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  • Business Development Manager - Remote position

    WuXi Apptec

    Remote job

    The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for STA Pharmaceutical, a WuXi AppTec company, in particularly to support the growth of emerging Discovery oligonucleotide and peptide (TIDES) Contract Development and Manufacture (CDMO) business. The candidate will work closely with the U.S. and Europe business development (BD) teams to pursue new business leads; follow up on critical issues, and aid in resolving customer inquiries. Assists marketing in delivering content and driving the success of new and existing services. This position will report to the Senior Director of Business Development, TIDES Discovery, and will help to support TIDES Discovery BD efforts in North America. Prospect for oligonucleotide and peptide new drug development companies that would benefit from the services of WuXi TIDES Discovery Services Uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing oligonucleotide and peptide clients Develop, grow, and maintain key accounts for Discovery oligonucleotide and peptide in WuXi Chemistry Achieve PO targets for key accounts and new accounts Attend conferences and meetings to present WuXi TIDES Discovery services to prospective and existing clients via email, phone, and web-conferencing systems. Act upon, refer, and follow up on leads from both sales and marketing campaigns. Qualify leads and work with necessary team members to complete RFQ/RFPs Work closely with all WuXi business units, project management teams, and marketing to ensure coordination of efforts and ensure good communication with all parties. Increase awareness of STA/TIDES's marketing initiatives, including scheduling meetings for tradeshows and driving registrations for webinars and seminars. Maintain abreast with industry trends, funding, regulatory influence, mergers and acquisitions, in-out licensing of products/technologies, government/private grants and contacts, new drug development and approvals, related patent grants and notifications, market growth of small, med, and large cap companies. Develop a social network of industry-related contacts via LinkedIn and other social networking platforms. Strategize quarterly business development plans and benchmark performance for continued success. Propose new ideas and strategies to increase performance and drive personal and team goals. Document information in Client Relationship Management (CRM) including contacts, pre-screened/qualified leads, and new account information as required. Advanced degree in chemistry or a related science field. A Ph.D. is preferred. Minimum of 1 year's relevant experience working in new drug development or CRO/CMO industry (oligonucleotide and peptide strongly preferred) Must be a self-starter, self-motivated, highly flexible, with excellent communication skills (verbal, written, and presentation skills). Must be organized and detail-oriented. Must have a proven track record of meeting or exceeding sales growth objectives and/or simultaneously managing several projects and timelines. Ability to perform within a professional environment and use judgment as dictated by the complexity of the situation. Experience with CRM (Customer Relationship Management) software (i.e., Salesforce) is preferred. Ability to accomplish the described duties through the use of appropriate computer equipment and software (i.e, Microsoft Word, Excel, Outlook, PowerPoint, and CRM) is required. Must be able to travel 35% An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
    $77k-119k yearly est. 1d ago
  • Mortgage Loan Executive Assistant

    Covita Lending LLC

    Columbus, OH

    Job Description The Loan Partner One (LP1), an Executive/Administrative Assistant, oversees the Loan Officer's lead, calendar, and database management for the Loan Officer (LO). The LP1 will directly communicate with new leads, active prospects, customers, clients, and business partners daily, ensuring a smooth workflow and strong team chemistry. This role requires strong communication, time management, priority management, and data entry skills. The LP1 must professionally represent the LO and team and strive to “wow” internally and externally daily. Benefits: Be a part of one of the biggest mortgage coaching communities in the country! Strong company culture Coaching and professional development Compensation: $60,000 - $65,000 yearly Responsibilities: Essential Duties of this Position Lead Management: Contact all new leads within 4 hours (or as required) Track all leads using the Lead Tracker Onboard all leads into the CRM, maintain and obsess over all lead-tracking ratios Ensure borrower appointments are scheduled (phone, video, or face-to-face) Provide daily, monthly, quarterly annual lead management reports Calendar Scheduling Management: Set 100% of all appointments for LO and team Confirm all appointments via email, text phone (24+ hours in advance) Review next-day schedules for LO before leaving each day Answer 90% of incoming calls for LO and team Manage recurring face-to-face business partner meetings for LO Ensure LO is prepared for the daily Phone “Power Hour” Database Management: Maintain database organization for the LO Send quarterly Letter-from-the-Heart (LFTH) Evidence of Success (EOS) snailmail Manage birthday, home closing anniversary programs Coordinate 2+ monthly leveraged events (lunch ‘n learns, happy hours, etc) Help LO send 2+ email newsletters (minimum) and monitor open rates Send handwritten notes, birthday cards, post-closing surveys, gifts, etc Additional Responsibilities Ensure LO stays on track for all daily appointments Manage LO's emails (if applicable) Handle incoming mail and maintain a spotless desk (if not virtual) for LO Maintain and support LO's tech tools Assist with all administrative duties as needed Stay “one step ahead” of LO at all times Qualifications: Standard Job Requirements NMLS License (if required by LO) High school diploma or equivalent 40-hour workweek minimum Experience with major Loan Origination Systems (Encompass, Calyx Point, etc) Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, OneNote) Excellent verbal and written communication skills Strong time management and organization Ability to work under pressure and meet deadlines About Company Covita Lending is an Independent Mortgage Broker based out of Columbus, Ohio, that operates in Ohio, Florida, Georgia, and South Carolina. Covita Lending offers a wide range of lending options to meet your financial needs and circumstances. With nearly 40 years of combined experience as top-producing loan officers, our assurance is that whether you are a first-time buyer, interested in refinancing your mortgage, or a real estate investor, we're here to guide you through the process.
    $60k-65k yearly 4d ago
  • Associate Copywriter

    Evoke 3.7company rating

    Remote job

    Associate Copywriter (ACW) In the journey of your life, your career should make a difference. At Inizio Evoke, we come together-to do the best work, in the best possible place. We're all in. Because it's everyone's role to make health more human. Who We Are Inizio Evoke DRIVE is a global health marketing, communications, and transformation platform unlocking growth through data-driven insights and human centricity. We study the why behind health decisions and create solutions that inspire meaningful change. Like the work we do for physicians, patients, and their loved ones, your career should make a difference. So, we come together-but not in an office, we're fully remote-united by our shared purpose and values. About the Role We are looking for an Associate Copywriter (ACW) to join our growing creative team and help ensure scientific and regulatory accuracy across every submission. If you're passionate about medical accuracy, thrive on detail, and want to support breakthrough creative in healthcare, this role is for you. The ACW is a critical role supporting the copy, editorial, and regulatory operations teams by managing references, annotations, and claims across high-volume, multi-brand submissions. You will help ensure every claim is traceable, every annotation is correct, and every tactic meets client and compliance standards-contributing directly to creative quality and client trust. You will report to an Associate Creative Director (Copy) in this role. What You'll Do * Source, validate, and organize medical/scientific references to support promotional claims across healthcare professional (HCP) and direct-to-patient (DTP) materials * Annotate manuscripts and prepare submission-ready reference materials * Ensure consistency of references and annotations across brands, tactics, and writers * Collaborate with editorial to confirm accuracy from manuscript through layout * Support Reg Ops by delivering properly formatted, client-ready annotation files * Serve as a point of contact for annotation and reference-related questions * Help maintain brand-specific reference libraries and stay aligned with client-specific submission rules (e.g., Gilead requirements) * Review and flag unsupported or inconsistent claims proactively * Participate in internal project reviews to stay aligned with creative and strategic direction Who You Are * Detail-driven and highly organized, with excellent file and workflow management * A clear communicator and strong collaborator, especially in cross-functional environments * Resilient and focused under pressure, able to manage multiple deadlines and priorities * Passionate about science, accuracy, and the role that regulatory excellence plays in great creative work * A self-starter with a commitment to quality and clarity * A good human-professional, team-minded, and curious Required Skills & Qualifications * Bachelor's degree in a science-related field (e.g., biology, psychology, chemistry) OR Significant employment experience in a science-related field requiring familiarity and comfort with scientific publications * Familiarity with reading and interpreting clinical literature * English or communications experience is a plus * Comfortable working in Microsoft Word and Adobe Acrobat * Excellent attention to detail, grammar, and written communication * Experience supporting annotation, claims, or fact-checking processes in a healthcare or scientific setting Bonus Points * Experience in a healthcare advertising, med comms, or pharma marketing agency * Familiarity with reference formatting (AMA or client-specific) * Exposure to client systems like Veeva or Zinc * Writing samples that show clarity, logic, and scientific understanding Work Environment & Benefits Inizio Evoke DRIVE offers a fully remote work environment and outstanding company-paid benefits, including medical, dental, 401(k), tuition reimbursement, and flexible time off. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. Don't meet every requirement? That's okay! We're committed to building a diverse and inclusive team. If you're excited about this role but your experience doesn't align perfectly, we encourage you to apply. You may be just the right person for this or another role.
    $92k-151k yearly est. Auto-Apply 27d ago
  • R&D Specialist III - Paint & Coatings

    Akzo Nobel N.V 4.7company rating

    Columbus, OH

    About AkzoNobel Since 1792, we've been supplying the innovative paints and coatings that help to color people's lives and protect what matters most. Our world class portfolio of brands - including Dulux, International, Sikkens and Interpon - is trusted by customers around the globe. We're active in more than 150 countries and use our expertise to sustain and enhance the fabric of everyday life. Because we believe every surface is an opportunity. It's what you'd expect from a pioneering and long-established paints company that's dedicated to providing sustainable solutions and preserving the best of what we have today - while creating an even better tomorrow. Let's paint the future together. For more information please visit ***************** 2024 Akzo Nobel N.V. All rights reserved. Job Purpose This job is for developing new products and / or maintaining existing products; it requires some professional work knowledge and experience to evaluate, select, and apply standard scientific techniques, processes, and criteria in the development, adaptation, and modification of new and existing products and technologies while under the guidance and supervision of Group Leader or similar. Key Responsibilities * Complete assigned tasks related to the research and development of new products, new technologies, and updates of existing products using assigned materials and methods. * Performs or oversees the work on technical workstreams such as new product introduction, raw material changes, product testing, and root cause analysis. * Implement, troubleshoot, and continuously improve plant processes (reduce cycle and increase efficiency, reliability, and sustainability, increase batch yields, decrease manufacturing costs, etc.). * Work collaboratively with Production, RD&I, CI, HSE&S, and others to develop processes, and define safe and efficient operating procedures. * Plan/schedule short term ( * Provide technical assistance and support to Production, Sales, and Marketing in support of product scale-up, quality control, application testing, and other cross-functional activities. * Investigate and determine corrective actions for production problems and customer complaints. * Investigate production problems related to formulation, quality control, and manufacturing issues. * Initiate the LWR (lab work request) process for product reformulation and proper manufacturing/QC instructions. * Maintains detailed technical records in the form of a Laboratory Notebook or Computer Databases. * Provide progress reports, monthly and quarterly reports, technical plans, and project summaries to ensure appropriate communication of project status and needs * Ensure proper testing procedures are in place and followed and review opportunities for alternative tests and equipment. * Review quality control documents and procedures. Perform quality audits and verify current practices against documentation. Update standard operation procedures when necessary. * Maintain and develop professional contacts including company personnel, vendors, and customers * Maintain a safe and clean work environment in accordance with company safety rules to ensure compliance with federal, state, and local environments and safety regulations * Participate in Special Teams including safety, HSE, housekeeping, etc. as required * Performs additional duties as assigned and required Job Requirements * A Bachelor's Degree in Chemistry or a related scientific field * 2-4 years of relevant experience; paint and coating related working experience preferred. * Knowledgeable of materials, products, and technologies frequently used within the scope an assigned project or laboratory group organization. * Ability to solve practical problems and deal with a variety of concrete variables in situations where standardization exists. * Ability to understand, interpret, and execute a variety of instructions furnished in written, oral, diagram, and/or schedule formats. * Ability to organize and interpret data, and develop insights based on knowledge of chemical structures and reactivity, propose, and test hypotheses, and draw conclusions. * Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. * Ability to keep detailed records. * Ability to write reports summarizing data and work results. * Must be fluent in English; oral and written. * Ability to apply concepts of algebra, basic statistics, and computer spreadsheet calculations. * Minimally able to use MS Word, Excel, and Outlook at a proficient level. * Able to perform common tasks utilizing MS PowerPoint, Optiva and SAP. * Prefer ability to utilize all indicated software at a proficient level. The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job. * Regularly required to stand and use hands to finger, handle, or feel objects, tool, or controls, walk, and sit, lift objects up to 40 pounds. * Wear a variety of personal protective equipment including safety glasses, safety shoes, chemical resistant gloves, laboratory coat, and/or positive and negative pressure respirators. Rewards & Benefits Salary range for this role is: $70,000 to $80,000. This is the range that we in good faith anticipate relying on when setting wages for this position. We may ultimately pay more or less than the posted range. This salary range may also be modified in the future. * Benefits beginning Day 1 * 401K retirement savings with 6% company match * Annual bonus 5% Short Term Incentive * Medical insurance with HSA. Dental, Vision, Life, AD&D benefits * Generous vacation (3 weeks), personal (1 week) and holiday (11 days) pay * Tuition Reimbursement * Career growth opportunities * Active Diversity and Inclusion Networks * Employee referral bonus Competencies Accepting Direction Accepting Responsibility Acquiring Information At AkzoNobel we are highly committed to ensuring an inclusive and respectful workplace where all employees can be their best self. We strive to embrace diversity in a context of tolerance. Our talent acquisition process plays an integral part in this journey, as setting the foundations for a diverse environment. For this reason we train and educate on the implications of our Unconscious Bias in order for our TA and hiring managers to be mindful of them and take corrective actions when applicable. In our organization, all qualified applicants receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age or disability. Requisition ID: #LI-SS1
    $70k-80k yearly 5d ago
  • Specialist Quality Assurance

    Us Tech Solutions 4.4company rating

    New Albany, OH

    + This position supports client's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. + The ideal candidate is a detail-oriented Quality Assurance professional with at least 2 years of GMP experience in a regulated manufacturing environment, preferably within pharmaceuticals or medical devices. + They should bring a solid understanding of QA documentation processes, including change controls, equipment qualifications, and master data approvals, and be comfortable working within SAP or EPR systems. + Strong project coordination skills and organizational discipline are essential, as this role supports a large-scale product launch and will require managing multiple deliverables on tight timelines. + A background in process development, manufacturing, or digital quality innovation is highly desirable. **Responsibilities:** + Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems. + Duties include presence on the shop floor, electronic batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records. + Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records, including Process and Equipment Validation Documents to completion. + The QA Specialist will also represent QA Functional area in the execution of projects necessary to achieve departmental operational goals. **Preferred Qualifications:** + Bachelor's Degree in Engineering, Biochemistry, Biology, Chemistry, or related science field. + Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices. + Experience managing projects through to completion meeting timelines. + Evaluating documentation and operations according to company procedures. + Experience working with Quality Systems Strong organizational skills and ability to manage multiple tasks at one time + Effective communication skills (both written and verbal). + Demonstrated ability to work as both a team player and independently. + Display leadership attributes and drive improvement initiatives. **Top 3 must have skills:** + Experience in and knowledge of GMP/GCP operations or similarly regulated industry + Affinity with digital innovation, data sciences and Quality engineering + Highly effective verbal and written communication skills, strong interpersonal skills + Great attention to detail and high degree of accuracy in task execution and GMP documentation + Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** . "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
    $47k-84k yearly est. 27d ago
  • Sterile Filling Technician I

    STAQ Pharma Inc. 3.7company rating

    Columbus, OH

    Job Description This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required. Hours of Work: Monday to Friday, 10 AM to 6:30 PM Due to production needs, you will be required to stay later if production requires SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for filling operations. Responsible for acquiring and maintaining classified area gowning qualification. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability.
    $32k-38k yearly est. 18h ago
  • Plant Manager

    Warabeya North America Inc.

    Columbus, OH

    Job Description The Plant Manager (PM) is responsible for all production, distribution, and maintenance activities in the Plant. The facility must be operated in a profitable, safe, and quality-conscious manner, meeting or exceeding all customer specifications, regulatory requirements of Federal, State and Local governments, as well as certifications as needed. This position also assists the purchasing department with quality issues; establishes and reviews sampling plans; interviews, hires, and trains QA personnel; assists with continuous product development; authorizes the release of raw materials and finished goods; and maintains plant documentation. Job Responsibilities: Ensure that all products are made and packaged according to Standard Operating Procedures and conform to customer or company specifications. Maintain orientation and training procedures to ensure that all new and existing employees understand their tasks and the machines used. Oversee management of all quality and food safety initiatives. Establish and maintain quality control procedures including Kaizen and root cause analysis to reduce waste and increase productivity. This includes direct intervention by PM in the case of more than 10% waste of a production run. Verify and improve capacities and scheduling requirements for maintaining at or below budget costs for labor and materials. Waste variance at less than 10% on all products unless equipment failure or natural disaster occurs beyond the control of PM. Recommend capital expenditures whenever "pay-back" analysis is at or under 24 months Ensure that all staff are trained in Good Manufacturing Practices as defined by the USDA and that all Company SOP's are in accordance as well Maintain lot tracking and recall systems Maintain HACCP plan in conjunction with QA/QC Ensure that all labeling is in accordance with USDA rules. Pass all regulatory inspections from USDA and local entities relating to the production for food products Manage the facility to be in compliance with OSHA regulations (Lock out/Tag out, Safety, MSDS). Administrate company policies for food safety (hand washing, hair nets, jewelry, and uniforms). Maintain positive employee morale. Manage the facility with progressive discipline for attendance, safety, product quality, attitude, harassment, etc. Oversee Maintenance Department to ensure equipment is safe and operates at an up-time percentage of 98%. Verify that Preventative Maintenance is being performed as required and that proper procedures and lubricants are utilized. Develop annual budgets with CFO and operate cost centers with less than 5% negative variance. Maintain facility in professional manner including customer areas and grounds Maintain a quality feedback procedure that identifies personnel requiring further training or discipline and that ensures that policies are enforced. Maintain yields at budget targets Maintain a working knowledge of all machines and manufacturing procedures for new product development, existing product problem solving and efficiency improvement. Supervise and assist the development of new products from Sales Department or customer requests maintaining yield and cost guidelines. Requirements and Qualifications Bachelor's degree in Chemistry, Food Science or related discipline required. Master's degree preferred Five years' experience in the food or pharmaceutical industry is required. Five years Management experience in a production facility is required. Aseptic processing experience strongly preferred. Knowledge of HACCP and GMPs, SQF, and OSHA Creative problem-solving skills. Excellent communication skills. Able to work in a dynamic and fast-paced environment Can do attitude and able to lead by example Credibility, both inside and outside the organization Honesty, integrity, and respect for others Excellent organizational and project management skills Meets deadlines consistently Highly self-motivated and commitment to continuing education Outstanding employee relations skills Ability to effectively prioritize and multitask Maintains confidentiality when needed Strong attention to detail Excellent oral and written communications skills Job Type: Full-time Pay: $135,000.00 - $150,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Schedule: 8-hour shift Weekends as needed Work Location: In person
    $135k-150k yearly 25d ago
  • Technical Services Consultant - Heavy Industry (Remote - 60% travel)

    Veralto

    Remote job

    **_Imagine yourself..._** + _Doing meaningful work that makes an everyday impact on the world around you._ + _Thriving in a supportive team environment that inspires you to strive for excellence._ + _Collaborating with a vibrant, diverse, global team._ It's possible with a role at ChemTreat (*************************** . ChemTreat, a Veralto (************************* company, is the nation's largest and fastest-growing specialty chemical company dedicated solely to industrial water treatment. We understand and respect the awe-inspiring power of water to impact industries, and to sustain and enhance lives. Our 2,000 associates across North and South America maximize this power for our customers-from power producers to food and beverage companies to the automotive industry-helping them grow their businesses while protecting people and the environment. When you join the ChemTreat team and the broader Veralto network, you'll have the chance to shape the future of our planet and the future of your career. You'll have opportunities to build new skills and invest in your development, all while doing meaningful work that makes an everyday impact on the world's vital water resources. Learn more about how our team is maximizing the power of water: ********************* **We offer:** + +20 days of vacation + Flexible working hours + Professional onboarding and training options + Powerful team looking forward to working with you + Career coaching and development opportunities + Health benefits + 401(k) Reporting to the **Technical Sales Manager** , the **Technical Services Consultant** is responsible for providing application support to sales representatives and clients in product screenings and treatment program selections. This role is key in troubleshooting treatment programs to meet customer cost and performance objectives. This role prepares reports, recommendations and results to assist the sales representatives in advancing the selling process. Ideal for someone passionate about water treatment technologies, problem-solving, and directly impacting client success across multiple industries. This position is part of the **Technical Services Department** in North America. **We are looking for someone based in** **Texas or Louisiana** **. The role is remote, with frequent travel throughout the U.S. and occasional trips to Canada and Latin America.** **In this role, a typical day will look like:** + Provide technical support to ChemTreat sales representatives in product screening, treatment program selection, and troubleshooting programs to meet customer objectives. + Actively participate in the technology selection stage of the sales process, acting as a key technical advisor and product advocate. + Conduct client interviews to understand business conditions, risks, and controls. + Perform plant surveys, equipment inspections, and on-site troubleshooting, including confined spaces as defined by OSHA. + Prepare proposals, trip reports, and assist in sales presentations and operator training. + **Travel up to 60% of the time, primarily within Texas and Louisiana, but also potentially across the US, Canada, and Latin America.** **The essential requirements of the job include:** + Bachelor's or Master's degree in Biology, Chemistry, Engineering, or related field, or comparable military experience. + 10+ years of experience in Water Treatment industry or utility operations experience, preferably in petrochemical or refining industries. + Technical knowledge in boiler internal treatment, BFW pretreatment, cooling water treatment, biological wastewater, and surface water clarification. + Comfortable with presenting treatment recommendations in written and oral communications. + Willingness to travel up to 60% of the time, primarily within Texas and Louisiana, but also to anywhere in the US, Canada and Latin America (Valid passport is required) **ChemTreat** is proud to be a part of the **Water Quality** segment of **Veralto** (NYSE: VLTO), a $5B global leader dedicated to ensuring access to clean water, safe food and medicine, and trusted essential goods. When you join Veralto's vibrant global network of 16,000 associates, you join a unique culture and work environment _where purpose meets possibility_ : where the work you do has an everyday impact on the resources and essentials we all rely on, and where you'll have valuable opportunities to deepen your skillset, pursue your ambitions, and grow your career. Together, we're Safeguarding the World's Most Vital Resources-and building rewarding careers along the way. **US ONLY** **:** The below range reflects the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future. An associate's position within the salary range will be based on several factors, including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, shift, travel requirements, sales or revenue-based metrics, any collective bargaining agreements, and business or organizational needs. The compensation range for this role is $170,000 - $200,000 USD per year. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. US residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Veralto Corporation and all Veralto Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available **here (********************************************* . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@veralto.com to request accommodation. **Unsolicited Assistance** We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at any of the Veralto companies (*************************************** , in any form without a valid, signed search agreement in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Veralto and its companies. No fee will be paid in the event the candidate is hired by Veralto and its companies because of the unsolicited referral. Veralto and all Veralto Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
    $48k-96k yearly est. 54d ago
  • 2026 Computational Beamline / Plasma Scientist Summer Intern - MS/PhD (Gloucester, MA)

    Applied Materials 4.5company rating

    Remote job

    **Who We Are** Applied Materials is a global leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. We design, build and service cutting-edge equipment that helps our customers manufacture display and semiconductor chips - the brains of devices we use every day. As the foundation of the global electronics industry, Applied enables the exciting technologies that literally connect our world - like AI and IoT. If you want to push the boundaries of materials science and engineering to create next generation technology, join us to deliver material innovation that changes the world. **What We Offer** Location: Gloucester,MA You'll benefit from a supportive work culture that encourages you to learn, develop, and grow your career as you take on challenges and drive innovative solutions for our customers. We empower our team to push the boundaries of what is possible-while learning every day in a supportive leading global company. Visit our Careers website to learn more. At Applied Materials, we care about the health and wellbeing of our employees. We're committed to providing programs and support that encourage personal and professional growth and care for you at work, at home, or wherever you may go. Learn more about our benefits (********************************** . Applied Materials' Ion Implantation Business Unit is searching for an intern to join our team in summer 2026! Our group works on developing plasma processing tools in ion implantation, dry etch, deposition and material modification. The position will entail the following: + Perform numerical investigations of elements of semiconductor processing tools using commercial and in-house software. + Analyze obtained results, draw scientific conclusions, and present at internal meetings. + Lead small design projects involving beamline and plasma source optimization. **Requirements** + Student must be pursuing a M.S. or Ph.D. program in Physics, Electrical Engineering, Nuclear Engineering, Mechanical Engineering, Chemistry, or a related field. + Student must be in good academic standing at their university, with a GPA of 3.0 or above on a 4.0 scale. + Experience in ion beam transport, magnet design or plasma modeling preferred. + Quick learner. **2026 Summer Internship program start/end dates:** Tuesday, May 26 - Friday, August 14 Monday, June 8 - Friday, August 28 Monday, June 15 - Friday, September 4 **Compensation** $41 - $50 per hour **Applications will be reviewed on a rolling basis. Note: This position may close early based on application volume or candidate selection.** ** ** **Additional Information** **Time Type:** Full time **Employee Type:** Intern / Student **Travel:** Yes, 10% of the Time **Relocation Eligible:** Yes The salary offered to a selected candidate will be based on multiple factors including location, hire grade, job-related knowledge, skills, experience, and with consideration of internal equity of our current team members. In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation such as participation in a bonus and a stock award program, as applicable. For all sales roles, the posted salary range is the Target Total Cash (TTC) range for the role, which is the sum of base salary and target bonus amount at 100% goal achievement. Applied Materials is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law. In addition, Applied endeavors to make our careers site (**************************************************** accessible to all users. If you would like to contact us regarding accessibility of our website or need assistance completing the application process, please contact us via e-mail at Accommodations_****************, or by calling our HR Direct Help Line at ************, option 1, and following the prompts to speak to an HR Advisor. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
    $41-50 hourly 27d ago
  • Microbiology Technical Sales Specialist (REMOTE+)

    The U.S. Pharmacopeial Convention (USP 4.8company rating

    Remote job

    **Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. **Brief Job Overview** The Technical Sales Specialist will serve as a subject matter expert in facilitating support related to USP Microbiology products and their use. The incumbent will (1) provide expertise to support the resolution of technical questions and ensure clear communication of product-related information, (2) collaborate internally and externally as a technical expert in microbiology and (3) engage in inside sales activities. This position requires close collaboration with the Technical Services team and colleagues across the USP Microbiology Unit, including the business development and marketing teams, to ensure technical inquiries are addressed effectively and accurately. The incumbent will be responsible for managing customer inquiries related to Microbiology products through a CRM, including responding to customers directly. The incumbent will be responsible for helping to resolve customer inquiries promptly and equipping internal teams with the knowledge and resources needed for various activities. The incumbent will also work to enhance and streamline processes, tools, and resources to improve inquiry resolution. Additionally, the Technical Sales Specialist will engage in inside sales activities, including nurturing leads and supporting efforts to convert those leads into business opportunities. **How will YOU create impact here at USP?** As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. _The Microbiology Technical Sales Specialist has the following responsibilities:_ - Manage and help resolve inquiries from customers, distributors, and USP colleagues via email, video call, and phone to efficiently address product and service issues and maintain high levels of customer satisfaction. - Ensure departmental efficiencies, including customer response time and issue resolution time, are met or exceeded by providing necessary technical product expertise and subject matter expertise. - Conduct inside sales activities, leveraging your technical and subject matter expertise to drive adoption of relevant products and offerings. - Assist in development of front-line support tools for scalability, including creating training material for new customers and new employees. - Assist/participate in support-related lab work that includes hands-on training of USP Microbiology products for customers, distributors, and colleagues. - In conjunction with colleagues, generate customer facing technical documentation including FAQs, troubleshooting guides, user guides, application notes. - Assist QA, marketing, sales, and other teams by providing support and expertise from a technical perspective. - Assist colleagues including business development, marketing and product development teams through contribution of technical expertise and information related to interactions with customers to ensure continuous product improvement. - Maintain critical customer related data using CRM software tools (SalesForce). **This role is Remote+, requiring 1-2x per month in office in St. Paul, MN.** **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: - Bachelor's degree in Microbiology, Biology, or related life science field plus five (5) to seven (7) years' experience in technical sales, application specialist, and/or QC microbiology laboratory roles in life science industry in North America - OR Master's degree in Microbiology, Biology, or related life science field plus three (3) to five (5) years' experience in technical sales, application specialist, and/or QC microbiology laboratory roles in life science industry in North America. - Microbiology working knowledge and expertise from technical or laboratory experiences. - Outstanding problem solving and interpersonal skills. - Excellent relationship-building skills with customers. - Excellent verbal and written communication skills. - Technical experience in microbiology. - Attention to detail while ensuring urgency to respond to customers. - Ability to multi-task, prioritize and manage time effectively. - Ability to work in full autonomy in a high-paced growth environment, with the capacity to use discretion and independent judgement. - Strong teamwork. - Proficiency using CRM software (SalesForce preferred). - Proficiency with Microsoft Office Suite software, including Excel, Word, PowerPoint. **Additional Desired Preferences** - Microbiology laboratory experience and/or microbiology experience in pharmaceutical industry. Experience with microbiology quality control testing in GMP environment is a plus. - Experience with environmental monitoring, disinfectant qualification/validation/efficacy testing, growth promotion testing, bioburden testing, sterility testing, and/or rapid microbiology methods is a plus. - 3+ years of experience in pharma/ biopharma microbiology QA/QC is a plus. - Advanced degree or certifications in microbiology-related field is a plus. - Strong problem-solving skills with customer-centric approach. **Supervisory Responsibilities** None, this is an individual contributor role. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Salary Range: USD $73,400.00 - $93,300.00 annually. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Chemistry & Scientific Standards **Job Type** Full-Time
    $73.4k-93.3k yearly 60d+ ago
  • Chemistry Practice Test Writer (Contract)

    Study.com 3.9company rating

    Remote job

    Chemistry Practice Test Writer Study.com is dedicated to making education easily accessible and highly valuable. We are looking for passionate individuals to work online and write practice test questions to help students prepare for various professional exams. As a Practice Test Writer, you'll write a variety of question types that contain clear and relevant content according to the project specifications. You will be provided materials such as learning objectives and sample questions in order to write questions that meet the content, format and difficulty of the real standardized tests. Some exams we help prepare learners for include: - Teaching Certificates (i.e. Praxis, ILTS, MTTC, GACE etc..) - Professional Certificates (i.e. SHRM, CPCE, FINRA Series 6, NCLEX etc..) - Military Exams (i.e. ASVAB, AFOQT, etc..) You will write practice tests based on your subject matter expertise. This is an online, remote contract role. All work is paid per piece. Required Skills: - A Master's Degree or higher and/or up-to-date professional license/credential in Chemistry. - You must have knowledge and experience in any of the given or related exams to provide high-quality, accurate information to students, or at least 2 years in your field. - You need to have excellent writing skills using correct English grammar and mechanics and the ability to follow directions. - As an online contractor, you'll need to be self-sufficient, motivated, and responsive to feedback. - This is a collaborative role that requires collaboration, strong communication skills, and being responsive to feedback. What We Offer: Reliable Payments: You'll receive payments twice a month and automated invoicing for your work. Remote Work: This is a fully online contracted work-from-home opportunity. Flexibility: Basically, there are no requirements! Work when you want, where you want, as often as you want, with no minimums/maximums. Support: Our supportive staff is available answer your questions and help you get up and running. About Study.com The mission of Study.com is to make education accessible, and over the last two decades we've become the leading online education platform, delivering a personalized learning experience across a broad continuum of education for over 30 million students, instructors, and professionals every month. We help empower millions of learners to achieve their education and career goals. We focus on increasing access to education because we know information is the ultimate equalizer and that education is key to upward mobility. Feel free to share this opportunity with any friends you think would be interested, too.
    $63k-108k yearly est. Auto-Apply 60d+ ago
  • Edibles Implementation Manager

    Green Thumb Industries 4.4company rating

    Remote job

    The Role This role requires 60-75% Travel. The Manager, Edibles Implementation will be directly responsible for scaling and deploying processes for cannabis infused edible products. This position will work with our Product Development team to determine scaled procedures for newly validated innovations. Once the scaled process is validated, the Edibles Implementation team is responsible for scaling the process up in our various Manufacturing facilities. Responsibilities associated with the technical role include supporting the Product Development team, supporting sites for new product validation runs, troubleshooting processing issues, escalating issues, documenting process deviations, supporting sites to quickly remedy production issues while providing best practices guidance. Green Thumb is growing fast, and as our Manager, Edibles Implementation, you will be tasked with supporting the evolving demands of our fast-paced business. You must have constant curiosity, a strong capability to train others, passion for our products and maintain a team first mentality. Responsibilities Technical Expertise: Extensive knowledge on edibles manufacturing processes, chemistry, and processing equipment. Stay up to date with the latest advancements in food processing technologies and best practices. Provide expert guidance to our manufacturing sites on food processing methods, equipment, and techniques to optimize production processes. Address and resolve technical issues, equipment malfunctions, and unexpected challenges in edibles processing. Process Improvement: Continuously assess and improve processing methods and operations for efficiency improvements, cost-effectiveness, and product quality. Recommend and implement process enhancements or automation where applicable. Instill optimized processes at manufacturing sites and challenge the status quo. Execute small batch experimentation to support all levels of formulation, scalability, automation, and national processing deviations. Training and Education: Provide training and guidance to production team on new product SOP's, best practices, safety protocols, and equipment operation. Create and deliver educational materials and refresher workshops as needed. Develop and transfer all pertinent documentation for a vertical, reliable and sustainable technical transfer for any new process. Team Management and Development Recruit, mentor, and manage other professionals responsible for supporting our production sites. Foster a collaborative and innovative work environment, encouraging cross-functional collaboration with other departments, including operations, quality assurance, and supply chain, to bring new products to market successfully. Set clear performance expectations, conduct regular performance reviews, and provide constructive feedback to ensure constant growth of our GTI team members. Documentation and Reporting: Maintain accurate records of production processes, quality control, and necessary safety measures/PPE required. Assist with the development of batch production records templates, SOP's, work aids and site readiness documents for a successful product launch. Prepare reports for management and regulatory authorities as required. Support product specification development and reviews as needed to maintain speed to market for new products. Food Safety, Quality and Compliance: Work with corporate quality team to ensure food processing operations meet all relevant regulatory and safety standards, such as FDA, USDA, and local health department guidelines. Develop and implement quality control protocols to maintain consistent product quality and safety. Identify and address any quality-related issues promptly and escalate to leadership with action plan. Aid compliance and accuracy involving product tracking, product security, and product creation. Safety & Compliance Be aware of hazards in the workspace. Retain and understand department specific training. Report safety incidents/ concerns and comply with follow-up actions. Be compliant with area safety requirements, state regulations and PPE requirements. Follow GMP, biosecurity, sanitation or other quality and compliance requirements. Perform record keeping accurately and completely as directed by a lead or supervisor. Maintain and calibrate tools, equipment and machinery as directed by a lead or supervisor. Report and escalate safety & quality concerns. Working Conditions While performing the duties of this job, the employee is regularly required to perform reaching, grasping, bending, stooping, talking, hearing, seeing and repetitive motions. Must be able to repetitively climb ladders and/or stairs and work from elevated platforms. Must be able to sit and/or stand for extended periods of time while maintaining focus. Must be able to lift, carry, and balance up to 50 pounds (and up to 100 pounds with assistance) AND must be able to do so with extreme care and caution when working with product. Must be able to work in an environment that is 85+ degrees and 70% humidity for extended periods. Ability to work in a fast-paced, changing, and challenging environment. Work involves daily exposure to allergens (such as cannabis, tree nuts, and coconut oil). Qualifications Associate or bachelor's degree preferred in related STEM discipline such as chemistry, biology or physics. Extensive hands-on experience in food processing, preferably in various product categories. In-depth knowledge of food safety regulations and industry standards. The ability to travel 50-75% of the time and many times with short notice. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work effectively in cross-functional teams. Strong organizational and project management skills. Ability to plan, design experiments, and problem solve. Effective time-management skills and ability to multi-task Capability of troubleshooting, fixing, and services a wide range of equipment and software without assistance. Excellent verbal and written communication skills with coworkers and management. Understanding & adhering to applicable federal, state and local laws and regulations as they pertain to the industry, safety regulations, local municipal codes and organizational rules, regulations, directives and standard operating procedures. Additional Requirements Must pass any and all required background checks Must be and remain compliant with all legal or company regulations for working in the industry Must possess valid driver's license Must be a minimum of 21 years of age Must be approved by state badging agency to work in cannabis industry The pay range is competitive and based on experience, qualifications, and/or location of the role. Positions may be eligible for a discretionary annual incentive program driven by organization and individual performance. Green Thumb Pay Range$110,000-$140,000 USD
    $110k-140k yearly Auto-Apply 60d+ ago
  • Automotive - Subject Matter Expert - Remote Worldwide

    Msccn

    Remote job

    ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Our partners have an ongoing need for Subject Matter Experts in the disciplines below. Apply today to be considered as projects become available. This post represents multiple ongoing projects/opportunities. You will be contacted after submitting interest to the role with the next steps, provided minimum qualifications are met. At OWL Learning (part of MPS Limited), we are looking for educational curriculum and content developers, instructional designers, media developers, editorial professionals, subject matter experts and instructional technologists who can help us create exceptional learning experiences for our clients. ONGOING PROJECTS Including but not limited to: ANATOMY & PHYSIOLOGY ANTHROPOLOGY ARTS ASTRONOMY AUTOMOTIVE BIOETHICS BIOLOGICAL SCIENCES BUSINESS LAW BUSINESS: GENERAL CAREER AND TECHNICAL EDUCATION CHEMISTRY COMMUNICATIONS COMPUTER SCIENCE COUNSELING CRIMINAL JUSTICE CULTURAL STUDIES CYBERSECURITY DEVELOPMENTAL ENGLISH EARTH SCIENCES ECONOMICS EDUCATION ENGINEERING ENGLISH ENGLISH AS A SECOND LANGUAGE ENGLISH FOR LANGUAGE LEARNERS ENVIRONMENTAL SCIENCES ETHICS FILM FINANCE FIRE SAFETY/ FIRE-FIGHTING/EMS FRENCH GENDER STUDIES GEOGRAPHY GEOLOGY GERMAN HEALTH SCIENCES HISTORY HUMAN DEV/FAMILY STUDIES HUMAN RESOURCE MANAGEMENT INFORMATION SCIENCE INFORMATION SECURITY LABOR AND HUMAN RELATIONS LIFE SCIENCES MACHINE LEARNING/NLP/AI MANAGEMENT MARKETING MATHEMATICS MEDICAL ADMINISTRATION< MUSIC NURSING NUTRITION PARALEGAL PHARMACY/PHARMACOLOGY PHILOSOPHY PHYSICAL SCIENCE PHYSICS POLITICAL SCIENCE PSYCHOLOGY PUBLIC HEALTH RADIOLOGIC SCIENCES RELIGIOUS STUDIES RESEARCH METHODS SOCIAL SCIENCES SOCIAL WORK SOCIOLOGY SPANISH TAXATION TRANSLATION WORLD LANGUAGES PROJECT DESCRIPTION As a Subject Matter Expert, you will be working to develop and/or review educational content, and/or deliver materials based on the project scope. Roles are 1099. APPLICANT QUALIFICATIONS Bachelor's degree in the discipline PREFERRED QUALIFICATIONS Masters degree in the discipline Relevant industry certifications Instructional design/teaching experience and/or familiarity with Bloom's taxonomy PROJECT DURATION Ongoing Needs REQUIRED AVAILABILITY/PAY INFORMATION This will vary by project. LOCATION Remote/Ability to work from home from anywhere in the world. Must have reliable internet access as the projects will be managed and coordinated via email and teleconference as needed.
    $86k-124k yearly est. 60d+ ago
  • Field Service Specialist (Remote Work / Travel Required)

    Dawar Consulting

    Remote job

    Our client, a world leader in the life sciences and diagnostics industry, is looking for a "Field Service Specialist". Job Duration: 12+ Months with high possibility of extension Rate: $40/hr on W2 Responsibilities: Perform on-site preventative maintenance, installations, and technical updates on products. Diagnose and address mechanical, hardware, software, and system failures. Document all activities in compliance with company quality procedures. Ensure customer satisfaction through effective communication and service. Maintain and control inventory and company property, adhering to expense guidelines. Required Skills: High school diploma plus technical training or equivalent experience. Knowledge of electronics, electro-mechanical systems, and information technology. Basic understanding of chemistry. Strong communication, organization, and customer service skills. Ability to adapt procedures and tools for complex tasks. Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K Interested! Please apply or send your resume to ********************** / ************************.
    $40 hourly Easy Apply 60d+ ago
  • Executive Director, CMC

    Centessa Pharmaceuticals, LLC

    Remote job

    Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. SUMMARY: Centessa continues to expand its CMC group and currently seeks an Executive Director of CMC, to lead our small molecule development programs across all CMC functions. This individual will be responsible for driving technical strategies, managing outsourced manufacturing partnerships, and overseeing all aspects of CMC development from early-to late-stage development and clinical studies. This high-impact leadership role requires a blend of scientific expertise, operational savvy, business acumen, technical efficiency, and strategic foresight. The ideal candidate brings deep experience in small molecule drug development, excels at cross-functional collaboration, and thrives in a growth-stage biotech environment. The Executive Director, CMC will report directly to the SVP, CMC and will have ownership across the CMC function to include strategy, direct reports, team management, cross-functional leadership, and external manufacturing on our pipeline programs. Travel to vendors both domestically and internationally will be required. RESPONSIBILITIES: Strategic Leadership Oversee the implementation of end-to-end CMC strategy across Centessa's development programs Translate development goals into robust CMC plans, ensuring alignment across R&D/early stage, Clinical, Quality, and Regulatory functions Develop long-term development manufacturing strategies that consider Phase 1/Phase 2 forecasting, demand forecasting, investment planning, inventory control, and vendor relationships Proactively identify and mitigate technical, production, and supply chain risks Operational Oversight Act as the CMC team representative member in cross-functional developmental teams Oversee outsourced manufacturing activities, including CDMO contract negotiations and performance management Ensure timely delivery of clinical supply and maintain timelines for Registration/Primary Stability, PPQ/Commercial, and Phase 1/Phase 2 drug substance and drug product batches. Manage the development of budgets and timelines for CMC operations and report regularly to leadership Drive cross-functional meetings and milestone planning to support timely execution across drug substance and drug product for development programs Interface closely with key stakeholders in Quality, Regulatory, Supply Chain, Clinical, Legal, Finance, Project Management, and Non-Clinical teams in the development and execution of CMC plans Assist in developing documents and maintain compliance consistent with GLP and GMP standards for pre-clinical, early- and late-stage clinical development (pre-IND through Phase 3+) Develop and oversee SOPs, protocols/reports, and phase-appropriate specifications for pharmaceutical development and manufacturing activities Oversee technical transfer activities of API and drug product for supply chain resilience Manufacturing and Technical Execution Supervise drug substance and drug product manufacturing and coordination of labeling, packaging, and distribution Oversee sourcing, planning, and logistics for raw materials, APIs, excipients, and required specialized critical reagents or equipment to meet production requirements Manage analytical method development and validation for starting materials, in-process controls, and final release and stability Participate in manufacturing site visits and pre-approval inspection readiness initiatives Identify, select, and manage CDMOs for process optimization, non-GMP and GMP manufacture and supply of API and drug product in support of ongoing pre-clinical and clinical programs, including delivery of scalable and cost-effective manufacturing routes that meet business requirements Regulatory Affairs Collaborate with Regulatory Affairs to support the preparation and submission of CMC sections (INDs, IMPDs, NDAs, etc) Address CMC-related and pertinent cross-functional questions from regulatory authorities and ensure submission and response timelines are met QUALIFICATIONS: Thorough understanding of cGMP requirements for pharmaceutical products Strong organizational, interpersonal, leadership, and decision-making skills Ability to work independently in a fast-paced dynamic environment with multiple projects and competing priorities Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products Excellent organizational skills, project management skills and detail-orientated leadership approach Strong experience with chemical and physical characterization of small molecules Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions Understanding of product quality attributes control strategies as applied to small molecule synthetic processes EXPERIENCE: Master's degree in Organic Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline (PhD preferred). Minimum 15 years of pharmaceutical industry experience including at least 8 years in CMC. Strong track record in CMC leadership across small molecule early-phase development and late-stage filing activities, including management of US and international CDMOs Extensive experience working with CDMOs and managing external partnerships In-depth knowledge of cGMP regulations and best practices in both clinical and commercial manufacturing Demonstrated success in process development, scale-up, and validation Prior experience drafting and submitting CMC content for regulatory filings in the U.S. and international markets, and interacting with global health authorities (IND, IMPD, NDA, MAA) Strong communication, project management, and organizational skills Proven ability to lead cross-functional teams in a fast-paced, evolving environment Strong skills in identifying and resolving critical issues Strong track record in effectively working with senior management Compensation The annual base salary range for this position is $285,000 - $370,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa's long-term success. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. POSITION: Full-Time, Exempt, Flexibility for Remote Work EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
    $97k-167k yearly est. Auto-Apply 8d ago
  • Professional Content Specialist, ESL (Part-Time)

    Monmouth University 4.4company rating

    Remote job

    Monmouth University is seeking applications for part-time ESL Professional Content Specialists in the Tutoring and Writing Services department. We are seeking certified instructors to provide English language instruction to a wide variety of non-native English language speakers. Professional Content Specialists are faculty members with strong teaching backgrounds and knowledge in content specific disciplines. They are committed to helping students by providing positive tutorial experiences in these content areas: sciences (biology/chemistry/physics), math (college algebra through calculus), or business (financial/managerial accounting/economics/business finance/money, credit, finance) or teaching ESL, TESOL, or TOEFL prep experience to adult learners. The goal of each tutorial is to assist students in developing strategies that will help strengthen their knowledge, develop transferable learning skills, and achieve academic success. This is an in-person, on campus, non-remote position. For additional information about the department, please visit the Tutoring Services webpage. Duties and Responsibilities: Provide academic support for First Year Advising referrals, Department of Disability Services referrals, probationary students, and students who receive MEWS notifications. Provide individual tutorial sessions. Learn how to use Navigate360 to document student attendance and notes about each tutorial session. Attend Tutoring Service meetings and training sessions as required. Communicate regularly with the Director about student progress and report any concerns. Follow up with students as needed. Enrichment Statement: Monmouth University values diversity and invites applications from underrepresented groups who will enrich the teaching and service missions of the university. Minimum Qualifications: English as a Second Language certification. Commitment to helping students maximize their learning through tutoring sessions. Commitment to providing learning/study strategies in all areas. Commitment to providing positive student/teacher relationships. Willingness to utilize technology to enhance the learning experience. Preferred Qualifications: College-level teaching experience. Experience in conducting tutorials. Knowledge of different learning styles, modalities, and experience with students of diverse learning abilities. Additional Application Material Required: Monmouth University requires all applications and supporting documents to be submitted via the university's career portal. In addition to the application, candidates must upload the following: Resume or Curriculum Vitae Cover Letter Optional Documents: Professional References Special Instructions to Applicants: We encourage candidates to include information in the cover letter that addresses their approach to teaching and their plans to advance diversity, equity, and inclusion in their position at Monmouth University. Questions regarding this search should be directed to: Dorothy Cleary at ******************** or ************ Note to Applicants: Adjunct positions remain posted continuously to expand the university's pool of qualified adjunct faculty. Screening of applications will commence when an open position becomes available. Should a position become available, you will receive an email advising you of the next steps. Working at Monmouth University perks: Earned sick leave: Monmouth University provides its part-time staff employees, including on-call staff and temporary employees, with earned sick leave according to the New Jersey Paid Sick Leave Act. Fitness Center - Employees are entitled to use the Fitness Center while employed in their PT or on-call capacity Recreational & Cultural Activities - Athletic and cultural events throughout the academic year are open to employees. Many of these events are open to employees free of charge or at reduced costs University Bookstore discount - Employees receive a ten percent (10%) discount on most items purchased in the University Bookstore. To view a full list of benefits, visit our benefits page at: Employee Benefits Information | Human Resources | Monmouth University Department: Tutoring and Writing Services Work Schedule: 4 to 8 hrs. p/ week Total Weeks Per Year: 28 Expected Salary: $24.00 per hour Union: N/A Job Posting Close Date N/A
    $24 hourly Easy Apply 60d+ ago
  • Director, External Manufacturing (CMC)

    Praxis Precision Medicines

    Remote job

    Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity The Director, External Manufacturing (CMC) will lead and manage outsourced manufacturing operations supporting Praxis's clinical and future commercial programs. This role will oversee Contract Development and Manufacturing Organizations (CDMOs) responsible for drug substance (API) and drug product manufacturing, ensuring high-quality, compliant, and timely supply of clinical materials. The ideal candidate is a strategic, hands-on CMC leader experienced in managing external partnerships and driving operational excellence in a dynamic biotech environment. Primary Responsibilities External Manufacturing Oversight Lead the strategy, selection, and management of CDMOs for both drug substance and drug product manufacturing. Serve as the primary operational interface between Praxis and external manufacturing partners. Oversee technology transfer, process scale-up, validation, and clinical supply readiness. Establish and maintain robust Quality and Technical Agreements with manufacturing partners. Manage and optimize the end-to-end supply chain process, including raw materials procurement, production planning, logistics, inventory management, and distribution. Lead supplier qualification, monitoring, and performance evaluations, addressing risks and identifying opportunities for improvement. Negotiate contracts and pricing agreements with suppliers and CMOs to achieve cost-effective outcomes while maintaining supply security. CMC Operations and Program Support Collaborate closely with Process Chemistry, Formulation, Analytical, Quality, and Regulatory teams to ensure seamless execution of CMC deliverables. Support CMC development strategies aligned with clinical timelines, regulatory expectations, and company objectives. Manage manufacturing planning, scheduling, and inventory to ensure uninterrupted clinical supply. Governance, Compliance, and Continuous Improvement Ensure all outsourced manufacturing is performed under appropriate GMP and regulatory standards. Implement key performance indicators (KPIs) and governance mechanisms to monitor and improve CDMO performance. Proactively identify and mitigate technical and operational risks across the external supply network. Drive operational excellence and process improvements to enhance efficiency and compliance. Qualifications and Key Success Factors Advanced degree preferred in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; bachelor's degree with extensive relevant experience considered. 15+ years of progressive CMC or manufacturing experience within the biopharmaceutical industry, including ≥8 years managing external manufacturing relationships. Proven experience in managing global CMC supply chains for commercial products in a regulated environment. Includes strong understanding of GMP, GDP, and ICH guidelines and their application in a commercial setting. Demonstrated experience overseeing both drug substance and drug product manufacturing at clinical or commercial scale. Excellent negotiation and vendor management abilities including experience working with CMOs and managing third-party relationships. Proven ability to manage complex projects and external relationships with technical and business acumen. Ability to navigate complex regulatory and compliance requirements. The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Compensation & Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together! To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience. Annualized Base Salary $210,000 - $230,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
    $210k-230k yearly Auto-Apply 21d ago
  • Simulation Software Engineer (Associate or Experienced) (Virtual)

    Jeppesen 4.8company rating

    Remote job

    Company: The Boeing Company The Boeing Company is looking for a Simulation Software Engineer (Associate or Experienced) (Virtual) with a focus on visualizations using Unreal Engine to join the High Fidelity Virtual Cab (HFVC) team. Contributing to the development and integration of airplane models, simulations and hardware emulations using high fidelity Unreal game engine visualizations of Boeing aircrafts and flight decks. Build polished Unreal Engine applications used for high-fidelity, real-time visualization-across aircraft simulation and other data-driven projects. You'll ship features in Blueprints and C++, integrate with complex live backends/simulations, and keep performance predictable and stable. The ideal candidate is a leader, self-starter, enjoys working collaboratively with others, has a commitment to customer satisfaction and process improvement, and is successful working in a multi-program environment. This position will support the development of solutions to a wide range of complex problems that require ingenuity and innovation. The candidate should be adaptable to new development environments and eager to work with and learn new technologies. At The Boeing Company, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great opportunity for professional growth. Find your future with us. Do you have a passion for software, airplanes, and people? Are you inspired by new technologies, leading, and working in a collaborative environment? If so, we invite you to apply for a job to join the Software Organization at Boeing as we enable the next generation of aerospace design and development! We do everything from simulating airplane models, to developing virtual flight decks, to creating the next generation software simulation tools. Position Responsibilities: Deliver features in Blueprints and C++ (plugins, subsystems, components) using our internal framework Integrate UE with real-time backends/simulations: ingest time-stamped data, handle sync/rates, and maintain smooth visuals Build clean UIs with UMG/Slate and bind them to live data. Profile and optimize with Unreal Insights; manage frame pacing, memory, loading, and asset streaming Package reliable builds, write concise docs/samples, and collaborate across engineering teams Basic Qualifications (Required Skills/ Experience): 2+ years of developing using Unreal Engine plus blueprint scripting 2+ years of experience in C++ programming 2+ years of experience using GitLab and/or Jira 2+ years of experience with scripting languages such as Python Preferred Qualifications (Desired Skills/Experience): Bachelor of Science degree from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), chemistry, physics, mathematics, data science, or computer science 3 + years related work experience or an equivalent combination of education and experience UE4/UE5 expertise with shipped work in Blueprints and C++ (UObject lifecycle, Actors/Components, Subsystems) C++: solid APIs, RAII, async/tasks, multithreading fundamentals. Real-time integration with complex simulations/backends (e.g., aircraft/robotics/industrial): ingest over sockets/WebSocket/shared memory (experience with middleware like DDS/HLA/DIS is a plus but not mandatory), manage timestamps, buffering, interpolation, jitter/latency, and determinism/fixed-tick update paths Visualization performance engineering: use Insights/stat groups to find bottlenecks and hold steady frame budgets; UMG/Slate optimization CI/CD exposure: Git + a pipeline (GitLab/GitHub/Azure), automated packaging/tests, symbols/artifacts, crash capture Windows + Visual Studio toolchain; strong debugging and logging habits Clear written/spoken communication; ability to map an interface contract/ICD into UE data models Geospatial/large-world workflows, transforms, coordinate frames XR (OpenXR) or multi-display rendering basics Python or C# for build/pipeline/content tooling Travel: less than 10% Drug Free Workplace: Boeing is a Drug Free Workplace (DFW) where post offer applicants and employees are subject to testing for marijuana, cocaine, opioids, amphetamines, PCP, and alcohol when criteria is met as outlined in our policies. CodeVue Coding Challenge: To be considered for this position you will be required to complete a technical assessment as part of the selection process. Failure to complete the assessment will remove you from consideration. Pay & Benefits: At Boeing, we strive to deliver a Total Rewards package that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities. The Boeing Company also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and a number of programs that provide for both paid and unpaid time away from work. The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements. Pay is based upon candidate experience and qualifications, as well as market and business considerations. Summary pay range for Associate Level: $84,150 - $129,950 Summary pay range for Experienced Level: $102,850 - $159,850 Language Requirements: Not Applicable Education: Not Applicable Relocation: This position offers relocation based on candidate eligibility. Export Control Requirement: This position must meet export control compliance requirements. To meet export control compliance requirements, a “U.S. Person” as defined by 22 C.F.R. §120.15 is required. “U.S. Person” includes U.S. Citizen, lawful permanent resident, refugee, or asylee. Safety Sensitive: This is not a Safety Sensitive Position. Security Clearance: This position does not require a Security Clearance. Visa Sponsorship: Employer will not sponsor applicants for employment visa status. Contingent Upon Award Program This position is not contingent upon program award Shift: Shift 1 (United States of America) Stay safe from recruitment fraud! The only way to apply for a position at Boeing is via our Careers website. Learn how to protect yourself from recruitment fraud - Recruitment Fraud Warning Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. EEO is the law Boeing EEO Policy Request an Accommodation Applicant Privacy Boeing Participates in E - Verify E-Verify (English) E-Verify (Spanish) Right to Work Statement Right to Work (English) Right to Work (Spanish)
    $102.9k-159.9k yearly Auto-Apply 2d ago
  • Lead, Regulatory Affairs CMC (Director)

    Astellas Pharma 4.9company rating

    Remote job

    Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders. Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. **Responsibilities and Accountabilities:** **Strategic Leadership:** + Define and implement global CMC regulatory strategies with a strong focus on North American requirements. + Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU. **Policy & Advocacy:** + Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. + Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. **Cross-Functional Collaboration:** + Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. + Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions. **External Engagement:** + Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. + Lead advocacy initiatives for innovative technologies and precedent-setting projects. **Operational Excellence:** + Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). + Ensure consistency and quality in dossier preparation across regions. **Expected Key Accountabilities from Global Regulatory Aspects** + Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. + Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. + Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities. + Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. + Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. + Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects. + Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. + Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. + Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. + Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions. + Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility. **Required** + Advanced degree in Chemistry, Engineering or equivalent degree (PhD, PharmD, MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotech industry, with significant exposure to North American regulatory requirements. + Proven track record in developing and implementing global CMC strategies and influencing regulatory policy. + Strong knowledge of FDA, ICH and global guidelines; prior experience in ICH initiatives highly desirable. + Expert technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and an in-depth knowledge of global regulatory CMC submission requirements, with a strong understanding of the application of ICH and other guidance. + Exceptional communication and leadership skills; ability to influence internal and external stakeholders. + Experience representing companies in trade associations and industry forums. + Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope. + Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral + dosage forms) is required. + Demonstrated track record for successful interactions with global health authorities related to CMC submissions. + Ability to navigate a global organization and to act globally and regionally as appropriate. + Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders in high impact situations. + Proven leadership skills is preferred. **Salary Range** $170,450 - $267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Regulatory CMC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans
    $79k-111k yearly est. 13d ago
  • Program / Project Assistant

    Universal Diagnostics

    Remote job

    The Opportunity: Universal DX is seeking a program/project assistant to join our growing team. You will report to the Director, Program Management and work closely with the program management team and cross-functional teams (product development, laboratory operations, manufacturing, quality, etc.) to support our Dallas-based laboratory and the development and commercialization of IVD tests. You will interact with cross-functional teams daily and will play a critical role in supporting the laboratory readiness and the design and development of Universal DX's screening test for colorectal cancer. As the program/project assistant, you will: * Working closely with assigned program managers, support the communication and coordination of cross-functional program initiatives to achieve organizational goals related to laboratory readiness and the development and commercialization of new IVD products. * Support the development and launch of program resources, tools, and trackers to ensure effective program operations. * Prepare and analyse reports and dashboards of program, project, and resource data to provide insight and support strategic decision making. * Facilitate team, department, and program-wide communications through the build out of content and maintenance of program resources (Confluence, Sharepoint, Smartsheet, etc.). * Work with PMO leadership to maintain and refine project portfolio and resource management processes, including development and delivery of program resources and guidance documents, training, and coaching to cross-functional team members. * Support the onboarding of new cross-functional team members. * May lead the planning and delivery of minor projects, deliverables, or sub-teams under the supervision of a program or project manager. What you will bring: * Bachelor's degree or equivalent experience, in business or a scientific/engineering field (e.g., Biology, Chemistry, Biotechnology, Engineering or a related discipline) * 0-2 years program/project management experience in the life sciences; 1+ years of direct industry experience preferred. * Experience with regulated environments and familiarity with medical device regulatory requirements (e.g. 21CFR812, ISO 13485, etc.); IVD-specific experience is a plus. * Awareness and interest in program and project management processes and methodologies; program/project management training or work towards CAPM/PMP or similar certification preferred. * Strong organizational, problem-solving, and multitasking skills, with the ability to manage multiple tasks and priorities in a fast-paced setting. * Experience with or exposure to project management tools and methods; previous experience using Smartsheet and MS office a plus. * Experience with data collection, analysis, and trending including report and/or dashboard development preferred. * Excellent communication and teamwork skills with the ability to facilitate and collaborate across departments and stakeholders effectively. * Ability to support teams working remote in different time zones.
    $29k-45k yearly est. Auto-Apply 54d ago

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