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Director, GMP QA (CMC/Development) – Permanent – New York Proclinical is seeking a Quality Systems Director for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The Director, GMP QA (CMC/Development) will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Senior Consultant– Digital Innovation, Solution Expansion and Value Realization (Commercial Transformation)- Life Sciences Infosys Consulting is looking for talented and highly motivated consultants to join our Life Sciences consulting practice specializing in Commercial Transformation Solutions. As a Senior Consultant, you will work with life sciences companies who are invested in commercial capabilities yet need to fully capitalize on their investment. You will assist clients in their innovation efforts to scale digital solutions operating across the full lifecycle of opportunity creation and value realization within the commercial life sciences domain. RESPONSIBILITIES • Opportunity Identification & Prioritization – Identify emerging commercial challenges across omnichannel engagement, market access complexity, and value-based care. Uncover high impact opportunities where AI, analytic, and digital solutions can enhance HCP engagement, filed effectiveness, pricing/access strategy, medical advice, and patient services, prioritizing based on measurable commercial value., • Solution Design & Business Case Development – Translate opportunities into scalable, tech-enabled commercial solutions, define a clear value proposition to cross-functional stakeholders and build robust business cases tied to KPIs such as revenue growth, adherence, access, and operational efficiency., • Expansion of Capabilities – Identify and evaluate current and innovative commercial tools and platforms to identify underutilized assets, drive adoption and scale across clients, in functions including sales, marketing, market access, medical affairs and patient support., • Solution Packaging and Integration – Analyze and modularize solutions to fit seamlessly within commercial workflows (e.g., sales operations, campaign execution, reimbursement processes). Drive interoperability with existing systems while balancing standardization and customization., • Client Engagement and Commercialization – Engage senior commercial stakeholders to position solutions around business outcomes. Lead pilot engagements with clients, demonstrate value, and drive enterprise-scale adoption. Support go-to-market strategies for both new and existing offerings., • Thought leadership and Enablement – Develop forward looking perspectives on commercial innovation in life sciences. Create reusable frameworks and equip internal teams with case studies and messaging to scale impact across clients. Job Description : Senior Consultant– Digital Innovation, Solution Expansion and Value Realization (Commercial Transformation)- Life Sciences Infosys Consulting is looking for talented and highly motivated consultants to join our Life Sciences consulting practice specializing in Commercial Transformation Solutions. As a Senior Consultant, you will work with life sciences companies who are invested in commercial capabilities yet need to fully capitalize on their investment. You will assist clients in their innovation efforts to scale digital solutions operating across the full lifecycle of opportunity creation and value realization within the commercial life sciences domain. RESPONSIBILITIES • Opportunity Identification & Prioritization – Identify emerging commercial challenges across omnichannel engagement, market access complexity, and value-based care. Uncover high impact opportunities where AI, analytic, and digital solutions can enhance HCP engagement, filed effectiveness, pricing/access strategy, medical advice, and patient services, prioritizing based on measurable commercial value., • Solution Design & Business Case Development – Translate opportunities into scalable, tech-enabled commercial solutions, define a clear value proposition to cross-functional stakeholders and build robust business cases tied to KPIs such as revenue growth, adherence, access, and operational efficiency., • Expansion of Capabilities – Identify and evaluate current and innovative commercial tools and platforms to identify underutilized assets, drive adoption and scale across clients, in functions including sales, marketing, market access, medical affairs and patient support., • Solution Packaging and Integration – Analyze and modularize solutions to fit seamlessly within commercial workflows (e.g., sales operations, campaign execution, reimbursement processes). Drive interoperability with existing systems while balancing standardization and customization., • Client Engagement and Commercialization – Engage senior commercial stakeholders to position solutions around business outcomes. Lead pilot engagements with clients, demonstrate value, and drive enterprise-scale adoption. Support go-to-market strategies for both new and existing offerings., • Thought leadership and Enablement – Develop forward looking perspectives on commercial innovation in life sciences. Create reusable frameworks and equip internal teams with case studies and messaging to scale impact across clients. BASIC QUALIFICATIONS Demonstrates proven success in roles and thorough abilities in one or more of the following areas: • Strong understanding of the pharmaceutical commercial business and sales and marketing processes., • Expertise in one or more commercial domains: Sales/field force operations, omnichannel marketing, market access/pricing, patient services, • Drug Launch and Lifecycle Management – supported end-to-end product lifecycle strategies including launch readiness, commercialization, and in-line brand optimization across therapeutic areas., • KOL/HCP Network and Scientific Engagement – Incorporated KOL engagement strategies and HCP network dynamics to enhance scientific exchange, influence pathways, and adoption of therapies., • Solid familiarity with sales and marketing systems – CRM, CMS, marketing automation systems, marketing analytics, and/or social listening platforms. Familiarity with commercial analytics tools and CRM platforms (e.g., Veeva, IQVIA, Salesforce)., • Experience translating business objectives to system requirements, ideally proven experience in developing new digital/AI driven solutions and scaling existing solutions across enterprise clients in a project set-up, • 5+ years of relevant professional experience in Life Sciences industry working for a consulting services organization and/or industry experience., • Bachelor’s degree, preferably in a Life Science, sales and marketing related field, • Candidates authorized to work for any employer in the United States without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time PREFERRED QUALIFICATIONS • Industry experience working directly at pharmaceutical, medical devices or pharmaceutical distributor organizations is a plus, • Experience working with Veeva or Salesforce commercial platforms (e.g., CRM, marketing automation, data/analytics layers) is a plus, • Familiarity with health care data stack (claims, HER, prescription data, specialty data, hub data, marketing, first and third-party data) is a plus, • Master’s degree or MBA is preferred, • Track record in driving commercial transformation, • Demonstrated thought leadership and critical problem-solving skills, • Experience leading strategic and tactical discussions with senior stakeholders For candidates based out of NY and NJ estimated annual compensation will be $116,875 to $148,125 Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits:- • Medical/Dental/Vision/Life Insurance, • Long-term/Short-term Disability, • Health and Dependent Care Reimbursement Accounts, • Insurance (Accident, Critical Illness , Hospital Indemnity, Legal), • 401(k) plan and contributions dependent on salary level, • Paid holidays plus Paid Time Off About Us Infosys Consulting is the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world’s top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants: • Ability to design and implement end-to-end solutions at scale, • A flat organization structure with direct access to our senior-most leaders, • An entrepreneurial environment full of bright, highly motivated consultants, • Opportunities for motivated consultants to impact local communities, • The ability to design your career and drive your professional learning and development, • A truly global culture

Job Description Responsible for a portfolio of customers in the pharmaceutical packaging industry. The successful candidate will work in a multicultural environment in a NYC based office, under the supervision of the Customer Service Manager. The position involves administering customer orders in an SAP computer system, coordinating manufacturing schedules with our plants (in EU and Asia) and delivery schedules with our Logistic partners, updating the forecast and supporting the Sales Managers within a specific customer portfolio. Building report and Clear communication with the customer base are the most critical functions. The Customer Service Representative will be engaged in facilitating account administration such as ensuring on time payments and inventory control. ESSENTIAL DUTIES AND RESPONSIBILITIES • Manage all ordering and logistic communication with client portfolio, • Create and maintain clients’ accounts in SAP (new customer, price list, cross reference lists, surcharges), • Maintain administrative files (Network/CRM: orders, paperwork, POs status), • PO management o Review all POs for accuracy and process orders o Ensure a good communication with customers (standard communication) o Follow up validation with planning department o Follow up shipment with logistic department and logistic partners • Update the forecasting tool to ensure all data are accurate, • Sales support (Samples, new development), • Late payment (reminders level 1, fill in tracking document), • Control and manage inventory in local US warehouse (when applicable) EDUCATION AND EXPERIENCE • Minimum of 2 years of trade school (with appropriate experience) or university degree in related subjects to job description., • Good communication skills (oral and written), • Team player, organized, detailed oriented, quick learner, • Comfortable in a multicultural, multilingual environment, • Experience: o Minimum of 1 - 3 years experience in similar position, Pharma/Packaging industry is a plus • Spanish and French prerequisite COMPUTER SKILLS • Very comfortable with IT tool (ERP system, forecasting tool, Microsoft Office suite). SAP experience is a plus

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com. The Production Technician I is responsible for the aseptic manufacturing of Cresilon’s products for the animal health industry. The Production Technician II will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP). • Perform line clearance of assigned production areas as required., • Perform equipment set up and disassembly activities., • Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment., • Formulate, fill, and pouch product in accordance with SOPs., • Troubleshoot all operating deviations and issues and coordinate with other functions when required., • Report both machine and operating deviations to area supervisor or designee., • Perform routine, preventative maintenance on equipment., • Perform cleaning and disinfection of the manufacturing spaces., • Perform cleaning and sterilization of manufacturing equipment., • Perform visual inspection of components and/or product in accordance with SOP’s and cGMP’s., • Perform sampling, intermediate, and finished goods packaging as per SOPs., • Package and ship raw materials for sterilization., • Perform material receiving, staging, material movements, and material replenishment as per SOPs., • Transport samples, materials, and equipment between multiple facilities., • Complete data entry and generate reports for material inventory movements., • Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards., • Maintain a clean production environment during shift., • Report all actual, near misses and potential accidents for further investigation., • Take immediate action to resolve any near miss situations., • Assist in investigation of all actual, near misses and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently., • Assist in project commissioning and validation activities, as necessary., • Prepare samples or prototypes as required for testing, or other evaluations, • Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process., • Complete all required trainings: Read and Understand (TM1), Computer Based Training with Quiz (TM2), Instructor Led (TM3/TM4), and On-the-Job Trainings (TM5)., • Oversee training of junior employees on production processes as assigned., • Ensure proper communication and handling over of shift duties., • Support Environmental and Personnel Monitoring (EM/PM) activities as directed., • Responsibilities may include other duties as assigned and as required Requirements • HS Diploma or Equivalent with 2+ years of relevant manufacturing experience in the pharmaceutical, biotechnology, or medical device industry OR 2 or 4 year degree with 0+ years of relevant experience., • Ability to read, understand, and execute written work instructions., • Ability to complete documentation accurately., • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals, • Ability to become gowning qualified to work in a cleanroom environment., • Ability to problem solve and achieve business objectives., • Ability to adapt training approach., • Willingness to be flexible, and open minded to new processes or changes in direction., • Team oriented, building relationships with peers and managers in a proactive manner., • Excellent verbal and written communication skills., • Proficient in Microsoft Office (Word, Excel, Outlook)., • Must be able to work overtime and/or second shift when needed. Benefits • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Monthly MetroCard Reimbursement, • $20-24/hr Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionMixlab, the fast-growing veterinary compounding pharmacy, is hiring a Part-time Pharmacist to help us in our NY pharmacy. We are looking for a pharmacist who is obsessed with details and is driven by an ability to #makeithappen for our customers and their furry (and scaly!) friends no matter what. You will be an integral part in helping us to ensure our pharmacy operations run smoothly and to make Mixlab a 100% dependable resource for our customers and veterinarians alike. This role is a full-time to be scheduled within the following hours of operation: Monday-Friday: 8 AM-7:00 PM EST, Saturday 8 AM - 4:30 PM EST. Responsibilities: • In partnership with pharmacy leadership, ensure performance of the pharmacy meets goals & expectations each day, • Answer workflow and pharmacy questions, • Ensure the smooth flow of orders within & between process areas, especially those where you are working on that shift, • Guide staff pharmacists in best practices and contribute to continuous improvement of Mixlab processes, • Ensure compliance with regulatory & licensing requirements and that the team behaves in line with Mixlab values, • Support and coordinate with the Pharmacy Manager, Department Leads, and PIC in the execution of daily/weekly operating plans, • Oversee compound pharmaceutical preparations in the lab, ensure the workflow operates as designed, and work proactively to address waste and errors, • Perform final verifications on all compounds prior to packaging, • Provide guidance and feedback as a subject matter expert to internal teams on compounding, workflow questions, etc., • Work alongside the quality team to enable and ensure robust quality assurance processes, • Maintain NY state license and other licenses as needed, • Perform Care Pharmacist duties on an as needed basis, • Be able and willing to perform primary workflow responsibilities as a pharmacist in all areas in the pharmacy About You:, • You are a licensed certified pharmacist in NY, in good standing with all State Boards of Pharmacy, • You have formal training in non-sterile compounding or equivalent experience, • You have 2+ years of experience in non-sterile compounding, with preference given to veterinary compounding experience, • Your attention to detail is impeccable, and you have incredibly high standards for accuracy and quality, • You are collaborative and have a desire to work in a team-oriented, fast-paced, startup environment. Physical Requirements:, • Good hand-eye coordination, • Ability to lift up to 30 lbs.What We Offer:, • 100% employer-paid health, dental, and vision insurance for our employees, effective on the first of the month following your start date, • Paid time off for vacation, holidays, and sick time, with the ability to accrue more vacation time with increased tenure, • Competitive starting wages with the opportunity for rapid career growth, promotion, and wage increases, • Company Stock Options, • Pre-tax commuter benefits, dependent care, HSA and FSA, • Employer-paid short and long-term disability leave, parental leave, and life insurance, • 401k with $300/year match, • Referral bonus payouts of up to $1,000 for a successful referral, • Human and pet wellness benefits, including a $650/year allowance for routine pet care through Wagmo, • Discounts on many items through Perkspot, • And more!Compensation at Mixlab is determined based on individual qualifications, experience, and skillset.Mixlab is the first modern pet pharmacy that focuses on creating high-quality, custom medications and delightful experiences for pets, their parents and veterinarians. By putting service at the heart of everything we do, we're able to provide the best personalized care for our furry friends, as well as those who care for them. Mixlab is proud to be a PCAB-accredited compounding pet pharmacy. Check us out on Instagram or see our 5 star reviews on Google, Yelp and Facebook! We are committed to a workplace that thrives on inclusion, diversity, equity, and access (IDEA). As such, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Mixlab is also committed to hiring practices that support access, equal opportunity and reasonable accommodation for individuals with disabilities. To request reasonable accommodation for your application or interview, please contact the Mixlab Talent Acquisition team at talent@mixlabrx.com or call 929-207-2659. Pay ranges at Mixlab are based on competitive market data for our industry and company size. In addition to base pay, our total compensation package for full-time employees includes benefits and equity. We determine individual pay based on qualifications for the role, experience level, and skillset, and we expect offers made to candidates to fall throughout the range advertised. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com. Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Description We’re seeking a Warehouse Group Leader to oversee inventory handling, personnel coordination, and day-to-day warehouse operations within a food-grade manufacturing environment. This role requires strong leadership, attention to detail, and the ability to manage product flow, documentation accuracy, and compliance with all food safety, GMP, and company standards. You’ll lead a shift of warehouse personnel, ensure accurate receiving and inventory control, coordinate outbound shipments, and support safe, efficient warehouse operations. Compensation • $22 hr, • Medical, dental, vision Shift • 1st: 8:00am - 4:40pm Requirements • Shift Leadership & Team Coordination – Assign tasks, supervise warehouse personnel, provide training, and ensure smooth shift operations. Step into full departmental responsibility when the Warehouse Manager is absent., • Receiving & Inventory Management – Receive finished goods, verify materials against invoices, maintain accurate inventory counts for raw, packaging, and finished goods, and ensure all items are properly tagged, labeled, and stored., • Shipping & Material Handling – Oversee loading and unloading of freight, ensure FIFO is followed for incoming and outgoing products, coordinate transportation schedules, and validate outbound accuracy., • Compliance, Documentation & SAP Use – Maintain complete and accurate paperwork for all inbound/outbound transactions; operate SAP warehouse applications and handheld scanners for receiving, posting, and tracking materials., • Quality, GMP & Food Safety Standards – Ensure all warehouse activities follow GMP, food-safety, and safety guidelines. Maintain a clean work area, ensure tools/equipment function properly, and immediately report discrepancies or damages., • Forklift Operation & Safety – Complete forklift and trailer inspections, maintain a zero-damage standard, and uphold a clean safety record in accordance with company policies., • Supplier & Customer Coordination – Communicate with suppliers regarding delivery schedules, prepare product samples as needed, and assist in reviewing open sales orders to ensure adequate inventory allocation Qualifications • Experience – Minimum 2 years of warehouse experience in a manufacturing environment, ideally within food, pharmaceutical, or nutraceutical industries., • Leadership & Teamwork – Demonstrated ability to lead a shift, train staff, delegate tasks, and maintain smooth warehouse operations., • Technical Skills – Experience with handheld scanners; ability to use SAP or similar warehouse management systems; strong understanding of inventory practices and FIFO., • Forklift Certification – Valid forklift license/certification with a strong safety record., • Documentation & Compliance – Ability to complete and manage paperwork accurately while following SOPs, GMPs, and food-safety guidelines., • Communication – Ability to read, write, and speak English effectively; strong coordination and reporting skills., • Physical Requirements – Ability to regularly lift 10 lbs and occasionally up to 50 lbs; ability to work in a fast-paced warehouse environment. Benefits • $22 hr, • Medical, dental, vision

Job Description JOB PURPOSE The Quality Assurance Manager is responsible for leading and maintaining the Quality Management System (QMS) to ensure cosmetic and OTC products are manufactured in compliance with FDA regulations, cGMPs, and applicable ISO standards. This role provides quality oversight for manufacturing operations, supports regulatory inspections, and drives continuous improvement across the organization. DUTIES & RESPONSIBILITIES · Develop, implement, and maintain the QMS in accordance with FDA, cGMP, and ISO requirements. · Oversee deviations, CAPAs, change controls, and root cause investigations. · Ensure effective document control and approval of quality-related records. · Establish and monitor quality metrics to assess compliance and performance. · Lead and support FDA inspections, customer audits, and third-party audits. · Prepare audit responses and ensure timely closure of observations. · Maintain inspection readiness and support regulatory submissions as needed. · Provide QA oversight of manufacturing, packaging, labeling, and warehouse operations. · Partner with Operations and related functions to ensure GMP compliance and product quality. · Support validation, supplier quality, and material qualification activities. · Lead, mentor, and develop the QA team. · Ensure GMP and quality training programs are implemented and maintained. · Promote a culture of quality, accountability, and continuous improvement. · Serve as a primary quality contact for customers. · Manage customer complaints and drive effective investigations and corrective actions. QUALIFICATIONS · Bachelor’s degree in a scientific or related field required. · 5+ years of QA experience in cosmetics, OTC, pharmaceutical, or regulated manufacturing. · Prior QA leadership or supervisory experience required. · Strong knowledge of FDA regulations, cGMPs, and cosmetic/OTC compliance. · Excellent communication, problem-solving, and organizational skills. PHYSICAL REQUIREMENTS · Ability to work in office and manufacturing environments. · Ability to stand, walk, and sit for extended periods. · Ability to lift up to 25 lbs and wear required PPE. Salary Range:$70K to $85K. At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer. Powered by JazzHR KL9vkbMchl

Job Description Overview About Us: Anvia Therapeutics is a dynamic and innovative biotech company dedicated to developing small molecule inhibitors targeted at treating inflammatory and autoimmune diseases. We foster a collaborative environment where scientific excellence and creativity drive our mission to develop impactful medicines. Overview The Senior Director, Clinical Development Operations is responsible for providing strategic direction and operational excellence across all phases of clinical development programs. This key leadership role oversees the planning, execution, and oversight of clinical trials from early-phase through market filings, ensuring program objectives are achieved within established timelines, budgets, and quality standards. This position reports directly to the Chief Executive Officer. Responsibilities Essential Responsibilities Strategy & Leadership • Ensures clinical trial objectives are aligned with clinical development strategy and overall corporate strategy., • Generates progress reports and presents clinical program strategy and status updates to Senior Management., • Contributes to business development activities and represents Development Operations on project and management teams. Clinical Operations & Execution • Directs the planning and execution of clinical trials across all phases of development, from early development through NDA/regulatory submissions., • Accountable for clinical program and study timelines, budgets, and managing actual spend to approved budgets, including tracking actuals and communicating deviations., • Oversees quality and risk management of clinical development programs, ensuring adherence to SOPs, GCP, ICH guidelines, and FDA regulations., • Oversees the development and implementation of clinical trial systems and workflows (e.g., IRT/IXRS, central lab, eCOA) including design, specifications, and UAT., • Oversees clinical supply forecasting, labeling/packaging, distribution, and chain of custody for clinical supplies. Vendor & External Partner Management • Oversees full-service CRO and vendor management activities, including RFP, vendor selection, scope of work development, performance management, and vendor governance., • Works with internal and external medical, scientific, and operational experts to maintain awareness of industry standards and best practices. Regulatory & Scientific Contributions • Authors and/or contributes to regulatory documentation and filings (e.g., IB, IMPD, IND) and correspondence with regulatory authorities and ethics committees., • Contributes to the writing, review, and finalization of clinical study protocols, Investigator Brochures, and clinical study reports., • Contributes to scientific publications and presentations. People & Team Development • Provides leadership, mentorship, and direction to the Clinical Development Operations team; responsible for recruiting, developing, training, and retaining top talent., • Ensures prioritization of activities and resourcing is aligned with clinical development program needs., • Develops and maintains company SOPs, work instructions, and training for Clinical Operations activities., • Constructively manages conflict within development teams and ensures timely resolution of issues., • Fosters a collaborative, highly integrated, and innovative team culture. Qualifications Qualifications • BA/BS in life sciences or a health-related field required, • Minimum 12+ years of progressive clinical operations and/or development operations experience within the pharmaceutical or biotechnology industry., • Demonstrated experience in clinical development programs and teams spanning early to late phase clinical development, • 5+ years of people management and leadership experience with a proven track record of building and developing high-performing teams., • Demonstrated working knowledge of ICH/GCP guidelines, data management, clinical systems, statistical programming, medical writing, pharmacokinetics/pharmacodynamics, protocol design, and drug product development and distribution., • Experience with global project teams and ability to work across multiple time zones and languages preferred., • Proficiency with MS Office Suite (Word, Excel, PowerPoint, Outlook, Project)., • Highly adaptable with the ability to thrive in a fast-paced, start-up or clinical-stage environment and develop creative solutions with limited infrastructure., • Excellent interpersonal skills with strong oral and written communication abilities., • Innovative, analytical, and highly organized with the ability to drive multiple projects to completion simultaneously., • Proven experience working at the senior management level and recognized as a strong leader in a high-science organization., • Willingness to travel up to 30%, as needed, to support clinical development programs. The salary range for this position is $200,000-$260,000 per year. The actual compensation offered will be based on factors such as relevant experience, education, and skills. In addition to base salary, we offer a comprehensive benefits package, including health insurance, paid time off, and retirement plan options. Our employment decisions are based on merit, qualifications, and business needs. We are committed to providing a work environment free from discrimination, harassment, and retaliation, and we undertake affirmative action efforts to promote equal opportunity for all employees and applicants. #LI-DNI

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