GMP jobs near me - 444 jobs

At Niagara, we're looking for Team Members who want to be part of achieving our mission to provide our customers the highest quality most affordable bottled water. Consider applying here, if you want to: Work in an entrepreneurial and dynamic environment with a chance to make an impact. Develop lasting relationships with great people. Have the opportunity to build a satisfying career. We offer competitive compensation and benefits packages for our Team Members. Production OperatorThis position is responsible for daily operations of the production floor; ensuring the shift meets established safety, quality, and production goals in compliance with all applicable legal and food safety requirements. Essential Functions Responsible for daily activities of the production line(s), ensuring product adheres to Niagara's standard of safety, quality, and throughput. Accurately completes applicable quality and production reports hourly. Physical and visual inspection of product is required to prevent non-conforming goods. Correctly reports all quality defects to the appropriate team members and shift leadership. Adheres to the highest standards of company and plant safety programs, guidelines, rules, and regulations. Abides by Niagara's Good Manufacturing Practices (GMP) and Food Safety Standards at all times. Maintains general housekeeping in all areas of production and additional areas assigned by plant leadership. Maintains appropriate level of raw materials as required, to ensure production lines incur minimal downtime. Demonstrates the aptitude and skill to work in all assigned areas of production; troubleshoots minor production line issues and performs relief duties when required. Regular and predictable attendance is an essential function of the job. Ability to work 12 hour shifts, day or night, on a rotating 2-2-3 schedule or schedule as dictated by production demand. Please note this job description is not designed to contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without prior notice. Qualifications Minimum Qualifications: 0 Years - Experience in Field or similar manufacturing environment 0 Years - Experience in Position 0 Years - Experience managing people/projects *experience may include a combination of work experience and education Preferred Qualifications: 2 Years - Experience in Field or similar manufacturing environment 2 Years - Experience in Position 2 Years - Experience managing people/projects *experience may include a combination of work experience and education Competencies This position embodies the values of Niagara's LIFE competency model, focusing on the following key drivers of success: Lead Like an Owner Makes safety the number one priority Keeps alert for safety issues and escalates immediately Effectively prioritizes tasks based on department goals Shows respect to others and confronts interpersonal issues directly Prioritizes resolution of customer issues effectively Responds promptly and honors commitments to internal and external customers InnovACT Makes recommendations to continuously improve policies, methods, procedures, and/or products Demonstrates adaptability by reacting appropriately to unexpected changes in situations or circumstances Increases performance through greater efficiency Find a Way Seeks to develop technical knowledge through learning from other experts Understands interdepartmental impact of individual decisions and actions Seeks solutions rather than placing blame Empowered to be Great Consistently looks for ways to improve one's self through growth and development opportunities Communicates clearly and promptly up, down, and across Communicates effectively to manage expectations Education Minimum Required: High School Diploma or GED Preferred: Associate's Degree Certification/License: Required: N/A Preferred: N/A Foreign Language Required: None Required Preferred: None Required Benefits Our Total Rewards package is thoughtfully designed to support both you and your family: Regular full-time team members are offered a comprehensive benefits package, while part-time, intern, and seasonal team members are offered a limited benefits package. Paid Time Off for holidays, sick time, and vacation time Paid parental and caregiver leaves Medical, including virtual care options Dental Vision 401(k) with company match Health Savings Account with company match Flexible Spending Accounts Expanded mental wellbeing benefits including free counseling sessions for all team members and household family members Family Building Benefits including enhanced fertility benefits for IVF and fertility preservation plus adoption, surrogacy, and Doula reimbursements Income protection including Life and AD&D, short and long-term disability, critical illness and an accident plan Special discount programs including pet plans, pre-paid legal services, identity theft, car rental, airport parking, etc. Tuition reimbursement, college savings plan and scholarship opportunities And more! *********************************************** * *Los Angeles County applicants only** Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable local and state laws. Any employment agency, person or entity that submits a résumé into this career site or to a hiring manager does so with the understanding that the applicant's résumé will become the property of Niagara Bottling, LLC. Niagara Bottling, LLC will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity. Employment agencies that have fee agreements with Niagara Bottling, LLC and have been engaged on a search shall submit résumé to the designated Niagara Bottling, LLC recruiter or, upon authorization, submit résumé into this career site to be eligible for placement fees.

YOUR PASSION, ACTIONS & FOCUS is our Strength Become one of our Contributors Join the KnipperHEALTH Team! Vice President of Operational Excellence The Vice President of Operational Excellence will lead strategic and tactical initiatives focused on improving operational efficiency, quality of customer service, and mistake-proofing across all facets of the organization's Marketing and Samples Management (MSM) and Third-Party Logistics (3PL) and warehousing services. This role is pivotal in transforming operational processes-including pick/pack, kitting, shipping/receiving, and warehouse execution-to deliver scalable, compliant, and cost-effective solutions for clients in the medical and pharmaceutical industry. Responsibilities Operational Strategy & Execution Develop and execute a comprehensive operational excellence roadmap across all warehouse operations in collaboration with site leadership and aligned with business goals, quality requirements, and client expectations. Lead continuous improvement programs in pick/pack, shipping, receiving, warehouse layout, and inventory movement. Champion lean methodologies, Six Sigma, and mistake-proofing (poka-yoke) practices to reduce variation and error in core processes. Own the standardization of operational workflows and drive process harmonization across sites and teams. Quality & Compliance Embed quality assurance principles directly into operational workflows and Standard Operating Procedures (SOPs). Partner with QA and Compliance to align warehouse and logistics processes with FDA, DEA, DSCSA, and GMP regulations. Lead root cause analysis and corrective/preventive action programs (CAPA) improvement plans for warehouse and distribution operations based on data information collected through Quality Management System. Implement and refine metrics and dashboards for performance tracking and compliance adherence. Leadership & People Management Lead and mentor a cross-functional team including warehouse supervisors, logistics managers, and quality leads. Drive a culture of accountability, safety, and continuous improvement through effective leadership and communication. Identify talent gaps and champion leadership development within operational teams. Ensure team alignment with organizational KPIs and customer service standards. Cross-Functional Collaboration Collaborate with Warehouse Operations, IT, Quality Assurance, Compliance, HR, and Client Services to optimize end-to-end process flow. Participates in regulatory inspections and audits as Compliance invites/requests. Serve as a key liaison to clients, ensuring operational transparency, issue resolution, and contract adherence. Guide automation initiatives and WMS enhancements to improve process visibility and scalability. The above duties are meant to be representative of the position and not all-inclusive. Qualifications Operational Strategy & Execution Develop and execute a comprehensive operational excellence roadmap across all warehouse operations in collaboration with site leadership and aligned with business goals, quality requirements, and client expectations. Lead continuous improvement programs in pick/pack, shipping, receiving, warehouse layout, and inventory movement. Champion lean methodologies, Six Sigma, and mistake-proofing (poka-yoke) practices to reduce variation and error in core processes. Own the standardization of operational workflows and drive process harmonization across sites and teams. Quality & Compliance Embed quality assurance principles directly into operational workflows and Standard Operating Procedures (SOPs). Partner with QA and Compliance to align warehouse and logistics processes with FDA, DEA, DSCSA, and GMP regulations. Lead root cause analysis and corrective/preventive action programs (CAPA) improvement plans for warehouse and distribution operations based on data information collected through Quality Management System. Implement and refine metrics and dashboards for performance tracking and compliance adherence. Leadership & People Management Lead and mentor a cross-functional team including warehouse supervisors, logistics managers, and quality leads. Drive a culture of accountability, safety, and continuous improvement through effective leadership and communication. Identify talent gaps and champion leadership development within operational teams. Ensure team alignment with organizational KPIs and customer service standards. Cross-Functional Collaboration Collaborate with Warehouse Operations, IT, Quality Assurance, Compliance, HR, and Client Services to optimize end-to-end process flow. Participates in regulatory inspections and audits as Compliance invites/requests. Serve as a key liaison to clients, ensuring operational transparency, issue resolution, and contract adherence. Guide automation initiatives and WMS enhancements to improve process visibility and scalability. Knowledge, Skills & Abilities: Exceptional communication and change management skills. Ability to lead cross-functional teams through complex transformation initiatives. Data-driven mindset with a passion for operational analytics and structured problem solving. Customer-focused with a strong track record of operational delivery in client-centric environments. Agile, decisive, and calm under pressure. PHYSICAL DEMANDS: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knipper is an equal opportunity employer

As an Enterprise Program Administrator, your primary responsibilities will be to work with your assigned customers, service vendors, and others as the need arises, to meet the customer's service requirements. This will include scheduling Preventive Maintenance and repair services, ensuring that service requests are acted on in a timely manner, and responding to customer requests and inquiries. You may also be responsible for recommending vendors, administering procurement functions, and reporting costs. This is a customer-facing role. Ability to work onsite as needed Principal Duties and Responsibilities: Schedule on-site repair for contract, warranty, and trade requests. Schedule all Preventive Maintenance and Compliance Services. Maintain and use accurate coding standards to ensure data accuracy. Has ownership of Support delivery for the assigned customer. Communicate with the customer to clearly identify and set expectations, address any expectation issues, and keep customers updated on the status of their calls. Handles customer feedback and communication. Communicates with and leads schedules with 3rd party service providers. Development of customer relationships, often requiring tact, persuasion and negotiation skills. Directly contact External and Internal Customers of all levels. Initiates partner concern to Support Management of Customer issues. Solves a variety of problems varying in complexity, involving multi-departments. End-to-end service management. Understand service management asset delivery needs, service levels, and cost. Run Third party service delivery within customer's system and processes. Report and supervise 3rd party delivery and costs. Recommend improvements for both delivery and costs that meet needs and requirements. Qualifications Degree or equivalent combination of education and experience. At least 3+ years of meaningful experience for entry to this level. Experience using Customer Database Systems. Previous experience working in a GMP environment (Preferred but not required). Knowledge of GxP guidelines and requirements (Preferred but not required). Vital planning and interpersonal skills. Previous experience scheduling service events. Excellent communication skills. Proven efficiency working in a team environment. Proven ability to optimally advise the actions of others. Ability to work with team members remotely. Excellent keyboarding skills and knowledge of PC applications -- including Microsoft and SAP products. Understand and apply appropriate quality improvement processes. Must align with all customer site access requirements, including GMP training and medical requirements. Shown ability to adjust quickly to process and policy changes. Must be available for occasional travel, including overnight training and other Agilent activities. Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 14, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $30.08 - $50.29/hr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit *************************************** Required: OccasionalShift: DayDuration: No End DateJob Function: Services & Support

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.

Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins. Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen - you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases. What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together. At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us. If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself. About the Role: The Lead, Quality Assurance Operations is responsible for the supervision and development of junior members of the Quality Assurance team and helping oversee GMP manufacturing activities. The Lead will provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance. The Lead will supervise junior members of the Quality Assurance team in activities such as document control, review of laboratory data, deviation management, internal & external audits, and training. Responsibilities: Serves as a quality resource for operations departments. Responsible to make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions regarding products. Perform detailed review and approval of batch production records and associated documentation for AAV gene therapy manufacturing, ensuring adherence to established procedures and cGMP regulations. Effectively communicate to management Quality issues that arise during the manufacturing of product. Proactively identify and implement items to enhance quality through continuous improvement (CAPA). Responsible for the leading, authoring, and reviewing of investigations, CAPAs and change controls to drive for resolution through root cause analysis. Responsible for the review and approval of controlled documentation including Standard Operating Procedures (SOPs), Work Instructions, Forms, Methods, Batch Records, etc. Develop and deliver comprehensive training programs to QA and manufacturing personnel on quality-related topics, ensuring proper understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements. Assist management in setting clear vision by ensuring goals and objectives are aligned with departmental goals and supervising each junior team member's team support. Oversee timecard reporting, task oversight, and scheduling as well as create and report metrics and internal KPIs. Provide supervision for employee relations through effective communications, coaching, training and development and eliminate roadblocks for the team to move forward. Supports regulatory audits as needed. Qualifications: Bachelor's Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience). 6-8 years in a quality assurance role within the pharmaceutical or biotechnology industry. Experience mentoring and developing junior team members, including providing guidance on QA best practices and fostering professional growth. Experience in supporting internal and external audits. Thorough understanding of pharmaceutical cGMP requirements and strong working knowledge of FDA and EU requirements/guidance documents. Direct experience in providing QA support for cGMP manufacturing operations. Knowledge of drug development regulations such as the GCPs, GMPs and GLPs. Proficiency in electronic quality management systems (eQMS) and document control software. Strong analytical and problem-solving skills, with the ability to analyze complex quality-related data and propose effective solutions. Ability to collaborate with diverse cross-functional technical groups to resolve issues, close gaps and ensure compliant outcomes which are efficient and robust. Excellent communication skills, including the ability to effectively communicate quality issues to senior management. Exceptional attention to detail and organizational skills to manage multiple priorities in a fast-paced environment. Ability to work hours necessary to support production and/or product transfer activities. Ability to work in confined spaces and near operating equipment. Ability to work onsite (Columbus, Ohio) 5 days/week. Ability to work in a cleanroom environment while wearing appropriate gowning and PPE. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned. Work Environment and Physical Demands This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. Must be able to lift heavy objects up to 50 lbs. Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We've Got You Covered: At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way: Health from day one Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family. Time to recharge A competitive paid time off plan - because rest fuels innovation. 12 weeks of fully paid parental leave so you can focus on family when it matters most. Rewarding your impact Annual bonus opportunities for all full-time team members. 401(k) with company match to help you plan for the future. Special employee discounts, including childcare and dependent care savings. Your wellness, supported Onsite fitness facility at The Hearth. Mental health counseling and financial planning services through our Employee Assistance Program. Employer-paid short and long-term disability coverage to protect your peace of mind. Fuel for your workday A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next. Grow with us Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

Job Description Worthington Woods Animal Care Center is seeking an experienced Veterinary Assistant to join our team! This is an excellent opportunity for Veterinary Assistants who are excited to fully utilize their skills in both surgery and outpatient care while making meaningful connections with clients and their pets. In this role, you will: Assist with patient preparation and recovery during surgical and dental procedures. Maintain detailed medical records to support accurate patient care. Support exam room workflow by assisting with outpatient care, patient handling, and preparing for appointments. Communicate with clients to check-in for appointments, review treatment plans, provide discharge instructions, and address questions with empathy and clarity. Anticipate the needs of your team to maintain an efficient schedule while upholding the highest standards of patient care. This position is ideal for Veterinary Assistants who enjoy engaging with clients and supporting outstanding patient care in a collaborative, team environment. This is a full-time position, with a 4-10s schedule and availability needed Monday-Friday, with rotating Saturdays. Full-time benefits and compensation**: Compensation: $17-20 per hour, for each hour worked* Bonus package: $500 for those with 3+ years of consecutive, current VA experience Health package: Medical, dental, and vision insurance Life insurance and disability Employee Assistance Program 401k options Paid time off in accordance with site policy and applicable law Personal pet discount Minimum qualifications and skill set: 3+ years of veterinary experience in a clinical setting Proficiency in the following skills: Radiology Surgery setup & assisting Phlebotomy Inpatient care Sample collection At Worthington Woods Animal Care Center, we treat each pet that comes through our doors as if they were our own. Our practice was established in 1987 by Dr. James Miller, DVM. We are a full service, family-owned animal practice, offering the latest equipment and medical procedures. Additionally, we offer boarding, pharmacy services, and a wide variety of pet foods and supplies. We have an enthusiastic and caring team ready to respond to the growing needs of our clients and their beloved pets. Join our family of caring animal lovers. Apply today! *To determine specific pay Company will consider the following factors: the applicant's education, training, or experience related to the job position, geographic location where the work is performed, and other relevant factors.**During the process, you may request more information about compensation and benefits for your specific location where the work is performed. Where required under applicable law, WVP provides eligible employees with leave, and similar benefits programs, all in accordance with state and local law.WVP is 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, age, protected veteran or disabled status, genetic information, or any other protected characteristic under federal, state or local laws. WVP will consider qualified applicants with a criminal history, in a manner consistent with the requirements of applicable state and local laws.Qualified Applicants with disabilities are entitled to reasonable accommodations under applicable state and local law, and the Americans with Disabilities Act. Please contact People Operations, if you need assistance completing the application process. #SPO

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.

The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel. **** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products. + Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes. + Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. + Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus. + Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. + Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. + Performs other duties as assigned related to CMC RA function. **Qualifications** **Education** : + BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products. + Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications will be a plus. **Skills:** + Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues. + Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval. + Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. + Comprehensive understanding of the global regulatory environment. + Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. + Strong leadership, communication, and negotiation skills. + Ability to manage complex projects and timelines across multiple regions. + Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + CMC reviewer (assessor) with FDA or EMA will be a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Nature and Scope This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes. * Performs sampling of components. * Conduct verifications and checks through accurate material inspections. * Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system * Management of BPCS for verification and disposition of materials * Maintain retain samples for all primary and secondary components and labeling * Performance of DAF (Destruction Approval) process for rejected materials * Use of Trackwise and Veeva for change controls, as needed * Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements * Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. * Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation. * Support generation of logbooks and sheets/labels as required. * Basic knowledge of cGMPs and supporting regulatory documents * Perform room, area and equipment clearances that may be necessary for this job function. * Able to perform tasks with minimal error rate. * Assist other Quality Assurance Operations Associates, as needed. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. * At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred. * Must be able to do work independently. * Experience in QA working in a cGMP manufacturing environment (preferred) * Working knowledge and understanding of quality assurance principles and familiarity with QA programs * Strong analytical skills, attention to detail and adherence to procedures. * Intermediate skills in Microsoft Word and Excel are required. * Excellent organizational, interpersonal and communication skills (written and oral) required. * Ability to take feedback constructively and function in a team-oriented work environment. * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. * Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

The Senior Project Controls Analyst leads project controls activities across complex pharmaceutical construction programs. This role requires deep expertise in cost and schedule integration, capital planning, and requisition review. The ideal candidate brings extensive experience supporting the construction of pharmaceutical plants, laboratories, and GMP environments. In addition to developing and maintaining cost and schedule control systems, the senior analyst will liaise with cross-functional teams, including design, procurement, and construction stakeholders, to ensure timely, accurate reporting and actionable recommendations.Organizational Responsibilities Leads the development and execution of cost control procedures for multi-million-dollar pharmaceutical capital projects. Supports requisition and invoice review processes, ensuring alignment with forecasted budget and contract requirements. Oversees detailed cash flow models and monthly forecast updates for executive reporting. Integrates schedule and cost data to track earned value and schedule performance indicators. Supports design coordination, procurement tracking, and construction delivery timelines. Coordinates with contractors, subcontractors, and client leadership for alignment on scope, risk, and cost exposures. Supports the development of programmatic dashboards and executive presentations. Other duties as assigned. Position Qualifications Bachelor's degree in engineering, construction management, finance, or a related field. 10+ years of experience in project controls, with substantial exposure to pharmaceutical project environments. Proficiency in cost and schedule management tools (e.g., Primavera P6, Excel, Power BI, SAP, Oracle). Demonstrated leadership in capital program forecasting, budget reconciliation, and schedule integration. Deep understanding of the pharmaceutical construction lifecycle and regulatory requirements (e.g., GMP, cleanroom design). Excellent interpersonal, written, and verbal communication skills, especially in client-facing settings. Additional Requirements Physical: Standing or sitting for long periods; must be able to lift up to 15 pounds at times and spend extended hours in front of a computer screen. Cognitive: Problem-solving, written, and verbal communication skills; computer and software skills; and ability to read and interpret text online or in printed form. About PMA At PMA, employee well-being is a daily priority. We offer a combination of workplace options that include a PMA office location; work-from-home; or a client site. Wherever we work, we openly share knowledge as we believe that collaboration with peers improves our work product and that pursuing subject matter expertise is a lifelong endeavor. We are committed to a culture of equity, diversity, and inclusion. We affirm and respect diverse backgrounds and opinions because we believe they yield the best solutions for our clients. We promote emotional intelligence and trust by nurturing these values within our new hires. We encourage staff to develop rewarding, long-term careers at PMA, and we implement formal leadership development programs that help you attain your goals. At PMA, shared success is a core value. Every employee who contributes is recognized, celebrated, and rewarded. We look for self-driven candidates eager to assume responsibility and join a community of respect founded on collaboration and accountability, not titles. If you aim to transform the project management practice toward continuous improvement of project outcomes, the profession, and yourself, PMA looks forward to warmly welcoming you to our team. We offer competitive pay and benefits, wellness programs for you and your family, and career development opportunities to advance your professional goals. As a PMA professional, you will be empowered to make timely and effective decisions and significant daily contributions to complex facets of project delivery. Join a team that has achieved a world-class reputation in the construction industry and has been voted a “Best Place to Work.” PMA offers competitive wages and comprehensive benefits, including medical, prescription, dental, vision, time off with pay, 401(k) with company match, life, disability, and professional development reimbursement for qualifying employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), disability, national origin, or any other characteristic protected by applicable laws, regulations, and ordinances. Qualified female and minority applicants are encouraged to apply. EOE, including persons with disabilities and veterans. VEVRAA federal contractor.

About the Company Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. Job Summary The Head of Global Regulatory Affairs is a key leadership position that will oversee and is accountable for global regulatory, quality strategies and policies for Adagene. This individual will be responsible for regulatory leadership and oversight to help develop global regulatory and quality compliance strategies, and guidance. As a Head of Global Regulatory Affairs this person will perform a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies. This individual must leverage their extensive experience to represent Adagene in regulatory affairs in discussions with internal and external stakeholders. This role will provide global regulatory expertise and contribute to the delivery of the Clinical, R&D and Operations strategies. This individual will lead cross-functional and multicultural team and diverse environment. The candidate must have an entrepreneurial mindset, highly motivated and purpose driven leader who is able to flexibly and effectively lead and interact with multi-disciplinary teams. This individual should have experience in championing new ideas in a dynamic, international, and innovative environment. The successful candidate will have a track record of accomplishments in global regulatory affairs, project management, strong collaboration, and communication skills. This position may require travelling to our company headquarters in Suzhou, China. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Serve as a key member of senior management team to provide leadership and guidance to ensure business objectives are aligned with company strategies and achieve operational objectives to gain product approvals. Provide counseling, training, and interpretation of FDA, CDE and other regulatory requirements to all company personnel. Lead, coach, and mentor the Regulatory departments and ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization. Oversee preparation and filing of all regulatory documents with the FDA, CDE and other regulatory agencies. Develop and maintain external relationships with key opinion leaders and regulatory officials. Direct the development of systems, practices, and processes to ensure effective ongoing review of clinical development plan, product design and/or manufacturing changes and adverse events. Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk. Responsible for company's product quality and reliability to meet or exceed regulatory. Lead company's Quality Compliance to ensure compliance with regulatory agencies and all applicable standards. Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities. Support the quality system, provide effective leadership support, training, and guidance to all company personnel. Serve as the ambassador to and develop strategies for responses to regulatory related inquiries from global regulatory agencies and ensure issues are addressed in a timely manner. Responsible for leading all regulatory activities for assigned projects in line with regulatory requirements, regional requirements and scientific and company policies and procedures. Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions. Lead Global Regulatory efforts for all INDs, NDAs, and life cycle management. Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible. Champion initiatives that contribute to global process improvements, which have a significant impact on business. Direct activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organization's (CRO's), material suppliers, consultants, and vendors. Other projects or responsibilities as may be required. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the job. Minimum Qualifications - Education and Experience A PharmD or PhD degree in a scientific discipline and a minimum of 10 years of pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA and international regulatory agencies is required for this position. Minimum 10-15 years of progressively responsible Regulatory experience in a pharmaceutical, biotechnology or related environment. Position also requires a minimum of 5-8 years of leadership experience in a global regulatory affairs role. Must have extensive knowledge of regulatory requirements, including ICH GCP, GMP, GLP, and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business. Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP GMP, CLP guidelines and relevant requirements Substantial experience in all aspects of regulatory affairs, including Clinical, Commercial support, CMC, with a track record of successful submissions and license approvals with CDER and CBER Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions. Excellent working knowledge of the US, European and Asian regulations for drugs and biologics. Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy. Must be able to travel (US/international) up to 25%. Preferred Qualifications - Education and Experience RAC Certification preferred Equal Opportunity Employer Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant. Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation. Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area. Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program. Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.

GLOBAL TECHNICAL SERVICE ADVISOR Dealer & Customer Support is recruiting for an open position as a Technical Service Advisor. Join our team and begin your journey towards moving people with passion and innovation! We are looking for someone passionate about service and the overall powersports world. Someone who shares our obsession to deliver and secure outstanding service experiences that move people on snow, water, dirt and asphalt. BECOME PART OF OUR TEAM Here at BRP, we're creating new ways to get people moving forward, where their experiences are measured by emotion rather than distance. All around the world, our products, achievements and aspirations are a reflection of our teams' exceptional expertise. Want to bring your true self on this adventure? YOU'LL HAVE THE OPPORTUNITY TO: * Act as a front of house advisor representing BRP globally by providing efficient expert advice, performing technical, mechanical and electrical diagnostics and answering dealer inquiries quickly focusing on right the first time and reflecting our quality service pledge. * Provide technical solutions to dealership technicians and support other department like warranty and customer care teams * Guide dealers on best practices related to BRP policy , processes and guidelines * Proactively support and coach our partners and dealer network with regards to technical support and dealer inquiries all while building and maintaining our dealer relationship. * Represent BRP and build relationships by participating in events * Highlight issues quickly, Identify and escalate emerging issues or trends and represent your sector in order to continuously and proactively improve and optimize our support services. YOU'LL THRIVE IN THIS ROLE IF YOU HAVE THE FOLLOWING SKILLS, EXPERIENCE AND COMPETENCIES: Required: * Basic technical degree or any relevant qualification in powersport, automotive, marine or small engine mechanics * At least 2 years of relevant experience in a powersport dealership or in a similar environment with general mechanical knowledge. * Strong troubleshooting and diagnostic skills with thorough understanding of electrical and mechanical theory * Ability to navigate and understand electronic parts catalogs, engineering drawings and bill of materials. * Effective written and verbal communication skills. * Strong interpersonal skills with the ability to work with a variety of individuals and departments. * This position is 100% remote based within the United States. Additional details: * Position requires current work authorization. Sponsorship now or in the future is not provided for this role. * Relocation support is not provided for this position. Candidates must be willing and able to relocate to the United States at their own expense. Do you have other qualifications? Tell us what is unique about you that is a great addition to the team. AT BRP, WHEN WE TALK ABOUT BENEFITS, WE GO ALL IN. Let's start with a strong foundation - You want it, we have it: * Annual bonus based on the company's financial results * Generous paid time off * 401k offering with a dollar-for-dollar match What about some feel good extra perks: * Flexible work schedule for eligible positions * Holiday shutdown between Christmas and New Years * Educational resources and growth opportunities * Discount on BRP products WELCOME TO BRP We're a world leader in recreational vehicles and boats, creating innovative ways to move on snow, water, asphalt, dirt and even in the air. Headquartered in the Canadian town of Valcourt, Quebec, our company is rooted in a spirit of ingenuity and intense customer focus. Today, we operate manufacturing facilities in Canada, the United States, Mexico, Finland, Australia and Austria, with a workforce made up of close to 16,500 spirited people, all driven by the deeply held belief that at work, as with life itself, it's not about the destination; It's about the journey. BRP US Inc. is an equal opportunity employer and makes employment decisions without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, disability status, veteran status, age, or any other status protected by applicable law. If you have a disability and would like to request an accommodation to apply for a position, you may contact us at ******************. #LI-remote

Field Application Specialist BH Job ID: 3201 SF Job Req ID: 15558 Ingersoll Rand is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. Job Title : Field Application Specialist, BioPharma Location : Remote, USA (Central or Southeast region) About Us Imagine a company with technology leadership of over 160 years, yet it operates with the energy of a startup. Ingersoll Rand has dedicated itself to Making Life Better for its employees, customers, shareholders, and planets. We produce innovative and mission-critical flow creation and life science technologies - from compressors to precision handling of liquids, gasses, and powers - to increase industrial productivity, efficiency, and sustainability. Supported by over 80+ brands, our products are used in various end-markets including life sciences, food and beverage, clean energy, industrial manufacturing, infrastructure, and more. Across the globe, we're driving growth with an entrepreneurial spirit and ownership mindset. Learn more at irco.com and join us to own your future. Job Overview : ILC Dover, an Ingersoll Rand company, has been pushing the boundaries of high-pressure materials since 1947; from military high-altitude suits to the iconic Apollo spacesuits worn on the moon. Today, we lead the way in advanced materials for pharmaceuticals, industrial packaging, and protective gear. As we continue to grow, we're seeking a Field Application Specialist, BioPharma, who is a technically savvy and strategically minded professional that will support sales by designing and presenting solutions for Pharma and/or OSD manufacturing. You combine commercial insight with the ability to clearly communicate value and ROI to customers. This role is an excellent opportunity to leverage your expertise as a key technical ambassador, driving adoption of our advanced powder handling, powder/liquid mixing, and high-containment systems. Collaborating across the full customer lifecycle, you'll identify opportunities, develop tailored solutions, and provide post-installation support to ensure operational excellence and regulatory compliance. Blending pre- and post-sales expertise, you will translate complex customer challenges into actionable, innovative solutions that deliver real impact in the BioPharma space. If you're driven by solving technical challenges and delivering real impact, we want on our team! Responsibilities: * Partner with the commercial team to identify opportunities, develop proposals, and close deals by providing technical insight and application expertise. * Engage with customers to understand their process needs and recommend tailored solutions from our broad technology product portfolio. * Support the tender process through technical documentation, presentations, and product demonstrations that highlight ILC Dover's value proposition and differentiation. * Act as a technical liaison between customers and internal teams, ensuring alignment from concept through execution. * Contribute to strategic growth initiatives by identifying new applications and markets for ILC Dover's technologies. * Represent ILC Dover at major industry exhibitions and conferences, showcasing our innovation and leadership in containment and process solutions. Requirements : * Bachelor's degree in Mechanical, Automation, Chemical, or Pharmaceutical/Biotech Engineering, or a related field, or equivalent and relevant work experience * 5+ years of experience in pharmaceutical or biopharmaceutical environments, with a strong focus on powder handling, mixing, and high containment. * Proven ability to conduct both in-person and remote customer engagements, including technical consultations and solution presentations. * Strong understanding of GMP, ATEX, and containment performance standards. * Proficient in Salesforce CRM and Microsoft Office Suite. Core Competencies: * Pre-Sales Engagement & Solution Design: Lead technical consultations, design tailored solutions, and support opportunity identification and deal closure. * Customer Consultation & Technical Expertise: Translate complex processes into actionable solutions, leveraging deep knowledge of powder handling, mixing, and high-containment systems. * Post-Sales Support & Knowledge Transfer: Ensure successful implementation, provide ongoing technical support, and share best practices to maximize customer outcomes. * Market Development & Strategic Representation: Identify new applications and markets, contribute to growth initiatives, and represent ILC Dover at industry events and conferences. * Collaboration & Communication: Work effectively with internal teams and customers, clearly articulating technical and commercial value while fostering strong relationships. Travel and Work Arrangements * This is a US Remote based role in the Central or Southeast region * Most be located near a major US airport * Anticipated Travel with this position is 25% - 50% The base salary range for this role is $100,000 $150,000, excluding eligible incentives. The pay range considers a wide range of factors that include a candidate's skills; experience and training; licensure and certifications; and geographic location. What We Offer At Ingersoll Rand, we embrace a culture of personal ownership - taking responsibility for our company, our communities, and our environment, as well as our individual health and well-being. Our comprehensive benefits package is designed to empower you with the tools and support necessary to take charge of your health, ensuring that together, we can continue to make life better. Our range of benefits includes health care options like medical and prescription plans, dental and vision coverage, as well as wellness programs. Additionally, we provide life insurance, a robust 401(k) plan, paid time off, and even an employee stock grant, among other offerings. These benefits are our commitment to you, so you can be your best at work and beyond. Ingersoll Rand Inc. (NYSE:IR), driven by an entrepreneurial spirit and ownership mindset, is dedicated to helping make life better for our employees, customers and communities. Customers lean on us for our technology-driven excellence in mission-critical flow creation and industrial solutions across 40+ respected brands where our products and services excel in the most complex and harsh conditions. Our employees develop customers for life through their daily commitment to expertise, productivity and efficiency. For more information, visit *************

Hilti Fieldwire, Inc.'s affiliate is hiring. This position is an opportunity to join the Hilti, Inc. team. The candidate selected for this position will be a Hilti, Inc. team member. If interested, please complete our application. Who we're looking for Crew Center by Hilti is seeking a motivated and curious Part-Time Sales Development Representative (SDR) to support our growing construction software business. This role is ideal for someone looking to gain hands-on experience in tech sales while learning about SaaS, sales operations, and customer engagement within a fast-paced, collaborative environment. As a Part-Time SDR, you'll work closely with an established team of sales professionals, supporting the sales process through daily outreach, value-added projects, and direct interaction with customers. This position offers meaningful exposure to Hilti's newest software products in North America and provides a strong foundation for future full-time opportunities. The primary responsibilities for our next Part-Time Sales Development Representative will be to:Support the sales organization through daily SDR activities and value-added projects Engage with customers and prospects to support pipeline generation efforts Assist with outbound and inbound sales outreach initiatives Partner with sales team members to support opportunity progression Participate in sales operations and cross-functional initiatives Learn and articulate the value of Crew Center and Fieldwire by Hilti software solutions Maintain accurate documentation and support sales reporting needs Collaborate with internal stakeholders across sales, marketing, and leadership teams We're looking for you to have the following skills and experiences: In pursuit of or completion of a bachelor's degree in professional sales, marketing, or a related business field Availability to work a minimum of 20 hours per week starting January 1, 2026 Strong interest in sales, SaaS, and customer engagement Excellent written, verbal, and presentation skills Ability to multitask, prioritize, and manage time effectively Comfort working in a remote environment Proficiency in Microsoft Excel, PowerPoint, and Word Ability to learn new software tools quickly Eligibility to work in the United States permanently without sponsorship Preferred Experience: 0 - 1 Year of experience Any prior sales experience Previous SDR experience Construction industry experience This Part-Time SDR role is a strong entry point into Crew Center and Fieldwire by Hilti, with high performers frequently advancing into full-time Account Executive (Software Sales) positions. You'll gain meaningful exposure to sales operations, SaaS marketing initiatives, and executive leadership, all while building foundational skills for a long-term career. Why Crew Center? As Hilti continues to expand its construction software portfolio, Crew Center plays a critical role in delivering a full-scope construction management solution. Crew Center is a field-first workforce management platform designed to simplify timekeeping and production tracking, helping contractors save hours each week through easy-to-use, highly effective tools. This role offers the excitement of working on a newer, startup-like product while benefiting from the stability, resources, and global reach of Hilti. Compensation This part-time role pays $21.00 per hour. Where is the job located? This role is remote within the US. -- Fieldwire is proud to be an Equal Opportunity Employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, Veteran status or any other characteristic protected by law.

About Forge At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from idea into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins. Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen - you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases. About The Role The Lead, GMP Manufacturing Support plays a critical role in maintaining and supporting GMP-compliant cleanroom environments (ISO 5-8 / Grade A-D) essential for the production of viral vector products. This role is responsible for overseeing contamination control strategies, coordinating day-to-day operations, and leading a team of personnel responsible for cleaning and GMP support activities. The ideal candidate brings a strong understanding of aseptic practices, contamination control, and GMP regulations, along with the leadership skills to promote a high standard of compliance, safety, and operational excellence. What You'll Do: Lead the cleanroom cleaning team to perform routine and non-routine cleaning operations per SOPs and GMP requirements. Oversee cleaning of aseptic fill areas, upstream/downstream suites, airlocks, corridors, and equipment in accordance with validated procedures. Perform verification of cleaning and sanitization activities and ensure accurate documentation; perform the manufacturing review of logbooks and associated documents; and resolve out-of-trend situations promptly. Act as SME for cleanroom behaviors, gowning, and contamination control best practices. Support deviation investigations, root cause analysis, and CAPA development related to cleaning issues or contamination events. Plan and assign daily tasks for effective resource utilization, collaborating with planning, and maintaining schedules. Train and coach new and existing staff on cleaning techniques, gowning, aseptic behavior, and cleanroom discipline. Collaborate with Manufacturing, Quality Assurance, Quality Control, Environmental Monitoring, and Facilities & Engineering to resolve issues and drive continuous improvement. Support cleaning validation and requalification activities for classified spaces and equipment. Manage cleanroom inventory to ensure availability of common-use items and uninterrupted operations. Oversee consumable expiration tracking and storage, implementing rotation protocols and guiding technicians to meet operational and regulatory standards. Other responsibilities may include supporting tubing sets preparation, process improvement initiatives and collaborating with cross-functional teams to ensure the efficient production of gene therapy products. May assist with preparing for regulatory inspections (FDA, EMA) as the subject matter expert for contamination control practices. What You'll Bring: Associate's or Bachelor's degree in a relevant scientific field (e.g., Biology, Chemistry, Engineering) or equivalent experience. Minimum 5 years of experience in a GMP manufacturing environment, preferably in biologics, gene therapy, or sterile manufacturing. Demonstrated leadership skills with experience overseeing or mentoring team members. Strong understanding of cleanroom classifications, contamination control principles, and GMP regulations. Experience working within a Quality Management System (QMS). Proven experience overseeing manufacturing support functions (e.g., cleaning and sanitization, tube set building and setup). Excellent communication, organization, and problem-solving skills. Exceptional computer skills, prior experience with a manufacturing software (e.g., MRP or ERP System), and ability to use data analytics to drive process improvements and results. Flexibility to work in shifts, including weekends and holidays, as required by manufacturing production schedules. Ability to work in classified cleanroom environments (ISO 5-8 / Grade A-D) for extended periods while fully gowned in aseptic/sterile PPE attire. Able to lift up to 40 pounds and remain standing or walking for extended periods throughout the shift. The work environment is fast paced. This position has the utmost responsibility for compliance with rules and regulations regarding a safe and collaborative work environment relative to actions and conduct. Other duties may be assigned in addition to those described that aligns with company objectives. Physical Requirements: This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed such as cleanroom gowning. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned. Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Forge Your Future with Us What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together. At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us. If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself. We've Got You Covered We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable. Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents Competitive PTO (plus 14 paid company holidays) Annual bonus for all full-time employees 401(K) company match Fully-stocked kitchen with free food/drinks Onsite gym 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care Employee Assistance Program Wellness benefits (financial planning services, mental health counseling, employer paid disability) Professional & Personal development resources

About Vita Global Sciences Softworlds Vita Global Sciences is a professional services company that caters to the life sciences industry. We specialize in offering clinical data analytics solutions and functional outsourcing services. Our team is proficient in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and PK/PD analysis. Our clients highly value our unwavering commitment to delivering exceptional results in a safe, compliant, and efficient manner. Our Ideal Candidate: Vita Global Sciences is currently seeking a Director of Business Development who can work remotely and lead the expansion of our Life Science business. The ideal candidate should be able to manage territories effectively, identify promising leads, create compelling proposals, and deliver impactful presentations. Our utmost priority is to deliver top-notch consulting services to our valued clients. This role requires a high level of professionalism and expertise, and we look forward to finding the right candidate who can help us achieve our goals..Job Responsibilities Must have a consultative selling approach when initiating relationships with clients in the Biotech and Pharma industries. Establish new client relationships to generate job requisitions for SOW ( outsourcing ) and FSP project-based opportunities. Build connections with potential clients by networking, reaching out through cold and warm calls, and following up on leads. Meet or exceed Gross Profit and Start goals as assigned by your manager. Assist our internal recruiting team in evaluating job requirements and matching consultants with clients. Remain updated on industry and technology trends relevant to your supported sectors. Qualifications Experience creating successful staffing and hiring plans for Clinical, Biotech, and Pharma companies, with a deep understanding of clinical research and the private sector. Prior work with CROs is a plus. Applicants must possess 4+ years of experience with outsourcing or working on project-based assignments. 4+ years of experience initiating and maintaining long-lasting client relationships and negotiating service contracts and fees. Involvement in RFI (Request for Information) and RFP (Request for Proposal). Knowledge of GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice). Great at analytics and organization. Can create revenue-generating marketing plans and execute them efficiently. Implements daily action plans. To succeed in this role, you must handle tasks quickly and prioritize well. You should also have excellent interpersonal skills and project management abilities and work well with the sales team.

Job Description CONTEXT The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design, deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with connected Digital platforms. JOB RESPONSIBILITIES Collaborate with Business Analysts and Software/Automation Engineers in the complete product lifecycle management of Digital Quality Automation Systems (Hamilton Venus, Waters Andrew+ with OneLab, etc.) and Enterprise Instrumentation Systems (Chromeleon Chromatography Data System, Scientific Data Management System (LogiLab), CFR Gateway (LogiLab), SoftMax Pro, MODA, etc.) including optimizations, support, maintenance updates and version upgrades Translate system/equipment/data integration requirements from various teams into deployable Digital Laboratory System solutions Manage change control for regulatory Digital documentation (SOPs, work instructions, etc.) required to demonstrate appropriate compliance Partner with stakeholders to validate and integrate key systems into the connected instrument pipeline, future robotics/automation capabilities and AI initiatives Identify opportunities to optimize current processes and implement upgraded solutions Ensure GMP compliance in the design, delivery and maintenance of all systems Maintain inspection readiness throughout the duration of the project Participate in internal and external audits as required REQUIREMENTS Bachelors degree or equivalent in science, engineering or computer science discipline 5 to 7+ years experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a biopharmaceutical GMP environment Direct experience with automation solutions such as Hamilton Venus Experience working with advanced automated laboratory analytical systems such as Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlers Experience with GAMP and GxP compliance regulation Experience with data integrity regulations, instrument integration and laboratory digital workflow optimization Experience with Digital systems hosted in the cloud and an understanding of connectivity between on-prem systems and SAAS/Cloud Strong understanding of core laboratory systems, related processes, and quality management workflows Ability to work independently and in a team setting, with the ability to effectively communicate cross-functionally Ability to support multiple concurrent projects in a fast-paced environment Strong interpersonal and relationship-building skills LOCATION On-site 3-4 days/week between Marlborough, MA and Norwood, MA This is a remote position.

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.

Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with. Every day, your talent, your innovative spirit, and your determination will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature. Sr. Application Technologist (Food Chef) - Your future position? As the Sr. Application Technologist (Food Chef), you will conduct flavour application and provide technical expertise to drive project, brief management with excellence and establish successful collaborations with customers & technologist, according to business goals and EH&S policies. You will report to the Technical Head and will be based in Mumbai, India. Sounds interesting? In this exciting role you also will be responsible in: * Execute daily brief-related tasks, including savoury application development (RTE, RTC, sauces, snacks), product evaluation, shortlisting, and selection of technical solutions. * Inspire customers with creative culinary concepts and convert them into desired formats (noodles, snacks, HORECA menus, sauces, etc.). * Lead evaluation of technical solutions for briefs, research, and portfolio projects. * Select optimal technical solutions per customer, regulatory, and cost requirements, guiding teams to deliver winning outcomes. * Engage closely with customers and seasoning creators to inspire and advise on technical excellence. * Serve as technical expert and advisor to marketing, sales, flavour creation, and customers. * Coach, train, and motivate seasoning creators and technologists. * Maintain flavour performance data through systematic evaluation and profile capture. * Maintain a safe, clean, and organized lab environment, ensuring full compliance with EH&S policies and accountability across all team members. You? Are you someone who wants to grow and shape your own world? Who needs a new challenge and bring excellent contribution to the company? Then come and join us - and impact your world. Your professional profile includes: * Academic qualification as a Culinary Graduate from a leading Institute of Hotel Management (IHM), Bachelor's Degree in Hospitality or equivalent. * Professional chef background with 10 years of experience in the food industry (RTC, RTE, spice blends, HORECA, etc.). * Minimum 6-8 years of proven experience working on the savory food category portfolio. * Demonstrated expertise in scale-up, industrial processing, production, and bench-to-batch application development. * Comprehensive understanding and hands-on experience in RTE, RTC, and industrial kitchen operations. * Strong knowledge of food applications and additives such as texturizers, tenderizers, and modified starches, including their functionality and application in food manufacturing environments. * Proven ability to contribute effectively to customer projects across Meat Analogue, QSR/HORECA, and Retail Savoury product segments, including direct participation in customer visits. * Adept at technical problem-solving within specialized application areas and translating market trends into innovative, customer-focused product concepts. * Skilled in supervising and guiding laboratory technicians and technologists, ensuring adherence to Good Manufacturing Practices (GMP) and safety standards in the Creation and Application Laboratory. * Excellent people management and project leadership capabilities. * Strong communication skills in a B2B environment with customers and clients. Our Benefits * Attractive package with benefits * Excellent opportunities for progressive learning and development * A creative team environment that will inspire you * Comprehensive healthcare and retirement plan #LI-Onsite #LI-Y At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives. You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions. Every essence of you enriches our world. Diversity drives innovation and creates closer connections with our employees, customers and partners. Givaudan embraces diversity and is committed to building an inclusive environment where everyone impacts our world. Remote working: On-site At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives. You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions. Join us and Impact Your World Diversity drives innovation and creates closer connections with our employees, customers and partners. Givaudan embraces diversity and is committed to building an inclusive environment where everyone impacts our world.