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Job Description Hi, we're Nuts.com! Nuts.com is a self-funded, profitable, rapidly growing multi-channel DTC specialty food and wellness company with over 550 people on our team. We're changing the landscape of snacking on nuts, dried fruit, chocolate and more! We planted our roots in Newark, New Jersey during the Great Depression, selling premium nuts on Mulberry Street's open-air market. We've come quite a long way since then, taking our multi-generational family business online in 1999. Even after 96 years, we continue to pride ourselves in expertly sourcing the highest quality foods and treating our customers like family. What's our team like? We're driven, collaborative and entrepreneurial. Energy and passion power our business and we look for candidates who share in that excitement to help us continue to build something special. The role: The Industrial Maintenance Technician is responsible for the installation, maintenance, troubleshooting, and repair of industrial equipment and machinery in a food processing plant. This position ensures that all equipment operates efficiently and in compliance with food safety regulations, company standards, and best practices. The role requires a strong understanding of mechanical, electrical, and electronic systems, as well as the ability to perform preventative maintenance and corrective repairs. This is a full-time position with scheduled hours from Sunday through Thursday, 11:00 AM to 7:30 PM. What you'll do: Maintenance and Repairs • Perform routine and preventive maintenance on all production machinery, equipment, and systems (conveyors, packaging equipment, mixers, roasters, etc), • Diagnose mechanical, electrical, and hydraulic issues and make necessary repairs, • Ensure all equipment complies with safety, regulatory, and environmental standards, • Maintain safe work practices and ensure compliance with OSHA and food safety regulations (e.g., SQF, FDA), • Complete maintenance logs and reports to ensure accurate documentation, • Work closely with production teams to minimize downtime and maximize productivity, • Communicate effectively with supervisors and management to report issues and recommend improvements, • Assist with the installation of new machinery or equipment, • Respond quickly to emergency breakdowns to minimize production delays, • Prioritize repairs to ensure minimal impact on production schedules What you'll bring: • High School Diploma or equivalent; Associate's degree in Industrial Maintenance, Electrical Engineering, or related field preferred, • Minimum 3 years of experience in industrial maintenance, preferably in a food processing or manufacturing environment, • Strong knowledge of electrical, mechanical, hydraulic, and pneumatic systems, • Demonstrated experience with VFFS, HFFS, standup pouch baggers, and associated combination scales, • Bilingual Preferred (Spanish, English), • Ability to lift up to 50 lbs regularly and perform physical tasks such as bending, kneeling, and standing for extended periods, • Ability to work in a noisy, fast-paced, and sometimes hot or cold environment, • Certifications (preferred, but not required): Forklift certification, OSHA safety training, and electrical and/or mechanical certifications What we offer • A high-growth and rewarding role in a foundationally strong and rapidly evolving business, • Hourly Pay Range: $25 - $30/hour based on experience, • Excellent benefits including a 401K Match, • Paid Maternity, Adoption and Paternity leave, • And all the Nuts.com snacks your heart desires + a 40% employee discount EEO STATEMENT Nuts.com is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, immigration status, age, sex or gender (including pregnancy), gender identity or expression (including transgender status), sexual orientation, marital status, veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Applicants with disabilities who require assistance or accommodation during the application or interview process should reach out to us at

Job Description Hi, we're Nuts.com! Nuts.com is a self-funded, profitable, rapidly growing multi-channel DTC specialty food and wellness company with over 550 people on our team. We're changing the landscape of snacking on nuts, dried fruit, chocolate and more! We planted our roots in Newark, New Jersey during the Great Depression, selling premium nuts on Mulberry Street's open-air market. We've come quite a long way since then, taking our multi-generational family business online in 1999. Even after 96 years, we continue to pride ourselves in expertly sourcing the highest quality foods and treating our customers like family. What's our team like? We're driven, collaborative and entrepreneurial. Energy and passion power our business and we look for candidates who share in that excitement to help us continue to build something special. The role: The Food Safety & Regulatory Compliance Specialist in the food industry is responsible for policy creation and implementation of the programs for food safety, and to ensure compliance of regulatory standards and 3rd party certifications. This position reports to the Food Safety Compliance Manager. The ideal candidate would be responsible for day-to-day and onsite activities related to supporting documentation for vendor approval, product specifications, and interacting with stakeholders seeking support from the food safety department and ensuring the company complies with all regulatory requirements. Stakeholders include external parties such as vendors, customers, regulators, and certifying agencies, as well as internal teams such as merchants, buyers, sales, copy writers, and operations teams. What you'll do: • Ensuring that all aspects of the food supply chain, from sourcing to production to distribution, comply with these regulations (e.g. FDA, USDA, SQF, CFIA)., • Overseeing Kosher, Organic, Certified Gluten Free, Prop 65 and BSE/Non-GMO compliance, • Reviewing and approving labels and packaging proofs for accuracy and compliance to claims., • Conducting research on regulatory and legal government policies., • Advising management on decisions impacted by regulations., • Preparing briefs, reports, and other documents for several audiences., • Support product documentation for currently sold products, new products, and for onboarding new vendors, • Periodic review and update of specification documents to ensure all claims are accurate including certifications, nutritional facts panel, allergens, and ingredients., • Manage requests for new vendors and new products, • Support Supplier Management Program through document review and approvals., • Developing and maintaining Standard Operating Procedures (SOPs) for food safety and quality., • Staying up-to-date on relevant food safety regulations and standards (e.g., FDA, USDA, SQF)., • Working with various departments, including production, quality control, and management, to ensure compliance and quality., • Collaborating with regulatory agencies and external auditors., • Ensuring accurate documentation of production and quality processes., • Assists with internal audits, verifying and documenting any quality and/or food safety issues, • Bachelor's degree in food science, food technology or related discipline preferred, • 2-5 years of relevant experience within the Food Quality/Safety/Regulatory space (food manufacturing highly preferred), • Experience with audit compliance and related audit requirements, • Experience with Organic, Gluten-Free, Kosher, Non-GMO verified programs high preferred, • Relevant certifications (e.g., HACCP, SQF) are a plus., • Competency with Electronic Quality Management Systems (EQCMS) along with excellent organizational skills, • Self-motivated, proactive thinking, • Strong knowledge of food safety regulations and standards., • Excellent organizational and documentation skills., • Ability to work independently and as part of a team., • Strong analytical and problem-solving skills., • A high-growth and rewarding role in a foundationally strong and rapidly evolving business, • Annual Salary Range: $60,000 - $80,000 plus annual bonus, • Excellent benefits including a 401K Match, • Paid Maternity, Adoption and Paternity leave, • And all the Nuts.com snacks your heart desires + a 40% employee discount EEO STATEMENT Nuts.com is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, immigration status, age, sex or gender (including pregnancy), gender identity or expression (including transgender status), sexual orientation, marital status, veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Applicants with disabilities who require assistance or accommodation during the application or interview process should reach out to us at

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are excited to accept applications for future opportunities. Join our talent pool for future openings by applying now. This is a W2-Temp 6-month role with potential FTE extension.We are seeking a highly skilled and detail-oriented Quality Assurance Engineer to join our team in the life science sector. The ideal candidate will have a strong background in quality assurance processes, with specialized experience in auditing, ensuring compliance with regulatory standards, and maintaining the highest quality standards in pharmaceutical production. This individual will play a crucial role in the review and assessment of manufacturing practices, quality control systems, and regulatory compliance within a highly regulated environment. • Develop, implement, and maintain quality assurance processes and procedures in alignment with industry standards and regulations., • Ensure all manufacturing processes comply with relevant regulations, including but not limited to FDA, EMA, ICH, and GMP guidelines., • Review batch records, validation documentation, and quality control data to ensure compliance and product quality., • Conduct internal and external audits to assess compliance with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards., • Collaborate with cross-functional teams to ensure effective implementation of audit findings and continuous improvement initiatives., • Prepare detailed audit reports, CAPA (Corrective and Preventive Actions) reports, and other documentation as required., • Maintain thorough and accurate records of quality assurance activities, audits, and regulatory communications., • Participate in the preparation and review of SOPs, work instructions, and other quality-related documents., • Lead or participate in continuous improvement initiatives, focusing on quality and operational efficiency. Requirements • Bachelor's degree in engineering or related technical field., • Minimum of 5+ years of experience in quality assurance within the life science industry., • Proven experience in conducting GMP audits, both internal and external, in a pharmaceutical or life sciences environment., • Experience with regulatory bodies such as the FDA, EMA, and other international regulatory agencies., • Familiarity with Quality Management Systems (QMS), CAPA, deviation management, and risk management., • Strong understanding of GMP regulations, FDA guidelines, and other applicable industry standards., • Excellent analytical and problem-solving skills., • Exceptional attention to detail and ability to identify potential areas of risk and non-compliance., • Strong verbal and written communication skills, with the ability to prepare clear and concise reports., • Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RW1 BenefitsW2 Temp positions include our medical and sick time benefits. Adhering to the requirements of New Jersey's law on salary transparency, the salary bracket for this role is set between $100,000 - $115,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes a Difference The Clinical Research Assistant for the Future of Medicine program is an entry-level clinical position designed to fully integrate individuals into the Care Access research process. The Future of Medicine program brings clinical trials directly into communities, making research more accessible and inclusive for diverse populations. As a Clinical Research Assistant for Future of Medicine, you'll bring your skills wherever the research happens whether that is in local clinics, at community events, and occasionally at regional events (with travel up to 25%). This role offers opportunities for growth and advancement within the Care Access Research organization. How You'll Make An Impact • As a Clinical Research Assistant, you'll support every stage of the research process: engaging with participants and collecting biospecimens, to managing data and maintaining regulatory compliance. You'll help bring clinical trials directly into local communities by supporting recruitment, outreach, and event operations. Along the way, you'll gain hands-on experience in clinical research with opportunities to grow your skills and career., • Clinical & Participant Care, • Perform independent venipuncture, including managing difficult draws and re-attempts per protocol., • Collect, label, process, package, and ship biospecimens while maintaining chain of custody and temperature controls., • Obtain informed consent under the direction of the Clinical Research Coordinator (CRC)., • Complete protocol-required visit procedures under CRC direction., • Communicate clearly with participants and on-site teams; escalate issues promptly., • Maintain effective, professional relationships with participants, investigators, and sponsor representatives., • Study Operations & Data Management, • Record and enter data in real time on paper or e-source documents, ensuring accuracy and legibility., • Request and manage medical records for potential and current participants., • Update study trackers, online recruitment systems, and site logs., • Request and issue study participant payments., • Maintain adherence to FDA regulations, ICH guidelines, and institutional SOPs., • Member Education & Community Engagement, • Participate in member education and pre-screening events, which may occur at multiple locations., • Set up and tear down event sites; prepare kits and supplies, ensuring aseptic technique and biohazard safety., • Assist with distribution of outreach and education materials., • Schedule participant visits and provide reminders., • Clinical Site & Administrative Support, • Assist with administrative tasks such as copying, scanning, filing, mailing, and emailing., • Support inventory management and ordering of equipment and supplies., • Contribute to maintaining an organized, compliant site environment., • Other Responsibilities, • Communicate clearly in both verbal and written form., • Perform other duties as assigned in support of study success. The Expertise Required, • Technical & Operational Proficiency, • Comfortable using eSource/mobile apps and standard office tools., • Proficiency in Microsoft Office Suite., • Ability to learn and adapt in a fast-paced, evolving environment., • Strong organizational skills with close attention to detail., • Professional & Interpersonal Skills, • Excellent verbal and written communication skills with a high degree of professionalism across diverse groups., • Friendly, outgoing personality with the ability to maintain a positive attitude under pressure., • Critical thinker and problem solver with strong initiative., • Ability and willingness to work independently with minimal supervision while contributing effectively to team and site goals., • High level of self-motivation, energy, and an optimistic "can do" attitude. Certifications/Licenses, Education, and Experience:, • Clinical Skills & Experience, • 1+ year of recent, hands-on phlebotomy experience in a clinical setting (≥200 venipunctures; ≥25–50 capillary sticks; ≥30–50 in the last 2–3 months)., • Demonstrated competency in specimen processing., • Working knowledge of medical and research terminology, ICH-GCP, HIPAA/PHI handling, and related federal regulations., • Some prior clinical research experience preferred., • Current national phlebotomy certification, such as:, • ASCP Phlebotomy Technician (PBT), • AMT Registered Phlebotomy Technician (RPT), • NHA Certified Phlebotomy Technician (CPT), • NCCT National Certified Phlebotomy Technician (NCPT), • State-specific licensure/certification if required (CA, WA, LA, NV). How We Work Together, • Location: This position is for a full-time, hourly role. The standard schedule is Tuesday through Saturday, averaging 32–42 hours per week. Work is typically split between community events and a local clinical site (for example, a Houston-based team member may spend three days at community events and two days at the local site), • Travel: As a Clinical Research Assistant for Future of Medicine, you'll bring your skills wherever the research happens whether that is in local clinics, at community events, and occasionally at national events (with travel up to 25%). Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to:

Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are excited to accept applications for future opportunities. Join our talent pool for future openings by applying now. This is a W2-Temp 6-month role with potential FTE extension. We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met. • Develop and execute commissioning, qualification, and validation protocols for required equipment and systems., • Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures., • Identify and assess risks associated with CQV activities and develop effective mitigation strategies., • Troubleshoot and resolve issues related to equipment and process performance., • Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines., • Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.)., • Additional responsibilities as required to drive successful validation project deliverables. Requirements • Bachelor’s degree in Engineering, Life Sciences, or a related field., • 5+ years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries., • Strong knowledge of regulatory requirements and industry standards., • Experience with validation lifecycle management and risk-based approaches., • Excellent analytical and technical problem solving skills., • Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.), • Effective communication and interpersonal skills., • Proactive with strong organization, time management, and project management abilities., • Excellent attention to detail with commitment to quality and compliance., • At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RW1 Benefits W2 Temp positions include our medical and sick time benefits. Adhering to the requirements of New Jersey's law on salary transparency, the salary bracket for this role is set between $100,000 - $115,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Job Description Sub-Investigator Key Responsibilities: • Assist the Principal Investigator (PI) in overseeing and managing clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements., • Provide medical oversight and ensure the safety and well-being of study participants throughout the trial, under the supervision of the PI., • Perform delegated study-related duties as assigned by the PI, which may include comprehensive patient assessments, physical exams, medical histories, and eligibility screenings., • Review and interpret eligibility, laboratory results, ECGs, and other diagnostic tests as required by the protocol and under PI supervision., • Assist the PI in making medical decisions regarding participant care, adverse events, and protocol deviations., • Ensure accurate, complete, and timely collection and documentation of all study data., • Communicate effectively with the PI, study team, and, as delegated, with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities., • Assist with investigational product accountability, storage, and administration according to protocol., • Participate in site initiation visits, monitoring visits, audits, and inspections as required., • Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas. Position Requirements: • Master’s degree in Nursing from an accredited program., • Current Nurse Practitioner certification (FNP, AGNP, or specialty certification) or Physician's Assistant (PA) certification and state licensure., • At least 3 years of experience in clinical research, either as a Sub-Investigator, research fellow, or similar role, with a strong understanding of clinical trial processes., • Demonstrated knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research., • Strong interpersonal and communication skills, with the ability to work effectively as part of a team., • Excellent clinical judgment and problem-solving abilities., • Meticulous attention to detail and strong organizational skills., • Ability to prioritize tasks and manage time efficiently., • Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus., • Commitment to ethical conduct and patient safety. Location: This position requires NP travel to the location of the study/program participant/patient. Travel may be local or across state lines based on licensure to practice.

Job Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. Principal Biostatistician: Roles and Responsibilities • Can create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams., • Can develop SAPs and iSAPs text and shells with no supervision., • Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments., • High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques., • Has the ability to apply drug development knowledge during production of complex statistical analyses., • Can perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations., • Leads complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor., • Is familiar with and stays current with the latest industry practices and updated regulatory guidelines., • Understands the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint)., • Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician., • Has high level knowledge of drug development as it pertains to biostatistics., • Produces and presents external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction., • Write blogs and/or white papers for posting on the company website, • Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study., • High proficiency with MS Office applications, • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management., • Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred., • Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required., • Submission experience (ISS/ISE), • Expert knowledge of scientific principles and concepts., • Reputation as emerging leader in field with sustained performance and accomplishment., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements. jUtnt8qhwh

Job Description The following is intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Job Summary: The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for TriMed products globally. Supervisory Responsibilities: None. Duties/Responsibilities: • Perform gap analyses between new/revised regulations and standards and the TriMed Quality Management System (QMS)., • Review and assess published literature, preclinical data, clinical investigation results, field performance data and other relevant post-market surveillance data in order to evaluate device safety and performance., • Compile Clinical Evaluation Plans and Reports., • Assess reportability of changes to: labeling, design, materials, manufacturing process, sterilization or packaging., • Working with other departments, gather data for completing Post-Market Surveillance Reports, Periodic Safety Update Reports, Critical Analysis Reports, Summary of Safety and Performance Reports, etc., • Compile needed post-market reports., • Facilitate the completion of actions identified as a result of post-market reports., • Compile necessary documentation for the creation of technical files. Maintain technical files., • Assist with writing submission documents for regulatory agencies (FDA, Health Canada, etc.) and Notified Bodies., • Develop responses to questions or deficiency letters from regulatory agencies and notified bodies., • Use technical/clinical writing skills to clearly describe technical information for third party reviewers., • Perform submissions using the regulatory agency’s electronic submission process, if applicable (ESG, EUDAMED, etc.)., • Maintain registrations, certifications, and/or licenses, as applicable., • Assist new product development teams to provide regulatory support to the project, • Develop positive working relationships with other departments., • Actively participate in third party audits of TriMed. Required Skills/Abilities: • Experience with US and international regulations, and regulatory submissions preferred., • Experience in writing/maintaining CE Technical Files preferred, • Experience in international medical device licensing preferred, • Excellent written and verbal communication skills, analytical skills and sound interpersonal skills, • Strong attention to detail and pride in accuracy, • Excellent proficiency in Microsoft Office (Word, Excel, Outlook, Power point), • Exceptional organizing and prioritizing skills, • Ability to manage and track progress of project deliverables in order to meet deadlines and budgets, • Ability to influence people and functions, • A team player with positive can-do attitude, • A self-motivated and energetic person with an ability to work well under pressure Education and Experience: • Bachelor’s degree preferred., • Two years of medical device, pharmaceutical, or other FDA-regulated industry experience required. Physical Requirements: • Ability and initiative to work in the following environments: ambiguous, fast paced, hands-on, and deadline dictated, • This position works in an open office environment or position can be performed remotely., • While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit. TriMed, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Job Description The Supply Chain Planner will manage material planning and purchasing activities to ensure on-time delivery and optimal inventory levels for clinical trial product manufacturing. This role coordinates with manufacturing, QA, QC, and cross-functional teams to align production schedules, resolve material shortages, and maintain supplier relationships. Responsibilities include developing replenishment strategies, managing supply forecasts, and driving process improvements within cGMP operations. Requirements Education: • Associate's degree required but prefer Bachelor's degree in Supply Chain, Engineering, Life Sciences, Information Systems, Business Management or related fields. Qualifications & Experience: • 3+ years of related experience in materials management and/or supply chain within cGMP operations. Cell therapy experience preferred., • Experience in material planning and/or finite scheduling in a medium to high volume environment., • Flexible and comfortable working with ambiguity. Strong understanding of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements (EMA, TGA)., • Strong organizational, analytical, and time management skills., • Ability to work well in a team environment with a positive attitude and a willingness to assist other areas of the organization., • Excellent verbal and written communication skills as well as strong focus and attention to detail., • Independence and self-starting mentality with an ability to handle multiple tasks at once in a fast-paced environment., • APICS certification is a plus., • Proficiency in ERP and MRP systems (I.e., Oracle, SAP, QAD, IBP). Benefits Competitive hourly rate: | $27.01 – $34.3/hour (W-2 only, no C2C) 12-month contract with possible extension Health benefits, holiday pay, and 401(k) program Paid time off (UTO) and professional development support Employee referral bonus program Opportunity to contribute to high-impact projects with a leading biopharma company

Job Description Job Overview We are seeking a dedicated and detail-oriented Warehouse Quality Control Supervisor to join our team. A Quality Supervisor in a warehouse is responsible for overseeing product quality, compliance with standards, and ensuring warehouse processes meet customer and regulatory requirements. The role bridges operations, inventory, and quality assurance. Heres a breakdown: Key Responsibilities • Quality Control & Assurance, • Inspect inbound and outbound shipments for accuracy, damage, and compliance with company/customer standards., • Enforce proper handling, labeling, and packaging practices., • Lead audits (internal and external)., • Team Supervision, • Train and oversee QC (quality control) staff or warehouse associates performing inspections., • Assign daily tasks, monitor performance, and provide coaching., • Ensure safety and compliance protocols are followed., • Process & Compliance, • Maintain SOPs (Standard Operating Procedures) for warehouse quality practices., • Ensure compliance with ISO, FDA, GMP, or customer-specific standards, • Investigate non-conformances, document issues, and recommend corrective actions., • Reporting & Metrics, • Track KPIs such as defect rates, audit scores, and returns., • Prepare reports for warehouse/operations management., • Experience in warehouse, distribution, or manufacturing quality control., • Knowledge of WMS systems and inventory processes., • Strong attention to detail and organizational skills., • Leadership and training abilities., • High school diploma; bachelors degree often preferred (supply chain, logistics, QA, or related)., • 25+ years in warehouse/QA environment., • Supervisory or lead experience. Qualifications: High school diploma or GED Warehouse Supervisor Exprience Quality control • Logistics Preferred: Operations management • Organizational skills, • Warehouse management system, • Supply chain management, • Product quality assurance, • Quality control process implementation

Job Description Hi, we're Nuts.com! Nuts.com is a self-funded, profitable, rapidly growing multi-channel DTC specialty food and wellness company with over 550 people on our team. We're changing the landscape of snacking on nuts, dried fruit, chocolate and more! We planted our roots in Newark, New Jersey during the Great Depression, selling premium nuts on Mulberry Street's open-air market. We've come quite a long way since then, taking our multi-generational family business online in 1999. Even after 96 years, we continue to pride ourselves in expertly sourcing the highest quality foods and treating our customers like family. What's our team like? We're driven, collaborative and entrepreneurial. Energy and passion power our business and we look for candidates who share in that excitement to help us continue to build something special. The role: The Quality Assurance Manager will be responsible for developing, implementing, and maintaining robust food safety and quality management systems that strictly comply with all regulatory requirements and company standards. Success in this role demands a professional who thrives in a fast-paced food manufacturing environment, spending the majority of your time directly on the production floor. The ideal candidate will have demonstrated experience with food quality and safety systems, including Good Manufacturing Practices (GMP) compliance, FDA Food Safety Modernization Act (FSMA), comprehensive record-keeping/documentation, employee training, problem-solving skills and change management within a food processing environment. This position reports directly to the Director of Food Safety and Quality Assurance. In the absence of the Quality Assurance Manager the Food Safety & Regulatory Compliance Manager will act as a back up. What you'll do: Food Quality Assurance & Compliance • Ensure all manufacturing processes, raw materials, packaging, work-in-process (WIP), and finished products consistently meet internal quality standards, regulatory requirements (e.g., FDA FSMA), and recognized food safety certifications (e.g., HACCP, GFSI, SQF, Gluten-free, Organic, Non-GMO, Kosher)., • Lead root cause analysis investigations for food safety and quality deviations, implementing effective Corrective and Preventive Actions (CAPAs)., • Manage internal and external food safety and quality audits, ensuring audit readiness and compliance., • Own and drive improvements in customer complaints metrics directly related to product quality and food safety., • Ensure the seamless integration and coherence of established Food Safety and Quality Assurance (FSQA) programs with on-floor operational processes., • Provide dedicated oversight for critical processes, including Allergen Control, Hygienic Zoning, Pest Control, GMP Audits, KPIs, Sanitation support, Pre-Operational Inspections, Line Changeovers, Line Clearances, Quality-focused Inventory Audits, Production Line Audits, and Fulfillment Audits., • Manage and drive improvements in Material Review Board (MRB) processes., • Create, maintain, and manage comprehensive food safety and quality documentation., • Develop and deliver comprehensive training programs for production staff and management on food safety, SQF system, quality assurance principles, GMPs, and revised procedures., • Actively participate in and lead continuous improvement initiatives focused on enhancing food safety, food safety culture, quality, and operational efficiency within quality assurance., • Analyze existing food safety and quality processes to identify opportunities for optimization and waste reduction., • Play a key role in food safety and quality improvement projects, ensuring timely completion., • Lead, mentor, and develop a team of Quality Assurance associates, championing their professional growth and fostering a highly engaged environment., • Step in and assist with other quality roles as necessary to ensure smooth operations. What you'll bring: • Bachelor's degree in Food Science, Engineering, or a related scientific discipline preferred., • 5+ years of progressive experience in food quality assurance or food safety management within a food manufacturing facility., • Demonstrated experience with internal and external audit compliance (e.g., GFSI standards, FDA, FSMA, Organic)., • Certifications in Internal Auditing, HACCP and PCQI are required; SQF Practitioner or BRC Lead Auditor certification is a significant plus., • Strong knowledge of FDA regulations (e.g., FSMA) and other relevant food safety guidelines., • Proficiency with Electronic Quality Management Systems (EQMS)., • Experience with Lean Six Sigma, 5 Whys, and Pareto analysis is highly desirable., • Self-motivated, proactive, and possessing a strong business acumen with the ability to navigate challenging situations independently., • Knowledge of OSHA protocols in a manufacturing environment., • Bilingual - Spanish is strongly preferred. What we offer • A high-growth and rewarding role in a foundationally strong and rapidly evolving business, • Annual Salary Range: $115,000 - $125,000 plus annual bonus, • Excellent benefits including a 401K Match, • Paid Maternity, Adoption and Paternity leave, • And all the Nuts.com snacks your heart desires + a 40% employee discount EEO STATEMENT Nuts.com is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, immigration status, age, sex or gender (including pregnancy), gender identity or expression (including transgender status), sexual orientation, marital status, veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Applicants with disabilities who require assistance or accommodation during the application or interview process should reach out to us at

Job Description Job Title : Regulatory Support Location: Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Requirements Mandatory skills: -experience in pharmaceutical environment. -Experience in regulatory environment is required. -High level exposure or knowledge about FDA inspection and internal audit process. -Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc. Job Title: Consultant JD details : -Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. -Represents Regulatory Affairs on cross-functional project teams. -Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. -Work with subject matter experts, and cross functional departments to support business needs. -Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation. -Gather and assemble information necessary for submissions in accordance with regulations/guidance. -Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary. -Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. -Maintain knowledge of local and global regulatory submission requirements. -Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives. -Provide Regulatory Affairs support during internal and external audits and inspections. -Exposure in Change management process, requirement gathering, qualifying the changes etc., -Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc. -Consistently support for regulatory systems access and change management. -Responsible for communicating business process improvements, business related issues, status updates or opportunities. Qualifications: -Bachelors’ degree, preferably in a life science or a related field -5 to 10 years of experience in pharmaceutical environment. -Experience in regulatory environment is required. -Excellent written, verbal communication and presentation skills. -High level exposure or knowledge about FDA inspection and internal audit process.

Job DescriptionCompany Description • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices., • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Responsibilities: • Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)., • Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets., • Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements., • Provides input in the design and development of case report forms and clinical databases., • Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs., • Programs for quality checks for clinical study raw data and report the findings to Data Management., • Provides input in the design and development of case report forms and clinical study databases., • MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years., • Experience in providing statistical programming support to early and late phase clinical trials., • Excellent skills in SAS programming and statistical reporting., • Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements., • Familiarity with FDA and ICH regulations and guidelines., • Excellent problem-solving skills., • Good written and verbal communication skills and organizational and documentation skills., • Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc., • Ability to prioritize and multi-task effectively., • Demonstrated positive attitude and the ability to work well with others.Additional Information All your information will be kept confidential according to EEO guidelines.

About Us Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands.We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. Purpose The Associate Director, QC, acts as senior leadership for the Quality Control operation at Evergreen Theragnostics. This position will oversee and lead the QC department at Evergreen. This role will be accountable for governing the department in terms of function and responsibility as well as providing technical guidance/decisions (when needed) for the operational levels to ensure an efficient and structured operation that can cater to internal as well as external needs within the organization to deliver quality radiopharmaceutical products. This role will be the primary accountable person for the success of the QC department operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance. They will ensures processes are designed and compliant per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistently with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. Key Responsibilities/Essential Functions • Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization., • Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill., • Define specific qualification standards for SMEs and the subsequent qualification processes., • Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department., • Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables., • Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements., • Oversee and manage departmental efficiency and proficiency to enable a lean operation., • Review and approve department related protocols, procedures, test methods, and studies as appropriate. Responsible to create, maintain and harmonize key business processes with internal and external stakeholders., • Partner with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage., • Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics’ business growth., • Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply. Partner with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized analytical process., • Leads, motivate, mentor, and develops team members to exceed and meet company goals., • Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (i.e. Change controls, Investigations, CAPAs, Protocol & report writing), • Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Report and take initiative to correct safety and environmental hazards., • Actively demonstrate Evergreen Theragnostics’ values. Typical Minimum Skills and Experience and Education • Requirements include a B.S. in relevant scientific/technical disciplines, advanced degrees (e.g., MS) or technological certificates preferred but not required., • 2+ years of experience in the radiopharmaceutical industry preferred but not required, • Minimum 10+ years experience in a GMP Quality Control Environment., • Minimum 5+ years experience in people management and conflict resolution., • Minimum 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections., • Previous experience with managing a microbiology department is preferred., • Previous experience working with sterile filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred. Other Requirements • Subject matter expert (SME) in various analytical test methods and analytical technology. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs, GCPs and GLPs and the ability to work and manage within a regulatory environment., • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product analytical processes., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing & testing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a fast paced, complex and changing environment., • Excellent analytical, technical and experiences., • Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills., • Understanding of FDA and/or EMEA quality and regulatory processes. Prior experience with regulatory filings is highly desired., • Experience working with external partners is highly desirable., • Ability to work independently in decision-making and resolution of program obstacles and conflicts., • Keen insight, independent judgment and tactful discretion are required., • Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”., • Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics’ to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism., • Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Evergreen Theragnostics and CDMO locations.

About Us Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. Purpose The Associate Director, Technology Development and Transfer, acts as a technology development and transfer lead in the Tech Ops organization at Evergreen Theragnostics. This position will lead and manage the Manufacturing Science and Technology (MSAT) team at Evergreen. This role will be accountable for the technical work between internal and external stakeholders to ensure design, development, and transfer of robust manufacturing processes for new products and key lifecycle injectable pharmaceutical finished products. This role will be the principal expert and process owner for the end-to-end manufacturing process for injectable pharmaceutical finished products at Evergreen Theragnostics. Ensures processes are designed and validated per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining associated tech development transfer business processes. Key Responsibilities/Essential Functions • Leads technology development and transfer projects for key lifecycle injectable radiopharmaceutical products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities., • Leads a team of engineers/scientists to execute the development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms., • Leads a team of engineers/scientists to Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies (PCS)., • Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes with internal and external stakeholders., • Partners with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage., • Partners with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics’ business growth., • Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process., • Leads, motivates, mentors, and develops team members to exceed and meet company goals., • Develops and maintains effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Leads a team of engineers/scientists to own QEs (i.e. Change controls, Investigations, CAPAs, Protocol & report writing), • Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders., • Requires approximately ~20% travel., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Reports and takes initiative to correct safety and environmental hazards., • Actively demonstrates Evergreen Theragnostics’ values. Typical Minimum Skills and Experience and Education • Requirements include a B.S. or M.S. in relevant scientific/technical disciplines, advanced degrees (e.g., PhD) or technological certificates preferred but not required., • 5+ years of experience in the radiopharmaceutical industry, including 3+ years focused on technology development and tech transfer activities., • If no prior radiopharmaceutical experience, 10+ years of work experience within pharmaceutical or medical device industry, 5+ years of technology development and transfer experience, within a matrixed pharmaceutical, medical device, or biotechnology organization., • Previous experience working with aseptically filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred. Other Requirements • Subject matter expert (SME) in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology operations. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment., • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes., • Ability to work within and lead different technical teams., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a prompt, complex and changing environment., • Excellent analytical, technical and experiences., • Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills., • Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired., • Experience working with external partners is highly desirable., • Ability to work independently in decision-making and resolution of program obstacles and conflicts., • Keen insight, independent judgment and tactful discretion are required., • Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”., • Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics’ to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism., • Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Evergreen Theragnostics and CDMO locations.

Job DescriptionAbout MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit or follow MMS on LinkedIn. This position requires proven Project Management experience in supporting marketing applications, as well as in the development and management of Risk Evaluation and Mitigation Strategies (REMS) programs. Responsibilities: • Understands various cost models and develops budgets for moderate complexity projects., • Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. Controls project scope via defined PM methodology and processes for change management., • Develops moderate complexity project timelines independently., • Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations., • Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends., • Intermediate excel skills (Hlookup, Vlookup, Pivot Table, etc.)., • Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account., • Participates in or leads RFIs/RFPs in collaboration with proposals team. Participates in or leads capabilities meetings - at least 2 annually., • Participates in or leads bid defenses - at least 1 annually., • Proficient in Word, Outlook, PowerPoint., • Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met., • Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000.Responsibilities:, • Bachelor’s Degree required, or relevant work experience., • Minimum of 5 years’ experience in project coordination or project management or similar field required., • Expert knowledge of scientific principles and concepts., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements. KqpqOtSfcs