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Engineering Manager jobs at Bristol-Myers Squibb - 274 jobs

  • Director, Manufacturing Engineer

    Otsuka Pharmaceutical Co., Ltd. 4.9company rating

    Palo Alto, CA jobs

    Director, Engineering page is loaded## Director, Engineeringremote type: Onsitelocations: Palo Altotime type: Full timeposted on: Posted 2 Days Agojob requisition id: R10061At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.**Position Overview:** We are seeking a highly skilled and experienced Director of Engineering to lead our engineering team. The ideal candidate will have a strong background in medical devices, including both hardware and consumables expertise. Knowledge of ultrasonic therapy and/or PZT is a plus. This role requires a visionary leader who can drive innovation, ensure regulatory compliance, and oversee the successful execution of engineering projects from concept to commercialization.**Key Responsibilities:*** **Leadership & Management:** + Lead and mentor a team of engineers, fostering a culture of innovation and excellence. + Oversee the hiring, training, and development of engineering staff. + Conduct performance evaluations and provide constructive feedback.* **Project Management:** + Plan, coordinate, and supervise engineering projects within the organization. + Ensure projects are completed on time, within budget, and meet quality standards. + Collaborate with cross-functional teams, including R&D, regulatory, and manufacturing, to align engineering efforts with company objectives.* **Technical Expertise:** + Provide technical guidance and support in the development of ultrasonic therapy devices for renal denervation. + Stay abreast of the latest advancements in medical device technology and integrate new innovations into product development.* **Regulatory Compliance:** + Ensure all engineering activities comply with FDA regulations and ISO 13485 standards. + Prepare and manage documentation for regulatory submissions and audits.* **Strategic Planning:** + Develop and implement engineering strategies that align with the company's long-term goals. + Manage budgets, resource allocation, and timelines for engineering projects.* **Quality Assurance:** + Establish and maintain engineering policies, standards, and procedures. + Ensure adherence to safety and environmental regulations.**Qualifications:*** Bachelor's or Master's degree in Engineering, Biomedical Engineering, or a related field.* Minimum of 10 years of experience in medical device development, with at least 5 years in a leadership role.* Proven track record of successful project management and product development in the medical device industry.* In-depth knowledge of ultrasonic therapy and renal denervation technologies.* Strong understanding of FDA regulations and ISO 13485 standards.* Excellent leadership, communication, and interpersonal skills.* Ability to work collaboratively in a fast-paced, dynamic environment.**Benefits:*** Competitive salary and performance-based bonuses.* Comprehensive health, dental, and vision insurance.* Retirement savings plan with company match.* Opportunities for professional development and career advancement.**Salary Range:** $221,695- $240,000 **(Annual Base Salary)**The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.**Equal Employment Opportunity** At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.Respecting your privacy is an essential part of the Company's privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant's application for employment, a Contract Worker's work, or a Former Employee's employment at Recor. Refer to our for more detail information. #J-18808-Ljbffr
    $221.7k-240k yearly 3d ago
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  • Manager - Engineering & Maintenance

    Biocon 4.3company rating

    Cranbury, NJ jobs

    1. Equipment & Facility Maintenance Lead maintenance of OSD manufacturing equipment such as blenders, granulators, fluid bed dryers, sifters, mills, tablet presses, capsule fillers, coating pans, dust collectors, compressors, chillers, boilers, AHUs, and dehumidifiers. Implement robust Preventive Maintenance (PM) and predictive maintenance programs. Conduct breakdown investigations and implement corrective actions. Ensure critical facility systems (HVAC, electrical, plumbing, fire systems, BMS/EMS) are maintained and operate to required standards. 2. Regulatory Compliance & Documentation Ensure compliance with FDA, cGMP, 21 CFR Part 11, OSHA, and related regulatory requirements. Maintain records including PM logs, calibration reports, service documentation, change controls, deviations, and CAPAs. Support internal and external audits (FDA, DEA, ISO, and customer audits). 3. Utilities & HVAC Systems Management Manage key utilities such as compressed air, nitrogen, vacuum, HVAC, chilled water, steam, and RO/DI water systems. Ensure qualified and compliant environmental controls for classified OSD manufacturing areas. Maintain pressure cascades, temperature and humidity controls, and HEPA-filtered air systems. 4. Equipment Qualification & Validation Work with Validation and QA teams on IQ/OQ/PQ protocols. Manage requalification schedules and ensure equipment remains in a validated state. Provide engineering assessments for change controls. 5. Safety, Risk Management & Compliance Ensure adherence to OSHA, NFPA, and site safety requirements. Implement safety programs including LOTO, confined space, hot work, and electrical safety. Conduct incident investigations and lead corrective actions. 6. Spare Parts & Vendor Management Maintain optimum inventory of critical spare parts. Manage vendors, annual maintenance contracts (AMCs), and service agreements to control maintenance costs. Evaluate and onboard modern technologies and suppliers. Qualifications & Experience Education: Bachelor's degree in mechanical, Electrical, Chemical, or Industrial Engineering (or equivalent). Preferred: Master's degree or certifications such as CMRP or PMP. Experience: 8-15 years of engineering and maintenance experience in OSD pharmaceutical manufacturing. Strong knowledge of manufacturing and packaging equipment, utilities, HVAC, and cleanroom systems. Experience with FDA/DEA audits and equipment validation. Must have a valid work permit.
    $88k-119k yearly est. 3d ago
  • Global Engineering Capital & Strategy Director

    Allergan 4.8company rating

    Greenlawn, NY jobs

    A global biopharmaceutical company is seeking a Capital Planning Leader in Greenlawn, New York. The successful candidate will provide leadership for capital strategy development, oversee capital planning processes, and lead project engineers. Candidates should hold a Bachelor's in Engineering and have 10-15 years of relevant experience. This role involves managing significant annual investments and optimizing the manufacturing network. A comprehensive benefits package is offered, along with participation in incentive programs. #J-18808-Ljbffr
    $156k-215k yearly est. 3d ago
  • Director, Engineering and Maintenance

    Alliance Medical Products 3.7company rating

    Irvine, CA jobs

    "Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact. Your Role: The Director of Engineering and Maintenance will have a vast understanding of engineering, engineering management, manufacturing, quality assurance, automation engineering, maintenance management in pharmaceutical , major CAPEX Site Project approval and execution and maintenance in close collaboration with all the relevant stakeholders. Definition, integration, and coordination of the medium and long-term strategic roadmap in accordance with the strategic vision of the site. Development and facilitation of effective governance structures at the site level, establishing robust processes to track, analyze and monitor measures of operational performance. Must have very strong technical credentials and also have the ability to manage and develop the people and functions that are part of the Engineering department. The Director of Engineering and Maintenance must also work closely with site initiatives for facility, equipment acquisition, site modifications, and qualifications. The role is member of the Site Lead Team. Your Profile: Responsibilities Accomplishment of investment projects according to customer's needs (time, cost, functionality). Interface with Project Management, manufacturing, M&ST and Quality Assurance. Meet agreed upon budget and ensure compliance goals are met. Evaluate critical utilities requirements to support site activities. Accomplishment of investment projects according to customers' needs (time, cost, functionality) Minimization of asset life cycle costs Provide management leadership and oversight to engineers, maintenance, facilities and automation teams Oversee Maintenance, Facilities and Calibration activities. Lead major CAPEX process or equipment projects as required. Provide technical support to the manufacturing group as required. Fulfill responsibilities as a member of the DCR, Deviation and CAPA team. Oversee design and installation of production tooling and equipment. Provide technical support for evaluating and resolving CAPAs. Responsible for department budgeting, equipment purchases, and project planning. Evaluates testing and manufacturing equipment in order to purchase or to make recommendations for purchase of equipment to be used in Manufacturing. To ensure availability of competent, high performing people and managing the engineering talent pool. To stay abreast of current and newly emerging technologies to ensure that appropriate manufacturing techniques are utilized to manufacture high volume, high yield and high value products in aseptic operations. Any and all other duties as assigned by immediate supervisor. Responsible for the maintenance strategy, equipment reliability and KPIs. As a member of SLT, periodically report progress status of key Site actions and key plant initiatives. Ensure robust integration of site strategy with corporate programs. Ensure the sharing and leverage of best practice/ expertise in site and with other plants Required Knowledge, Skills and Abilities Ability to function well in a team environment. Requires extensive interfacing with manufacturers of equipment and vendors of diverse educational backgrounds. Must possess excellent oral and written communication skills. Must interface well cross functionally. Strong well-rounded engineering and project management experience. Superior analytical and computer skills. Capable of using good reason and judgment to make and defend recommendations. Proficient in computer skills, with Windows, Word, Excel, AutoCAD 14, Solid Works, Microsoft Project etc. Required Education and Experience Bachelor of Science Degree in Engineering or equivalent 15 years engineering experience in the pharmaceutical industry 7 or more years' experience in managing an engineering team, and maintenance and facility management. >5 years of GMP experience, including aseptic processes and clean utilities Demonstrated responsibility for CapEx and maintenance budgets > $3M Your Benefits: Siegfried offers competitive pay and benefits including: Medical, dental and vision coverage for employee and dependents Life, short- and long-term disability FSA and HSA 401k with a company match Generous PTO Target base salary -$200,000 - $230,000 Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.
    $200k-230k yearly Auto-Apply 35d ago
  • Director, Data Governance & Engineering, Research

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    Vertex is in an exciting time of growth and innovation, and technology and data are valued as strategic assets. We're seeking a visionary Director of Engineering and Data Governance to lead the strategy, planning, and governance of data and custom software solutions for our research, pre-clinical teams, and manufacturing teams. Reporting to the Sr. Director of DSE (Data & Software Engineering) Governance, you will drive innovation, ensure data quality, and enable impactful research through cutting edge data & AI products. This is a high-visibility leadership role with significant influence on Vertex's scientific and business outcomes. Your expertise in understanding engineering capabilities, managing engineering demand, estimating engineering projects, communicating project and function status, and driving governance and standards will be crucial in directing our engineering staff to deliver and support high value business-driven data and software at the right time, with approved resources, and with high quality. Key Duties & Responsibilities * Partner with DTE Leadership to develop and execute data and analytics strategy aligned to the research and manufacturing business strategy and develop data and analytics roadmaps to enable the data strategy. * Collaborate with cross-functional leaders to identify and deliver high-impact data and software solutions. * Oversee the management, documentation, use, and quality assurance processes for prioritized data projects and data assets, including proprietary data sets, third party data, research and pre-clinical data. * Establish and enforce data governance standards, frameworks and best practices. * Collaborate with stakeholders to define project goals, deliverables, timelines, budgets, and resource requirements. * Collaborate with resource managers to source, allocate and assign internal or contingent workers to project and operational activities * Monitor project progress, manage risks, and communicate status to senior leadership. * Collaborate with cross-functional DTE and business teams, including portfolio management, privacy, security, business engagement, DCS (Data and Computational Sciences), data science teams and HR to ensure data and software development needs are understood and solutions are aligned with prioritized business objectives. * Foster a culture of innovation, continuous improvement, and accountability. Knowledge and Skills: * Strong knowledge and experience with leading and managing data, AI/ML, reporting and analytics projects and assets for the research, pre-clinical, and manufacturing domains in the biopharmaceutical industry. * Knowledge and experience in the research functional area and the related business processes and data. * Strong understanding of data management, data governance, data architecture, software engineering, and cloud computing * Strong communication and presentation skills, with the ability to communicate technical and non-technical topics to senior leaders and engineering teams. * Proven ability to serve as a control function and enforce annual planning agreements by finding ways to say "yes" to prioritized commitments and "no" to lower priority requests * Strong understanding and awareness of data privacy, data security and compliance to relevant rules including GxP regulations. * Strong knowledge of modern technologies like AI/ML, LLMs, cloud computing, cybersecurity, data platforms like AWS, Snowflake and Databricks * Strong project management and resource planning skills. * Excellent communication and stakeholder management abilities. * Experience with Agile methodologies. Education and Experience * Bachelor's degree required (preferably in a technology or engineering discipline). * 10+ years' experience working in growing technology roles with at least 6 years in IT leadership positions. * 6+ years' experience in a similar governance, planning, or strategy role with a focus on bio pharma #LI-HYBRID Pay Range: $184,000 - $276,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $184k-276k yearly Auto-Apply 60d+ ago
  • Director, Data Governance & Engineering, Research

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA jobs

    Vertex is in an exciting time of growth and innovation, and technology and data are valued as strategic assets. We're seeking a visionary Director of Engineering and Data Governance to lead the strategy, planning, and governance of data and custom software solutions for our research, pre-clinical teams, and manufacturing teams. Reporting to the Sr. Director of DSE (Data & Software Engineering) Governance, you will drive innovation, ensure data quality, and enable impactful research through cutting edge data & AI products. This is a high-visibility leadership role with significant influence on Vertex's scientific and business outcomes. Your expertise in understanding engineering capabilities, managing engineering demand, estimating engineering projects, communicating project and function status, and driving governance and standards will be crucial in directing our engineering staff to deliver and support high value business-driven data and software at the right time, with approved resources, and with high quality. Key Duties & Responsibilities Partner with DTE Leadership to develop and execute data and analytics strategy aligned to the research and manufacturing business strategy and develop data and analytics roadmaps to enable the data strategy. Collaborate with cross-functional leaders to identify and deliver high-impact data and software solutions. Oversee the management, documentation, use, and quality assurance processes for prioritized data projects and data assets, including proprietary data sets, third party data, research and pre-clinical data. Establish and enforce data governance standards, frameworks and best practices. Collaborate with stakeholders to define project goals, deliverables, timelines, budgets, and resource requirements. Collaborate with resource managers to source, allocate and assign internal or contingent workers to project and operational activities Monitor project progress, manage risks, and communicate status to senior leadership. Collaborate with cross-functional DTE and business teams, including portfolio management, privacy, security, business engagement, DCS (Data and Computational Sciences), data science teams and HR to ensure data and software development needs are understood and solutions are aligned with prioritized business objectives. Foster a culture of innovation, continuous improvement, and accountability. Knowledge and Skills: Strong knowledge and experience with leading and managing data, AI/ML, reporting and analytics projects and assets for the research, pre-clinical, and manufacturing domains in the biopharmaceutical industry. Knowledge and experience in the research functional area and the related business processes and data. Strong understanding of data management, data governance, data architecture, software engineering, and cloud computing Strong communication and presentation skills, with the ability to communicate technical and non-technical topics to senior leaders and engineering teams. Proven ability to serve as a control function and enforce annual planning agreements by finding ways to say “yes” to prioritized commitments and “no” to lower priority requests Strong understanding and awareness of data privacy, data security and compliance to relevant rules including GxP regulations. Strong knowledge of modern technologies like AI/ML, LLMs, cloud computing, cybersecurity, data platforms like AWS, Snowflake and Databricks Strong project management and resource planning skills. Excellent communication and stakeholder management abilities. Experience with Agile methodologies. Education and Experience Bachelor's degree required (preferably in a technology or engineering discipline). 10+ years' experience working in growing technology roles with at least 6 years in IT leadership positions. 6+ years' experience in a similar governance, planning, or strategy role with a focus on bio pharma #LI-HYBRID Pay Range: $184,000 - $276,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $184k-276k yearly Auto-Apply 52d ago
  • Director of Process Engineering

    TTM 4.2company rating

    New York jobs

    TTM Technologies, Inc. - Publicly Traded US Company, NASDAQ (TTMI) - Top-5 Global Printed Circuit Board Manufacturer TTM Technologies, Inc. is a leading global manufacturer of technology products, including mission systems, radio frequency (“RF”) components, RF microwave/microelectronic assemblies, and technologically advanced printed circuit boards (“PCB”s). TTM stands for time-to-market, representing how TTM's time-critical, one-stop design, engineering and manufacturing services enable customers to reduce the time required to develop new products and bring them to market. Additional information can be found at *********** The Director of Process Engineering is responsible for providing leadership and direction to the process engineering group engaged in the manufacturing/test for complex electronics, including SMT, Wirebond, Die Attach, environmental testing and electrical testing. Duties and Responsibilities: Responsible for setting the engineering vision and strategy to meet overall long- and short-term company goals. This includes definition and communication of goals, key objectives, and metrics. Ensures that process engineering meets the business needs of the company as they relate to capabilities, processes, technologies, and capacity. Stays current with related manufacturing trends. Develops and enforces a culture of strong engineering discipline including robust process definition, extensive testing prior to production implementation, robust change management processes, clear and complete manufacturing instructions, statistical process monitoring and control, proactive error proofing, etc. Develops and maintains tactical and strategic plans to achieve the proper balance of process development and process maintenance. Ensures metrics are in place to monitor performance against the goals and takes appropriate corrective actions as required. Ensures that structured problem-solving techniques are used and that adequate validation is performed for any issues being address or changes being made. Prioritizes and coordinates resolution of problems related to equipment, safety, product, quality or process issues. Ensures adequate equipment capacity and process capability. Responsible to for Capital Expenditure tracking and qualification of new equipment. Implements plans to improve process capability using statistical analysis. Interfaces with customers on product design, product needs and product issues. Root cause analysis of issues associated with the plant. Evaluation of equipment through DOE and capability testing. Maintain the necessary communications and effective relationships with other company functions required to support the operation. Supports business development proposals and engineering efforts by providing technical resources necessary. Key member of site Technical Review Board (TRB). Develops and maintains an effective process engineering organization through the selection, training, development, compensation and motivation of all personnel assigned to their organization. Recommends and approves organizational structures and staffing requirements in support of company business objectives. Complies with laws, company policy and procedures including but not limited to Equal Opportunity Employment, Affirmative Action, Business Ethics, EPA, OSHA and other federal, state and local regulatory agencies. Other duties as required. Essential Knowledge and Skills: Able to exhibit a professional manner in dealing with superiors, colleagues, and customers Thorough knowledge of process improvement methodologies to include SPC, Root Cause Analysis, Design of Experiments, and Problem Solving techniques Knowledgeable on labor issues including safety, security, employee relations, scheduling and training Experience with electronics manufacturing processes and AS9100 requirements Ability to read, write and communicate in English to the degree necessary to perform the job Education and Experience: Bachelor of Science degree in Engineering or related science required 10 years' experience in engineering processes in electronics manufacturing industry technology with prior management experience, preferably in the Aerospace & Defense market #LI-PG1 Compensation and Benefits: TTM offers a variety of health and well-being benefit programs. Benefit options include medical, dental, vision, 401K, Flexible Spending Account, Health Savings Account, accident benefits, life insurance, disability benefits, paid vacation & holidays. Benefits are available 1st of the month following date of hire. Compensation for roles at TTM Technologies varies depending on a wide array of factors including but not limited to the specific office location, role, skill set and level of experience. As required by local law, TTM provides a reasonable range of compensation for roles that my be hired in New York, California and Colorado. For California-based roles, compensation ranges are based upon specific physical locations. Export Statement: Must comply with TTM Export Control Policies and Procedures and all applicable laws including ITAR, EAR and OFAC including but not limited to: a) being able to identify ITAR product on the manufacturing floor and understand that access to these products and related technical data is restricted to only US Citizens and US Permanent Residents; b) recognition of Foreign Person visitors by badge differentiation; c) understand and follow authorization procedures for bringing foreign visitors into facilities (VAL); d) understand the Export and ITAR requirements for shipments leaving the US; e) manage vendor approvals for ITAR manufacturing and services. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
    $134k-193k yearly est. Auto-Apply 48d ago
  • Director, Process Engineering

    Elanco 4.9company rating

    Fort Dodge, IA jobs

    At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Director, Process Engineering This Director has the responsibility to provide leadership for Process Engineering support at our Fort Dodge facility. This support includes both primary and secondary loop engineers with the purpose of ensuring that qualified and compliant equipment and is used in the manufacturing of Animal Health Products. Additionally, the director partners to influence and implement improvements across functional disciplines to ensure that the site achieves all business plan objectives and remains compliant with all regulatory requirements. Your Responsibilities: Provide leadership and development for the Process Engineering team by setting clear objectives, managing performance through regular reviews and coaching, and creating robust development and succession plans to build a high-performing, technically proficient organization. Oversee the entire equipment lifecycle, from commissioning to qualification and ongoing support, to ensure all manufacturing systems are compliant with cGMP, Elanco standards, and regulatory requirements, guaranteeing the production of safe and effective Animal Health Products. Act as a key change agent by partnering with manufacturing, quality, and other site functions to identify and implement process improvements; drive the adoption of automation and leverage strong engineering fundamentals and root cause analysis to enhance efficiency, reduce site expenses, and solve complex technical challenges. Champion a world-class safety culture by embedding Health, Safety, and Environmental (HSE) principles into all engineering activities, driving proactive risk reduction, ensuring timely incident reporting, and fostering an environment of accountability where every team member is engaged in preventing injury. Align departmental activities and resources to meet both short-term operational needs and long-term strategic business objectives, effectively managing headcount, overtime, and departmental expenses to deliver on site and functional goals. What You Need to Succeed (minimum qualifications): Education: Bachelor of Science in Engineering or equivalent relevant experience. Experience: A minimum of 5 years of experience in an engineering role within a regulated manufacturing environment, including proven experience leading technical teams or projects. Top Skills: Demonstrated leadership ability to influence and guide teams, coupled with strong technical knowledge of engineering fundamentals, equipment commissioning/qualification, and manufacturing HSE standards. What Will Give You a Competitive Edge (preferred qualifications): Proficiency with systems such as SAP (Maintenance module) and Trackwise for managing engineering and quality processes. Direct experience with Process Safety Management (PSM) principles and implementation. Experience in a biologics, vaccines, or sterile manufacturing environment. Demonstrated ability to manage departmental resources and align team objectives with broader site goals. Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: Multiple relocation packages Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 8-week parental leave 9 Employee Resource Groups Annual bonus offering Up to 6% 401K matching Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
    $109k-149k yearly est. Auto-Apply 2d ago
  • Director, Business Development - Clinical Research

    Frontage Laboratories 3.9company rating

    Secaucus, NJ jobs

    Director, Business Development - Clinical Research Director, Clinical Business Development Full Time Remote-USA Based Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Frontage Clinical Services At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion. Responsibilities: Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization Ensure appropriate strategy/solution is proposed to clients Monitor actions and results against plans Lead client visits to the Frontage facilities Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities Monitor sponsor satisfaction by regular communication with the clients/sponsors Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (sales f orce) system Represent Frontage at trade shows and other meetings Education, Skills and Experience Required: BS degree or above, life science preferred. 3+ years' experience in a clinical operation role and /or 1+ years' experience selling early-stage clinical research services. Solid understanding of the principles of drug discovery and development. Knowledge and experience in DMPK & Safety Toxicology Knowledge and understanding of FDA, GCP, and ICH regulations and guidance Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel. Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities. Excellent oral and written communication skills. Ability to travel. Established industry client network is a plus. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
    $129k-191k yearly est. Auto-Apply 60d+ ago
  • Director, External R&D

    Sanofi 4.3company rating

    Waltham, MA jobs

    Job Title: Director, External R&D About the Job The Director, External R&D (ER&D) will be responsible for sustaining Sanofi Vaccines' portfolio of new vaccines, vaccine candidates and vaccine technologies by identifying, evaluating and developing strategic partnerships with the global external network of public and private industry organizations. The position will report to and will work closely with the Global Head, External R&D, Vaccines R&D. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: Proactively scan the external network of companies, academic institutions and government sponsored R&D organizations to identify and evaluate scientific and technological innovations relevant to the business of Sanofi Vaccines. As a member of the ER&D team, develop and maintain the relationships with the vast network of external organizations through various platforms such as participating in partnering meetings and networking conferences, e.g., World Vaccine Congress, BIO, JPMorgan Healthcare, etc. Provide a critical scientific and technical analyses of the external opportunities and collaborate with internal stakeholders (e.g., R&D, Medical Affairs, Franchise Strategy) to formulate the basis for recommendations on the external innovations. Work closely with the Business Development and Legal teams to support business negotiations with potential external partners; provide scientific and technical input to support the constructive negotiations, accurate deal structure evaluations and appropriate deal structure; support the evaluation of the external party's confidential technical/due diligence materials by assembling the evaluation team, coordinating the interactions with the partner and contributing to the final technical due-diligence report. Present to the Vaccines Leadership the outcomes of the assessments arising from the external company engagements to Vaccine Leadership as well as governance committees, including the External Innovation Evaluation Committee (EIEC), Therapeutic Area Review Committee (TARC), as appropriate. Work collaboratively with internal stakeholders (R&D functions, mRNA Center of Excellence, Vaccine Portfolio Strategy, Vaccine Medical Affairs, Vaccine Public Franchise) to align the external engagement strategies with the needs and priorities of the organizations. Work collaboratively with other teams within the External Scientific Affairs (ESA) organization to advance the mission of the ESA, including scouting for licensing/acquisitions, external funding, and vaccine innovation projects. About You Minimum Requirements: M.D. or Ph.D. in bacteriology, virology, immunology, non-infectious disease, or other scientific discipline 7+ years of post-graduate experience Skills & Capabilities: Experience in Vaccines R&D and external partnering preferred Demonstrated interpersonal skills - ability to work with individuals at different levels and managing through influence Resourceful, entrepreneurial, and constantly up-to-date with vaccine-relevant innovation opportunities for Sanofi Vaccines Demonstrated team and negotiation skills Fluent English communication skills, verbal and written and ability to work in an international context Up to 15% per year of domestic or international travel Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $178,500.00 - $257,833.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $178.5k-257.8k yearly Auto-Apply 17d ago
  • Director, External R&D

    Sanofi Group 4.3company rating

    Waltham, MA jobs

    **Job Title:** Director, External R&D **About the Job** The Director, External R&D (ER&D) will be responsible for sustaining Sanofi Vaccines' portfolio of new vaccines, vaccine candidates and vaccine technologies by identifying, evaluating and developing strategic partnerships with the global external network of public and private industry organizations. The position will report to and will work closely with the Global Head, External R&D, Vaccines R&D. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. **Main Responsibilities:** + Proactively scan the external network of companies, academic institutions and government sponsored R&D organizations to identify and evaluate scientific and technological innovations relevant to the business of Sanofi Vaccines. + As a member of the ER&D team, develop and maintain the relationships with the vast network of external organizations through various platforms such as participating in partnering meetings and networking conferences, e.g., World Vaccine Congress, BIO, JPMorgan Healthcare, etc. + Provide a critical scientific and technical analyses of the external opportunities and collaborate with internal stakeholders (e.g., R&D, Medical Affairs, Franchise Strategy) to formulate the basis for recommendations on the external innovations. + Work closely with the Business Development and Legal teams to support business negotiations with potential external partners; provide scientific and technical input to support the constructive negotiations, accurate deal structure evaluations and appropriate deal structure; support the evaluation of the external party's confidential technical/due diligence materials by assembling the evaluation team, coordinating the interactions with the partner and contributing to the final technical due-diligence report. + Present to the Vaccines Leadership the outcomes of the assessments arising from the external company engagements to Vaccine Leadership as well as governance committees, including the External Innovation Evaluation Committee (EIEC), Therapeutic Area Review Committee (TARC), as appropriate. + Work collaboratively with internal stakeholders (R&D functions, mRNA Center of Excellence, Vaccine Portfolio Strategy, Vaccine Medical Affairs, Vaccine Public Franchise) to align the external engagement strategies with the needs and priorities of the organizations. + Work collaboratively with other teams within the External Scientific Affairs (ESA) organization to advance the mission of the ESA, including scouting for licensing/acquisitions, external funding, and vaccine innovation projects. **About You** **Minimum Requirements:** + M.D. or Ph.D. in bacteriology, virology, immunology, non-infectious disease, or other scientific discipline + 7+ years of post-graduate experience **Skills & Capabilities:** + Experience in Vaccines R&D and external partnering preferred + Demonstrated interpersonal skills - ability to work with individuals at different levels and managing through influence + Resourceful, entrepreneurial, and constantly up-to-date with vaccine-relevant innovation opportunities for Sanofi Vaccines + Demonstrated team and negotiation skills + Fluent English communication skills, verbal and written and ability to work in an international context + Up to 15% per year of domestic or international travel **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SP \#LI-SP \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $178,500.00 - $257,833.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
    $178.5k-257.8k yearly 60d+ ago
  • Senior Research Director, Analytical Chemistry - Synthetic Molecule Design and Development

    Eli Lilly and Company 4.6company rating

    Indianapolis, IN jobs

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients. Position Summary: The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is seeking experienced, innovative, and motivated scientists to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development. Responsibilities: Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development. Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions). Apply prior experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets. Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites. Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation). Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing. Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction. Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions. Welcome varied perspectives to create new solutions. Actively engage in the external environment; recognize and apply external innovation across the Lilly synthetic portfolio. Basic Requirements: Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field 8+ years' experience in a pharmaceutical industry setting with specific focus on small molecules, synthetic peptides, or oligonucleotides. Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities. Must possess strong communication (oral, written), organizational, and leadership skills. Additional Preferences: Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations. Demonstrated ability to drive and accept change. Good interpersonal skills and a sustained tendency for collaboration. Demonstrated success in persuasion, influence, and negotiation. Additional Information: Travel: 0 to 10% Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $250,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $144k-250.8k yearly Auto-Apply 58d ago
  • Director, External R&D

    Sanofi 4.3company rating

    Pennsylvania jobs

    Job Title: Director, External R&D About the Job The Director, External R&D (ER&D) will be responsible for sustaining Sanofi Vaccines' portfolio of new vaccines, vaccine candidates and vaccine technologies by identifying, evaluating and developing strategic partnerships with the global external network of public and private industry organizations. The position will report to and will work closely with the Global Head, External R&D, Vaccines R&D. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: * Proactively scan the external network of companies, academic institutions and government sponsored R&D organizations to identify and evaluate scientific and technological innovations relevant to the business of Sanofi Vaccines. * As a member of the ER&D team, develop and maintain the relationships with the vast network of external organizations through various platforms such as participating in partnering meetings and networking conferences, e.g., World Vaccine Congress, BIO, JPMorgan Healthcare, etc. * Provide a critical scientific and technical analyses of the external opportunities and collaborate with internal stakeholders (e.g., R&D, Medical Affairs, Franchise Strategy) to formulate the basis for recommendations on the external innovations. * Work closely with the Business Development and Legal teams to support business negotiations with potential external partners; provide scientific and technical input to support the constructive negotiations, accurate deal structure evaluations and appropriate deal structure; support the evaluation of the external party's confidential technical/due diligence materials by assembling the evaluation team, coordinating the interactions with the partner and contributing to the final technical due-diligence report. * Present to the Vaccines Leadership the outcomes of the assessments arising from the external company engagements to Vaccine Leadership as well as governance committees, including the External Innovation Evaluation Committee (EIEC), Therapeutic Area Review Committee (TARC), as appropriate. * Work collaboratively with internal stakeholders (R&D functions, mRNA Center of Excellence, Vaccine Portfolio Strategy, Vaccine Medical Affairs, Vaccine Public Franchise) to align the external engagement strategies with the needs and priorities of the organizations. * Work collaboratively with other teams within the External Scientific Affairs (ESA) organization to advance the mission of the ESA, including scouting for licensing/acquisitions, external funding, and vaccine innovation projects. About You Minimum Requirements: * M.D. or Ph.D. in bacteriology, virology, immunology, non-infectious disease, or other scientific discipline * 7+ years of post-graduate experience Skills & Capabilities: * Experience in Vaccines R&D and external partnering preferred * Demonstrated interpersonal skills - ability to work with individuals at different levels and managing through influence * Resourceful, entrepreneurial, and constantly up-to-date with vaccine-relevant innovation opportunities for Sanofi Vaccines * Demonstrated team and negotiation skills * Fluent English communication skills, verbal and written and ability to work in an international context * Up to 15% per year of domestic or international travel Why Choose Us? * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $178,500.00 - $257,833.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $178.5k-257.8k yearly Auto-Apply 16d ago
  • Director, External R&D

    Sanofi Group 4.3company rating

    Pennsylvania jobs

    **Job Title:** Director, External R&D **About the Job** The Director, External R&D (ER&D) will be responsible for sustaining Sanofi Vaccines' portfolio of new vaccines, vaccine candidates and vaccine technologies by identifying, evaluating and developing strategic partnerships with the global external network of public and private industry organizations. The position will report to and will work closely with the Global Head, External R&D, Vaccines R&D. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. **Main Responsibilities:** + Proactively scan the external network of companies, academic institutions and government sponsored R&D organizations to identify and evaluate scientific and technological innovations relevant to the business of Sanofi Vaccines. + As a member of the ER&D team, develop and maintain the relationships with the vast network of external organizations through various platforms such as participating in partnering meetings and networking conferences, e.g., World Vaccine Congress, BIO, JPMorgan Healthcare, etc. + Provide a critical scientific and technical analyses of the external opportunities and collaborate with internal stakeholders (e.g., R&D, Medical Affairs, Franchise Strategy) to formulate the basis for recommendations on the external innovations. + Work closely with the Business Development and Legal teams to support business negotiations with potential external partners; provide scientific and technical input to support the constructive negotiations, accurate deal structure evaluations and appropriate deal structure; support the evaluation of the external party's confidential technical/due diligence materials by assembling the evaluation team, coordinating the interactions with the partner and contributing to the final technical due-diligence report. + Present to the Vaccines Leadership the outcomes of the assessments arising from the external company engagements to Vaccine Leadership as well as governance committees, including the External Innovation Evaluation Committee (EIEC), Therapeutic Area Review Committee (TARC), as appropriate. + Work collaboratively with internal stakeholders (R&D functions, mRNA Center of Excellence, Vaccine Portfolio Strategy, Vaccine Medical Affairs, Vaccine Public Franchise) to align the external engagement strategies with the needs and priorities of the organizations. + Work collaboratively with other teams within the External Scientific Affairs (ESA) organization to advance the mission of the ESA, including scouting for licensing/acquisitions, external funding, and vaccine innovation projects. **About You** **Minimum Requirements:** + M.D. or Ph.D. in bacteriology, virology, immunology, non-infectious disease, or other scientific discipline + 7+ years of post-graduate experience **Skills & Capabilities:** + Experience in Vaccines R&D and external partnering preferred + Demonstrated interpersonal skills - ability to work with individuals at different levels and managing through influence + Resourceful, entrepreneurial, and constantly up-to-date with vaccine-relevant innovation opportunities for Sanofi Vaccines + Demonstrated team and negotiation skills + Fluent English communication skills, verbal and written and ability to work in an international context + Up to 15% per year of domestic or international travel **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SP \#LI-SP \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $178,500.00 - $257,833.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
    $178.5k-257.8k yearly 60d+ ago
  • Senior Research Director, Analytical Chemistry - Synthetic Molecule Design and Development

    Eli Lilly and Company 4.6company rating

    Gas City, IN jobs

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients. Position Summary: The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is seeking experienced, innovative, and motivated scientists to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development. Responsibilities: Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development. Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions). Apply prior experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets. Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites. Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation). Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing. Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction. Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions. Welcome varied perspectives to create new solutions. Actively engage in the external environment; recognize and apply external innovation across the Lilly synthetic portfolio. Basic Requirements: Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field 8+ years' experience in a pharmaceutical industry setting with specific focus on small molecules, synthetic peptides, or oligonucleotides. Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities. Must possess strong communication (oral, written), organizational, and leadership skills. Additional Preferences: Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations. Demonstrated ability to drive and accept change. Good interpersonal skills and a sustained tendency for collaboration. Demonstrated success in persuasion, influence, and negotiation. Additional Information: Travel: 0 to 10% Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $250,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $144k-250.8k yearly Auto-Apply 60d+ ago
  • Project Manager, Engineering Projects

    Capsugel Holdings Us 4.6company rating

    Bend, OR jobs

    Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Lonza Pharma & Biotech has an exciting opportunity for a Project Manager, Engineering Projects at our Bend, Oregon site. In this role, you will lead complex capital projects that shape the future of pharmaceutical manufacturing and ensure compliance with the highest safety and quality standards. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental, and vision insurance. Access to global benefits: *************************************** What you will do Deliver site capital projects within scope, budget, and schedule. Lead projects from concept through design, construction, and qualification. Ensure compliance with safety, quality, and regulatory standards. Manage contractors and oversee procurement processes. Identify and mitigate project risks. Coordinate engineering and GMP documentation handover. Mentor team members in project management best practices. What we are looking for 5+ years of engineering experience in the pharmaceutical industry. 5+ years of project management experience. Strong knowledge of cGMP and regulatory compliance. Proficiency with Microsoft Project, AutoCAD, SAP, and CMMS systems. Ability to lead cross-functional teams and manage contractors. Excellent communication and problem-solving skills. Bachelor's degree in engineering or related field. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
    $80k-122k yearly est. Auto-Apply 23d ago
  • Project Manager, Engineering

    Fenwal 4.3company rating

    Melrose Park, IL jobs

    Job SummaryThe Engineering Project Manager leads and coordinates cross-functional projects to ensure delivery on time, within scope, and on budget. The role requires a balance of technical knowledge, structured project management, and leadership skills to plan, organize, and execute projects while maintaining clear communication with stakeholders.Responsibilities Project Management Plan, structure, and execute projects from initiation to completion, ensuring timelines, resources, and deliverables are aligned. Apply project management methodologies to ensure effective execution and risk management. Define clear project goals, milestones, and timelines, and implement structure from the start. Technical Leadership Leverage knowledge of product properties (aseptic, TS, bags, syringes, etc.), manufacturing technologies, and pharma execution strategies. Support design reviews, qualification activities, and technical decision-making. Drive structured problem solving and simplify complex challenges into actionable steps. Business & Financial Management Oversee project budgets, ensure cost control, and deliver within approved financial parameters. Monitor and report on project performance to stakeholders, including senior leadership. Team Leadership & Collaboration Motivate, guide, and align cross-functional teams while managing conflicts and facilitating decision-making. Communicate clearly and transparently with all stakeholders, including internal teams, customers, and senior leadership teams (SLT). Ensure every voice is heard and considered in the decision-making process. Continuous Improvement Encourage team self-reflection and learning, fostering a culture of continuous improvement. Identify and implement process enhancements to improve efficiency and effectiveness. Travel Expecting 20-30% travel based on projects All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. 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.
    $73k-105k yearly est. Auto-Apply 60d+ ago
  • Director RD&A

    Kerry 4.7company rating

    Beloit, WI jobs

    Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role We are seeking a dynamic and experienced Director of R&D to lead our Stocks and Broths platform in North America. This role will drive innovation, technical leadership, and product development across customer segments including retail, QSR, foodservice, and industrial manufacturing. The Director will be responsible for shaping the future of authentic, clean label, and functional stocks and broths, partnering closely with cross-functional stakeholders to deliver value through science-backed, culinary-inspired solutions. This is a high-impact leadership role that combines strategic thinking with hands-on technical expertise, offering the opportunity to directly influence product innovation for major North American food brands. Key responsibilities Strategic & Technical Leadership - Lead the North America R&D strategy for the Stocks and Broths portfolio, aligning with regional commercial goals and global R&D platforms - Identify and capitalize on growth opportunities by leveraging consumer trends, customer insights, and emerging technical capabilities - Drive development of clean label, natural, and functional ingredient solutions with differentiated sensory and nutritional benefits - Stay current with industry trends, competitive landscape, and regulatory changes affecting the stocks and broths category Innovation & Product Development - Lead product development across diverse platforms, including shelf-stable, refrigerated, and frozen formats - Oversee end-to-end R&D processes from bench-scale research through pilot testing to full-scale production in Kerry and customer facilities - Partner with process engineering, culinary, sensory, and regulatory teams to ensure technical feasibility, regulatory compliance, and consumer appeal - Establish and maintain technical standards, protocols, and best practices for the stocks and broths platform Customer Partnership & Business Development - Act as a trusted technical advisor and innovation partner to key North American customers, providing deep expertise in culinary and savory solutions - Lead technical discussions, co-creation sessions, and product presentations with customers - Support business development efforts by translating customer needs into viable technical solutions - Build and maintain strong relationships with customer R&D and procurement teams Team Development & Cross-Functional Collaboration - Manage, mentor, and develop a team of food scientists, technologists, and culinary developers across multiple locations - Foster a high-performance, collaborative culture focused on scientific rigor, curiosity, and measurable business impact - Work closely with commercial, operations, supply chain, quality, and regulatory teams to ensure seamless project execution - Champion knowledge sharing and best practice development within the broader Kerry R&D organization Qualifications and skills Education & Experience - Bachelor's degree in Food Science, Food Technology, Culinary Science, or related field; Master's or PhD strongly preferred - 10+ years of progressive R&D experience in the food industry, with demonstrated expertise in savory systems, broths, stocks, or protein-based products - 5+ years of leadership experience managing technical teams and complex projects - Proven track record of leading product development projects from concept through successful commercialization Technical Expertise - Deep understanding of clean label formulation principles and natural processing technologies (hydrolysis, fermentation, extraction) - Expertise in flavor chemistry, protein functionality, and thermal processing as applied to stocks and broths - Knowledge of scale-up processes and manufacturing considerations for liquid food products - Familiarity with U.S. regulatory standards (FDA, USDA) and customer quality requirements Recommended salary range for this position is Minimum 177K/ Midpoint 244K/ Maximum 311K
    $91k-128k yearly est. 60d+ ago
  • Engineering Project Manager

    SPL 4.6company rating

    Waunakee, WI jobs

    Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an Engineering Project Manager Incumbent is responsible for planning, administering, and completing assigned projects which may cross several functional areas. The Engineering Project Manager provides engineering guidance, planning, budgets, managerial reports and technical support for active pharmaceutical ingredient processes, and facility projects. This requires experience in design, construction and management of facility expansions and equipment installations. Leads process and equipment changes to achieve production requirements. Analyze production and utility equipment operations, routine maintenance, and energy requirements of pharmaceutical manufacturing systems to optimize economical operation and meet regulatory requirements. Responsibilities include: Provide engineering guidance and project management to complete assigned engineering projects starting with development of project scope through detail designing, budgeting, funding approval, project scheduling, construction completion and/or equipment installation, start-up commissioning, validation, and documentation. Develop design (process, facility, etc.) parameters for the manufacture of active pharmaceutical ingredients, including equipment and facility specifications. Develop funding justification, seek approval, and then accomplish and control projects within funding approval. Provide scope, hire, manage, supervise, review, and seek authorization of contracts for consulting engineering firms and construction contractors to accomplish the actual changes of processes, equipment, and facilities. Supervise installation, start-up, commissioning, and support validation of processing equipment. Document performance of processing systems to achieve validation and compliance with QA and other regulatory requirements and agencies. Design tests and methods to analyze process and utility conditions to optimize operational efficiencies and/or to meet defined process and product specifications. Effectively manage multiple projects at the same time. Lead cross-functional, data-driven troubleshooting of process and utility upsets using 5-Why, Ishikawa, FMEA, and A3/DMAIC; convert findings into durable CAPAs. Optimize process and clean utilities (WFI/RO, clean steam, compressed air/N₂, cleanroom HVAC pressure cascades) to improve yield, uptime, and energy/water intensity. Design and execute DOEs to tighten control of CPPs/CQAs; translate results into setpoints, tolerances, and alarm limits with documented rationale. Establish and maintain SPC/CPV trending and simple dashboards; act on signals (trend shifts, OOS/OOT) with timely investigations. Institutionalize gains through cGMP change control: update URS/specs, redlines/as-builts, SOPs, and training; ensure re-qualification (IQ/OQ/PQ) where required. Strengthen asset reliability via criticality analysis and CMMS-backed PM/PdM (e.g., vibration, thermography), and close out punch lists with pristine documentation. Job Requirements and Qualifications: Position will be filled up to the mid-level and determined at discretion of the hiring manager. Education: Bachelor's degree in engineering required (mechanical or chemical preferred). Working toward WI Professional Engineer License with FE Test Experience: 5 plus years of experience required; 10 plus years of experience preferred WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Qualifications JOB SUMMARY Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an Engineering Project Manager Incumbent is responsible for planning, administering, and completing assigned projects which may cross several functional areas. The Engineering Project Manager provides engineering guidance, planning, budgets, managerial reports and technical support for active pharmaceutical ingredient processes, and facility projects. This requires experience in design, construction and management of facility expansions and equipment installations. Leads process and equipment changes to achieve production requirements. Analyze production and utility equipment operations, routine maintenance, and energy requirements of pharmaceutical manufacturing systems to optimize economical operation and meet regulatory requirements. Responsibilities include: Provide engineering guidance and project management to complete assigned engineering projects starting with development of project scope through detail designing, budgeting, funding approval, project scheduling, construction completion and/or equipment installation, start-up commissioning, validation, and documentation. Develop design (process, facility, etc.) parameters for the manufacture of active pharmaceutical ingredients, including equipment and facility specifications. Develop funding justification, seek approval, and then accomplish and control projects within funding approval. Provide scope, hire, manage, supervise, review, and seek authorization of contracts for consulting engineering firms and construction contractors to accomplish the actual changes of processes, equipment, and facilities. Supervise installation, start-up, commissioning, and support validation of processing equipment. Document performance of processing systems to achieve validation and compliance with QA and other regulatory requirements and agencies. Design tests and methods to analyze process and utility conditions to optimize operational efficiencies and/or to meet defined process and product specifications. Effectively manage multiple projects at the same time. Lead cross-functional, data-driven troubleshooting of process and utility upsets using 5-Why, Ishikawa, FMEA, and A3/DMAIC; convert findings into durable CAPAs. Optimize process and clean utilities (WFI/RO, clean steam, compressed air/N₂, cleanroom HVAC pressure cascades) to improve yield, uptime, and energy/water intensity. Design and execute DOEs to tighten control of CPPs/CQAs; translate results into setpoints, tolerances, and alarm limits with documented rationale. Establish and maintain SPC/CPV trending and simple dashboards; act on signals (trend shifts, OOS/OOT) with timely investigations. Institutionalize gains through cGMP change control: update URS/specs, redlines/as-builts, SOPs, and training; ensure re-qualification (IQ/OQ/PQ) where required. Strengthen asset reliability via criticality analysis and CMMS-backed PM/PdM (e.g., vibration, thermography), and close out punch lists with pristine documentation. Job Requirements and Qualifications: Position will be filled up to the mid-level and determined at discretion of the hiring manager. Education: Bachelor's degree in engineering required (mechanical or chemical preferred). Working toward WI Professional Engineer License with FE Test Experience: 5 plus years of experience required; 10 plus years of experience preferred WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
    $75k-107k yearly est. 11d ago
  • Engineering Project Manager

    Pharmatek Consulting 4.0company rating

    Saint Louis, MO jobs

    Candidate will be responsible for Multiple Automation Engineering Projects : Manage design, installation, and quality testing aspects of automation projects in a GMP facility. Understand and manage the Lifecycle of automation projects Manage the materials planning, budget development, and cost control Manage a detailed project schedule and work plan Contribute to identifying and addressing complex technical issues Interface with vendors, when necessary, to ensure vendors deliver parts, materials, components, equipment, and services on -time, on -budget, and to technical specifications Requirements Good technical understanding of the automation space. Need technical knowledge of IT/automation (i.e. server upgrades, DeltaV, PLC ) and technical knowledge in the automation space is also necessary, but that's just to be effective as a PM. A successful candidate for this position should possess technical knowledge including, but not limited to: data exchange, supervisory control (including SCADA systems and HMI's), historians, programming and configuration (specifically in control logic), distributed control systems (DeltaV) and integration with enterprise systems.
    $66k-97k yearly est. 60d+ ago

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