Catalent Pharma Solutions jobs in Somerset, NJ - 63 jobs

The Global Head of Field Scientists & Strategic Alliance will accelerate the growth of the cell therapy business by providing scientific and technical expertise in support of sales efforts and expand Catalent's cell therapy network through strategic alliances. She/he will represent Catalent Cell Therapy capabilities at external/internal conferences, meetings, and industry events and will partner with the Business Development team to win new business. **The Role** (daily responsibilities) + Manage and coach global team of Field Application Scientists. + Provide technical expertise and industry knowledge to support business development efforts and expand the client pipeline in the cell therapy business. + Partner with Business Development (BD) in all regions on new business opportunities. + Work with prospective clients to understand their process and development needs and translate to proposals that encompass the right offerings. + Provide technical leadership and support to BD by helping to understand customer needs and by identifying and adapting the right Catalent solution/offering. + Provide technical training and support to the commercial teams. + Serve as a knowledge and thought leader to create service offerings that meet the market trends and diverse customer needs. + Represent Catalent Cell Therapy capabilities at external meetings, events, conferences, academia, etc. + Lead the efforts to establish strategic alliances with potential partners to expand Catalent's network in cell therapy. + Other duties as assigned. **The Candidate** (requirements) + Master's degree in Biological Sciences or Engineering, PhD strongly preferred. + 15+ years of relevant experience in areas that could include pharmaceutical, manufacturing, quality, project management, business management, business development, commercial operations + 5+ years of direct operational experience in cGMP manufacturing of cell-based therapies or experience in supporting customers in the cGMP space. + Expertise in cGMP ecosystem support functions (process development, analytical assay development and MS&T) is a plus. + Extensive customer facing experience in a CDMO or similar setting + Experienced deal maker in project-based organizations with proficient negotiation skills + Ability to travel up to 50% **Pay:** The annual pay range for this position in New Jersey is $220,200 - 318,000 The annual pay range for this position in Massachusetts is $220,200 - 318,000 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 + 26 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 (*************************************************************************************************************************** .

Tris Pharma, Inc. (******************* is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and 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 it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success. This position is temporary to potential hire opportunity, based on company needs and successful performance. Located in Monmouth Junction, NJ, Tris has immediate openings for (2) Packaging Technician Leads for 2nd SHIFT. Shift is 4 days/week for 10 hrs. Mon-Thurs, Hours are 3:00 pm - 1:00 am The Packaging Technician Lead 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, sets-up, and maintains various pharmaceutical packaging equipment as assigned, and thoroughly and accurately documents all activities to ensure compliance with regulatory guidelines. The incumbent collaborates closely with the Supervisor, Packaging and may be asked to perform many senior and supervisory packaging functions/initiatives in the supervisor's absence including, but not limited to coordination of daily packaging activities and supervision of safety and workflow, etc. 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; Operates 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 * Assists with organization of daily schedule and assigns personnel to the various workspaces to meet the demand of planning * Reports and investigates any deviations from processes or procedures * Maintains a presence on the packaging floor at all times, Trains new employees and mentors lower-level technicians, as appropriate * May assist with the development and writing of SOPs and investigation reports and contributes to the circulation of the documents under approved procedures * Assists in maintaining a safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources, maintaining compliance with established policies and procedures Works extra hours or weekends as required by management to meet the demands of the schedule Requirements REQUIREMENTS * High school diploma or equivalent REQUIRED * Ability and willingness to learn manufacturing procedures and federal regulations pertaining to manufacturing processes REQUIRED * Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. REQUIRED * Strong record keeping skills/ability REQUIRED * Excellent verbal and written communication and skills REQUIRED Minimum education and years of relevant work experience * High school diploma or equivalent AND minimum 5 years experience working in a pharmaceutical or biotechnology cGMP regulated environment. 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 * Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. * Proficiency with Microsoft Office * 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) * Ability and willingness to work additional hours as required by business needs Special knowledge or skills needed and/or licenses or certificates preferred * Solid dose manufacturing experience * 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: $23-28/hour. There is an additional $1.50 per hour for the shift differential. 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.

Job Title: Manager, Quality Assurance Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Quality Assurance Manager to join our team. In this role, you will be responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. In addition, you will be responsible to direct batch record review, control and release, handle investigation process (CAPA) assuring that any discrepancies are investigated thoroughly and in a timely manner. Key Responsibilities: * Regular and predictable onsite attendance and punctuality. * Directs the batch record review process. Makes final accept/reject disposition on product lots. Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner. * Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches. * Places lots on HOLD if Quality issues are detected and notifies senior management. * Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner. * Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements. * Conducts routine investigation and departmental meetings to facilitate the performance of release function. * Manages personnel for in-process filling and inspection/packaging monitoring * Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise. * Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control. * Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization. * Performs QA review and approval of LIR's (Laboratory Investigation Reports). * Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. * Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments. * Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. * Assists the QA management in developing on department budget. * Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. * Manages attendance records for all direct reports. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Minimum: Bachelor's degree in Pharmacy, Biology, Chemistry or a related field * Preferred are beneficial [List the required qualifications such as education, skills, and experience] Preferred Qualifications: * Additional college courses in Microbiology, cGMPs, Statistics or Quality Management Skills: * Must have history of strong documentation skills and attention to detail * Familiarity with cGMPs and CFR for US and EU * Excellent organizational skills and ability to multi-task and perform work in a timely manner * Demonstrates ability to lead a department, projects and meetings effectively * Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management * General computer skills and ability to prepare presentations and address large groups * Demonstrated attention to details and accuracy * The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Compensation: Base Salary: $92,850 to $158,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Dayton, NJ, US, 08810 Nearest Major Market: New Jersey

**Title: Principal Real World Research Delivery Lead (RWRDL)** Are you ready to take on a challenge and accelerate your career? This is an **excellent opportunity for a self-driven, autonomous leader** eager for growth and progression. Parexel is seeking a **Principal Real World Research Delivery Lead (RWRDL)** to join our team and deliver innovative Real World Research (RWR) solutions for global clients. This is a great opportunity to join our team as a senior leader driving Real World Research (RWR) solutions for global clients. In this role, you'll **lead cross-functional teams** , manage **budgets and timelines** , and serve as the **primary client contact** for innovative RWD projects. We're looking for a **strategic project leader** with strong communication skills, adaptability, and a go-getter mindset. Experience in **RWD/RWE** , **data privacy** , and **drug development** is a plus. **Career Growth:** Shape new services, mentor emerging leaders, and gain visibility in a lean PM model. As a senior leader, you will: + **Lead cross-functional teams** and act as the primary client contact for complex RWR and RWD projects. + Oversee **project proposals, budgets, timelines, and milestones** while ensuring compliance with SOPs and data privacy standards. + Collaborate with multidisciplinary teams to design and implement RWR-enabled solutions. + Mentor junior team members and help shape new services in a lean PM model. **What We're Looking For:** + Strong **project leadership experience** with proven ability to manage multiple projects and decentralized teams. + Excellent **communication skills** , adaptability, and a proactive, go-getter mindset. + Knowledge of **RWD/RWE methodologies** , data privacy, and drug development processes. + Ability to thrive in dynamic environments and lead independently. **Preferred Experience:** + RWD/RWE expertise, commercial experience, and familiarity with late-phase clinical research. + Understanding of RWD platforms, project management systems, and GCP environments. **Education:** Bachelor's degree in a science or clinical-related field; Prince II or AMPM certification preferred. **Why Join Us?** + **Career progression** and visibility in a growing RWD space. + Opportunity to **develop new services and mentor emerging leaders** . + Work on impactful projects that shape the future of clinical research. If you're ambitious, adaptable, and ready to make a difference, **apply today and lead the way in Real World Research!** \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management** + Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. + Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. + Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. + Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. + Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. + Keep client and team informed of project status. + Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. + Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. + Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. + Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. + Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed. **Client** **Liaison/Service** + Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management. + Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. + Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management. + Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management. + If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects. **Training/Compliance** + Keep abreast of new advances in medical writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management. + Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate. + Develop and present external training courses. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform + Analyze efficiency of work and discuss improvement ideas with Medical Writing + Services management and colleagues, e.g., evaluation of software to increase productivity and document quality. **Skills:** + Excellent interpersonal, negotiation, verbal, and written communication skills. + A flexible attitude with respect to work assignments and new learning. + Motivation to work consistently in a fast-paced, rapidly changing environment. + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects. + Knowledge of resource management and productivity metric management. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Ability to travel. + Fluent in written and spoken English. **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Unlock the Power of Data in Clinical Research!** Are you passionate about transforming complex data into actionable insights? Join Parexel as an **Analytical Data Science Programmer Consultant** **/ Statistical Programmer II** and play a pivotal role in advancing drug development. In this dynamic position, you'll collaborate with industry experts to create high-quality, traceable programming deliverables-ranging from statistical outputs to interactive dashboards-while ensuring compliance with global standards. Bring your expertise in SAS, R, and CDISC standards to a team that values innovation, precision, and scientific impact. If you thrive in a fast-paced environment and want to make a difference in oncology research, this is your opportunity to shine! **Ready to elevate your career? Apply today and help shape the future of clinical data science.** The Analytical Data Science Programmer Consultants support Project Lead ADS for transforming statistical analysis plans into high-quality, traceable programming deliverables. This includes both static and dynamic outputs, such as tables, listings, figures, and interactive data visualizations or dashboards. The role involves creating and validating datasets in accordance with Study Data Tabulation Model and Analysis Data Model standards, ensuring compliance with client standards. Job Description **Responsibilities:** + Work with Project Lead ADS to develop, validate, and maintain datasets and statistical outputs for clinical trials, including Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and tables, listings, and figures (TLFs), ensuring programming accuracy, traceability, and compliance with internal processes and regulatory expectations + Develop and support programming outputs across a wide range of data types, including exploratory biomarker data and real-world data + Collaborate on Exploratory Data Analyses (EDAs), enabling insight generation to inform drug development strategies and enhance scientific communication **Qualifications:** + Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field + A minimum of 3 years of experience in statistical programming in a clinical development setting supporting Oncology trials/research, or an advanced degree with 1-3 years of equivalent work experience + Proficient in and have recent working knowledge of SAS and R + Basic understanding of statistical quality, endpoints, and QC processes + Experience with Clinical Data Interchange Standards Consortium (CDISC) standards (e.g., SDTM and ADaM) + Demonstrated ability to deliver programming outputs independently + Fluent in English **Preferred Qualifications:** + Demonstrate critical thinking, strong organizational and problem-solving skills + Effective communication skills with the ability to translate complex statistical concepts for non-statistical audiences + Experience with drug development (early and/or late stage) + Oncology experience is highly desired + Excellent communication skills, including the ability to influence and translate complex data for non-technical stakeholders \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Account Executive, Micronization, Pharma Product Delivery** Catalent Pharma Product Delivery 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, micronization and various Solid Dose technologies and products that include Rx, Gx, OTC, VMS and Animal Health products. As an Account Executive, you will join our dynamic Business Development Team and your primary role is to evaluate and assess contract development and manufacturing opportunities with customers with micronization business. The Business Development function is responsible for identifying, negotiating, and securing new development, tech transfer, and commercial supply business for particle size engineering or micronization products with new customers, and for managing business relationships and growing business with existing customers. Reporting to the Vice President of Business Development, Inhalation and Micronization, this role is responsible for identifying, negotiating, and closing development and commercial business for our miconization business in the U.S. .The role has day-to-day interactions with the Inhalation leadership team, Corporate Marketing, Sales, Sales Operations, Commercial and Site Operations teams. This individual will be responsible for the East Coast. This role will ideally be based in a key city on the East Coast, preferably Boston or NY metropolitan area. Additional locations will likely be considered. **The Role:** + Identify, qualify, and pursue particle size engineering or micronization business opportunities within the assigned portfolio of accounts (current customers and prospects). + Identify key account decision-makers and influencers. + Prepare well for calls/visits, anticipating and addressing barriers. + Document and validate customer needs before presenting solutions. + In cooperation with R&D and Contract Management, prepare and present quotations for project development work to customers. + Cooperate with management, commercial operations, legal and finance teams in the preparation and negotiation of any development agreements and all commercial supply agreements. + Manage the business relationships with assigned customers. Responsibilities include, but are not limited to, pricing, contract extensions/amendments, forecasting, periodic business review meetings, and support of other customer service-related issues. + Other tasks as assigned. **The Candidate:** + BA/BS degree in a scientific discipline, business, or related field (MS, MBA, or Ph.D. is preferred). + A minimum of 3 years of combined business development/sales and scientific/technical experience in the pharmaceutical contract service sales (CDMO), pharmaceutical, biotechnology, or life sciences industries. + Experience/understanding of the proposal development process, business quotes, budgeting, and managing to defined timelines. + Excellent written and verbal communication and negotiating skills are required. **Pay:** The annual pay range for this position in New Jersey is **$91,500 - $132,000** The annual pay range for this position in Massachusetts is **$91,500 - $132,000** 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 (*************************************************************************************************************************** .

+ **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

This is a full-time salaried position, based **onsite** out of our **Bridgewater ,NJ** location. The Catalent Legal & Compliance Department seeks to add a **Senior Paralegal** to provide to the Company's Clinical and Specialty Services (CSS) business which has 13 sites across the globe, handling more than 320,000 patient kits to >1,200 clinical trials in 80+ countries. The **Senior Paralegal** will be a key member of the department, reporting and providing direct support to attorneys and business personnel on a wide variety of matters for the CSS business unit, and liaising as needed with other support and business functions to resolve issues **The Role:** + Routinely update the Legal Department's matter tracking documents + Coordinating signature of legal documents + Support attorneys in the preparation and negotiation of a variety of commercialcontracts + Liaise with external service providers as necessary + Review and negotiate confidentiality and non-disclosure agreements + Monitor and track incoming requests for legal assistance + Other duties as assigned **The Candidate:** + Associate's degree, required; Paralegal Certificate preferred + Minimum 5 years of paralegal experience with a corporate legaldepartment and/or law firm, required + Life science experience, preferred + Proficient in Microsoft Office applications, with capability and willingness to become proficient in all of the Company's matter and contract management systems + Strong interpersonal skills, including diplomacy and flexibility, and the ability to interface effectively with personnel at many different levels throughout the Company + Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds **Pay:** The anticipated salary range for this position in **New Jersey** is **$110,000 - $155,000** , plus bonus (10%), 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 (*************************************************************************************************************************** .

Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities. This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence cross‑functional teams in a fast‑changing environment. Key Responsibilities: Documentation & Compliance - Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements. - Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes). - Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals. Regulatory Submissions - Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. - Provide local input for change control and post-approval requirements. - Collaborate with global functions to obtain documentation aligned with local requirements. Audit & Inspection Support - Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure. - Provide local expertise and responses to inspection queries. Cross-Functional Collaboration - Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes. - Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies. Strategic Leadership - Lead regulatory strategies for product launches and integrations at the affiliate level. - Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships. - Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation. Education - Bachelor's degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent. - Advanced degree (Master's or PhD) preferred in law, legal affairs, or natural sciences. - Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus. Experience - 3-5+ years of local regulatory knowledge and experience in a health authority-facing role. - Demonstrated previous life cycle management experience is required. - Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. - Proven expertise in managing regulatory submissions, timelines, and cross-functional teams. - Strong project management and leadership skills. - Experience influencing Commercial Operations stakeholders and driving business-critical decisions. - Demonstrated ability to adapt and succeed in rapidly changing environments. \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are looking to fill a **Scientist III - (HPLC) Chromatography - Separations & Molecular Biology - Immunoassay Experience** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Description** Support of routine bioanalytical testing of samples from cell-line development, in-process, process development/characterization, forced degradation, release & stability, and pre-formulation. Other potential opportunities include method development/optimization, workflow optimization, and template development. **Responsibilities** + Support of high-throughput, pre-formulation, pre-qualification, robustness, or admixture testing + Results processing and documentation by following appropriate methods / protocols / procedures + Sample management and monitoring of controlled temperature units. + Following all appropriate laboratory safety and hygiene procedures **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in analytical chemistry or biologics testing lab + MS (1-2 yrs.) of relevant experience in analytical chemistry or biologics testing lab **Required Skills and Experience** + Must have separations experience for large molecules or plate-based assay experience. + Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques: + Liquid Chromatography (HPLC / UPLC) + Protein A Titer, Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX, AEX, CEX), Reverse Phase (RP), or Hydrophobic interaction chromatography (HIC) + Electrophoretic methods such as capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and/or capillary isoelectric focusing (cIEF) + ELISA (HCP, proA) and binding potency assay + qPCR and basic molecular biology techniques (gel electrophoresis, etc.) + High-throughput liquid handling system, e.g., Tecan, Bravo, etc. + Basic instrumentation troubleshooting + **Ability and willingness to train in molecular biology and immunoassay testing** + **Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.)** **Desired Skills and Experience** + Familiarity with compendial testing such as UV 280, pH, and Physical Observations + **Ability to follow complicated scientific protocols / procedures** + Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases) + Good documentation practices & utilization in electronic lab notebooks (ELN) + Analytical software such as Empower. + Knowledge of Laboratory Information Management Systems (LIMS) + Sample submission & sample management + Monitoring of controlled temperature units + Experience with BSL2 (Biosafety Level 2) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Analyst, Portfolio & Offer Development to join our team. In this role, you will be responsible for forecasting, pricing and portfolio management while providing reporting and interaction with the national account sales directors. This is a great opportunity to gain exposure to the commercial Generics product portfolio. It is expected that this candidate is versatile, has continuous improvement mindset and learn the core fundamentals of the generics commercial process. Working in a fast-paced environment and being flexible and adaptive will allow for multiple opportunities to engage in cross-functional initiatives. Responsibilities: Pricing/Offer Development * Develop pricing proposals for Generics business products in response to customer inquiries. * Maintain customer pricing proposal databases and models. * Assist with the preparation price increase analyses as required and WAC reviews quarterly. * Perform ad-hoc analysis as necessary. Portfolio Management * Assist in life cycle management and portfolio optimization processes. * Monitor competitive developments and establish new sources of competitive intelligence. * Performing forecasting / quantitative analyses (including pro-forma financial modelling, valuation, accretion/dilution, IRR/NPV, etc.) on new lifecycle management opportunities. * Further develop customer level forecast and monthly reporting. * Create and maintain monthly sales reporting - partnering with sales team on variance & supporting commentary analysis. * Assist with the preparation of customer business reviews (forecasting / allocation / backorder analytics). * Gather and maintain up to date information on sales and market share, and information with promotional potential * Participate on cross functional, multidisciplinary teams and contribute to reaching product objectives. Qualifications: * Bachelor's degree in Finance, Accounting, Marketing, Business, or Engineering required. * 0-2 years of relevant experience; pharmaceutical industry experience is preferred. * Quick learner with strong critical thinking and problem solving skills (both conceptually and technically). * Strong communication, excellent organization and coordination skills and impeccable attention to detail with the ability to effectively handle multiple complex issues simultaneously. * Experience in Excel including pivot tables and integrating and consolidating large volumes of data from various sources. * Ability to work both independently and as a flexible team player while working in a dynamic, fast-paced and entrepreneurial environment. Compensation: Base Salary: $56,000 to $95,000 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries. * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards programs * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-DP1 Location: Berkeley Heights, NJ, US, 07922 Nearest Major Market: New Jersey

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, hands-on SR. Director/Director, Procurement. Title and salary commensurate with experience. The Director/ Senior Director, Procurement is responsible for multiple facets of the Procurement function within a pharmaceutical manufacturing environment including, but not limited to, purchasing, sourcing, logistics, warehousing, etc. The incumbent manages and leads a small team to develop and implement procurement strategies and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards and objectives Leads and/or oversees functions (i.e., purchasing/procurement, warehousing, logistics, etc.) to ensure day to day management and oversight of company's supply chain, logistics and inventory levels across organization to ensure continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfaction Collaborates cross functionally with internal stakeholders (i.e., Operations, Research and Development (R&D), Finance, etc.) to support purchasing controls/budget and a comprehensive procurement strategy aligned with organization's overall goals and objectives; Identifies and implements cost-saving opportunities through strategic sourcing and supplier relationship management Identifies and participates in sourcing strategies and builds long-term collaborative supplier/vendor relationships; Negotiates contracts, terms and pricing to ensure optimal value to organization; Provides expertise and guidance in supplier selection and contract negotiation, as needed; Monitors supplier performance and conduct regular business reviews; Provides guidance and oversight for new sourcing, contracts, service agreements and capital equipment requirements Identifies and mitigates risks in procurement, ensuring business effectiveness, continuity and compliance; Develops and enforces ethical procurement practices and drive sustainability initiatives Leverages procurement technologies (i.e. Enterprise Resource Planning (ERP)) to enhance efficiency and transparency; Remains current on market trends and emerging technologies to leverage best practices and innovative solutions Ensures annual procurement budget (savings, cost avoidance, inflation) are met; Tracks/analyzes procurement spending and other key metrics to identify and address cost-saving opportunities, as appropriate; Analyzes market trends to forecast pricing and supply availability Leads and/or oversees Order Fulfillment Process from production release to customer delivery; Ensures timely and accurate shipment of finished goods to domestic and international markets; Collaborates with customer service, planning and distribution teams to meet service level agreements Oversees Warehouse operations, including receiving, storage and distribution of materials and products; Implements inventory control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality, and regulatory standards in warehouse operations Manages, coaches and mentors direct reports Requirements REQUIRED QUALIFICATION Bachelors degree and minimum 9 years experience in procurement, logistics and/or supply chain related positions of increasing technical and strategic responsibility in pharmaceutical or biotechnology manufacturing. Proven track record of strategic sourcing, contract negotiation, and supplier management Strong knowledge of FDA regulations, current Good Manufacturing Practices (cGMPs) and pharmaceutical supply chain dynamics Working knowledge of sustainable procurement practices, supplier diversity and responsible sourcing Proficiency with JDEdwards (JDE) or other ERP systems Strong negotiation skills People management experience Work Arrangements: This position requires working in our Monmouth Junction, NJ office 5 days per week. Anticipated salary range: $210 to $260. 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-office

Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. **Job Title** : Investigator Financial Analyst II **Job Introduction** : At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking an **Investigator Financial Analyst** **II** to join our team. As an Investigator Financial Analyst, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences to patients by steering the investigator budget management for crucial projects. Through the collaboration and diversity of the Investigator Payment Division the Investigator Financial Analyst is provided with opportunities to excel and discover where your skills can take you. **Who we are looking for** : Curious individuals interested in understanding investigator budget economic drivers. Who are detailed-oriented while assisting in translating the clinical conduct into a financial impact and proactively advising the project leader and the project financial analyst on how to influence critical budget and cash flow levers to prevent negative impact project financials. **What you'll do** : + Lead the monthly investigator payment forecast cycle and support project analysis requirements, including a review of accruals, costs incurred, contracts signed, and patients enrolled. + Collaborate with clients, clinical team members, and other members of the organization to gather information and/or explain the financial impact of the observed clinical conduct. + Manage all required variance analyses for the set of projects, with insight and identify risks in the project forecast and to the budget. + Present updates on financial status of investigator payments for assigned projects and create information in response to client financial reporting needs for assigned projects in the area of project reporting, forecasting, or transactional details for the projects within the portfolio. **Why join us:** Be part of groundbreaking projects that are pushing the boundaries of the industry. Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. Enjoy work life balance and flexible working hours. **Parexel US Benefits** : + Health, Vision & Dental Insurance + Tuition Reimbursement + Vacation/Holiday/Sick Time + Flexible Spending & Health Savings Accounts + Work/Life Balance + 401(k) with Company match + Pet Insurance Full list of benefits available here: *********************************** **About Parexel International:** At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you're exposed to a world of experiences and open doors. If this job does not sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are looking to fill a **Scientist 3 -** **Third Shift** **Analytical Chemist Pilot Plant** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ** . This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **Description** The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. **Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager** to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards. Health Authority Engagement: Support the preparation of materials for health authority engagements Qualifications: + Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). + Strong project management skills with a track record of managing complex projects and meeting deadlines. + Excellent organizational and communication skills. + Excellent time management abilities + Proficient in Microsoft Office Suite + Proven experience with project management software ie. Smartsheet + Strong communication and interpersonal skills + Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: + Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are seeking a motivated **Senior / Regulatory Affairs Consultant - Advertising & Promotion** to join Parexel and work as a trusted partner within a major client engagement. In this role, you will partner with cross-functional teams to ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You'll play a key role in supporting product launches, campaigns, and ongoing promotional activities while safeguarding compliance and patient trust. Key Responsibilities - Review and approve advertising and promotional materials, including direct-to-consumer campaigns, medical education, and social media content. - Provide regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal) during promotional material development. - Participate in promotional review committees, ensuring alignment with FDA regulations and company standards. - Collaborate with global teams to ensure consistency across markets while meeting US-specific requirements. - Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations. - Support preparation of responses to regulatory inquiries related to promotional activities. - Track and manage promotional submissions and approvals in regulatory systems - Manage SOPs and electronic review systems. Qualifications - Education: Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field. Experience: - 3-5 years of pharmaceutical/biotech related industry experience. - Direct experience in advertising and promotional regulatory review. - Familiarity with FDA regulations governing promotional materials. Skills: - Strong organizational skills with the ability to manage multiple projects under tight timelines. - Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional partners. - Attention to detail combined with strategic thinking. - Proficiency with Microsoft Office and regulatory systems (e.g., Veeva PromoMats, eDMS). - Ability to create and revise Ad/Promo SOPs to ensure promotional materials are updated as required by FDA regulations and company standards. Competencies: - Knowledge of US regulatory requirements for advertising and promotion. - Demonstrated problem-solving ability and sound decision-making. - Ability to work effectively in a matrix environment and collaborate across diverse teams. - Strong interpersonal skills with cross-cultural awareness. - Fluency in English (verbal and written). \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Global Head of Field Scientists & Strategic Alliance will accelerate the growth of the cell therapy business by providing scientific and technical expertise in support of sales efforts and expand Catalent's cell therapy network through strategic alliances. She/he will represent Catalent Cell Therapy capabilities at external/internal conferences, meetings, and industry events and will partner with the Business Development team to win new business. **The Role** (daily responsibilities) + Manage and coach global team of Field Application Scientists. + Provide technical expertise and industry knowledge to support business development efforts and expand the client pipeline in the cell therapy business. + Partner with Business Development (BD) in all regions on new business opportunities. + Work with prospective clients to understand their process and development needs and translate to proposals that encompass the right offerings. + Provide technical leadership and support to BD by helping to understand customer needs and by identifying and adapting the right Catalent solution/offering. + Provide technical training and support to the commercial teams. + Serve as a knowledge and thought leader to create service offerings that meet the market trends and diverse customer needs. + Represent Catalent Cell Therapy capabilities at external meetings, events, conferences, academia, etc. + Lead the efforts to establish strategic alliances with potential partners to expand Catalent's network in cell therapy. + Other duties as assigned. **The Candidate** (requirements) + Master's degree in Biological Sciences or Engineering, PhD strongly preferred. + 15+ years of relevant experience in areas that could include pharmaceutical, manufacturing, quality, project management, business management, business development, commercial operations + 5+ years of direct operational experience in cGMP manufacturing of cell-based therapies or experience in supporting customers in the cGMP space. + Expertise in cGMP ecosystem support functions (process development, analytical assay development and MS&T) is a plus. + Extensive customer facing experience in a CDMO or similar setting + Experienced deal maker in project-based organizations with proficient negotiation skills + Ability to travel up to 50% **Pay:** The annual pay range for this position in New Jersey is $220,200 - 318,000 The annual pay range for this position in Massachusetts is $220,200 - 318,000 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 + 26 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 (*************************************************************************************************************************** .