US Pharma Lab jobs in North Brunswick, NJ - 45 jobs

About the Role Reporting to the Senior Customer Service Manager, the Customer Service Operations Analyst will serve as a key bridge between commercial operations, customer service, supply chain, and data analytics. This role combines order management and 3PL execution with reporting, analytics and dashboards that help Sales and Supply Chain monitor performance and resolve issues quickly. The position requires an understanding of pharmaceutical distribution practices, ERP systems, and analytics tools, along with strong communication and problem-solving skills. Responsibilities Customer Support & Relationship Management Serve as a primary point of contact for customers, wholesalers, distributors, specialty pharmacies, and healthcare providers regarding orders, product availability, shipments, and returns. Maintain strong relationships with customers and internal stakeholders (Sales, Finance, Operations, Regulatory, Quality, and IT). Communicate proactively regarding order status, delays, product allocations, and launch readiness. Manage new customer setup, contract alignment, and master data accuracy within ERP and revenue management systems. Order Management & Fulfillment Process and validate customer purchase orders, ensuring compliance with pricing, contract terms, and company policies. Partner closely with the 3PL provider to monitor order processing, inventory, shipping accuracy, and issue resolution. Coordinate backorders, allocations, and recall activities with Supply Chain and Quality. Maintain audit-ready documentation in compliance with FDA, DEA, DSCSA, and PDMA regulations. Business Analysis & Reporting Develop and maintain operational and performance dashboards for customer service metrics (orders processed, fill rates, service levels, returns, and backorders). Analyze sales order patterns, customer data, and inventory trends to identify opportunities for efficiency and improvements in customer experience. Provide business insights to Sales, Supply Chain, and Finance through data visualization tools (Power BI, Tableau, Excel). Process, Data & Systems Partner with IT and process owners to improve ERP workflows, reduce manual work, and make reporting more reliable. Help keep customer, product, and pricing data accurate across systems so orders, invoices and reports are correct. Support continuous improvement initiatives that enhance accuracy, turnaround time, and compliance. Skills Strong analytical and problem-solving abilities with proficiency in data analysis, reporting, and visualization. Excellent written and verbal communication skills. Exceptional attention to detail and organizational skills. Strong working knowledge of Microsoft Office Suite (Excel, Outlook, Word, PowerPoint). Ability to manage multiple priorities in a fast-paced, regulated environment. Customer-first mindset with an analytical and process-oriented approach. Ability to translate data insights into operational improvements. Collaborative team player who builds strong cross-functional relationships. Requirements Bachelor's degree in Business, Supply Chain Management, Data Analytics, or related field. Minimum of 4-6 years of combined experience in customer service, sales operations, or business analysis within the pharmaceutical, biotech, or healthcare industry. Experience with ERP systems (SAP, Oracle, JD Edwards, or similar) and data visualization/reporting tools (Power BI, Tableau, or Excel). Prior experience collaborating with third-party logistics (3PL) providers strongly preferred. Familiarity with pharmaceutical distribution and compliance regulations (FDA, DEA, DSCSA, PDMA) required. The base salary range for this position is $85,000 - $105,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.

The Executive Administrative Assistant will be part of a fast-paced, growing organization in our Princeton, NJ office. The incumbent will provide personalized and timely support in daily calendar planning, setting up meetings, and travel arrangements for the Head of Rare Disease and key leaders within the Rare Disease leadership team. This role requires someone who can manage multiple tasks, is a quick learner, has agility to respond to new or changing requests, and who has strong people orientation and collaboration skills. Responsibilities Provides daily administrative support and assistance, onsite and virtually to the assigned leaders. Tasks may include calendar planning, setting up meetings, arranging travel, preparing expense reports, capturing and distributing agendas, preparing documents and letters, etc. Performs other office tasks such as maintaining office records, ordering supplies, filing, and receiving/sending out mail. When required, attends meetings to take notes/record minutes and send out summary of key actions to participants. Provides timely administrative support to write emails, format documents, prepare presentations, reports, etc. for assigned leaders. Acts as a point of contact for leaders and prioritizes incoming requests for leaders' time, setting up meetings accordingly. Screens and directs phone calls and distributes office correspondence as required. Serves as the backup to the CEO EA Performs other duties as assigned or requested. Requirements: Excellent verbal and written communication skills with internal and external customers, leveraging strong interpersonal skills Able to effectively interact with all levels of management, associates, and the board Strong organizational skills and attention to detail Excellent time management skills with a proven ability to meet deadlines Agile and able to function well in a high-paced and at times stressful environment, managing multiple projects and sometimes competing priorities Strong problem-solving abilities and ability to work through challenges to deliver results Collaborative and people-oriented; has a customer service orientation High integrity, discretion, and confidentiality Able to work independently with minimal supervision; proactive and self-directed Strong MS Office skills in Word, PowerPoint, and Excel as well as Concur and ADP Workplace preferred. Ability to learn new or updated software Extensive knowledge of office administration and clerical procedures Strong planning and organizational skills Able to type minimum of 50 words per minute 5+ years of experience as an administrative assistant, supporting executive-level clients 1-3 years of experience as an office manager preferred Experience working in a fast-paced environment, adapting to changing needs and supporting multiple partners Experience working in a healthcare or pharmaceutical organization is preferred High school diploma required; Bachelor's degree in Business Administration or related field preferred TRAVEL Very occasional travel may be required, with advance notice Role is located at our Princeton office WORKING CONDITIONS Office environment, with prolonged periods sitting/standing at a desk and working on a computer Must be able to lift up to 15 pounds at times Must be able to be on site in our Princeton, NJ office 3-5 days per week The base salary range for this position is $100,000 - $130,000 ; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our manufacturing facility is located in our Monmouth Junction, NJ headquarters has an immediate need for several TEMPORARY Packaging Technicians/Operators on 1st and 2nd shift. 1st shift is Monday-Thursday, 5:00 AM - 3:00 PM 2nd shift is Monday-Thursday, 3:00 PM - 1:00 AM Summary The Packaging Technician is responsible for supporting and assisting in the packaging of a range of pharmaceutical products in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates and maintains various pharmaceutical packaging equipment as assigned, and thoroughly and accurately documents all activities to ensure compliance with regulatory guidelines. ESSENTIAL FUNCTIONS Primary duties/responsibilities * Supports and assists in the packaging of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications * Performs the day-to-day activities of the packaging process as assigned; Monitors and supports various types of Packaging equipment including, but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. to ensure efficient packaging of goods * Assists in set up, change over and test runs of equipment for various sized batches and various products, as needed * Collaborates with other production staff and departments * Accurately and consistently completes and documents batch records and other required paperwork * Precisely follows work orders and specifications * Adheres to all plant safety policies and procedures Requirements REQUIREMENTS: * Special knowledge or skills needed and/or licenses or certificates required * High school diploma or equivalent and 1 year work experience * Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. * Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment * Ability to adapt to changing priorities and deadlines * Fluent in English (verbal and written) * Ability to identify and distinguish colors * Ability and willingness to work additional hours as required by business needs Special knowledge or skills needed and/or licenses or certificates preferred * Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs * Packaging experience in a pharmaceutical, biotechnology or related highly regulated manufacturing environment * Associates degree or some college coursework Travel requirements 0% Physical requirements * Manufacturing based position * Ability to lift up to 50 lbs * Ability to use Personal Protective Equipment (PPE) * Ability to stand for extended periods Anticipated pay rate: $17-19/hour. Pay rate offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees (does not pertain to temporary employees), are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI

This is a full-time hourly paid position, based onsite out of our **Bridgewater, NJ** location. Our Bridgewater location is the corporate office for Catalent. **The Role:** + Provide administrative support to Corporate Office and U.S. Field Operations + Respond to inquiries in the Corporate/U.S. Field Employee group email box + Establish and maintain effective relationships with the HR team, leaders and employees; foster open communication and support problem-solving initiatives + Manage Kronos data entry and system updates for non-exempt employees + Support all aspects of payroll, including communication with managers/employees, addressing issues, updating/submitting intake sheets, and answering payroll-related questions + Administer employee leaves including STD, LTD, FMLA, state-specific leaves, and parental leave (Catalent & state programs) + Process HRIS (Workday) transactions related to compensation changes, reporting structures, offboarding, leaves, and recruiting to maintain data integrity + Maintain personnel files, medical files, and I-9 documentation in compliance with company and legal standards + Other duties as assigned **The Candidate:** + Associates degree required, with preference to degrees in Human Resources, Business Administration, or related field with minimum two years of HR or administrative experience + Bachelor's degree with combination of HR project work and internship experience, preferred + Proficiency in MS Office Suite, specifically: Excel (advanced skill preferred), PowerPoint, Outlook and Word + Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds **Pay:** **New Jersey Posting** The anticipated salary range for this position in New Jersey is $62,400 - $72,800 plus bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why You Should Join Catalent:** + Defined career path and annual performance review and feedback process + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Generous 401K match + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement WellHub - program to promote overall physical wellness **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

+ **Work Schedule: Monday - Friday, 8:00am-5:00pm.** + **100% on-site** Catalent is a leading global CDMO, trusted by pharma, biotech and self-care companies to accelerate the development, manufacturing and delivery of products that improve lives. With advanced technologies, deep expertise and a worldwide network, we partner with innovators to transform bold ideas into life-changing therapies and self-care solutions. Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent's cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium. The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production. The Senior Specialist, Quality Operations candidate provides Quality advanced oversight and guidance for all programs in support of GMP Manufacturing of Cell Therapy products at our US Cell Therapy facility located in Princeton, NJ. In this role, you'll lead the development and management of Quality Systems, ensure compliance with regulations, and support audits and inspections. You'll serve as the dedicated Client QA Representative, partnering with cross-functional teams-Manufacturing, Process Development, Technology Transfer, and more-to maintain site compliance and drive continuous improvement. The Senior Specialist, Quality Operations will report to the Director, Quality. **The Role:** + Provide advanced QA oversight for GMP documentation, batch record review, and compliance activities. + Lead development and management of Quality Systems, including change control, risk management, and supplier qualification. + Support and manage investigations (OOS, deviations), CAPAs, and engineering change requests. + Review and approve validation protocols, COAs/COCs, calibration, and maintenance records for completeness. + Compile, track, and present quality metrics for batch release, client projects, and site compliance programs. + Drive process improvements to reduce defects, improve turnaround times, and ensure timely batch disposition. + Serve as dedicated QA liaison for client projects from initiation through closure, including audits and meetings. + Coordinate and facilitate risk assessments, maintain site risk register, and report to leadership. + Author, review, and revise SOPs; conduct internal audits; and support external audits and inspections. + Train new QA staff and contribute to Management Reviews and Annual Product Reviews. + Other duties as assigned. **The Candidate:** + Bachelor of Science degree required, preferably in a Life Sciences discipline; Master of Science degree preferred. + Minimum of 7 years' experience within the biologic, biopharmaceutical, or regulated industry. + Experience performing cGMP internal audits and/or supplier audits. Auditor certification (CQA or equivalent) is a plus. + Cross-site, inter and intra departmental project management experience and experience with electronic document management systems desired. + Proficient in GMP regulations, batch record review, and batch disposition processes, with ability to apply scientific and regulatory principles to resolve operational and quality challenges. + Experience with Risk Management and Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. + Proficient with biological manufacturing processes including cell banking, microbial/cell culture, fermentation, purification, and fill/finish. + Strong communication skills (verbal, written, oral), proven ability to work independently and collaboratively, prioritize tasks, and apply problem-solving skills in a fast-paced GMP environment. The anticipated salary range for this position in New Jersey is $110,000 - $125,000 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should Join Catalent:** + Defined career path and annual performance review and feedback process. + Diverse, inclusive culture. + Potential for career growth on an expanding team. + Cross-functional exposure to other areas within the organization. + 152 hours of paid time off annually + 8 paid holidays. + Medical, dental, vision and 401K benefits effective day one of employment. + Tuition Reimbursement. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. We have an opening in our Monmouth Junction, NJ facility for a Manager, Accounting. This position works closely with Accounting Senior Management to assist and support in ensuring company financial records remain accurate while meeting reporting deadlines. The incumbent establishes and approves internal controls and guidelines for preparing transactions complying with Generally Accepted Accounting Principles (GAAP). She/he also oversees the monthly financial reporting process. ESSENTIAL FUNCTIONS Prepares and/or reviews appropriate general ledger entries and account reconciliations Manages company's financial accounts, internal controls, payrolls, cash receipts and financial assets for timeliness, compliance and accuracy Prepares monthly, quarterly and annual consolidated financial statements; Assists with regulatory reporting, as applicable Researches and corrects accounting issues for compliance with GAAP and other appropriate regulations; Proactively reports issues to upper management for resolution, as necessary Coordinates and participates in internal and external audits, as needed Participates in interviewing and training new employees and mentors Accounting team members, as needed Requirements REQUIREMENTS Certified Public Accountant (CPA) OR in process of obtaining CPA with Bachelors degree in Accounting and a minimum 6 years experience in public industry or corporate accounting REQUIRED. Accounting experience in the pharmaceutical or biotechnology industry PREFERRED Hands on knowledge of GAAP rules and regulations REQUIRED Current, hands-on experience performing general accounting functions (i.e., general ledger, reconciliations, monthly/quarterly/annual financial statements, payroll, etc.) REQUIRED Experience working with external auditors REQUIRED Strong record keeping ability REQUIRED Work Arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office. Anticipated salary range: $120,000 to $145,000/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid

About Us Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally. Job Summary The Medical Science Liaison will serve as a liaison to the medical/scientific community and will be responsible for establishing, developing, and maintaining relationships with medical experts in the Retina and/ or Ophthalmology Division nationwide. Position Responsibilities Ensure the appropriate dissemination of clinical and scientific information regarding marketed and pipeline compounds in a timely, ethical, and customer-focused manner Implement clinical and educational strategies in collaboration with other ANI colleagues for designated customers that include potential clinical trial site placement and sponsorships Work to pair our key scientific leaders educational and research needs with available ANI resources and will provide the latest emerging data in response to specific healthcare professional inquiries Present healthcare professionals and decision makers with accurate, unbiased, balanced, and timely answers to unsolicited requests for information about ANI products Establish scientific and clinical relationships with key opinion leaders and academic centers to expand research and educational opportunities for ANI products Provide study support from protocol and budget development to submission and completion for Phase IV as well as Investigator Initiated Trials (IIT's) Document and forward reports of adverse events to appropriate ANI personnel Keep abreast of medical and scientific developments in assigned therapeutic area Proactively report competitive activities as well as events that can influence the use of ANI products Develop and deliver very specialized scientific/educational programs including but not limited to formulary presentations for managed care and related organizations Assist Medical and Scientific Affairs as well as agency personnel in the development of presentations and slide kits Actively participate in advisory boards, speaker training events, clinical investigator meetings, regional national and international meetings when required Assist in processing of field request for medical education funding Actively participate in key medical and scientific conferences by staffing medical information booths; gathering competitive intelligence on competitors and attending scientific sessions Represents the organization as a prime field medical contact Skills / Competencies Excellent presentation skills as well as the ability to successfully interact with medical professionals at all levels Working knowledge of FDA and OIG requirements as well as clinical trial design and statistics is required Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is preferred Strong interpersonal communication and presentation skills are required Ability to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through on requests from key experts in the scientific community Strong communication skills; must be able to provide succinct, strategic, and actionable insights to senior management A proactive self-starter who can lead work and manage others independently, with the ability to see the next step and take action without prompting Thorough understanding of the healthcare environment including all external stakeholders Ability to work effectively in a fast paced, rapidly changing and expanding environment Outstanding work ethic and integrity, including high ethical and scientific standards Deals with scientific concepts and complexity with confidence Ability to manage multiple priorities and manage time efficiently Work is primarily independent in that it is performed without appreciable day-to-day direction. Completed work is reviewed from a relatively long-term perspective for desired results against objectives Requirements The qualified candidate will have an advanced degree in a health-sciences related field such as a PharmD, MD, PhD 2+ years prior Field Medical position within the pharmaceutical industry Previous experience in Retina/ Ophthalmology strongly preferred Willingness to travel 60 % or more of the time Extensive travel is integral to the performance of this position The base salary range for this position is $165,000 - $220,000 ; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term incentive program based on performance and company results. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company. #LI-REMOTE

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our Facilities-Manufacturing Maintenance Department is growing, and we have openings for Manufacturing Maintenance Mechanics at various levels, requiring various levels of experience, at our Monmouth Junction, NJ facility. Hours: Monday-Friday, 7:00 AM - 3:30 PM Title and salary commensurate with experience. (See below) The Manufacturing Maintenance Mechanics are responsible for Maintenance and Operations support, including but not limited to: maintenance, troubleshooting, repair and upgrade of Facilities and Production equipment in order to meet customer requirements including deadlines and quality in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) standards. Essential Functions/Duties & Responsibilities: Responsible for all aspects of Facilities and Production equipment maintenance while complying with cGMPs, SOPs and FDA requirements Performs routine and complex work related to the troubleshooting, repair and upgrade of manufacturing equipment; Responsible for preventive maintenance (PM), repair and continuous improvement of facilities and manufacturing equipment Assists in performing Root Cause Analysis on equipment failures to support investigations Precisely follows work orders and specifications Adheres to all plant safety policies and procedures Higher level Mechanics: Trains new employees and mentors lower-level mechanics, as appropriate Assists in maintaining a safe and clean work environment by educating and directing personnel on the use of all control points, equipment and resources; Maintains compliance with established policies and procedures Requirements Requirements Minimum education and years of relevant work experience Mechanic I: High school diploma or equivalent AND minimum 3 years experience as a maintenance/mechanic or related specialty working in a cGMP regulated environment in a pharmaceutical or biotechnology facilities, consumer products, packaging and/or manufacturing department(s) Mechanic II: High school diploma or equivalent AND minimum 5 years experience as a maintenance/mechanic or related specialty working in a cGMP regulated environment in a pharmaceutical or biotechnology facilities, consumer products, packaging and/or manufacturing department(s) Mechanic III - High school diploma or equivalent AND minimum 7 years experience as a maintenance/mechanic or related specialty working in a cGMP regulated environment in a pharmaceutical or biotechnology facilities, consumer products, packaging and/or manufacturing department(s) Special knowledge or skills needed and/or licenses or certificates REQUIRED Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs Hands on, working knowledge of Facilities and Production equipment and Production processes Hands on, working knowledge of electrical, pneumatic and hydraulic systems Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. Excellent verbal and written communication and skills Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects Fluent in English (verbal and written) Some college and/ or trade school certification in machining, welding and/or metal fabrication Physical requirements Manufacturing based position Ability to lift up to 50 lbs Ability to use Personal Protective Equipment (PPE) Ability to stand for extended periods Anticipated salary range: $38/hr - $50/hr. Pay rate to be offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another. We believe in each other and in respectful, open and honest communications to help support individual and team success. We have an immediate opening at our Monmouth Junction, NJ offices for a Legal Counsel to join our small in-house Legal team. This role plays a crucial role in providing comprehensive legal guidance across business departments/functions and various aspects of business operations. Reporting directly to the Senior Vice President (SVP)/General Counsel Chief Compliance Officer (CCO), the incumbent serves as a cross-functional subject matter expert (SME), supporting Senior Leadership in strategic and risk aware decision-making, as well as ensuring compliance with regulatory requirements and company Standard Operating Procedures (SOPs), as appropriate. ESSENTIAL FUNCTIONS Primary duties/responsibilities * Reviews, negotiates and drafts a diverse array of commercial contracts (i.e., licensing, co-development, manufacturing and supply, distribution agreements, clinical trial, partnership agreements, etc.); Collaborates closely with internal stakeholders to gather specifications and key business terms necessary for effective contract negotiations * Provides strategic legal advice on a wide range of legal issues, analyzing legal risks associated with business transactions, clinical research activities and product commercialization; Offers guidance on matters subject to disputes and ensures alignment with corporate objectives * Supports contract management by developing and maintaining contract templates to streamline contracting process, enhancing efficiency and consistency in contract administration; Successfully collaborates with external customers and internal clients regarding contract development, negotiations and disputes * Supports regulatory submissions and communications with various regulatory authorities (i.e., FDA), new product launches, pricing/rebate analysis, drug price reporting, reimbursement activities and commercial/research publications (i.e., healthcare economic material, etc.) * Stays current on laws and regulations impacting the pharmaceutical and healthcare industries, advises on legal rights under contracts, compliance requirements and regulatory submissions, as needed; Collaborates with internal stakeholders to ensure adherence to local, state and federal laws and regulations * Develops and administers training programs to internal clients on transactional and regulatory matters and industry best practices empowering stakeholders with knowledge and skills necessary to effectively navigate legal issues * Collaborates with internal departments including, but not limited to: Commercial, Finance, Human Resources (HR), Regulatory Affairs and Compliance, to provide legal guidance and support on laws, regulations, standard operating procedures and company policies affecting business; Works closely with outside counsel, as needed * Proactively assesses legal risks and provides guidance to executive leadership and business teams, contributing to informed decision-making and mitigating potential liabilities; Independently creates legal documents for departmental and internal client use Requirements Minimum education and years of relevant work experience Juris Doctor (JD) degree from accredited law school, including bar admission within one or more U.S. state(s) and minimum 5 years legal experience in the pharmaceutical, biotechnology or related industry in positions of increasing strategic and leadership responsibility REQUIRED * Excellent understanding and experience working with transactions, laws and regulations associated with development, manufacture, marketing and sale of pharmaceutical products REQUIRED * Current, hands-on experience drafting, reviewing, negotiating, and executing a wide variety of transactional and legal documents (i.e., master services agreements, confidentiality agreements, drug distribution, supply, commercial agreements, market access, clinical trials, pricing and reimbursement, etc.) REQUIRED * Strong working knowledge of, and/or direct exposure to, pharmaceutical business functions such as Compliance, Regulatory Affairs, Government Affairs, Commercial Operations, HR and Finance REQUIRED * Ability to influence without direct authority REQUIRED Work Arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office. Non-local candidates must be able to come into office multiple times a month. Anticipated salary range: $155 to $185K/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid

Catalent Pharma and Consumer Health (PCH) is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help patients and consumers receive better treatments and products. The business includes Softgel, Liquid Filled Hard Shell, Liquid in Bottle, Zydis ODT, and various Solid Dose technologies and products including Rx, Gx, OTC, VMS, and Topicals or Topical Skin Care. Working for Catalent PCH is an opportunity to join a diverse and experienced team helping to improve future patient outcomes by working on prescription products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's along with some of the leading Consumer products in world including pain therapies, cough and cold, and other such essential Vitamins, and Cosmetics in patient friendly dosage forms. The Business Development Specialist is expected to support the Region's growth by collaborating with internal and external stakeholders to expedite the achievement of the Region's goals and objectives, focusing on identifying key business targets and expanding the customer base. The Business Development Specialist (BDS) will report to the Regional Director of Business Development. In this role, this individual will assist in prospecting with regional sales team members with new business opportunities that align with Catalent's strategic goals, participate in onsite (in factory) and customer face-to-face meetings with the regional individual sales team members, support the progress and enact actions within the Regional territory plans prepared by the regional sales team members. **The Role:** + Identify and engage potential clients through cold calling, networking, and industry research. + Support Regional sales team members in developing and executing sales strategies. + Collaborate with seasoned colleagues to transfer opportunities seamlessly and ensure a smooth sales process. + Present and promote CDMO services to prospective clients, highlighting key benefits. + Assist in contract negotiations and closing deals under guidance from senior team members. + Utilize and maintain accurate CRM (Customer Relationship Management) system to track and manage customer interactions, update contact information, and monitor progress on leads and opportunities. Provide regular follow-up reporting on sales activities, including pipeline updates, lead conversion rates, and sales forecasts. + Stay informed about industry trends, competitor activities, and market developments. + Other duties as assigned. **The Candidate:** + Bachelor's degree in science, business administration or another related field preferred; Advanced scientific degree and/or Master of Business Administration / commercially orientated degree is advantageous but not essential. + 0-3 years of relevant experience in B2B sales, Business Development, Project Management, or another customer-facing role. Previous experience with Catalent preferred. Pharma or Consumer Health industry experience preferred. + Sales/business development experience in the contract pharmaceutical industry preferred. + Hunting mentality mandatory. + Demonstrate willingness to learn new methods and partner with other BD team members to learn basics of selling. + Eagerness to learn and develop expertise in CDMO sales. + The ability and willingness to travel up to 75% of the time to meet with clients and attend industry events. + Excellent communication in English plus local language of territory (if applicable) and interpersonal skills, with the ability to build rapport and establish trust with potential clients. **Pay:** The annual pay range for this position in New Jersey is $76,000 - $110,000 The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Join a high growth and fast paced organization with a people focused culture + Global exposure, defined career path and annual performance review and feedback process + Competitive Medical, Dental, Vision and 401K + 19 days PTO & 8 paid holidays **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

This role will report into the Commercial Acute Care team at ANI and requires a mix of strategic agility, business acumen, leadership, management of projects and an ability to work collaboratively with multiple stakeholders. We are seeking seasoned strategic commercial leaders, with strong business acumen skills, executive presence, and who are passionate about people development and deeply motivated by the quest of delivering value to patients and their families. The ideal candidate will have sales leadership experience in (at least) one of the following practice areas: Primary Care, Family Practice, General Practice, Internal Medicine, Podiatry, and Orthopedic. Experience building a team to launch a drug in a competitive space with a track record of market growth is desired. Reporting to the VP Sales Acute Care, the Area Business Director (ABD) will be a key member of the Sales Leadership Team accountable for Purified Cortrophin Gel sales performance through their development and leadership of a high-performance team that consistently delivers results. This role will require appropriate coordination across our patient HUB, Market Access, Training, Business Operations, Legal and Compliance teams. He/she will foster a culture of accountability and lead a sales team to meet or exceed targets. Skills required include developing Account Specialists to ensure best in class account management, while demonstrating organizational, analytical, and problem-solving expertise. ABDs must be flexible, and adaptable with sensitivity to the potential constraints of a commercial start-up. Candidates will be goal-oriented and accountable for their individual and area performance, while acting in a professional and compliant manner. Position Responsibilities Hire, lead and retain a team of Account Specialists rooted in strategy and accountability to ensure the team meets or exceeds sales forecasts while following all compliance expectations. Work with VP of Sales to develop regional and territory business plans based on revenue goals, marketing plans, and required competencies and capabilities. Review and analyze Area performance metrics to identify trends and opportunities to improve performance. Partner with the Field Operations team responsible for establishing the call plan, targets, incentives, collecting data, and measuring performance. Collaborate with US Marketing, Channel and Reimbursement, Patient Support Services, Business Operations, Medical Affairs, Legal, Compliance and other internal stakeholders to support the field with appropriate materials and programs; monitor progress and drive course correction where necessary. Conduct field visits, regional team meetings to align teams, ensure direct reports understand product and unique market landscape to meet or exceed targets as well as monitor execution, identify issues/opportunities and define new actions. Bring key competitive intelligence and work closely with the Marketing team to develop relevant insights and market solutions; help define sales excellence metrics and monthly dashboards. Lead and support in National and regional conferences/exhibits. Collaborate with Legal, Regulatory, Compliance and other internal stakeholders to ensure tactics and operations are executed with the highest standards of integrity and compliance. Performs other duties as assigned or requested. Qualifications/Requirements Bachelor's degree required; Advanced degree in business or science preferred 10+ years of demonstrated success in primary or specialty pharmaceutical sales, with a minimum of 3 years in a people leadership role required Experience in Podiatry and Specialty Care strongly preferred Understanding and experience working with in-house patient support services required Understanding and experience working with drugs requiring prior authorization or specialty pharmacy required Understanding of patient services and specialty channel distribution preferred Familiarity with relevant legal and regulatory pharmaceutical industry requirements Experience leading and executing Area-level business planning activities Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual) Must reside within the geography and have the ability to manage a multi-state territory with diverse customer base Driver's license required; Overnight travel is required and will range from 50%- 85% depending on the geography and business needs of the individual territory. The base salary range for this position is $180,000 - $220,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term and long term incentive program based on performance and company results. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. We have an opening in our Monmouth Junction NJ facility for an experienced Network Engineer. The incumbent is a hands-on, internal user-focused member of our IT department responding in a timely fashion to internal queries and concerns, investigating and resolving IT problems, documenting all issues and escalating appropriate situations to IT management as needed. ESSENTIAL FUNCTIONS Primary duties/responsibilities * Designs/Implements/Maintains existing Network Infrastructure * Redesign existing Network Infrastructure based on current best practices * Creates Technical Documentation as needed for the environment * Monitors Network performance to determine if adjustments need to be made * Maintains network infrastructure backups * Replace faulty network hardware components when required * Maintain, configure, and monitor EndPoint Security/Virus & malware protection * Writes training documentation as needed * Follows best practices for System Development Life Cycle (SDLC) * Decommissions systems * Manages Cisco Networking Infrastructure, which includes Network Switches and Firewalls. Creates rules and DMZs, as needed * Manages Wireless Networks and identifies network issues and create solutions * Creates and modifies network documentation utilizing Microsoft Visio * Uses RADIUS, specifically Microsoft NPS, to create rules and troubleshoot network issues * Manages DHCP, DNS, Networking, Firewalls (software and hardware), as needed * Creates dashboards for monitoring Requirements KNOWLEDGE/SKILLS/ABILITIES REQUIRED Bachelors degree in Computer Science or IT Infrastructure degree and minimum 2 years related experience in an IT business environment, preferably pharmaceutical or biotechnology OR combination education and minimum 6 years' relevant experience as a Network Engineer in an IT business environment, preferably pharmaceutical or biotechnology. * Experience with Endpoint Security REQUIRED * Experience with Microsoft Server and Desktops, preferably Windows 10 and Windows Server 2019 and above REQUIRED * Strong understanding and working knowledge of Office365 REQUIRED * Strong working knowledge of Cisco IOS and routing protocols REQUIRED * Strong working knowledge of VMWare REQUIRED * Strong working knowledge of EMC storage REQUIRED Work Arrangements: This position has some hybrid potential but requires selected candidate to be in office majority of the week. Anticipated salary range: $150 to $180k/year. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our Product Development laboratory, located in our Monmouth Junction, NJ headquarters is growing, and has positions open for experienced PD Senior Scientists I and II. Title and salary commensurate with experience. (See below) Summary The Product Development (PD) Senior Scientist, under minimal guidance, designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials of complex projects using risk-based approach. The incumbent plans, coordinates and executes current Good Manufacturing Practices (cGMPs) pilot and pivotal/submission batches, including all required documentation. She/he prepares technical and product development reports and regulatory submission document and performs critical analysis. The incumbent collaborates closely with other functions within and outside Research and Development (R&D) to ensure project timelines are met. She/he also trains new employees and mentors lower level scientists, as appropriate. ESSENTIAL FUNCTIONS Primary duties/responsibilities * Carries out responsibilities in accordance with the organization's policies, Standard Operating Procedures (SOPs), and state, federal and local laws * Designs, plans and conducts product development activities, including pre-formulation, formulation, process development and scale up studies of complex projects to ensure good scientific standards are met * Documents all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (cGDP) and cGMP; Summarizes data, discusses results and makes conclusions in technical reports; Meets project deadlines and performance standards, as assigned * Creates invention disclosures; Collaborates with internal and external counsel to perform patent landscape analysis, draft patent applications, and respond to office actions * Utilizes risk-based approaches and Quality by Design (QbD) principles in guiding pharmaceutical development and identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) and control strategies. Uses problem solving tools to trouble shoot, as needed * Designs and conducts physical and chemical characterization in liaison with analytical teams * Performs critical data analysis using statistical tools including stability analysis * Plans, coordinates and manufactures cGMP pilot and pivotal batches, including drafting of protocols, master batch records and reports * Liaises, coordinates and manages PD activities with external labs, Clinical Research Organizations (CROs) and Clinical Development Manufacturing Organizations (CDMOs), including cGMP manufacturing activities; Collaborates closely with other functions within and outside R&D to ensure project timelines are met * Presents and updates project status and issues/challenges to management * Supports technical services and operations to trouble-shoot scale up and commercial processes * Collaborates with, and assists, Regulatory Affairs with coordination and submission of pivotal batches to CROs * Ensures cleanliness and functioning of PD areas and proper maintenance of equipment and instruments; Supports review of qualification documents for process equipment * Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports * Creates and revises PD Standard Operating Procedures (SOPs), as needed * Collaborates with Quality Assurance (QA) department on investigations, Corrective Action Preventive Action (CAPAs) and changes controls, as needed; Supports Technical Services and Operations departments to troubleshoot scale up and commercial processes * Participates in training of new employees and mentors lower level scientists Requirements KNOWLEDGE/SKILLS/ABILITIES REQUIRED Minimum education and years of relevant work experience PD Senior Scientist I: Bachelors degree in Pharmaceutical Science or related scientific field and minimum 10 years experience in pharmaceutical formulation and product development OR Masters degree in Pharmaceutical Science or related scientific field and minimum 8 years experience in pharmaceutical formulation and product development. OR PhD in Pharmaceutical Science or related scientific field and minimum 3 years experience in pharmaceutical formulation and product development PD Senior Scientist II: Bachelors degree in Pharmaceutical Science or related scientific field and minimum 15 years experience in pharmaceutical formulation and product development OR Masters degree in Pharmaceutical Science or related scientific field and minimum 12 years experience in pharmaceutical formulation and product development OR PhD in Pharmaceutical Science or related scientific field and minimum 7 years experience in pharmaceutical formulation and product development. Special knowledge or skills needed and/or licenses or certificates required * In depth experience designing and conducting oral controlled release solids and liquids pharmaceutical formulation and process development studies with high scientific standard of multiple dosage forms * Working knowledge of QbD and risk-based approaches * Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines * Strong technical writing skills and experience (i.e., SOPs, investigations, protocols, reports, submission documents, etc.) * Proficiency with Microsoft Office * Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members * Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines * Planning, organization and time management skills including the ability to support and prioritize multiple projects * Fluent in English (verbal and written) * Ability to distinguish colors Anticipated salary range PD Senior Scientist I: $100k-125k/yr. Anticipated salary range PD Senior Scientist II: $120k-150k/year Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

About the Role The Associate Director Commercial Training - Rare Disease leads the strategic development and execution of training programs for a highly specialized sales force. This role ensures field teams are equipped to navigate the clinical complexities of selling in the rare disease space. The Associate Director collaborates across Sales, Marketing, Medical Affairs, Market Access, and Patient Services to design and deliver impactful training aligned with brand strategy and patient-centric engagement. Experience in Rare Disease is required with preferred experience in Ophthalmology. Responsibilities Lead the Rare Disease Training curriculum, for both in-line and launch/expansion products Partner with the Training team, stakeholders, collaborative business partners to ensure training programs/content supports entire Training department and organizational goals Oversee the design and delivery of comprehensive programs (e.g., onboarding, launch readiness, advanced scientific selling, NSM/POA workshops) through strong partnership with Medical, Legal, and Regulatory to ensure all training content meets compliance standards Direct and lead agency partners in development of training programs/materials while remaining within budget Plan and execute leadership meetings that support meaningful business objectives and team building Lead Field Trainer Team through execution of new hire training sessions and participation in national meetings Be viewed as a strategic partner for Field Sales through participation in sales meetings and occasional field rides Skills / Competencies Strategic thinker, problem solver Excellent written, oral presentation, and interpersonal skills Strong leadership, organizational, collaboration skills Exceptional problem-solving skills and ability to identify new approaches Expertise with technology platforms and programs (e.g. MS PowerPoint, MS Word, MS Excel, Learning Management Systems, Veeva) is highly desirable Qualifications/Requirements: Requires minimum of a Bachelor's Degree; Master's Degree preferred 10+ years of biotech industry experience required Training, Marketing or other role outside of Sales in the pharma/biotech industry required Experience in Rare Disease required with preferred experience in Ophthalmology Excellent level of professionalism and the ability to lead in a cross-functional environment Ability to collaborate with internal and external stakeholders at various levels Experience developing training tools that enable the enhancement of clinical and business acumen is required Knowledge of adult learning principles is required Knowledge of training design concepts and platforms is a plus The ability and willingness to travel domestically as required up to 30%; some nights, weekends and overnight travel may be required to attend meetings, field rides, and congresses. The base salary for his position is $175,000-$210,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term and long term incentive program based on performance and company results.

**Senior Contract Specialist** **This is a full-time salaried position, onsite expectations our of Tampa, FL or Bridgewater, NJ.** **The Senior Contract Specialist** serves as a business partner to our Business Development and Legal organizations. **The Senior Contract Specialist** will support the development and execution of contracts with new and existing customers ensuring Catalent has strong, profitable contracts with business terms that align with guidelines and represent a win-win for Catalent and our customers. The **Senior Contract Specialist** is also accountable for organizing internal stakeholders, subject matter experts, Legal and supporting functions across the global Catalent organization to provide for long-term sustainable contracts. **The Role:** + Negotiate contracts in partnership with Business Development, Legal and other functional leads to achieve timely deal closure and growth expectations + Mitigates risk through understanding of proposed terms and conditions and develops recommendations for contract language to meet business needs + Identify and communicate risk areas throughout the negotiation contract lifecycle and the renewal process. Escalate issues appropriately + Drive compliance with Legal, organizational and departmental policies and procedures with adherence to processes and business rules + Experience leading contract negotiations and drafting contracts + Demonstrated knowledge of contract terms and terminology enabling a comprehensive review and commentary of business contracts + Other duties as assigned **The Candidate:** + Bachelor's degree, required + Minimum of five years of contracting and negotiating experience, with relevant experience in the Pharmaceutical, Biotechnology or Consumer Health industries + Experience leading contract negotiations and drafting contracts + Demonstrated knowledge of contract terms and terminology enabling a comprehensive review and commentary of business contracts + Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds **Pay:** **New Jersey Posting** The anticipated salary range for this position in **New Jersey** is **$100,000 - $130,000** , plus bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why You Should Join Catalent:** + Defined career path and annual performance review and feedback process + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Generous 401K match + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

About Us Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally. At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential. About the Role The Associate Director of Marketing Operations will support the commercial organization by ensuring the effective execution of customer and field-facing initiatives. This role oversees various functions within Commercial, including the Medical Legal Regulatory (MLR) review process, Speaker Programs, Employee Points Program, and the distribution of sales materials. Responsibilities Collaboration: Work closely with marketing, sales, IT, and other cross-functional partners to develop strategy, coordinate activities, and plan for performance measurement associated with marketing operations functions Collaborate within the Commercial Operations team to convey to Commercial team and executive leadership holistic, actionable learnings Medical Legal Regulatory Review: Oversee the MLR (Medical, Legal, and Regulatory) review process across multiple brands, ensuring consistency and efficiency within Veeva Vault PromoMats as the centralized platform for managing promotional materials. Responsible for maintaining and improving MLR review process in collaboration with commercial, medical, regulatory, legal, and vendor management partners to support MLR activities across various brands. This includes scaling the process to support additional brands as needed. Lead and manage MLR meetings involving cross-functional teams from multiple brands, partnering with vendor coordinators to build and manage meeting agendas. Facilitate meetings, ensuring that MLR reviewer comments and job requirements are thoroughly documented, and ensure continuous improvement of the review process. Champion best practices and ensure adherence to Standard Operating Procedures (SOPs) across all brands. Incorporate insights from various brand teams to help develop high-quality jobs, ensuring all materials align with company policies and guidance. Provide guidance and training as needed to all MLR participants. Manage MLR coordinator for support SOWs and budgets ensuring cost efficiency and quality of support. Speaker Bureau Management: Speaker programs will be managed in Veeva Events Management system Accountable for operational and technology support for field-based Speaker Programs Effectively manage multiple external vendor/partner relationships to ensure high quality services, the utmost compliance with the company and industry policies, practices and regulations, and seamless integration with internal processes and teams Responsible for the effective planning and execution of P2P programs to support best-in-class HCP customer engagement. Conducts or coordinates appropriate analysis to support recommendations and to further enhance P2P knowledge and expertise. Samples Distribution: Design and implement a direct to practitioner (DTP) sampling program. Collaborate and manage internal business partner expectations and distribution requests. Ensure seamless execution of the samples distribution process, Acknowledgement of Contents (AOC) process and annual reporting requirements. Manage the samples distribution inventory and budgets. Literature Distribution: Oversee and manage promotional material literature warehouse and distribution vendor. Collaborate and manage internal business partner expectations and distribution requests, including marketing and sales training. Ensure seamless execution of the distribution process, including daily order requests, National Sales Meetings and conference orders. Manage the distribution budgets. Employee Points Program: Supervise and administer the Employee Points Program vendor including providing reports as needed. Oversee the allocation and distribution of points. Manage budgets related to points distribution. Train new hires about the process and maintain training documentation. Identify new ways to improve the points program and more engaging to build the culture of ANI thru employee recognition in collaboration with leadership and other partners. Skills Thrive in a fast-paced, dynamic environment with minimal supervision. Adapt well under pressure and maintain flexibility in changing situations. Strong collaboration and teamwork skills. Experience with Veeva Vault PromoMats required; Veeva Events Management preferred. Proficient in business productivity software, including Teams, Excel, Word, and PowerPoint. Curious and open to new insight methodologies, with a drive to expand tools to better support the business. Strong strategic thinking paired with excellent tactical execution. Analytical mindset, intellectual curiosity, business acumen, and creative problem-solving skills. Ability to communicate and present effectively, both verbally and in writing, across all organizational levels, from Product Managers to Senior Executives. Demonstrated success as a high performer and thought leader. Strong organizational and prioritization skills to meet established deadlines efficiently. Requirements: Typically requires a bachelor's degree in a related field 3-5 years of relevant commercial / marketing operations experience. Minimal periodic travel required for role The base salary range for this position is $145K-175K; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term (and long term) incentive program based on performance and company results. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our AR&D lab is located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced TEMPORARY Analytical Research and Development Scientist III. This is a temp to possible permanent position. Summary The Analytical Research and Development (ARD) Scientist III, under guidance, performs laboratory analyses of raw materials, in process (IP), finished product (FP) and stability (ST) samples, as well as maintenance and calibration of analytical instruments. The incumbent also executes physical characterization studies to facilitate product understanding and performs technical and specialized analytical tasks, conducts research on assigned problems and studies to support product development, method development and technical investigations. She/he supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations. The incumbent also assists and trains lower-level scientists. ESSENTIAL FUNCTIONS Primary duties/responsibilities · Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs), and state, federal and local laws · Sets up and operates analytical instruments (i.e., High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet Visible spectroscopy (UV/Vis), Infra-Red Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, Inductively Coupled Plasma Mass spectrometry (ICP-MS), dissolution apparatus, etc.) to support sample testing · Performs all laboratory analyses of raw materials, IP, FP and ST samples; Prepares standard and sample solutions as required by the test methods. · Performs wet chemistry tests such as Limit of Detection (LOD), pH and titration · Performs physical tests and studies (i.e., particle size, viscosity, density, rheological measurements, microscopies and thermal analysis) · Performs all necessary calculations associated with test analyses · Designs and executes pre-formulation studies (i.e., pH solubility, pH stability and excipients compatibility studies) in collaboration with Product Development (PD) department · Executes designed studies to support laboratory investigations · Performs non-routine testing such as method comparisons and evaluations · Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs) · Assists and trains lower-level scientists · Creates and reviews ARD SOPs as needed · Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and Good Manufacturing Practices (cGMPs) · Cleans and organizes ARD lab areas · Performs related duties, as assigned Requirements Requirements KNOWLEDGE/SKILLS/ABILITIES REQUIRED Minimum education and years of relevant work experience Bachelor's degree in Chemistry or related science field and minimum 8 years' experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR Master's degree in Chemistry or related science field and minimum 5 years' experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR PhD in Chemistry or related science field with 1-3 years' experience in analytical/method development or method validation in the pharmaceutical, biotechnology and/or academic research field. Special knowledge or skills needed and/or licenses or certificates required · Understanding of spectroscopic and chromatographic techniques and concepts · Hands on experience in setting up and operating multiple analytical instrumentation which may include: HPLC, UV/Vis, GC, TLC, ICP-MS and dissolution apparatus · Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements · Ability to perform analytical testing, calculations and data analysis · Ability to perform wet chemistry and physical characterization studies · Ability to train and mentor lower levels scientist · Proficiency with Microsoft Office · Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members · Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines · Planning, organization and time management skills including the ability to support and prioritize multiple projects · Fluent in English (verbal and written) Special knowledge or skills needed and/or licenses or certificates preferred · Proficiency with Empower software Travel requirements 0% Physical requirements Laboratory based position Ability to lift up to 30 lbs Ability to use Personal Protective Equipment (PPE) Ability to stand for extended periods of time Pay rate for temp- $45-55/per hour. Pay rate is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Anticipated salary range for permanent employee: $95k to $115k. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Benefits and bonus are not offered for temp employees. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

About the Role The Manufacturing IT Manager is responsible for overseeing all manufacturing and shop-floor IT systems within a GMP-regulated pharmaceutical environment. This role ensures uptime, compliance, and integration across Production, Packaging, Serialization, Quality, Engineering, Supply Chain, Labs, and EHS. The leader will support machine-level operations, drive digital transformation, and ensure strict adherence to GxP and data integrity requirements. Responsibilities 1.Manufacturing Systems & Shop-Floor Technology Own and manage key manufacturing systems such as MES, ERP, LIMS, QMS, data historians, SCADA/ DCS systems, and shop-floor interfaces. Provide machine-level line support for production and packaging equipment, including HMIs, scanners, printers, weigh scales, robotics, vision systems, batch controllers, and line integration technology. Manage equipment connectivity, automation interface issues, and real-time troubleshooting on the production floor. 2. Serialization & Track-and-Trace Management Lead IT oversight for Serialization systems across all packaging lines. Manage Level 2-4 serialization systems (e.g., Antares, Systech, Tracelink, Optel). Support aggregation systems, label printing solutions, vision inspection tools, handheld devices, and data exchanges with ERP and regulatory systems. Ensure compliance with DSCSA, EU FMD, and other global serialization regulations. Coordinate with Quality and Supply Chain for audit readiness and traceability. 3. GMP Compliance, CSV & Data Integrity Uphold GMP, cGMP, and GAMP 5 standards across all manufacturing and lab systems. Lead Computer System Validation (CSV) activities including URS, FS, DS, IQ/OQ/PQ, periodic reviews, and change control. Maintain ALCOA+ principles for data integrity and electronic record management. Ensure all systems comply with 21 CFR Part 11, Annex 11, and established pharma QC/QA processes 4. Cross-Functional Leadership & Stakeholder Partnership Serve as the primary IT partner for Production, Packaging, Quality, QC Labs, Warehouse, Engineering, Maintenance, EHS, and Supply Chain. Run prioritization forums, change control boards, and business engagement reviews. Translate operational needs into digital roadmaps and practical solutions. 5. Digital Transformation & Continuous Improvement Drive initiatives such as paperless batch records, digital logbooks, automated reporting, IoT sensors, and machine connectivity (Pharma 4.0). Manage upgrades, migrations, and integrations for manufacturing and packaging systems. Lead vendor management, contracts, service agreements, and performance reviews. 6. Infrastructure, Cybersecurity & OT Environment Oversee plant networks, servers, manufacturing VLANs, and segregated OT environments in partnerships with Network and Security Teams. Ensure cybersecurity compliance for connected manufacturing equipment, SCADA systems, and serialization infrastructure. Align with corporate IT on patching, backups, DR, and user access governance. 7. Operational Support & Incident Management Provide real-time support for batch execution, packaging operations, serialization events, and lab workflows. Lead troubleshooting during downtime, deviations, and equipment-system integration failures. Maintain a structured on-call rotation model for 24/7 support. 8. Team Leadership & Development Lead a team of shop-floor IT analysts, automation support engineers, and system administrators. Develop capabilities in GMP systems, shop-floor automation, integration, and validation. Foster a culture of compliance, urgency, and continuous improvement. Skills Hands-on expertise in: Understanding of DSCSA, EU FMD, and global track-and-trace frameworks. Serialization technologies ( Optel, Tracelink) Packaging line automation (vision systems, scanners, printers, PLC/SCADA) MES (e.g., Werum PAS-X, Mater controls), ERP (SAP/Oracle), LIMS/QMS Computer System Validation (CSV), GAMP 5, cGMP, and data integrity Strong troubleshooting skills at machine, network, and application level. Excellent communication, leadership, and vendor management capabilities. Requirements: Bachelor's degree in supply chain, IT, Regulatory Affairs, or Manufacturing , IT , Engineering. 8 years of IT experience with at least 5 years supporting GMP-regulated pharmaceutical manufacturing. 5+ years of experience in pharmaceutical serialization, Tracelink, or EPCIS-based systems Less than 25% Travel (Baudette, EW) The base salary (hourly) range for this position is $120,000-$150,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term (and long term) incentive program based on performance and company results. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.

The Associate Director/Director, Strategic Development & Advocacy (SD&A) is a non-sales field based marketing role responsible for building advocacy and support for ANI Rare Disease's 1st US-based branded product. This entails proactively engaging national, regional and global Thought Leaders (TLs), forging strategic partnerships with advocacy organizations, and collaborating with relevant entities to gather insights on disease areas and treatment landscapes pertinent to ANI Rare Disease to help develop marketing strategy. Additionally, this SD&A role will collaborate with the Marketing Lead responsible for Commercial Advisory Boards and other consultancy arrangements. This includes establishing needs, selecting healthcare professional participants, and managing the contracting process. Furthermore, they will contribute to promotional Speaker Programs, assisting in speaker bureau member selection and serving as a primary point of contact for commercial expert speakers. They will also be involved in sponsorships and Patient Advocacy Organizations engagement on behalf of marketing. As a distinguished business leader within the team, this individual is expected to excel in cross-functional collaboration, executing Thought Leader engagement plans, and initiating projects to address business needs. They should demonstrate a keen ability to anticipate market trends and uncover competitive intelligence to inform marketing strategy effectively. Success in this role hinges on a collaborative mindset, extensive experience in working with Thought Leaders, and a track record of driving results in alignment with ANI's ethical business practices. *Director-level candidates are expected to function as senior field leaders with responsibility for shaping regional strategy and influencing enterprise decision-making . Position Responsibilities Develop and implement corporate objective-based Thought Leader engagement plans to identify and gather insights from current and emerging Thought Leaders in dynamic markets. Track Thought Leader insights that impact the brand and provide feedback to identify market gaps and/or market opportunities to support the development of commercial and marketing strategy, initiatives, and resources. Act as the primary liaison between the company and Thought Leaders, representing ANI brand interests effectively and collaborating with ANI leadership and relevant functions. Ensure alignment with the vision and strategic imperatives set by the brand team, facilitating the implementation of corporate objectives. Manage regional and national conventions, congresses (e.g., ITU Thought Leader identifying), and commercial advisory boards supporting marketing initiatives. Identify, coordinate, and contract appropriate Thought Leaders to support fulfilling business needs including but not limited to approved consulting opportunities (e.g., Advisory Boards, training, etc.). Involved with Sponsorships and Patient Advocacy Organizations for the purpose of enterprise-wide coordination (not tactical) of specific functional activities. Support the development and execution of Speaker Bureau working with cross-functional teams to deliver high-quality Speaker Programs. Operate in accordance with ANI's code of conduct and all policies and procedures, maintaining the highest standards of ethical conduct and compliance. Skills / Competencies Leadership: Ability to lead and inspire teams, influence stakeholders, and drive initiatives forward. Communication: Excellent verbal and written communication skills to effectively convey ideas, engage with thought leaders, and collaborate with internal and external stakeholders. Strategic Thinking: Capacity to think strategically, anticipate market trends, and develop innovative approaches to address business needs. Relationship Building: Strong interpersonal skills to cultivate and maintain relationships with thought leaders, advocacy organizations, and other key stakeholders. Project Management: Proficiency in managing multiple projects simultaneously, setting priorities, and meeting deadlines. Collaboration: Ability to collaborate cross-functionally, work effectively in team environments, and foster a culture of collaboration within the organization. Problem-Solving: Strong analytical and problem-solving skills to identify challenges, develop solutions, and drive continuous improvement. Adaptability: Flexibility to adapt to changing priorities, market dynamics, and organizational needs. Ethical Conduct: Commitment to ethical business practices and compliance with industry regulations and company policies. Industry Knowledge: Deep understanding of the pharmaceutical or biotech industry, particularly in rare diseases, and familiarity with relevant therapeutic areas. Market Awareness: Ability to stay abreast of competitive intelligence, market trends, and evolving treatment paradigms. Business Acumen: Understanding of business principles, including budget management, resource allocation, and revenue generation. Influence and Negotiation: Skill in influencing without authority, negotiating skills, and driving alignment among diverse stakeholders. Education / Experience / Qualifications 10+ years of commercial experience in the pharmaceutical or biotech industry with a similar high-science therapeutic area in the rare disease market. 5+ years Rheumatology therapeutic area expertise preferred; Nephrology and/or Neurology experience considered secondary preferred Director-level candidates will be considered with a minimum of 2+ years of Rheumatology and/or Nephrology/Neurology experience if accompanied by equivalent field marketing role. Bachelor's degree in life sciences, pharmacy, or a related field (advanced degree preferred). Proven track record in developing and implementing Thought Leader strategies through compliant and engaging interactions via existing and meaningful relationships with key Thought Leaders. New York City, NY Northeast or TX/South Central location required. Field-based role requiring approximately 50-65% travel, including select evenings and weekends to support programs and congresses Travel expectations may vary based on territory and business needs The base salary range for this position is 200,000-235,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term and long term incentive program based on performance and company results. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.