problems. Every single day, the manufacturing team strives to create quality products for our customers-and are sometimes met with unforeseen issues to tackle. The high-caliber talent at Baxter meets these challenges head-on, as a team, to create products with the customer's needs top-of-mind. We build relationships with each other to get work done. We provide opportunities for you to continue to learn through training, conferences, certifications, and support for advanced degrees. Growth from role to role or level to level is encouraged and is supported by management to ensure employees are consistently engaged with their work. What you'll be doing Will provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations. Responsible for supervising the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities -to meet customer requirements including deadlines and quality standards. Audit, refine, and improve processes and equipment operation within the manufacturing areas. Drive to utilize resources and raw materials in the most efficient and productive manner possible. Support and Emphasize the Safety and Quality commitments of the department. Interview, hire, coach, motivate, develop and discipline staff. Conduct annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Monitor progress. Facilitate and verify appropriate training for employees in the area. Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals. Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments. Represent the Company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs. Provide a positive and equitable working environment emphasizing the Baxter. Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed. Candidate should not be allergic to PENICILLIN or CEPHALOSPORINS What you'll bring HS diploma or equivalent required and 2 years manufacturing and 1 year of leadership experience. Bachelor's degree and 1 year of experience. Bachelor's degree required for ongoing career progression Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment In-depth process knowledge of related manufacturing equipment and processes. good understanding and/or hands-on familiarity with the principles of lean manufacturing. Ability to manage multiple priorities in a manufacturing plant setting. Ability to interact with all levels of personnel to analyze and solve problems related to manufacturing, Quality, documentation, and personnel issues. Strong assessment and troubleshooting skills. Collect and analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions Strong professional writing skills and ability to prepare technical reports. Ability to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry. Ability to respond to detailed inquiries, and present information to groups and senior management. May be required to supervise multiple groups. Ability to work weekends and overtime when necessary is required. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $64,000 - $88,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Job DescriptionJoin our team at BioSpectra, Inc., where we lead the way in delivering high-purity ingredients to the top 25 pharmaceutical companies globally. We are dedicated to maintaining the highest standards of excellence in the industry. Currently, we are looking for a Manufacturing Supervisor. As a key player in our organization, you will lead a manufacturing shift within our Bangor Manufacturing facility but be open to assist when required at our Stroudsburg facility. We are looking for a detail-oriented individual with strong leadership skills to drive operational excellence and foster team success. BioSpectra, Inc. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA, and Scarborough, Canada. Why should you join BioSpectra, Inc.? Support our current customers who are the top 25 pharmaceutical companies in the world Develop your career with a growing organization with ample opportunities for professional and personal development Comprehensive Benefits Package (Medical, Dental, Vision, Company paid Life Insurance, Tuition Reimbursement) 401K Retirement Savings Plan - Company matches $2 per $1 of employee contribution on the first 4% Excellent Paid Time Off Programs include vacation, sick, & personal time, plus paid holidays Job Summary: The Manufacturing Supervisor leads their team to accomplish the safety, quality, delivery and cost objectives of the manufacturing department. A supervisor reviews the daily production schedule, assigns work to their team, coordinates plant activities, ensures their team is trained and inspects chemical operator activity throughout the shift. Responsible for ensuring finished goods meet the production schedule and are in compliance with quality standards set for the facility. Leads by example and holds their team accountable for performance/results. Essential Duties and Responsibilities: Ensures team compliance with all current quality/cGMP and safety systems Tracks, records and reports production data / KPI's on a daily basis. Leads shift change meeting. Clearly communicates management priorities to team. Maintains operational/batch data. Reads and analyzes charts, work orders or production schedules to determine production requirements. Ensures new employees are trained, coached and evaluated. Continuously assesses team performance on production floor and verifies compliance with cGMP/SOP requirements. Ensures team members are trained, coached and developed to maintain coverage of critical tasks/functions in support of manufacturing operations. Maintains training records for team. Schedules/facilitates training as required. Executes daily production schedule as planned. Initiates discrepancies as they occur and provides input on root cause and preventative actions. Consults with Manufacturing Department Managers to coordinate operations and activities within and between departments. Confers with management and/or subordinates to resolve worker problems and complaints. Reviews and provides feedback for SOP/TOI revision documents. Inspects materials, products or equipment to detect defects or malfunctions. Routinely inspects documentation, processing rooms, equipment and finished good packaging during their shift to ensure compliance with cGMP manufacturing. Monitors gauges, dials, and other indicators to ensure operations conform to production or processing standards. Sets up and adjusts machines and equipment. Monitors production area and enforces safety or sanitation regulations. Inspects process rooms Conducts batch record review and reconciliation. Completes work order forms. Utilize ERP system to issue, track and record manufacturing operation. Other duties may be assigned as deemed appropriate by management Qualifications: High School diploma or equivalent. Minimum of two years of supervisory experience in the chemical manufacturing industry: candidates with less experience may be selected at the discretion of management. Demonstrated ability to lead and supervise employees to achieve production goals while ensuring that quality, regulatory, safety, and environmental requirements are met. Capability to lead, coach, inspire, and motivate employees to develop effective teamwork and achieve outstanding performance standards. Demonstrated capabilities to diagnose and solve problems, assess situations and take appropriate actions, make decisions effectively, and communicate to employees at all levels of the organization. Mechanical reasoning and critical thinking skills required in order to troubleshoot chemical manufacturing process. Proficient with ERP system use. Proficient in Microsoft Office (Excel, Outlook, PowerPoint, Word) Must be able to read, write, speak, and understand English. Work Hours: Exempt Position Shift: 12-Hour Alternating 3 days on/3 days off (7:30pm-8:00am) Minimum of 40-45 Hours Week, or other agreed upon documented schedule Ability and willingness to work from all BioSpectra facilities- Primary Location: Bangor, PA If you are ready to take on a challenging role, make an impact, and grow with a dynamic company that values innovation and quality, this position is for you! Apply now to be a part of our dedicated team and contribute to our ongoing success!

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Leads and supports manufacturing employees to manufacture safe, quality products per cost standards while meeting manufacturing schedule requirements. Job Responsibilities and Essential Duties * Leads activities of shift performance to meet manufacturing schedule. * Completes production requirements by expediting work results; monitoring progress; resolving problems. * Improves workflow by eliminating stoppages; analyzing delays; recommending new methods. * Leads/participates in timely resolution of activities related to non-conformances. * Maintains team/line/associate productivity & efficiency to meet or exceed standard labor requirements. * Provide guidance, direction and leadership to establish and maintain a strong (resilient) manufacturing team by orienting, assigning, and coaching employees; communicating job expectations; developing personal growth opportunities, appraising job contributions. * Maintain timely execution of job specific training for manufacturing team members to meet organizational requirements. * Maintains safe and healthy work environment by following and enforcing standards and procedures; complying with legal regulations. * Interfaces with Materials Management to coordinate materials for production. * Track and maintain employee attendance records & address performance problems. * Contributes to team effort by accomplishing related results as needed. Minimum Requirements * Bachelor's degree, or equivalent (Operations Management, Engineering, or other technical discipline preferred). * Minimum four years leadership experience in a manufacturing environment, two of which must be direct supervisory experience, preferably in a medical device environment. Required Knowledge, Skills and Abilities * Team Leader capable of developing team structure, demonstrated Leadership Skills. * Experience in the implementation and sustainability of lean manufacturing concepts * PC proficiency required (email, MS Office applications). * Ability to manage multiple priorities in a manufacturing plant setting. * Demonstrated business ethics, integrity and discretion required. * Flexible and adaptable to changing circumstances, procedures, and environment. * Working knowledge of Quality Systems Regulation requirements for medical devices. * Strong computer skills, including MS Office (Word/Excel) applications. * Knowledge of Oracle a plus. Supervision/Management of Others * Supervisory Skills - The ability to coach, develop and motivate associates to optimize team effectiveness. Ability to impact team morale, sense of belonging and participation. Quality Requirements * Build Quality into all aspects of their work by maintaining compliance to all quality requirements. * Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function). * Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function). * Attend all required Quality & Compliance training at the specified interval. * Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements. Environmental/Safety/Physical Work Conditions * Ensures environmental consciousness and safe practices are exhibited in decisions. * Duties are performed in a Controlled Environment * May require the use of personal protective equipment as dictated by the work environment. * Use/work in the immediate vicinity of 70/30 isopropyl alcohol (IPA) solution used for the preparation of work areas (line clearance) and used during the manufacturing process. Annual salary of $75,000 to $95,000 with 8% STIP #LI-YA2 #LI-Onsite About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: * Health, Dental, and Vision insurance benefits * 401k plan with company match * Paid Time Off * Wellness initiative & Health Assistance Resources * Life Insurance * Short and Long Term Disability Benefits * Health and Dependent Care Flexible Spending Accounts * Commuter Benefits * Parental and Caregiver Leave * Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

The Supervisor/Sr. Supervisor, Manufacturing, Floor Operations (Supervisor) leads a team of manufacturing associates to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Supervisor will plan, assign, and monitor daily tasks to ensure timely "Right First Time" execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor will also lead teams on projects to author standard operating procedures (SOPs) or Master Batch Records (MBRs); implement corrective and preventive actions (CAPAs); and help specify, commission, and qualify new facilities and/or equipment. A proven and qualified Supervisor will use knowledge and experience in upstream processing (seed expansion, bioreactor operations, cell culture harvest), downstream processing (purification and bulk filling) to teach others, troubleshoot, and continuously improve daily operations, and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. The Supervisor will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Additionally, the Manufacturing Support supervisor manages the staff who clean the GMP facilities. The Supervisor will review manufacturing procedures and train manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production batch records and production orders to ensure a comprehensive and accurate set of actions have occurred. It is management's expectation that all deviations/events are documented and escalated according to KBI internal notification processes. The Sr. Supervisor will use leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, troubleshoot issues, and track/trend metrics. Position Responsibilities * Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution. * Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology. * Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. * Ensure timely corrections to batch documentation and logbooks. * Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. * Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. * Author, train, review manufacturing procedures * Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed. Position Requirements Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent. Sr. Supervisor * Bachelor's degree in a related scientific or engineering discipline and 8 years' experience in related cGMP manufacturing operations; or high school degree and 12 years' experience, or equivalent. * 2+ years prior leadership/supervisory experience. * Demonstrated knowledge of upstream (cell culture or microbial fermentation) or downstream unit operations for production of biopharmaceuticals is preferred. * Experience in single-use platform technology is preferred. For Supervisor, prior experience in a leadership/supervisory role is preferred. * Knowledge of quality systems and regulatory expectations is preferred. * Excellent written and verbal communication skills are required. * Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor * Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. * Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. * Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. * MS Office, ERP, EDMS, production equipment software, other * Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Supervisor/Sr. Supervisor, Manufacturing, Floor Operations (Supervisor) leads a team of manufacturing associates to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Supervisor will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor will also lead teams on projects to author standard operating procedures (SOPs) or Master Batch Records (MBRs); implement corrective and preventive actions (CAPAs); and help specify, commission, and qualify new facilities and/or equipment. A proven and qualified Supervisor will use knowledge and experience in upstream processing (seed expansion, bioreactor operations, cell culture harvest), downstream processing (purification and bulk filling) to teach others, troubleshoot, and continuously improve daily operations, and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. The Supervisor will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Additionally, the Manufacturing Support supervisor manages the staff who clean the GMP facilities. The Supervisor will review manufacturing procedures and train manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production batch records and production orders to ensure a comprehensive and accurate set of actions have occurred. It is management's expectation that all deviations/events are documented and escalated according to KBI internal notification processes. The Sr. Supervisor will use leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, troubleshoot issues, and track/trend metrics. Position Responsibilities Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology. Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks. Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. Author, train, review manufacturing procedures Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed. Position Requirements Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent. Sr. Supervisor Bachelor's degree in a related scientific or engineering discipline and 8 years' experience in related cGMP manufacturing operations; or high school degree and 12 years' experience, or equivalent. 2+ years prior leadership/supervisory experience. Demonstrated knowledge of upstream (cell culture or microbial fermentation) or downstream unit operations for production of biopharmaceuticals is preferred. Experience in single-use platform technology is preferred. For Supervisor, prior experience in a leadership/supervisory role is preferred. Knowledge of quality systems and regulatory expectations is preferred. Excellent written and verbal communication skills are required. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. MS Office, ERP, EDMS, production equipment software, other Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Manufacturing Supervisor, Solution Prep leads a team of manufacturing associates to perform both upstream and downstream preparation of solutions and growth media used for processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The individual will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor may also support core production operations (cell culture or purification), lead teams on projects to author standard operating procedures (SOPs) or batch and solution records; implement corrective and preventive actions (CAPAs); support continuous improvement and other initiatives involving safety, quality, delivery, engagement, & cost in accordance to KBI/JSR business objectives. A proven and qualified supervisor will use knowledge and experience to execute production operations, coach staff, troubleshoot, and continuously improve daily operations and/or manufacturing support operations. The Supervisor will have a working knowledge of bioprocessing equipment. including but not limited to, filters, filter integrity testers, balances, pumps, analytical instruments, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). The Supervisor will review manufacturing procedures and instruct manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production documents to ensure accuracy and completeness. It is management's expectation that supervisors uphold the company's core competencies and departures from specifications and/or policies are reported according to KBI internal notification processes. Job Responsibilities Support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology. Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks. Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. Author, train, review manufacturing procedures. Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed. Minimum Requirements Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent. Demonstrated knowledge of mammalian cell culture (or microbial fermentation) or purification operations for production of biopharmaceuticals is preferred. Experience in single-use platform technology is preferred. Knowledge of quality systems and regulatory expectations is preferred. Excellent written and verbal communication skills are required. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Language Ability Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. Computer Skills Knowledge of and experience using MS Office, ERP, EDMS, production equipment software is required Equipment Use Knowledge of and experience using upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment is required Working Conditions The job requires working 12-hour shifts (2-2-3 schedule) which include working weekends and holidays and may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel. Duties and Responsibilities Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completed Responsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss Maintain weekly/daily schedule Use production schedule and activities, communicate necessary to do tasks to associates and/or leads Communicate and maintain the thaw / equilibration schedules for chemicals and/or equipment Maintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as needed Review Master Production Batch records in timely manner and provides suggestions/corrections to PE member Review SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframes Complete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for review Initiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions Identify safety risks and alerts management to take corrective action Provide timely communication to management and clients of issues, challenges as well as opportunities for process improvements Other duties as assigned Regulatory Responsibilities Ensure all work is conducted following a high standard of GMP compliance and written SOP and batch records Comply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirements Supervisory Responsibilities Assign and direct work, provide direction, resources and resolve problems Participate in recruiting Provide feedback on performance to Formulation Manager Train team members and ensures proper training is completed prior to assigning tasks Experience Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products Two (2) to three (3) years' work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of same Leadership experience as a team lead of supervisor type role preferred Education Bachelor's degree preferred An equivalent combination of education and experience may be considered Knowledge, Skills & Abilities Possess working knowledge of formulation/compounding processes and equipment cGMP and cGLP practices Experience with Microsoft Office and general computer proficiency Attention to detail Able to follow rules and regulations Mechanical aptitude Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities Honesty, integrity, respect and courtesy with leadership and peers Ability to build collaborative relationships Supervisory skills Conflict resolution Able to perform complex work instructions and trouble shoot complex problems Physical Requirements Able to meet gowning requirements Visual acuity Fine and gross motor skills to manipulate tools and equipment Able to remain stationary for continuous prolonged periods of time Able to lift 30lbs repeatedly Able to wear PPE Able to be medically qualified to participate in respirator program Able to use standard office equipment with or without reasonable accommodation

The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel. Duties and Responsibilities Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completed Responsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss Maintain weekly/daily schedule Use production schedule and activities, communicate necessary to do tasks to associates and/or leads Communicate and maintain the thaw / equilibration schedules for chemicals and/or equipment Maintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as needed Review Master Production Batch records in timely manner and provides suggestions/corrections to PE member Review SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframes Complete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for review Initiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions Identify safety risks and alerts management to take corrective action Provide timely communication to management and clients of issues, challenges as well as opportunities for process improvements Other duties as assigned Regulatory Responsibilities Ensure all work is conducted following a high standard of GMP compliance and written SOP and batch records Comply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirements Supervisory Responsibilities Assign and direct work, provide direction, resources and resolve problems Participate in recruiting Provide feedback on performance to Formulation Manager Train team members and ensures proper training is completed prior to assigning tasks Experience Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products Two (2) to three (3) years' work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of same Leadership experience as a team lead of supervisor type role preferred Education Bachelor's degree preferred An equivalent combination of education and experience may be considered Knowledge, Skills & Abilities Possess working knowledge of formulation/compounding processes and equipment cGMP and cGLP practices Experience with Microsoft Office and general computer proficiency Attention to detail Able to follow rules and regulations Mechanical aptitude Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities Honesty, integrity, respect and courtesy with leadership and peers Ability to build collaborative relationships Supervisory skills Conflict resolution Able to perform complex work instructions and trouble shoot complex problems Physical Requirements Able to meet gowning requirements Visual acuity Fine and gross motor skills to manipulate tools and equipment Able to remain stationary for continuous prolonged periods of time Able to lift 30lbs repeatedly Able to wear PPE Able to be medically qualified to participate in respirator program Able to use standard office equipment with or without reasonable accommodation