Pharmaceutical compliance jobs in Union City, New JerseyCreate job alerts

Prime Staffing is seeking a travel Pharmacist for a travel job in Newark, New Jersey. Job Description & Requirements • Specialty: Pharmacist, • Discipline: Allied Health Professional, • Start Date: 09/15/2025, • Duration: 13 weeks, • 40 hours per week, • Shift: 8 hours, • Employment Type: Travel About the Position \n Specialty: Pharmacist Experience: Minimum 1–2 years of hospital or clinical pharmacy experience preferred License: Active Pharmacist license required Certifications: BLS required (with expiration date); other certifications as applicable Must-Have: All time-off requests must be submitted with the initial application \n Description: We are seeking a detail-oriented Pharmacist to join our healthcare team. The role involves verifying prescriptions, dispensing medications, monitoring drug therapies, and providing education to patients and staff. Strong knowledge of pharmaceutical practices and patient safety standards is required. \n This is a full-time position, with variable shifts including weekends and holidays. Onboarding and compliance processes typically take 2–4 weeks. \n Requirements \n Required for Onboarding: \n\n • Active Pharmacist License\n We offer a wide range of staffing services including temporary, temp-to-perm, and direct hire placements. Our extensive network of qualified candidates includes nurses, allied healthcare professionals, corporate support professionals and executives.

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Pay Range: (Minimum to mid pay range specific to NY,CA,CO,WA,MD,CT,IL,NV,,KY,MI,NJ,ME,MO,MA,MT) 130,000.00 - 150,000.00 USD Annual About Brink's: The Brink's Company (NYSE:BCO) is a leading global provider of cash and valuables management, digital retail solutions, and ATM managed services. Our customers include financial institutions, retailers, government agencies, mints, jewelers, and other commercial operations. Our network of operations in 51 countries serves customers in more than 100 countries. We believe in building partnerships that secure commerce and doing that requires fostering an engaged culture that values people with different backgrounds, ideas, and perspectives. We build a sense of belonging, so all employees feel respected, safe, and valued, and we provide equal opportunity to participate and grow. Job Description Brink's Global Services is a division of Brink's Inc, the world's premier provider of secure logistics and security solutions in more than 122 countries across 5 continents. Brink's Global Services specializes in the secure transportation and handling of valuable goods throughout the logistic value chain, from raw materials and components to finished products within the mining, banknote, precious metal, jewellery, security, art, and pharmaceutical industries The company has a proud history of providing growth and advancement opportunities for its employees. We have a challenging opportunity for a Director, Commercial Operations in NYC Job Summary: This position reports to the VP, Commercial Excellence of BGS US and will have total management oversight of the BGS US Sales Operations. This position requires up to 10% travel to facilities and internal meetings throughout the United States and internationally as needed to work on the Sales Operations, marketing research, and reporting capabilities. This position will require strong organizational skills, and the ability to work independently while managing a small to mid-size team of sales analysts. Candidate must have a proven track record of leadership, sound technological savvy and strong analytical and business skills. The ability to develop workflows associated with the implementation of a new CRM and process mapping to align with multiple lines of business will be essential. Key Responsibilities: • Responsible for the annual rate review process ie. reviewing all BGS US rate agreements to ensure they conform to Sox compliance and are properly priced rule in the billing systems, • Design, implement, document, and manage tools to monitor workflows and business processes to onboard new clients and monitor & review all costing & pricing rules posted to BITS, • Lead implementation of Cargowise CRM software and work with the consultants to develop onboarding training materials and SOP's, • Collaborate with the Director of Customer Service to optimize the automation of workflows to enhance the customer NPS initiatives, • Own the tech/automation process and enhancements for inbound customer inquiries, inbound leads, and affiliate inquiries (email, phone systems, and ticketing software), • Conceptualize and monitor the inbound lead process for the commercial organization, • Parter with the VP, Commercial Excellence to prepare the data analysis for senior leadership to show global initiatives and pacing towards goal obtainment, • Drive the forecasting efforts with the VP, Commercial Excellence to accurately predict the new and expansion business efforts for the US market, • Provides market data analytics for pricing, prospecting, marketing, product and program development efforts. Uses internal and external data sources to complete data analytics requirements., • Partner with Finance team to minimize billing errors throughout the data-capture process and serve as a bridge to the commercial team to address any/all Account Receivable discrepancies, • Collaborate with senior leadership team to automate new hire onboarding and document procedural updates and changes on an ongoing basis, • Work with Operations and Finance teams to enhance pricing models; identify areas of opportunity to improve margins ie. additional revenue opportunities, operational efficiencies, contract process improvements, etc., • Reviewing and evaluating the sales cycle from start to finish and ensuring the function is fully compliant with all key controls and SOX requirements., • Help in the strategic planning and market positioning for the multiple LOB's, and with preparation of LOB specific reporting., • Coordinate with DCE to evaluate CRM utilization and process improvements and ensure the CRM system is aligned to internal and external Audit compliance policies., • Lead Cargowise system preparatory work as it relates to rationalization of rate structures including coordination with BGS HO and Affiliates as required., • Establish & implement sales, marketing, and customer-service related procedures & processes within the CRM based on LOB client profiles., • Cultivate relationships within the other superusers in BGS branches, and international affiliates to share best practices for the CRM utilization., • Travel to develop business unit affiliate relationships and ensure that network wide commitments are met and that all CRM policies meet compliance and overall company strategy standards., • Build, foster and manage relationships with vendors and subcontractors as needed to ensure the CRM is optimized for our needs., • Work closely and develop strong productive relationships with internal support departments including but not limited to Operations, Finance, Security and Finance. Minimum Qualifications: • Five (5) years of experience of CRM implementation and development of workflows, customer profiles and training materials., • 2-3 years of experience in developing marketing and commercial strategies for multiple lines of business including all related marketing materials., • Analytical and data mining skill sets, • Experience in developing responses to client RFQ's, • Five (5) years of experience working with Microsoft Office Suite, • Willing to travel 20% of the time on a local, national, and international level. Preferred Qualifications: • Experience in domestic/international, freight forwarding, and logistic services., • Possess a bachelor's degree in business administration, Logistics, Supply Chain, Sales Management, or related discipline, • CRM experience in a logistics/freight forwarding company, • Strong business acumen and demonstrated success working with multiple internal resources., • Experience in developing training materials and SOP's., • Experience in developing reports for management, • Experience within fast paced, competitive, blue chip/ corporate level environment. Professional Skills: • Possess a strong industry understanding, and the knowledge to contribute effectively to successful proposal creation, • Intermediate level experience with Excel and project planning software (CRM, MS Project, MS Office, and Visio)., • Excellent communication, interpersonal and influencing skills, • Strong time management skills, • Skilled in working cross culturally, in developing relationships with stakeholders regionally and globally, • Excellent marketing, training, and implementation skills, • Ambitious, enthusiastic, and well-motivated with a strong work ethic, • Fast paced, high energy level and able to juggle priorities, • A confident, assertive 'doer', • Commercially and financially aware, • Adapts quickly to change, • Highly credible and professional, both internally and externally If you have the background and integrity we require and are looking for a challenging opportunity, we hope you will consider employment with Brink's Global Services U.S., Inc. Brinks provides an outstanding total compensation package for this position. In addition to a competitive salary, we offer to eligible employees, medical, dental, vision, and life insurance plans. We also offer a 401(k) Plan. If you are interested and meet the requirements for this position, please apply. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class. What's Next? Thank you for considering applying for a job at Brink's. To be considered for this position, you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature. Upon completion of the application process, you will receive an email confirming that we have received your application. We will review all candidates and notify you of your status should we deem you fit for a job. Thank you again for your interest in a career at Brink's. For more information about future career opportunities, join our talent network, like our Facebook page or Follow us on X. Brink's is an equal opportunity/affirmative action employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, marital status, protected veteran status, sexual orientation, gender identity, genetic information, or history or any other characteristic protected by law. Brink's is also committed to providing a drug-free workplace. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.

The Display and Exhibits Coordinator will coordinate the full logistics of all congresses and exhibits programs which include but not limited to, reviewing requests for accuracy, securing approvals, managing registration, executing customer-specific agreements, payment processing, marketing materials management, and program reconciliation. • Database management - manage promotional educational programs within the firm's proprietary events management platform, • Budget management - assisting customer representatives within their program planning budget to ensure they meet client business rules and guidelines, • Coordinate all life cycles of Congresses and Exhibits from start to finish, • Communicate daily with customer team and appropriate stakeholders, • Run daily metric reports to ensure all tasks within the C&E are executed within a timely fashion, • Coordinate with account stakeholders (via telephone and email) regarding their event status as well as required follow-ups for any missing information. Able to read, interpret, and execute legal contracts on behalf of stakeholders., • Ensure payments are processed in an efficient and timely manner, • Adhere to performance metrics, standard operation processes and procedures, as well as compliance guidelines for the related customer, • Maintain current knowledge of appropriate regulations, e.g., OIG, PhRMA Code, • Adherence to various policies (i.e., confidentiality, sensitive communication, intellectual property), • Effectively manage high volume of meetings while also responding to emails and phone calls Competency Requirements: • Strong interpersonal, verbal, and written skills both internally and externally with the ability to effectively engage with the customer, • Skilled in Customer Service, and the ability to solve problems while ensuring customer satisfaction is met, • Strong organizational skills with great attention to detail, • Familiar with health sciences and regulated environments, • Ability to work independently, with competent decision-making skills, and successfully manage multiple priorities in a fast-paced environment, • Strong working knowledge of Gmail and Microsoft Office Product Suite, and able to quickly learn to utilize similar tools and software as needed, • Positive attitude at all times and the ability to work with a team and maintain a “Whatever it Takes” attitude, • Ability to boost team morale, • Ability to take constructive feedback and adjust in order to progress forward, • Ability to take on additional ad hoc tasks as needed to support the team without complaint, • Ability to work flexible schedules and/or extended hours to meet clients’ business needs, • Ability to maintain productivity while performing repetitive planning tasks every day, • Basic Math and Spelling proficiency, • Ability to work and thrive in a team atmosphere Education/Skills Experience Desired: • A background in event planning is preferred, but not required, • B.S. or B.A. degree or equivalent experience, • 3+ years’ experience working at a pharmaceutical/biotech or third-party agency a plus, • Great for individuals with a Sales, Hospitality, or Customer Service background, • Must be a go getter and very personable at the same having patience with the process, • Possess strong analytical and problem-solving skills

Core Responsibilities Writing • Write copy to the highest standard (quality and scientific) for a range of educational materials including development of oral presentations, publications, print items, and digital platforms, and for different audiences, • Develop, implement, and manage the delivery of medical education and communications materials that are aligned with client objectives and specifications and meet budgetary and schedule requirements Client Activity • Take and correctly implement briefs from the client or client services team, • Act as a senior lead to clients and thought leaders for specified projects/accounts, • Review work of more junior writers and provide feedback to ensure medical writing standards are consistently achieved, • Develop and maintain in-depth knowledge of therapy areas relevant to own accounts, including product data and educational messaging, terminology, and competitor awareness, • Accurately interpret client/author comments and precisely apply feedback, • Liaise professionally with pharmaceutical clients and key thought leaders to discuss scientific aspects of the project and act as the point of contact for both clients and key thought leaders on specified projects, • Provide on-site support as appropriate, eg, data gathering, on-site writing, thought leader support, • Contribute to the organic growth of accounts and development of new business proposals where appropriate Experience/Skills Required • Experience/Skills Required, • Excellent scientific writing style with skills to adapt content and style to different audience groups, • Excellent attention to detail: style/consistency, good grammar, scientific accuracy, and experience in QCing work and sign-off of printer proofs, • Experience in developing in-depth knowledge of therapeutic areas/medical products, • Excellent time management skills and demonstrated ability to forecast and manage workload, • Flexible approach to working, with the ability to reprioritize and work under pressure when needed, • Ability to review work, coach, and provide feedback to team members, • Excellent interpersonal and communication skills, including client/key thought leader presentation skills, • IT skills (including MS Office, database/internet searching, etc), • Knowledge of print/production procedures, • Budgetary awareness and experience of estimating scientific hours to input into budgets, • Understanding of drug development and compliance guidelines for medical writing

About the Company: Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Key Duties and Responsibilities: • Finished Product Distribution: Ensure a smooth flow of inbound and outbound shipments by implementing an efficient end to end tracking system. Ensure receipt appointments of inbound trucks. Release of products in saleable status, engaging customer service to ensure release of orders before cutting time, provide delivery feedback for critical orders and minimize back orders by keeping a close coordination with sales team., • Process Optimization: Support and develop of SOP documents which ensure a good distribution practice. Develop systems to solve problems and quarantine root causes in 3PL and flow distribution. Support SAP enhancements implementation, processimprovement and Serialization implementation., • Inventory Control: Maintain inventory control systems to assure visibility throughout the supply chain and comply with financial and regulatory requirements., • Creates and maintains net production and purchasing requirements based on forecast, lead time, shelf life and safety stock policy., • Provide, Run and analyze month to end reports for Business unit performance., • ERP (SAP). Support SAP implementation. Perform inventory transaction by using SAP system. Analyze and verify data integrity., • DSCSA – EPCIS compliance. Monitoring and solving inbound and outbound disruptions. Specific Responsibilities: We seek a highly motivated individual with analytical capabilities and pharmaceutical experience (Biological Product in preference) to be part of our commercial operations. Responsibilities include, but are not limited to: • Responsible to ensure customer orders delivery on time. Perform cycle counts in case any order discrepancy, • Minimize and resolve claims within one week. Implement root cause analysis to avoid discrepancies in the future., • Approve and follow up returns from customers and work with finance for credit request submission., • Prepare monthly supply chain reports by showing inventory value, turn over, cost per unit, short date / expired, damages and on time In Full order., • Provide weekly report of inbound status of Biosimilar products, quality, customs hold, in transit., • Follow up and support release products as required into saleable, quarantine, customer allocation., • Prepare/oversee inbound shipment reports to ensure customs release and delivery in 3PL in fashionable time, • Weekly Customs shipment report showing status of final release from customs., • Support in preparation the annual 3PL budget., • Assist and support Financial and external audit of our in/out processes and 3PL. Basic Qualifications: • Must be legally authorized to work in the United States without restriction., • Bachelor’s degree from an accredited college or university, or equivalent required., • Minimum 5 years of Pharmaceutical Management with direct involvement in establishing and managing inventory, customer service, orders tracking, 3PL management., • Supply and Logistic acumen and working knowledge of distribution KPI to manage and control inbound, outbound and 3PL operation., • Must be self-motivated and able to work with a general level of autonomy and independence., • Good professional ethics and compliance of applicable laws and regulations., • SAP ERP user experience is a must. Savvy Implementation is big plus., • DSCSA knowledge and implementation experience is a must., • Overall OTC Transactions in SAP. (Sales Order, Return Order, Free of Charge Order, Credit Memo, Debit Memo, Deliveries and Invoices., • Collaborate with Finance team for the periodic closing., • Maintain complete and accurate standard sales operating procedures and related internal control documentation., • Overall OTC Transactions in SAP. (Sales Order, Return Order, Free of Charge Order, Credit Memo, Debit Memo, Deliveries and invoices) Celltrion USA is an equal opportunity employer . It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

Job DescriptionJob title: Pharmacist In Charge Pharmacy Name: Kingston Pharmacy Location: 1106 Saint Johns PI, Brooklyn, NY - 11213 Position Type: Full-Time (Immediate Joining Preferred) Company Overview: Kingston Pharmacy is looking for a dedicated and experienced Pharmacist to join our team. We are committed to delivering exceptional patient care and ensuring that our pharmacy operates in full compliance with all relevant laws and regulations. If you are passionate about pharmaceutical care and ready to make a difference, we invite you to apply. Candidates available for immediate start are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide thorough guidance on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure compliance with federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain precise records and responsibly manage controlled substances., • Staff Training: Train and mentor pharmacy staff to uphold best practices., • Collaborative Care: Collaborate with healthcare providers to enhance patient care., • Inventory Management: Monitor and manage inventory levels to avoid shortages or excess., • Insurance Processing: Efficiently handle insurance claims and reimbursements., • Customer Service: Professionally address and resolve patient inquiries and concerns.Job Requirements:, • Required: Valid pharmacist license as per state regulations., • Required: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: 3-5 years of experience in a pharmacy setting.Skills:, • In-depth knowledge of federal and state pharmacy laws and regulations., • Proficiency in pharmacy management software., • Excellent communication and interpersonal abilities., • Strong organizational skills with a keen attention to detail., • Ability to thrive in a fast-paced environment., • Dedication to providing outstanding patient care.Preferred Qualifications:, • Certification in Medication Therapy Management (MTM)., • Experience in inventory management and implementing cost-saving measures., • Proven success in managing a pharmacy team effectively.Benefits:, • 401(k) matching, • Performance-based bonuses, • Competitive salary, • Paid time off, • Opportunities for training and professional development, • Wellness resourcesPerks:, • Competitive Compensation: Attractive salary and benefits packages., • Supportive Environment: Work within a collaborative team that values your contributions., • Career Advancement: Opportunities for growth and development within the organization., • Work-Life Balance: Flexible schedules to support a healthy work-life balance.Why Join Us?, • Supportive Environment: Be part of a team that values your input and fosters your growth., • Growth Opportunities: Advance your career with ample professional development options., • Balanced Schedule: Enjoy a healthy work-life balance with our flexible schedules., • Competitive Packages: Benefit from attractive compensation and growth potential.We look forward to receiving your application! Kingston Pharmacy an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

Job DescriptionJob Title: Pharmacist PIC Pharmacy Name: Galaxy PharmacyLocation: 220 Newark Ave, Jersey City, NJ - 07302 Position Type: Full-Time (Immediate Joining Preferred) Job Description:Galaxy Pharmacy is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities:- Medication Dispensing: Accurately dispense prescription medications to patients.- Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions.- Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations.- Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly.- Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices.- Collaborative Care: Work with healthcare providers to manage and improve patient care.- Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock.- Insurance Processing: Handle insurance claims processing and reimbursement efficiently.- Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements:- Must Have: A valid state required pharmacist license- Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution.- Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: - Strong knowledge of federal and state pharmacy laws and regulations. - Proficiency with pharmacy management software systems. - Excellent communication and interpersonal skills. - Ability to work efficiently in a fast-paced environment. - Strong attention to detail and organizational skills. - Commitment to providing exceptional patient care. Preferred Qualifications:- Certification in Medication Therapy Management (MTM).- Experience with inventory management and cost-saving measures.- Proven track record of effectively managing a pharmacy team. Benefits:- 401(k) matching- Performance-based bonus- Competitive salary- Paid time off- Training and development opportunities- Wellness resources We look forward to reviewing your application. Galaxy Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionJob Title: Pharmacist Pharmacy Name: Bentley Pharmacy Location: 1172 East Tremont Ave, Bronx, NY - 10460 Position Type: Full-Time (Immediate Joining Preferred) Job Description:Bentley Pharmacy in Bronx is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities:- Medication Dispensing: Accurately dispense prescription medications to patients.- Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions.- Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations.- Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly.- Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices.- Collaborative Care: Work with healthcare providers to manage and improve patient care.- Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock.- Insurance Processing: Handle insurance claims processing and reimbursement efficiently.- Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements:- Must Have: A valid state required pharmacist license- Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution.- Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: - Strong knowledge of federal and state pharmacy laws and regulations. - Proficiency with pharmacy management software systems. - Excellent communication and interpersonal skills. - Ability to work efficiently in a fast-paced environment. - Strong attention to detail and organizational skills. - Commitment to providing exceptional patient care. Preferred Qualifications:- Certification in Medication Therapy Management (MTM).- Experience with inventory management and cost-saving measures.- Proven track record of effectively managing a pharmacy team. Benefits:- 401(k) matching- Performance-based bonus- Competitive salary- Paid time off- Training and development opportunities- Wellness resources Perks:- Competitive Compensation: Attractive salary packages and benefits.- Work Environment: Join a supportive and collaborative team that values your contributions.- Career Advancement: Opportunities for professional growth and development within the company.- Work-Life Balance: Balanced work schedule to help maintain a healthy work-life balance. Why Join Us:- Supportive Environment: Be part of a team that values and supports your contributions.- Growth Opportunities: Advance your career with opportunities for professional development.- Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules.- Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Bentley Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionJob Title: Pharmacist In Charge PIC Pharmacy: Kingston Pharmacy Location: 1106 Saints Johns PL, Brooklyn, NY 11213 Position Type: Full-Time Immediate Start Preferred Company Overview: Kingston Pharmacy is looking for a dedicated and experienced Pharmacist to join our team. We are committed to delivering exceptional patient care and ensuring that our pharmacy operates in full compliance with all relevant laws and regulations. If you are passionate about pharmaceutical care and ready to make a difference, we invite you to apply. Candidates available for immediate start are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide thorough guidance on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure compliance with federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain precise records and responsibly manage controlled substances., • Staff Training: Train and mentor pharmacy staff to uphold best practices., • Collaborative Care: Collaborate with healthcare providers to enhance patient care., • Inventory Management: Monitor and manage inventory levels to avoid shortages or excess., • Insurance Processing: Efficiently handle insurance claims and reimbursements., • Customer Service: Professionally address and resolve patient inquiries and concerns.Job Requirements:, • Required: Valid pharmacist license as per state regulations., • Required: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: 3-5 years of experience in a pharmacy setting.Skills:, • In-depth knowledge of federal and state pharmacy laws and regulations., • Proficiency in pharmacy management software., • Excellent communication and interpersonal abilities., • Strong organizational skills with a keen attention to detail., • Ability to thrive in a fast-paced environment., • Dedication to providing outstanding patient care.Preferred Qualifications:, • Certification in Medication Therapy Management (MTM)., • Experience in inventory management and implementing cost-saving measures., • Proven success in managing a pharmacy team effectively.Benefits:, • 401(k) matching, • Performance-based bonuses, • Competitive salary, • Paid time off, • Opportunities for training and professional development, • Wellness resourcesPerks:, • Competitive Compensation: Attractive salary and benefits packages., • Supportive Environment: Work within a collaborative team that values your contributions., • Career Advancement: Opportunities for growth and development within the organization., • Work-Life Balance: Flexible schedules to support a healthy work-life balance.Why Join Us?, • Supportive Environment: Be part of a team that values your input and fosters your growth., • Growth Opportunities: Advance your career with ample professional development options., • Balanced Schedule: Enjoy a healthy work-life balance with our flexible schedules., • Competitive Packages: Benefit from attractive compensation and growth potential.We look forward to receiving your application! Kingston Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

Job DescriptionJob Title: Pharmacist in charge Pharmacy Name: Meta Specialty Pharmacy Location: 1230 Metcalf Avenue, Bronx, NY - 10472 Job Description: Meta Specialty Pharmacy is seeking a dedicated and highly skilled Pharmacist to join our team. The ideal candidate will be responsible for dispensing medications, providing pharmaceutical care, and ensuring compliance with all relevant laws and regulations. If you are a motivated professional with a commitment to excellence in patient care, we invite you to apply for this position. Immediate joining candidates are preferred. Key Responsibilities:- Accurately dispense prescription medications to patients.- Provide patient counseling on medication usage, side effects, and interactions.- Ensure compliance with federal, state, and local pharmacy regulations.- Manage and maintain accurate records of controlled substances.- Oversee and train pharmacy staff to ensure adherence to best practices.- Collaborate with healthcare providers to manage patient care effectively.- Maintain inventory levels and manage stock to prevent shortages and overstock.- Handle insurance claims processing and reimbursement efficiently.- Address and resolve patient inquiries and concerns in a professional manner. Job Requirements:- Must - Have: A valid state required pharmacist license. - Must - Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution.- Preferred: Minimum of 3-5 years of experience is a plus.- Strong knowledge of federal and state pharmacy laws and regulations.- Proficiency with pharmacy management software systems.- Excellent communication and interpersonal skills.- Ability to work in a fast-paced environment and manage multiple tasks.- Strong attention to detail and organizational skills.- Commitment to providing exceptional patient care. Preferred Qualifications:- Certification in Medication Therapy Management (MTM).- Experience with inventory management and cost-saving measures.- Proven track record of managing a pharmacy team effectively Benefits:- 401(k) matching- Bonus based on performance- Competitive salary- Paid time off- Training & development- Wellness resources We look forward to reviewing your application. Meta Specialty Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionJob Title: Pharmacist Pharmacy Name: SAI Apteka PharmacyLocation: 151 Nassau Ave, Brooklyn, NY - 11222 Position Type: Full-Time (Immediate Joining Preferred) Job Description:SAI Apteka Pharmacy is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities:- Medication Dispensing: Accurately dispense prescription medications to patients.- Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions.- Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations.- Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly.- Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices.- Collaborative Care: Work with healthcare providers to manage and improve patient care.- Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock.- Insurance Processing: Handle insurance claims processing and reimbursement efficiently.- Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements:- Must Have: A valid state required pharmacist license- Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution.- Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: - Strong knowledge of federal and state pharmacy laws and regulations. - Proficiency with pharmacy management software systems. - Excellent communication and interpersonal skills. - Ability to work efficiently in a fast-paced environment. - Strong attention to detail and organizational skills. - Commitment to providing exceptional patient care. Preferred Qualifications:- Certification in Medication Therapy Management (MTM).- Experience with inventory management and cost-saving measures.- Proven track record of effectively managing a pharmacy team. Benefits:- 401(k) matching- Performance-based bonus- Competitive salary- Paid time off- Training and development opportunities- Wellness resources Perks:- Competitive Compensation: Attractive salary packages and benefits.- Work Environment: Join a supportive and collaborative team that values your contributions.- Career Advancement: Opportunities for professional growth and development within the company.- Work-Life Balance: Balanced work schedule to help maintain a healthy work-life balance. Why Join Us:- Supportive Environment: Be part of a team that values and supports your contributions.- Growth Opportunities: Advance your career with opportunities for professional development.- Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules.- Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. SAI Apteka Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionJob Title: Pharmacist Pharmacy Name: Bentley Pharmacy Location: 1172 East Tremont Ave, Bronx, NY - 10460 Position Type: Full-Time (Immediate Joining Preferred) Job Description:Bentley Pharmacy in Bronx is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities:- Medication Dispensing: Accurately dispense prescription medications to patients.- Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions.- Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations.- Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly.- Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices.- Collaborative Care: Work with healthcare providers to manage and improve patient care.- Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock.- Insurance Processing: Handle insurance claims processing and reimbursement efficiently.- Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements:- Must Have: A valid state required pharmacist license- Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution.- Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: - Strong knowledge of federal and state pharmacy laws and regulations. - Proficiency with pharmacy management software systems. - Excellent communication and interpersonal skills. - Ability to work efficiently in a fast-paced environment. - Strong attention to detail and organizational skills. - Commitment to providing exceptional patient care. Preferred Qualifications:- Certification in Medication Therapy Management (MTM).- Experience with inventory management and cost-saving measures.- Proven track record of effectively managing a pharmacy team. Benefits:- 401(k) matching- Performance-based bonus- Competitive salary- Paid time off- Training and development opportunities- Wellness resources Perks:- Competitive Compensation: Attractive salary packages and benefits.- Work Environment: Join a supportive and collaborative team that values your contributions.- Career Advancement: Opportunities for professional growth and development within the company.- Work-Life Balance: Balanced work schedule to help maintain a healthy work-life balance. Why Join Us:- Supportive Environment: Be part of a team that values and supports your contributions.- Growth Opportunities: Advance your career with opportunities for professional development.- Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules.- Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Bentley Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionJob Title: Pharmacist Pharmacy Name: Relion PharmacyLocation: 151 Nassau Ave, Brooklyn, NY - 11222 Compensation: $60 -$75 Company Overview: Relion Pharmacy is looking for a dedicated and experienced Pharmacist to join our team. We are committed to delivering exceptional patient care and ensuring that our pharmacy operates in full compliance with all relevant laws and regulations. If you are passionate about pharmaceutical care and ready to make a difference, we invite you to apply. Candidates available for immediate start are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide thorough guidance on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure compliance with federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain precise records and responsibly manage controlled substances., • Staff Training: Train and mentor pharmacy staff to uphold best practices., • Collaborative Care: Collaborate with healthcare providers to enhance patient care., • Inventory Management: Monitor and manage inventory levels to avoid shortages or excess., • Insurance Processing: Efficiently handle insurance claims and reimbursements., • Customer Service: Professionally address and resolve patient inquiries and concerns.Job Requirements:, • Required: Valid pharmacist license as per state regulations., • Required: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: 3-5 years of experience in a pharmacy setting.Skills:, • In-depth knowledge of federal and state pharmacy laws and regulations., • Proficiency in pharmacy management software., • Excellent communication and interpersonal abilities., • Strong organizational skills with a keen attention to detail., • Ability to thrive in a fast-paced environment., • Dedication to providing outstanding patient care.Preferred Qualifications:, • Certification in Medication Therapy Management (MTM)., • Experience in inventory management and implementing cost-saving measures., • Proven success in managing a pharmacy team effectively.Benefits:, • 401(k) matching, • Performance-based bonuses, • Competitive salary, • Paid time off, • Opportunities for training and professional development, • Wellness resourcesWhy Join Us?, • Supportive Environment: Be part of a team that values your input and fosters your growth., • Growth Opportunities: Advance your career with ample professional development options., • Balanced Schedule: Enjoy a healthy work-life balance with our flexible schedules., • Competitive Packages: Benefit from attractive compensation and growth potential.We look forward to receiving your application! Relion Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

Job DescriptionJob title: Pharmacist Pharmacy Name: OMM PharmacyLocation: 942 Manhattan Ave, Brooklyn, NY - 11222 Position Type: Full-Time (Immediate Joining Preferred) Company Overview: OMM Pharmacy is looking for a dedicated and experienced Pharmacist to join our team. We are committed to delivering exceptional patient care and ensuring that our pharmacy operates in full compliance with all relevant laws and regulations. If you are passionate about pharmaceutical care and ready to make a difference, we invite you to apply. Candidates available for immediate start are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide thorough guidance on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure compliance with federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain precise records and responsibly manage controlled substances., • Staff Training: Train and mentor pharmacy staff to uphold best practices., • Collaborative Care: Collaborate with healthcare providers to enhance patient care., • Inventory Management: Monitor and manage inventory levels to avoid shortages or excess., • Insurance Processing: Efficiently handle insurance claims and reimbursements., • Customer Service: Professionally address and resolve patient inquiries and concerns.Job Requirements:, • Required: Valid pharmacist license as per state regulations., • Required: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: 3-5 years of experience in a pharmacy setting.Skills:, • In-depth knowledge of federal and state pharmacy laws and regulations., • Proficiency in pharmacy management software., • Excellent communication and interpersonal abilities., • Strong organizational skills with a keen attention to detail., • Ability to thrive in a fast-paced environment., • Dedication to providing outstanding patient care.Preferred Qualifications:, • Certification in Medication Therapy Management (MTM)., • Experience in inventory management and implementing cost-saving measures., • Proven success in managing a pharmacy team effectively.Benefits:, • 401(k) matching, • Performance-based bonuses, • Competitive salary, • Paid time off, • Opportunities for training and professional development, • Wellness resourcesPerks:, • Competitive Compensation: Attractive salary and benefits packages., • Supportive Environment: Work within a collaborative team that values your contributions., • Career Advancement: Opportunities for growth and development within the organization., • Work-Life Balance: Flexible schedules to support a healthy work-life balance.Why Join Us?, • Supportive Environment: Be part of a team that values your input and fosters your growth., • Growth Opportunities: Advance your career with ample professional development options., • Balanced Schedule: Enjoy a healthy work-life balance with our flexible schedules., • Competitive Packages: Benefit from attractive compensation and growth potential.We look forward to receiving your application! OMM Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

Job Description Supervisory Compounding Pharmacist Location: Brooklyn, NY Job Type: Full-Time role Schedule: Monday to Friday 8:30 AM – 5:30 PM (Flexible) Compensation: $76 - $85 /hour (based on experience) We are seeking a skilled, detail-oriented, and passionate Compounding Pharmacist to join our team at Medcals Lab. Our facility operates in full compliance with USP <795>, <797>, and <800> standards, ensuring the highest quality and safety in compounding practices. In this role, you will collaborate closely with healthcare professionals, patients, and pharmacy staff to deliver customized medications that make a real difference in patient outcomes. Key Responsibilities: • Compounding Expertise: Prepare both sterile and non-sterile compounded medications according to prescriptions and regulatory guidelines., • Managing staff and workflow, • Order verification and review, • Customer service, counseling, • Customization: Develop tailored formulations to meet unique patient needs., • Quality Assurance: Maintain strict adherence to USP standards, state regulations, and internal SOPs., • Inventory Management: Monitor, order, and manage compounding supplies and equipment., • Patient Care: Provide consultations to ensure proper medication usage and address patient questions., • Team Collaboration: Work closely with pharmacy staff and healthcare providers to ensure safe, effective, and timely medication delivery., • Compound 360 software documentation, • Education: Bachelor’s in Pharmacy (B.S. Pharm) or Doctor of Pharmacy (Pharm.D.)., • Licensure: Valid and active pharmacist license in [State], in good standing with the State Board of Pharmacy., • Experience: Strong knowledge of compounding principles, aseptic techniques, and compounding equipment., • IV compounding experience with USP <797> preferred. At Medcal Pharmacy, we pride ourselves on providing personalized pharmaceutical solutions that improve lives. This is a per diem position, offering flexibility and the opportunity to work with a dedicated, supportive team while practicing at the highest standards of pharmacy care. Company DescriptionWe specialize in fertility medications and offer sterile and non-sterile compounding. UPS standards 795,797, and 800We specialize in fertility medications and offer sterile and non-sterile compounding. UPS standards 795,797, and 800

Job Description We are looking for Onsite Licensed Pharmacist to join our New Jersey Team! Specialty Rx is a Long-Term Care pharmacy providing pharmaceutical services to long-term care facilities and assisted living communities. Specialty Rx takes pride in delivering personalized care and quality pharmacy services. Please apply here Licensed Pharmacists, please apply; we offer a competitive salary and benefits package. License Pharmacist Responsibilities: • Evaluate medication orders for appropriateness of drug, dosage, potential interactions, and proper administration., • Ensure that dispensed medicines are correctly supplied and labeled., • Communicate with facilities’ nursing staff, physicians, and other healthcare team members in regard to medication-related queries., • Supervise the preparation of any medicines License Pharmacist Requirements: • Active Pharmacist with NJ Board of Pharmacy a must, • Previous experience in Long Term Care preferred, • Strong analytical and critical thinking skills, • Strong attention to detail, • Ability to work independently, accurately, and efficiently, • Must be multi-tasking and reliable, • Computer literate, knowledge of Frameworks LTC system, PLUS Full Time-Hours: 4:00pm-Closing (Monday through Friday/rotating weekends) (2nd Shift Differential) EEO Statement, SpecialtyRx, Inc. is fully committed to employing a diverse workforce. We recruit and retain talented individuals without regard to gender, race, age, marital status, disability, veteran status, sexual orientation gender identity, or any other status protected by federal, state, or local law. EO/Minorities/Females/Disabled/Veterans Company DescriptionSpecialtyRx is focused on supporting the healthcare facility as a unit. As an administrator or nurse manager, you need reliable medication dispensing, fail-proof availability and delivery, expert compounding and interchange services, and more all while meeting industry standards and maintaining compliance with federal and state regulations. That's where a long-term partnership with SpecialtyRx transforms your care capacity. Through quality medication therapy, strong communication, and continued education, we effectively increase efficiency, reduce costs, and enable better care all around.SpecialtyRx is focused on supporting the healthcare facility as a unit. As an administrator or nurse manager, you need reliable medication dispensing, fail-proof availability and delivery, expert compounding and interchange services, and more all while meeting industry standards and maintaining compliance with federal and state regulations.\r\n\r\nThat's where a long-term partnership with SpecialtyRx transforms your care capacity. Through quality medication therapy, strong communication, and continued education, we effectively increase efficiency, reduce costs, and enable better care all around.

Inizio Engage has a long-standing partnership with worldwide leading pharmaceutical company to offer support for an expanding product portfolio in primary care. We are seeking a performance driven Pharmaceutical Field Sales Representative with strategic problem- solving skills, that can collaborate with multiple stakeholders. The Ideal candidate will demonstrate a track record of sales success or related experience, regardless of industry background. Pharmaceutical experience is not required. We are seeking individuals who can quickly make a meaningful impact, leveraging their proven ability to deliver results, build relationships and adapt in a dynamic environment. The Pharmaceutical Field Sales Representative will achieve sales and activity targets on assigned territories across primary care customers and meet all relevant standards as set by Inizio and Sales leadership. This is your opportunity to join Inizio Engage and represent a top pharmaceutical company! What’s in it for you? • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? • Driving demand through clinical selling and education to targeted Physicians, • Establish, maintain and develop strong relationships with HCPs (includes physicians, Nurses, NP, PA, MA, etc.), • Deliver sales messaging, patient and product information to targeted HCP offices, • Achieve or exceed activity targets as set by the company, • Complete administrative items daily, • Comply with all client and Inizio policies, including compliance and ethics requirements, and trainings, • Effective time management and coordination of:, • Routing plans, • Daily/weekly call activities, • Demonstrate persistence towards accomplishing defined sales objectives, • Must have a dependable automobile with insurance coverage in compliance with company guidelines., • Collaborate with geographic partners What do you need for this position? • Bachelor’s degree, • Business to Business sales experience preferred, • Comfort with Technology/Virtual Engagements, • Ability to travel up to 20% of time as required (some territories could be more than 20%), • Overnight Travel Required, • Valid driver’s license and clean driving record About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Reporting directly to the CEO, the Marketing Manager is responsible for all marketing and partnership development activities to support the strategic direction of Manhattan Restorative Health Sciences (MRHS). They will be responsible for supporting a patient-centric work environment, in alignment with MRHS’ core values: Inspiration, Purpose, Professionalism, Collaboration, and Innovation. Responsibilities: Marketing: • Develop an annual marketing plan for MRHS with clearly defined goals and a plan for execution, • Collaborate with leadership to identify and execute strategic initiatives utilizing the standard business cases and project charters, • Oversee the overall branding and public relations function for MRHS, • Maintain a Brand Center for MRHS and audit collateral to ensure compliance for branding and messaging (print and electronic media), • Maintain editorial calendars, • Lead patient experience initiatives and report to the CEO and or other stakeholders as required, • Support a culture of service excellence by triaging high priority patient concerns while investigating the causes and providing an immediate solution(s), • With input from the leadership team, develop a quarterly business development plan, • Identify and prospect potential business development/partnerships opportunities, • Evaluate business deals to include projected value, prepare presentations and briefing books, • Collaborate with key stakeholders to structure the negotiations and contracts, • Maintain and monitor the business development pipeline, • Collaborate with other department leads to implement and track “new patients referral seen”, • Represent MRHS at events to explore new business development e.g., Trade Shows, Conferences, Corporate Events, Membership Associations, etc., • Maintain relationships with key vendors and pharmaceutical representatives, • Administrative oversight for the Marketing function and all its direct reports, • Participate in the hiring and onboarding of staff as needed across the organization, • Conduct training and performance appraisals for direct reports, • 4 - 8 years of experience in the marketing field, including leading the execution of an end to end marketing program, • Undergraduate degree in a related field, • Graduate degree preferred; but not required All qualified applicants will receive consideration for employment without regard to age, sex, sexual orientation, gender identity, national origin, race, color, religion, disability, or protected veteran status, or any other legally protected basis, following applicable laws. For more information, visit MRHSclinics.com Company DescriptionOur team of world class, award-winning physicians and specialists are driven to develop innovative 'body and mind' treatment plans for our patients, and to advance impactful medical research for all.Our team of world class, award-winning physicians and specialists are driven to develop innovative 'body and mind' treatment plans for our patients, and to advance impactful medical research for all.

Job DescriptionWho we are… Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. What you’ll be doing The Director, Corporate Communications and Patient Advocacy will play a critical role in building and implementing our overall communications and patient advocacy engagement strategy. This individual will be responsible for development and execution of company and product communications, in partnership with Head of Corporate Communications and Patient Advocacy and other cross-functional colleagues, for both external and internal audiences. The role will have a strong focus on corporate positioning, digital presence and engagement to drive awareness and appreciation of Nuvation Bio with key stakeholders. You will be responsible for… • Support identify and engagement of key advocacy stakeholders, which could include: patients, caregivers, healthcare providers, and advocacy groups for engagement and collaboration based on mutual goals., • Develop, management, and maintenance of strategic corporate and PR communication materials, including press releases, presentations, Q&As, digital content, internal communications and more., • Oversee Nuvation Bio’s digital brand identity and serve as lead on strategy, content and execution deliverables for digital components, including but not limited to Corporate website and social channels., • Develop compelling, authentic, and consistent messaging related to Nuvation Bio’s strategies, initiatives, pipeline, and performance. Ensure that all communications incorporate Best Practices and comply with pertinent SEC rules and FD regulations., • Work collaboratively with the Head of Corporate Communications and Patient Advocacy, with Executive Team and other functional leadership, as well as related agencies to ensure consistent messaging for external/internal stakeholders, maximizing efficient use of resources, • Own specific workstreams that support external and internal communications initiatives and patient advocacy engagement, including media relations, digital and social media campaigns, patient ambassador programs event and patient advocacy related projects., • Proactively craft regular progress reports and presentations for key stakeholders, including the executive committee and cross-functional team, to provide updates on program performance and milestones. Maintain pulse on Nuvation Bio public sentiment via Meltwater and other services.What Knowledge & Experience you'll bring to us..., • Bachelor’s degree and a minimum of 8+ years of experience working in the biotech/pharmaceutical industry, with direct experience designing and executing corporate communications within a publicly traded company and/or in an agency setting., • Proven ability to speak the language of a pharmaceutical/biotech company and break down complex scientific concepts for both internal and external audiences., • Demonstrated track record of conducting successful, proactive communications programs that employ creativity and use of a variety of tools, forums, media and metrics., • Experience leading digital initiatives and developing thought leadership content, including executives and our CEO., • Understanding of the advocacy landscape and core engagement principles / best practices., • Trusted for flawless execution of proactive and reactive initiatives., • Maintains strong relationships with healthcare reporters, and industry media., • Knowledge of up-to-date compliance, legal, regulatory and other issues that impact communications and can apply them, accordingly, including knowledge of SEC and disclosure requirements., • Strategic agility, able to balance proactive/planning with reactive elements of the position. Thrives in the opportunity to support the full spectrum of biotech communications and patient advocacy needs, from internal communications efforts to medical meetings to thought leadership, and can successfully toggle as needs arise., • Dynamic, team player with excellent organizational, interpersonal, and influence skills. Experience working with and managing agency partners. Demonstrates leadership abilities with room to grow into management as function evolves., • Enthusiastic about Nuvation Bio’s vision and mission and endorse and promote our values.Behavioral skills to be successful..., • Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges., • Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives., • Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource., • Emotional intelligence, curiosity, and a knack to figure out a way to build something better, • Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders., • Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity., • Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.What we have for you!, • Competitive Base Salary, Bonus, and Equity Plans, • Unlimited Vacation and 10 Sick Days Annually, • Excellent Medical, Dental, and Vision Coverage, • 401K with Company Matching Disclaimer Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law. This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.

Job DescriptionMandatory Requirements • Minimum bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field from an accredited institution. Master’s degree preferred., • 4–8 years of analytical experience (preferably at least 3 years in analytical quality assurance)., • Proficient in Microsoft Office and quality applications/software programs., • Strong knowledge and experience with analytical laboratory activities for APIs and drug products, including analytical development and Quality Control (QC)., • Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and USP monograph requirements., • Understanding of laboratory equipment operation, qualification, calibration, and software audit trail review (e.g., HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers)., • Knowledge of FDA and ICH guidance requirements., • Effective interpersonal skills and ability to work in a team environment., • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products., • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) during routine laboratory operations., • Confirm compliance of method validations, verifications, comparison reports, and other study reports., • Prepare and review laboratory investigations (OOS/OOT/Deviations) and ensure compliance., • Verify laboratory chemicals, reagents, and standards for completeness of labeling per SOPs., • Assess and implement Pharmacopoeia changes (editions, supplements, amendments) as they become effective., • Review laboratory audit trails during data review against SOPs., • Coordinate with analytical laboratory teams to provide required documents to cross-functional teams., • Maintain incoming documents with proper tracking, recording, storage, and archival., • Identify system gaps during routine monitoring and report improvement opportunities to the supervisor., • Participate in review of data related to laboratory investigations and incidents to ensure compliance., • Support departmental and cross-functional projects and assignments as directed by management.Education and Experience, • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field required; Master’s preferred., • 4–8 years of analytical experience, with preference for 3+ years in analytical quality assurance., • Proficiency with computer systems, Microsoft Office, and quality applications.Technical Knowledge and Computer Systems Skills, • Operation, qualification, and calibration of laboratory equipment and software audit trail review., • Experience with HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meters, stability chambers, etc., • Knowledge of USP monograph requirements, FDA, and ICH guidance., • Strong documentation and technical writing skills; ability to apply scientific principles and practices., • Ability to work independently and as part of a team in a fast-paced manufacturing environment.Professional and Behavioral Competencies, • Proficient English communication skills (verbal and written)., • Self-starter with initiative to seek training or direction as needed., • Willingness to work assigned shifts (first or second shift); schedules may be Monday to Friday., • Knowledge of good manufacturing and documentation practices preferred., • Self-motivated, organized, and able to handle multiple tasks simultaneously with attention to detail.

Job Description SPCSHP, part of independent group MSQ Partners, has spent 25 years helping brands make meaningful human connections through curiosity and belief. As a diverse community of creative specialists, we like to think of ourselves as “explorers, not settlers” — building partnerships with ambitious brands including such as Chase, Dairy Queen, BOTOX® Cosmetic, Early Warning and Dropbox. With a range of proprietary offerings and tools and a team of over 100 diverse crew members, we are constantly growing and are thrilled by the prospect of you joining our next endeavor. We are looking for a pharma focused Group Account Director to take a key position at SPCSHP. Strategically minded with strong creative sensibilities and an entrepreneurial spirit, the ideal candidate will take a consultative approach to the account learning every facet of the account itself and the client's business to lead to a large, fluid team across a variety of exciting client initiatives. Roles + Responsibilities: • Partners with Director level through CMO level client contacts across business units, while maintaining a presence with the day-to-day client team, • Leads multiple tracks of campaign development and management work, • Possess the ability to sell advanced strategic concepts, drive initiatives, and live the Agency’s values, • Demonstrate micro and macro knowledge of the client’s business with continuous research of brand, its categories, and competitors, • Responsible for the development of the highest quality creative work by sharing knowledge of the client/business/brand and demonstrating strong creative judgment, • Have a finger on the pulse of clients’ cross channel marketing, including social presence, social trends, and channel shifts, • Ensures smooth running of finances and administrative systems, • Has experience with scoping, timeline creation, project management, margin, and revenue growth, • Problem solves day-to-day account issues as needed, • Looks for additional business opportunities for agency and growth opportunities for clients, • Have a perspective on the account discipline practice and a passion contributing to discipline culture, • 10+ years as a strategic brand partner to senior and C-suite clients in direct-to-consumer pharmaceutical marketing with deep FDA compliance knowledge (fair balance, ISI, etc.), • Proven success launching new pharma products and marketing premium-priced elective treatments, • Expertise in consumer funnels from “consideration to consultation”, • Strong understanding of compliance review processes and consumer media behavior in the aesthetic/beauty space, • Skilled at building strategic consensus across diverse stakeholders, • Track record of industry-recognized brand strategy and creative leadership, • Experience selling cross-disciplinary work and managing multimillion-dollar portfolios The salary band for this role is $150-200k. Where a prospective new hire's base salary will fall within this band depends on several factors including their qualifications and experience, the skill level required in the role, market rates, and the salaries of existing crew members at SPCSHP within the same role to maintain equity.

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 . 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 BGB Group Group Copy Supervisor Our Agency BGB Group is a healthcare communications agency that offers a wide range of services, including traditional pharmaceutical advertising, promotional medical education, payer marketing, and consulting services. Known for excellence and professionalism, we're hired as strategic and creative partners by our biopharmaceutical clients to drive category/brand awareness and growth. Position Overview As a Group Copy Supervisor, you will lead the development of compelling, strategy-driven content for healthcare brands across multiple therapeutic areas. You will oversee a team of writers, ensuring the highest standards of medical accuracy, creativity, and compliance with regulatory guidelines. In collaboration with cross-functional teams, you will help drive brand messaging, maintain consistency, and mentor junior and mid-level writers. This role requires both hands-on writing expertise and strong leadership skills. Role Requirements: • Lead the development of scientific and promotional content, ensuring alignment with brand strategy and compliance requirements., • Oversee and mentor a team of copywriters, providing guidance, feedback, and career development support., • Partner with creative, medical, and account teams to develop compelling, high-quality content across multiple channels (digital, print, video, social, etc.)., • Review and edit content for scientific accuracy, clarity, engagement, and adherence to brand voice., • Stay up-to-date with industry trends, regulatory guidelines, and competitive landscape to inform strategic content development., • Present content to internal teams and clients, articulating rationale and addressing feedback., • Manage workload and workflow to ensure timely delivery of high-quality materials., • Bachelor's or advanced degree in Life Sciences, English, Journalism, Communications, or a related field., • 6+ years of experience in healthcare/pharmaceutical copywriting, with at least 2 years in a supervisory role., • Strong understanding of medical and scientific concepts, as well as experience translating complex information into compelling content., • Familiarity with regulatory requirements (e.g., FDA, OPDP, medical/legal review processes)., • Exceptional writing, editing, and communication skills., • Ability to multitask, manage multiple projects, and work effectively in a fast-paced agency environment., • Experience working across a variety of therapeutic areas is preferred. The salary range provided is for the NYC-hybrid position, which requires occasional in-office presence, and represents what a potential hire may expect to earn in this role at BGB. For candidates in other locations, salary will be adjusted to reflect local market rates. Actual salary decisions will be influenced by several factors that we use to determine overall fit, including experience (both direct and indirect), education, training, demonstrated qualifications, and organizational need. Salary is only one component of the total rewards package offered at BGB Group. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected basis, in accordance with applicable law.

Job DescriptionJob Title: District Sales Manager Location: New Jersey (Home Base) & New York (Field) Job Type: Full-Time (Monday – Friday, 9:00 AM – 5:00 PM) About the Role: We are seeking a highly motivated and experienced District Sales Manager to lead and develop a team of sales representatives. The ideal candidate will have a strong background in sales, preferably within the healthcare industry. This role requires a dynamic leader who can drive sales, meet targets, and ensure customer satisfaction through strategic planning and effective team management. Key Responsibilities: • Oversee, train, and mentor a team of sales representatives to achieve sales goals and business objectives., • Develop and implement sales strategies to drive revenue growth and market expansion., • Conduct regular in-person training sessions, presentations, and performance reviews for the sales team and clients., • Present sales strategies and solutions to employees and clients to strengthen partnerships and increase engagement., • Monitor sales performance, analyze data, and adjust strategies as needed to optimize team success., • Ensure high levels of customer satisfaction by maintaining strong client relationships and addressing concerns proactively., • Work in-office at the home base in New Jersey for 2-3 days per week and spend the remaining days in the field with sales representatives across New York. Qualifications & Requirements:, • Bachelor’s Degree in related discipline., • 2+ years of experience in pharmaceutical sales or healthcare environment is preferred., • Strong ability to train, coach, and motivate a sales team to exceed targets., • Excellent presentation and communication skills for both employees and clients., • Strong analytical and problem-solving abilities to assess performance and drive improvements., • Ability to travel between New Jersey and New York on a weekly basis., • Conduct field coaching, develop business plans, and ensure alignment across stakeholders., • Lead sales training, monitor performance metrics, and drive compliance with company policies., • Facilitate team collaboration and share best practices., • Identify top-performing representatives for recognition and career growth opportunities., • Manage analytics, optimize physician engagement, and support marketing initiatives. Salary: $70,000 – $80,000 plus commission and a travel stipend. Final compensation will be determined by factors such as experience, location, skills, and job-related knowledge. Benefits: • 401(k), • Health insurance, • Paid time off If you are a results-driven sales leader looking for an opportunity to make an impact, we want to hear from you! Apply today to join our team.

Job Description Company overview With an annual budget of $2.3 billion and more than 7,000 employees throughout the five boroughs, the New York City Department of Health and Mental Hygiene (NYC DOHMH) is one of the largest public health agencies in the world, serving 8 million New Yorkers from diverse ethnic and cultural backgrounds. We're tackling a broad range of public health issues with innovative policies and programs and getting exceptional results, but our work is never finished. The breadth of our innovative programs provides the widest range of choices for every member of our team. With grant funds from the Centers for Disease Control and Prevention (CDC), DOHMH is undertaking a new initiative that will meet critical infrastructure needs and make possible strategic investments that will have lasting effects on public health. Investments and improvements through this initiative will help modernize DOHMH’s foundational capabilities and data infrastructure, enabling it to partner in complex health and health care environments and, in turn, support better public health outcomes, including COVID-19. This initiative supports larger efforts to rebalance investments in public health and more equitably serve communities and populations. The selected candidate will be an employee of Public Health Solutions, a nonprofit organization which is the fiscal and administrative manager of the grant but will work be supervised by DOHMH. This is a grant-funded position ending in November 2027. DOHMH’s Office of Emergency Preparedness and Response (OEPR) was created to promote DOHMH’s and NYC’s ability to prevent, prepare for, respond to, and recover from health emergencies. The OEPR is responsible for coordinating agency-wide emergency preparedness planning, exercises and training, evaluation of incident response, and exercise performance as well as coordinating with community stakeholders, city, state, and federal partners on public health emergency planning and response. The OEPR also works with healthcare partners to optimize the provision of health services during a large-scale disaster. The Bureau of Emergency Field Operations (BEFO) is responsible for the planning, exercise, training, logistics, operations, and staffing of Citywide public health emergency plans and field operations including: Post Emergency Canvassing Operations (PECO), Community Reception Centers (CRC), quarantine operations, and antibiotic or vaccine Points of Dispensing (PODs). Job description DOHMH has an opening for a Vendor Manager. Reporting to the Senior Supply Chain Manager, this position oversees the Group responsible for coordinating and managing the services from various vendors, including a 3PL warehouse, which improve the readiness of NYC’s Public Health Emergency Stockpile, and the Citywide Health Emergency Field Operations Logistics Group, for response operations. Duties • Manage the Vendor management Group, including two coordinators, creating, and maintaining oversight of Group goals, objectives and milestones, and tracking through completion, • Oversee the execution, tracking and spend down of Bureau yearly fiscal contracts, procurement processes, and Bureau purchase order requests, • Manage the contractual relationship between DOHMH and the City’s 3PL emergency stockpile RSS warehouse, continuously enhancing readiness capabilities and ensuring all requirements are adhered to, including:, • Ensuring vendor purchases and maintains DOHMH indicated PPE (Living Stockpile) inventory in their nationwide distribution centers, that would be earmarked for NYC to use during an emergency, and update formulary as needed., • Overseeing the conduct of quality checks (inventory accuracy, product integrity) for PPE (Living Stockpile) and rotation to ensure stock is unexpired, and within acceptable shelf life., • Ensuring proper storage and maintenance of ventilators that would need to be brought to a “patient-ready” upon request, • Manage the maintenance, including rotation and shelf-life extension coordination, of a pharmaceutical cache to support first responders, healthcare workers and PODs, to support mass prophylaxis in response to an aerosolized anthrax release, • Oversee the adherence and maintenance of the cGMP compliance quality program, and liaise with ASPR/SNS to conduct yearly audits of the facility and validate product integrity, • Assist with the development, documentation, and testing of CHEFO ERG/ICS logistics roles, functions, responsibilities, and coordination processes; participate in drills and exercises, • It is expected that the Vendor Manager will be a key member of the incident command structure during emergency Qualifications: • Three or more years’ experience managing staff in an office setting supporting procurement, supply chain, or logistics operations through work related, but not limited to, any of the following areas: sourcing and procurement, fiscal process management and/or supply chain improvement, • Three or more years’ experience managing staff in an office setting supporting procurement, supply chain, or logistics operations through work related, but not limited to, any of the following areas: sourcing and procurement, fiscal process management and/or supply chain improvement., • Strong project/program management skills with experience developing written reports, policy/procedures and executive-level briefings, • Exceptional writing, communications, organizational and interpersonal skills, • The ideal candidate for this position must be a pro-active and self-motivated individual with the ability to work in teams and in a highly dynamic environment with multiple stakeholders and timelines. Additional Desired Qualities • Successful completion of the Incident Command System (ICS) and National Incident Management System (NIMS) courses (100, 200, 700, and 800), • Strong analytical skills and ability to manage and report complex information., • Desire to grow professionally, develop new skills and willingness to work outside of comfort zone., • Ability to prioritize and work in fast-paced environment with hard deadlines., • Generous Paid Time Off and Holidays., • An attractive and comprehensive benefits package including Medical, Dental and Vision., • Flexible Spending Accounts and Commuter Benefits., • Company Paid Life Insurance and Disability Coverage., • 403 (b) + employer matching and discretionary company contributions., • College Savings Plan. Additional Information: • This is a temporary grant-funded position ending in November 2027., • This individual must reside in the tri-state area (NY, NJ, CT) by their confirmed start date., • Preference may be given to individuals residing in New York City (5 boroughs) or surrounding New York State counties., • This individual will be expected to work non-business hours during emergencies. PHS is proud to be an equal opportunity employer and encourages applications from women, people of color, persons with disabilities, lesbian, gay, bisexual and transgender individuals, and veterans. Monday-Friday, 9am-5pm 35 hours per week

Job DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. • Develop and maintain training program within Quality Control which includes, onboarding and continuous training, • Manage deviations, CAPAs, change controls and document review to ensure compliance, • Ensure OOS investigations are completed adequately., • Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories, • Identify resources needed for training and compliance and build team accordingly, • Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements., • Monitor effectiveness of CAPAs, change control activities, and audit observation closure., • Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators, • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory experience in a cGMP environment a must, • 3-5 years’ experience in the pharmaceutical, biologics ore related industry, • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position, • Sound understanding of cGMPs, • Experience in laboratory training and compliance, • External laboratory management experience, • Strong knowledge of testing methodologies, philosophies, method validation and method transfers., • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Experience with laboratory training programs, • Knowledge of GMP requirements, • Excellent organizational and leadership skills, • Outstanding analytical problem-solving abilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Manage CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionOur Biotechnology client located in Allendale, NJ is seeking a Human Resources Business Partner who will provide human resources consultation and support to the Quality Department. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role reports to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • Understand business needs in order to assess the HR implications of various business strategies., • Acts as liaison to other functions to ensure achievement of business objectives., • -Provide staffing and placement support to departments and divisions., • Facilitates the recruitment and on-boarding process for all new hires. HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups.Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support.Talent Acquisition: designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry.Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution.Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values.HR SME: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures.Compensation: Ensures our compensation practices continue to attract and reward top talent. Oversee the salary administration to include annual performance management and compensation processes.Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies. REQUIREMENTS, • -Bachelor’s degree in business, Human Resources or related field., • Minimum of ten years progressive HR/business leadership experience is required., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • Prior experience in working in a matrix and complex operating environment preferred. Fast paced, challenging industry, • Build strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns fast, while being adaptable to the changing environment., • Look to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communication proficiency: for both written and verbal communication, • Work collaboratively with all levels of employees., • Flexibility and adaptable in a high pressured, clinical and/or pharmaceutical environment., • Work with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives, • Must have high level of interpersonal skills to ensure accurate flow of all information.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description The Opportunity: A highly ranked and leading global pharmaceutical company located in New Jersey seeks an Associate Senior Counsel - Market Access to join their legal team. This position is hybrid in Essex County with a compensation package between $236K - $248K, plus bonus, LTI and a competitive benefits package. Primary Duties: The Associate Senior Counsel - Market Access will report to an Associate General Counsel and will serve as a strategic legal advisor to the company's commercial teams, with a focus on market access, customer contracting, trade relations, government price reporting, patient support programs, and broader pharmaceutical regulatory matters.. Additional responsibilities are as follows: • Provide proactive legal counsel and day-to-day support on a broad range of market access and commercial matters., • Draft and negotiate complex agreements with key stakeholders across the healthcare supply chain, including payors, PBMs, wholesalers, GPOs, distributors, and pharmacies., • Advise on manufacturer-sponsored patient support programs, including co-pay assistance, coupons, reimbursement support, patient assistance programs, and adherence initiatives., • Ensure compliance with all applicable pharmaceutical laws and regulations, including the Anti-Kickback Statute, False Claims Act, federal and state pricing laws, PhRMA Code, and FDA guidelines., • Serve as legal representative on promotional review committees for market access materials., • Monitor and communicate relevant legal and enforcement developments, such as DOJ and OIG guidance and industry trends, to internal stakeholders., • Mitigate legal and reputational risks for assigned business clients by implementing sound legal strategies and policies., • Juris Doctor (JD) from an accredited law school., • Active member in good standing of a U.S. state bar., • Minimum seven years of legal experience, including at least four years advising the pharmaceutical or life sciences industry., • Deep understanding of FDA regulations, fraud and abuse laws, and/or government price reporting requirements., • Demonstrated ability to work in a fast-paced, cross-functional, and matrixed business environment.

Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Company Overview Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future. Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays. Position Title: Territory Manager, Sales The Territory Manager, Sales is responsible for the on-label promotion and execution of sales strategies for approved Esperion products to targeted customers within the posted geographic area. As a member of the Company’s field sales force, the Territory Manager, Sales is responsible for all aspects of personal promotion within their assigned geography. They will be expected to execute the implementation of Esperion sales processes within the local geography in accordance with approved sales and marketing resources and while ensuring they operate in an effective, efficient, and compliant manner at all times. This role reports into the Regional Sales Manager. Territory: Brooklyn, NY Essential Duties and Responsibilities* • Achieve individual territory sales goals as approved by Esperion Commercial Leadership, • Review performance metrics with RSM to ensure territory is achieving maximum sales results., • Develop and maintain strong business relationships with key customers in the assigned geography, • Effectively promote and educate Health Care Providers (HCPs) on the use of Esperion products through one-on-one meetings, virtual engagements, company-approved promotional speaker programs, and other company-approved programs, • Analyze local market trends, develop, execute and monitor performance and results to maximize the appropriate use of Esperion products, • Demonstrate successful use of sales and marketing tools and resources such as to achieve business objectives., • Demonstrate and maintain appropriate knowledge of Esperion product payor coverage to deliver against market access objectives for the assigned territory, • Periodically attend local, regional and national congresses to promote Esperion brands to HCP attendees, • Demonstrate accurate and timely completion of all administrative tasks such as sample inventory, call submission & reporting, expense management, vehicle mileage reporting, and related duties as required by Esperion, • Ensure compliance with all corporate policies and procedures, completing all required compliance training, and consistently demonstrating behaviors aligned with company values, • Follow all Esperion Expense Report guidelines and adhere to allocated territory budget, • Establish and maintain effective communications among Regional Sales Managers (RSMs) and Territory Managers (TMs); organize and monitor performance to achieve the business potential of the Territory, • Monitor and strive to maintain consistency between Sales and Marketing efforts and ensure high standards for executing business initiatives, • Work closely with sales leadership and Market Access to maximize pull-through from commercial & government payers Qualifications (Education & Experience) • Bachelor’s degree required. Preferred degree in sciences (eg. Biology, Chemistry, Physics, Kinesiology, Pre-med, other STEM background) and 1 - 3 years of pharmaceutical or relevant sales experience; or equivalent education and experience., • Will also consider candidates with military background or similar experience demonstrating drive and discipline., • Experience calling on or working with Healthcare Professionals preferred but not required., • Must be willing and able to travel up to 30% including overnight stays for territory business and occasional Regional and National Sales Meetings, • Valid driver’s license and clean driving record that meets Esperion employment standards, • Documented track record of consistent high performance in sales, academics, athletics, or other similar endeavours., • Desire to work in a start-up environment or successful experience operating in an entrepreneurial sales model with sole responsibility of product promotion within a large geographic territory, • Ability to embrace a performance driven and growth culture., • Passionate about the mission and reputation of the Company, • Demonstrated excellent presentation and communication skills., • Ability to influence and work successfully with varied audiences, including customers, colleagues, scientific and technical leaders, • Strong interpersonal and selling skills

Job DescriptionQuality Assurance Manager (Compliance)Allendale, NJ The Manager, Quality Assurance manages the PPU support unit services of the QA Department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Start-up Compliance arm of the Quality Assurance Department., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential

Job DescriptionHuman Resources ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Human Resources Business Partner will provide human resources consultation and support to assigned divisions. Understand business needs in order to assess the human resources implications of various business strategies. Acts as liaison to other functions to ensure achievement of business objectives. Provides staffing and placement support to departments and divisions. Facilitates the recruitment and on-boarding process for all new hires. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role will report to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups., • Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support., • Talent Acquisition: Designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry., • Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution., • Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values., • HR Expert: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures., • Compensation: Ensures our compensation practices continue to attract and reward top talent. Overseeing salary administration to include annual performance management and compensation processes., • Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies.REQUIREMENTS, • Bachelor’s degree in business, Human Resources or related field., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • 10 + years progressive HR/business leadership experience is required., • 5+ years in clinical and/or pharmaceutical industry., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • Prior experience in working in a matrix and complex operating environment preferred. fast paced, challenging industry., • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns, fast, while being adaptable to the changing environment., • Looks to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communications proficiency: for both written and verbal communication., • Works collaboratively with all levels of employees., • Works with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives.

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 . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. 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., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. 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. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description Who we are: For over 20 years, Global Relay has set the standard in enterprise information archiving with industry-leading cloud archiving, surveillance, eDiscovery, and analytics solutions. We securely capture and preserve the communications data of the world's most highly regulated firms, giving them greater visibility and control over their information and ensuring compliance with stringent regulations. Though we offer competitive compensation and benefits and all the other perks one would expect from an established company, we are not your typical technology company. Global Relay is a career-building company. A place for big ideas. New challenges. Groundbreaking innovation. It's a place where you can genuinely make an impact – and be recognized for it. We believe great businesses thrive on diversity, inclusion, and the contributions of all employees. To that end, we recruit candidates from different backgrounds and foster a work environment that encourages employees to collaborate and learn from each other, completely free of barriers. Your role: As Senior Manager, Healthcare Regulatory Intelligence, you are a market-facing thought leader, leveraging your extensive background in regulation and compliance within highly regulated Life Sciences institutions. Your experience, ideally including roles within regulation, compliance and regulatory governance, will contribute to a distinct team of subject matter experts at Global Relay, enhancing our brand value both internally and externally. Your primary challenge will be optimizing productivity amidst a diverse and unstructured role, requiring flexibility and autonomy. Reporting to the Global Head of Regulatory Intelligence (UK), the role will have regular formal and informal interactions. Supervisory guidance will be available to support your efforts, while allowing for autonomous work. Your responsibilities: Internal responsibilities: • Support and enhance brand awareness for the New York office across all relevant stakeholders, • Provide marketing support by assisting with PR, messaging in collateral, and content for marketing events, that elevate Global Relay's brand recognition, • Assist in business development efforts by participating in key customer meetings and briefings, and be ready to share your subject matter expertise, • Offer support to product teams by advising on market practices, challenges, competitor offerings, and regulatory expectations, • Contribute to Global Relay Intelligence & Practice (GRIP), our business' daily regulatory content service, by writing articles, providing editorial input, and participating in interviews for multimedia content, • Contribute to internal training materials, educating those less familiar with Life Science best practice, and business development teams on market dynamics and compliance processes, • Stay abreast of regulatory changes by regularly consuming and filtering relevant news sources, and disseminating insights across the organization, • Participate in Executive Briefings (extensive prospect and client meetings), collaborating on workshops and product pitches to customers and prospects, • Work in close collaboration with product teams to ensure innovative solutions meet specific compliance requirements and mitigate risks effectivelyExternal responsibilities:, • Host and lead industry roundtables, facilitating discussions on evolving compliance practices and attending social events to engage with compliance officers, • Speak on panels and as a keynote speaker at industry events, representing Global Relay and staying informed about market trends and competitor positioning, • Utilize your extensive network of regulatory and compliance practitioners to raise awareness of Global Relay's capabilities and stay updated on market practices, • Minimum of 10 years of experience in a regulatory or compliance role within the Life Sciences industry (particularly pharmaceutical manufacturing), with a demonstrated understanding of Healthcare and Life Sciences laws and regulations, • Bachelor's degree in a relevant field, ideally with additional certifications or advanced degrees (such as a law degree or CPA), • Familiarity with 21 CFR Part 11, Good Manufacturing Practices (GMP), FDA, EMA, ICH, and DOJ ECCP, • Strong communication skills, both written and verbal, with the ability to articulate complex regulatory concepts clearly and persuasively, • Ability to work autonomously and collaboratively within a cross-functional team environment, demonstrating flexibility and adaptability to changing priorities, • Experience in "mobile device compliance challenges, e.g. ephemeral messaging," as well as SaaS electronic message archiving, compliance, and supervision in highly regulated industries, • Excellent project management skills, including the ability to manage multiple projects simultaneously and drive them to successful completion Global Relay advertises the pay range for this role in compliance with applicable pay transparency laws. Individual pay rates are determined by evaluating factors such as expertise, skills, education, and professional background. The range below reflects the expected annual base salary, which is only one element of our comprehensive total rewards package designed to reflect our company pay philosophy, culture and values. We aim to foster an inspiring work environment and support employees' work-life rhythms. We provide a comprehensive health benefits program, including extended health coverage and short-term / long-term disability insurance. Employees receive annual allotted vacation days, which increase based on tenure. Other benefits include paid sick days, maternity/parental leave enhanced program, commuter benefits, corporate bonuses, and a 401(k)-retirement plan with company contribution matching. For employees based at our New York office, we provide additional perks and amenities to enhance your work experience including a subsidized meal program, courtesy of our in-house culinary team! Base salary range$180,000—$250,000 USD What you can expect: At Global Relay, there's no ceiling to what you can achieve. It's the land of opportunity for the energetic, the intelligent, the driven. You'll receive the mentoring, coaching, and support you need to reach your career goals. You'll be part of a culture that breeds creativity and rewards perseverance and hard work. And you'll be working alongside smart, talented individuals from diverse backgrounds, with complementary knowledge and skills. Global Relay is an equal-opportunity employer committed to diversity, equity, and inclusion. We seek to ensure reasonable adjustments, accommodations, and personal time are tailored to meet the unique needs of every individual. We understand flexible work arrangements are important, and we encourage that in our work culture. Whether it's flexibility around work hours, workstyle, or lifestyle, we want to ensure our employees have a healthy work/life balance. We support and value a hybrid work model that blends collaboration with the team in the office and focus time from the comfort of your home. To learn more about our business, culture, and community involvement, visit .

Job Description Overview Physician Affiliate Group of New York (PAGNY) is adding an Chief of Emergency Medicine to the group at NYC Health + Hospitals/Metropolitan. The hospital is part of NYC Health + Hospitals. Metropolitan Hospital accommodates over 313,000 outpatient visits, nearly 70,000 emergency room visits and more than 13,000 inpatient admissions annually. The hospital maintains a strong academic affiliation with New York Medical College to maintain its high healthcare delivery standards. The mission of NYC Health + Hospitals is to extend equally to all New Yorkers, regardless of the ability to pay, comprehensive health services of the highest quality in an atmosphere of humane care, dignity, and respect. Their Values are built on a foundation of social and racial equity and has established the ICARE standards for all staff. NYC Health + Hospitals is the nation’s largest municipal health care delivery system in the United States. Dedicated to providing the highest quality health care services to all New Yorkers with compassion, dignity and respect, and regardless of immigration status or ability to pay. Responsibilities Direct, oversee, manage and evaluate all aspects of clinical services and medical education provided by members of the Department to deliver accredited medical services that meet all medical standards required by law; perform full range of administrative/operational responsibilities to ensure the efficient achievement of departmental goals and effective delivery of medical care to patients and the community at large, in conjunction with the Chief Medical Officer, the Executive leadership of the facility and the HHC Board of Directors. The Chief of Service is identified as the leader of the department. Today, the leader is challenged to help his/her department to evolve. Medicine is changing and while we continue the search for new pharmaceutical and technological advances to improve care, it has become critical that we examine and improve the delivery of care. The Chief of Service will be actively engaged in the measurement and management of quality and safety and leading the advances in the delivery of the Triple Aim. The Triple Aim, as articulated by CMS, is to simultaneously deliver better quality of care, better health for the population that we serve and to do this at lower cost. • Set expectations, monitor, document, and manage the performance of all clinical staff who report to this position., • Exercise responsibility for the quality and safety of Direct Patient Care Services including, but not limited to, the performance of ongoing performance improvement activities and compliance with all Performance Indicators, within your appointed specialty area., • Exercise responsibility for such other Departmental duties including, but not limited to, making recommendations for the granting of Medical Staff privileges, and the appointment and reappointment of Medical Staff, as set forth in the Regulations including, but not limited to, Joint Commission standards., • Reports to the Medical Director, with respect to the performance of the Contract Services Providers under your direction and supervision; represent your appointed specialty area(s) in a medical advisory capacity to the Corporation and the Chief Medical Officer; cooperate with the Corporation with respect to the purchase of supplies and equipment and the development of capital projects; and formulate special policies and procedures and techniques., • Design, implement and manage policies, systems and processes within the department to ensure the efficient and effective achievement of established goals., • For Chiefs of Service in service lines, collaborates with the service line administrator and nursing leader to develop and accomplish specific objectives designed to achieve the strategic goals of the health care facility., • Assume fiduciary responsibilities within the departmental structure set by the Senior Vice President, the Executive Director and the Chief Medical Officer. These responsibilities include identifying the need to increase and decrease clinical and support staff according to need, and to maximize efficiency of departmental services, creating revenue generating opportunities, and reducing waste. Qualifications A current, valid and unrestricted license to practice medicine in accordance with the laws of the State of New York; a valid DEA registration; status as a provider in good standing in the Medicare and Medicaid programs; board certification in the appropriate board specialty (may be waived by the President of HHC); and good standing with the health care facility’s Medical Staff (the “Medical Staff”) with appropriate privileges granted in accordance with the usual procedures of the health care facility. Demonstrated leadership and managerial abilities are essential including personnel, finance, quality and clinical resource management; maturity in clinical practice in area of specialty is preferred. Exceptional Benefits Include: • Competitive compensation package, • 10% 401K company contribution after one year of service, with 3% company contribution starting day one, • Choice of a three tiered, starting at FREE medical plans starting day one, • Excellent dental insurance including orthodontics coverage starting day one, • Generous paid time off program, • CME days and dollars, • Eligibility for loan forgiveness through the National Student Debt Forgiveness Center, • Visa candidates are considered, • Malpractice Provided, • Annual Based Salary: $356,797.67 Physician Affiliate Group of New York (PAGNY), a tax-exempt organization affiliated with NYC Health + Hospitals, is one of the largest physician groups in New York State and directly employs nearly 4,000 physicians and allied health professionals who serve seven of New York City’s public hospitals, numerous public health community-based practices, and the city’s Correctional Health Service. Physician Affiliate Group of New York, P.C. (“PAGNY”) is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view PAGNY’s EEO policies, please click here. Please click here to view the Federal “EEO is the law” poster or visit for more information. The annual base salary listed complies with the New York City law on Salary Transparency in Job Advertisements. The annual base salary listed is for full-time employment and does not include bonuses/incentive compensation or benefits. Total compensation depends on many factors, including experience, specialties, historical productivity, and historical collections. Actual total compensation may differ.

Job Description Accelerating Life-Changing Solutions to Global Healthcare Challenges is the vision that unites us through a shared sense of purpose, whatever the role. It speaks to the significant challenges that exist within global healthcare, and how we, as one team, can help to deliver better solutions and outcomes for our partners and for patients everywhere, sooner. Your job description outlines the important role and responsibilities that you own in achieving this vision. Importantly too is how we go about living our vision. This is defined by the Prime mission: Through a pioneering fusion of the finest expertise in science, strategy, evidence, technology and creativity we deliver the world-class outcomes that our global partners trust to achieve their goals. It speaks to collaboration and to everyone’s responsibility to bring together the diverse expertise that exist across our team to deliver world-class outcomes. On this foundation, we have defined four core values, these represent the shared principles that guide our behaviours every day, whatever your role: Be Brave, Be Human, Be Passionate, Be Exceptional. At Prime these values are integral to who we are. They are there to guide you in your role and support you on your personal journey to success. They shape our culture and support us in achieving our vision together, as one global team. The role As an Associate Medical Writer you will support the scientific team by drafting and preparing a variety of medical communication materials, such as abstracts, posters, manuscripts, slide decks, and presentations. Working closely with senior team members, you will ensure all content meets high standards of grammatical and scientific accuracy, reflects client objectives, and complies with industry regulations. You are also responsible for fact-checking, incorporating internal and external feedback, and adapting to client preferences in writing style and terminology. Beyond writing, the role involves managing assigned projects to meet deadlines, collaborating with scientific and client services colleagues, and conducting in-depth research on therapeutic areas, competitors, and products. Associate Medical Writer responsibilities also include tracking time accurately against project budgets, maintaining proficiency with relevant software, and staying informed on compliance requirements and industry best practices. This role provides the opportunity to develop scientific writing expertise while contributing to high-quality deliverables for clients. Requirements • A life sciences degree, ideally combined with a science Masters or PhD, • Strong communication skills, • Good knowledge of pharmaceutical industry and processes, • Excellent attention to detail and organisational skills, • 42 days paid time off, • WORKsmart - Flexibility around core working hours, • Hybrid Working, • 5% contribution to 401k, • ADP Totalsource

Job Description BGB Group Finance Coordinator Our Agency BGB Group is a healthcare communications agency that offers a wide range of services, including traditional pharmaceutical advertising, promotional medical education, payer marketing, and consulting services. Known for excellence and professionalism, we're hired as strategic and creative partners by our biopharmaceutical clients to drive category/brand awareness and growth. Position Overview The Finance Coordinator will assist with administrative functions related to the processing of accounts payable transactions, as well as general ledger and revenue team support. This individual will report to the Assistant Corporate Controller. Responsibilities include: Accounts Payable • Review, code, process and post all vendor invoices accurately, • Interact with vendors as needed to resolve pricing and/or quantity discrepancies, • Review employee expense reports for compliance with policies including proper receipts, documentation, and manager signature approval, • Process employee expense reimbursement requests, • Maintain and close all finance requests via NetSuite/OpenAir, • Generate and process weekly check runs, • Prepare year end 1099 reports and file electronically, • Support business team with client fee reconciliation reports, • Analyzing and entering project cost transfers for hours and out of pocket expenses, • Monitoring agency accounts receivable and apply daily cash receipts, • Assist with month end close, including journal entries and bank reconciliations, • Analyzing new business investments and measuring ROI, • Assist with the back-end administration of our financial application system (NetSuite), • Bachelor's Degree is required; concentration in Finance/Accounting preferred, • 1-2 years of prior accounting experience is a plus, • Must be a self-starter who works well in a fast-paced, team-oriented environment, • Ability to interact with people at all levels of an organization The salary provided is for the NYC-hybrid position, which requires occasional in-office presence, and represents what a potential hire may expect to earn in this role at BGB. For candidates in other locations, salary will be adjusted to reflect local market rates. Actual salary decisions will be influenced by several factors that we use to determine overall fit, including experience (both direct and indirect), education, training, demonstrated qualifications, and organizational need. Salary is only one component of the total rewards package offered at BGB Group. BGB Group is an equal opportunity employer. All applicants will be considered without regard to race, color, religion, sex, age, national origin, citizenship status, sexual orientation, disability, veteran status or any category or class of person protected by law.

Job DescriptionWho we are… Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. What you’ll be doing The Director, Publications & Medical Strategy is an integral member of the Medical Affairs Team. This individual, in conjunction with the Medical Strategy Lead, will be responsible for developing and executing the publication plans, as well as supporting evidence generation plans for taletrectinib and NSCLC. He/she/they must work collaboratively with cross-functional counterparts in Development, Research and Commercial as well as other partners in the organization to drive execution of the Publication and Evidence Generation plans. This individual will develop deliverables including integrated evidence generation plans for taletrectinib, scientific publications, and scientific communication platforms. Key aspects of the role include the development and execution of a forward-thinking evidence generation strategy for taletrectinib, including execution of the publication and medical communications strategy, data gap analysis, and integrated evidence planning. You will be responsible for… • Collaborate directly with executive leadership, Clinical, Medical Affairs, Biostatistics colleagues and external authors to shape and execute the medical communication strategy and evidence generation plans, • Lead the development and execution of comprehensive strategic publications for the company portfolio assets, in alignment with corporate and medical objectives, • Guide the creation and refinement of scientific communications materials such as QA, slide decks, and scientific platforms based on publications; ensure consistency and strategic messaging across publications and communication channels, for the lead assets in NSCLC and glioma., • Drive prioritization and decision-making for key publications; anticipate and resolve challenges related to data dissemination and stakeholder alignment., • Ensure all publications adhere to ICMJE, GPP, and internal compliance standards., • With Medical Strategy Lead, support the development and execution of an Evidence Generation Plan for taletrectinib, including the Publication Plan and ISR strategy., • With Medical Strategy Lead, develop and execute external research and collaborations (ISR) strategy that is aligned to company goals and prioritized data gaps., • Evaluate ISR concepts & protocols to ensure scientific rigor and alignment with Medical Affairs strategy., • Additional responsibilities as assigned in Medical Strategy.What Knowledge & Experience you'll bring to us..., • Advanced degree in life sciences (PharmD, PhD, Doctor of Nursing Practice, or MD), • 5+ years minimum experience in biotech and/or pharmaceutical industry, • An equivalent combination of education and experience may be considered, • Experience writing, developing peer-reviewed scientific publications required; CMPP preferred, • Understanding of publication best practices, GPP/ICMJE guidelines, and regulatory-compliant scientific communication., • Oncology experience required; NSCLC experience preferred., • Experience conducting gap assessments and executing evidence generation plans including the developing and running of medical affairs company sponsored studies, such as EAP and ISRs, • Experience managing agencies and/or vendors., • Excellent verbal, written, and presentation skills with the ability to effectively communicate complex scientific data to diverse audiences, • Works independently. Thrives in a fast-paced, dynamic environment and can manage multiple priorities at one time with little direction, • Ability to travel to Nuvation Bio Headquarters and professional congresses as appropriate (~25%)Behavioral skills to be successful..., • Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges., • Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives., • Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource., • Emotional intelligence, curiosity, and a knack to figure out a way to build something better, • Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders., • Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity., • Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.What we have for you!, • Competitive Base Salary, Bonus, and Equity Plans, • Unlimited Vacation and 10 Sick Days Annually, • Excellent Medical, Dental, and Vision Coverage, • 401K with Company Matching Disclaimer Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law. This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.

Job DescriptionMandatory Requirements • Minimum bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field from an accredited institution. Master’s degree preferred., • 4–8 years of analytical experience (preferably at least 3 years in analytical quality assurance)., • Proficient in Microsoft Office and quality applications/software programs., • Strong knowledge and experience with analytical laboratory activities for APIs and drug products, including analytical development and Quality Control (QC)., • Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and USP monograph requirements., • Understanding of laboratory equipment operation, qualification, calibration, and software audit trail review (e.g., HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers)., • Knowledge of FDA and ICH guidance requirements., • Effective interpersonal skills and ability to work in a team environment., • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products., • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) during routine laboratory operations., • Confirm compliance of method validations, verifications, comparison reports, and other study reports., • Prepare and review laboratory investigations (OOS/OOT/Deviations) and ensure compliance., • Verify laboratory chemicals, reagents, and standards for completeness of labeling per SOPs., • Assess and implement Pharmacopoeia changes (editions, supplements, amendments) as they become effective., • Review laboratory audit trails during data review against SOPs., • Coordinate with analytical laboratory teams to provide required documents to cross-functional teams., • Maintain incoming documents with proper tracking, recording, storage, and archival., • Identify system gaps during routine monitoring and report improvement opportunities to the supervisor., • Participate in review of data related to laboratory investigations and incidents to ensure compliance., • Operation, qualification, and calibration of laboratory equipment and software audit trail review., • Experience with HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meters, stability chambers, etc., • Knowledge of USP monograph requirements, FDA, and ICH guidance., • Strong documentation and technical writing skills; ability to apply scientific principles and practices., • Ability to work independently and as part of a team in a fast-paced manufacturing environment.Professional and Behavioral Competencies, • Proficient English communication skills (verbal and written)., • Self-starter with initiative to seek training or direction as needed., • Willingness to work assigned shifts (first or second shift); schedules may be Monday to Friday., • Knowledge of good manufacturing and documentation practices preferred., • Self-motivated, organized, and able to handle multiple tasks simultaneously with attention to detail.

Job DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS degree in a Quality/ Process related field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Quality Systems Training (Deviation/CAPA)Working Environment While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionMandatory Requirements • Minimum bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field from an accredited institution. Master’s degree preferred., • 4–8 years of analytical experience (preferably at least 3 years in analytical quality assurance)., • Proficient in Microsoft Office and quality applications/software programs., • Strong knowledge and experience with analytical laboratory activities for APIs and drug products, including analytical development and Quality Control (QC)., • Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and USP monograph requirements., • Understanding of laboratory equipment operation, qualification, calibration, and software audit trail review (e.g., HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers)., • Knowledge of FDA and ICH guidance requirements., • Effective interpersonal skills and ability to work in a team environment., • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products., • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) during routine laboratory operations., • Confirm compliance of method validations, verifications, comparison reports, and other study reports., • Prepare and review laboratory investigations (OOS/OOT/Deviations) and ensure compliance., • Verify laboratory chemicals, reagents, and standards for completeness of labeling per SOPs., • Assess and implement Pharmacopoeia changes (editions, supplements, amendments) as they become effective., • Review laboratory audit trails during data review against SOPs., • Coordinate with analytical laboratory teams to provide required documents to cross-functional teams., • Maintain incoming documents with proper tracking, recording, storage, and archival., • Identify system gaps during routine monitoring and report improvement opportunities to the supervisor., • Participate in review of data related to laboratory investigations and incidents to ensure compliance., • Support departmental and cross-functional projects and assignments as directed by management.Education and Experience, • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field required; Master’s preferred., • 4–8 years of analytical experience, with preference for 3+ years in analytical quality assurance., • Proficiency with computer systems, Microsoft Office, and quality applications.Technical Knowledge and Computer Systems Skills, • Operation, qualification, and calibration of laboratory equipment and software audit trail review., • Experience with HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meters, stability chambers, etc., • Knowledge of USP monograph requirements, FDA, and ICH guidance., • Strong documentation and technical writing skills; ability to apply scientific principles and practices., • Ability to work independently and as part of a team in a fast-paced manufacturing environment.Professional and Behavioral Competencies, • Proficient English communication skills (verbal and written)., • Self-starter with initiative to seek training or direction as needed., • Willingness to work assigned shifts (first or second shift); schedules may be Monday to Friday., • Knowledge of good manufacturing and documentation practices preferred., • Self-motivated, organized, and able to handle multiple tasks simultaneously with attention to detail.