Dosage Forms jobs near me - 36 jobs

Job Description PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside. PharmaLogic offers you an exceptional opportunity to join our dynamic team as an On-Site QA Specialist! Hours - 10:00 PM to 6:00 AM As the Quality Assurance Specialist, you will play a vital role in the PharmaLogic quality program to assure compliance with cGMP and other standards for the manufacture of drugs for administration to patients. Responsible for completion of required quality assurance tasks of finished drug product as directed by cGMP SOPs and serves as site expert on PET quality assurance. The position involves a hands-on role in all quality assurance duties for the site, including materials acceptance and quarantine, batch release & record review, drug quality control, sterility, environmental monitoring, equipment maintenance / qualification/ calibration, investigation (IR, OOS, deviation, etc.) and corrective actions (CAPA), SOP writing, maintenance and review, inspection readiness, data quality and integrity, ANDA documentation and other routine QA functions. The QA Specialist is responsible for assisting in FDA inspections at the site. Ideally, there will be separation of QA functions from production and QC functions. However, depending on the size of the facility, these activities may be performed by the same person if there is the ability to segregate batch release from production through appropriate cross-training for batch release. For smaller facilities, the site QA Specialist may assume other duties which may include production activities, operation of the facility's cyclotron and associated chemistry modules and analytical equipment for production and QC of PET radiopharmaceuticals. The position may be required to perform various radiation safety and quality related tasks as directed by management. Job Responsibilities and Duties: Ensure compliance with all regulatory commitments and company policies and SOPs including cGMP and radiation safety. Actively promote adherence to SOPs, as well as safety rules and awareness. Report and take initiative to correct safety & environmental hazards. Provide immediate notification of quality related issues to site Manager, PET Operations Management and Q&R as necessary. Oversee production operations to assure that PET drugs meet requirements for identity, strength, quality and purity. May Perform PET radiopharmaceutical Quality Control (QC) in cGMP environment May perform aseptic processing related tasks Responsible for quality assurance oversight of routine production, packaging and shipping of radioisotopes. Examine and approve/reject components, closures, in-process materials, packaging materials, labeling and finished dosage forms to assure that all meet specification; manage onsite inventory quarantine and control process according to SOPs to assure specifications are met. Assure approved vendors used and maintain documents and records, including COA. Review batch, laboratory and production records to assure completeness, accuracy and conformance before batch release; authorize or reject batch according to SOPs or oversee batch release by other qualified team members. Perform batch trending analysis. Notify facility manager if any recall necessary to assure that recalled materials are not administered to patients. Initiate change to SOPs, participate in authoring and review of SOPs, maintain documents under control in QMS. Assure SOPs match processes and procedures in PET manufacturing operation and report concerns to Management. Document and Trend deviations, IRs, events and initiate investigation and assure documentation of corrective actions and retraining as applicable. Initiate and complete CAPA investigation as deemed necessary, and report results and trends. Maintain facility compliance with environmental monitoring and aseptic control, Review and trend environmental monitoring results and all testing records. Maintain records for inspection. Perform annual retraining upkeep of training files. Assure aseptic processing of samples and products, as per SOP. Assure aseptic processing area suitably cleaned, maintained, controlled to prevent mix-ups or contamination; assure personnel qualified in aseptic technique and cleaning of the area and that approved cleaning agents and processes used according to SOP. Assure environmental monitoring records are complete and readily available, including annual personnel media fill qualifications. Assure equipment is functional, within calibration, suitable for use, maintained and documented per SOP. Assure equipment qualified and operated under specified conditions; maintain vendor IQ/OQ and site PQ documents. Assure master production, laboratory controls/analytical tests and other control records are consistent with actual work procedures and any discrepancies reported to PharmaLogic Quality and Regulatory. Assist in maintaining records to comply with FDA and SOP requirements. Maintain, monitor, and report out on the location QA program to management. Support the site lead for FDA and other agency, vendor and internal quality audits, as directed. Maintain site audit readiness by thorough records, personnel, and facility review. Maintain site copy of ANDA and all related filing documentation up to date, available and organized for review. Draft ANDA related documents for submission including annual reports and other updates as required. Assists in conducting periodic and annual quality audits, training, SOP review and other activities as directed Job Requirements │ Skills │Education: BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 1-3 years Quality experience in the pharmaceutical industry, or an equivalent combination of education and experience preferred. Pharmacy tech certification a plus; experience with aseptic technique a plus Experience working with ionizing radiation and laboratory equipment desirable including troubleshooting and repairs. Strong analytical, critical thinking and customer service skills. Experience working on a cross-functional team in fast-paced environment. Strong knowledge of cGMP environment and regulations. Knowledge of CFR21 Part 212 preferred. Strong attention to detail and experience with managing multiple projects and priorities. Come join our winning team and begin a fulfilling career with us by applying today. PharmaLogic is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class. Benefits Include: 401(k) retirement benefit program Medical Dental care Disability insurance Employee assistance program Life insurance On-site parking Paid time off Vision care Hours - 10:00 PM to 6:00 AM 40 hours/week

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Job Title: Principal Scientist, Drug Product Design (Remote) Reports to: Senior Director, Drug Product Design About Us: At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged, it's celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you! The Role: We're looking for a passionate and curious, Principal Scientist to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a Principal Scientist at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It's a role where your curiosity will fuel both your personal growth and the success of the team. What You'll Do: Dive deep into drug product manufacturing process development, process technical transfer, and GMP manufacturing of biologics, always looking for ways to improve efficiency, reduce risk, and innovate. Identify, review contracts, and maintain relationships with existing and future drug product manufacturers. Provide technical oversight for drug product manufacturing activities (including person-in-plant responsibilities), bringing fresh perspectives to manufacturing process development and technical transfer that challenge the status quo. Collaborate with cross-functional teams and external clients to ensure technical success and uninterrupted supply of drug product. Represent the Drug Product Design function on internal teams and external partnerships. Keep up with the latest trends and developments in GMP drug product manufacturing and use your knowledge and experience to inspire and influence both internal and external stakeholders. Travel: 10-25% to manufacturing sites for client products. Who You Are: A recognized expert in drug product manufacturing of sterile dosage forms, including frozen, liquid, and lyophilized formulations in vials, pre-filled syringes, and cartridges. A curious problem-solver with knowledge of analytical techniques for product and process characterization enabling continuous learning and growth in a dynamic environment. Someone who is experienced with Quality Management Systems and other GxP systems to support GMP manufacturing. A self-starter who is comfortable with ambiguity and thrives in environments where curiosity and experimentation are encouraged. Excellent communicator, both verbally and in writing, able to gain alignment and advance project goals in multi-company collaborations Knowledgeable of global regulatory expectations for the development and manufacturing of biologic drug products and biosimilars. Why Join Us: Growth Opportunities: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow. Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life, with hybrid work schedules in many of our various locations. Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged. Innovative Projects: You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. A Place for Big Ideas: We don't just talk about thinking outside the box-we throw the box away. If you've got ideas, we want to hear them. Are You Still Curious? If you've read this far, then chances are you've got a curious mind, just like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads you and how it will shape the future of Just-Evotec. Let your curiosity guide your career. #BeCurious and explore the endless possibilities at Just-Evotec! The base pay range for this position at commencement of employment is expected to be $145,000 to $170,000; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

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 continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Process Engineer - Technical Services. In this role, you will be responsible for Leading the Registration/ Process Validation (Process Design, Process performance qualification, & Continuous Process Verification)/ Process transfer of in-house products (on-site development/ transferred or procured filings/ re-launch etc.) and champion cross coordination with multiple groups and alignment with Hikma's quality/ compliance requirements. Leading the transfer of 3rd party/ CMO products (externally contracted for development/ manufacturing/ testing, Buy-ins, Site Transfers (in/ out), life-cycle) from R&D to Commercial Operations as a Process Champion from Hikma. Developing and executing production strategies (e.g batch record documentation, GMP systems set-up etc.) for evaluation, scale-up, process validation, site transfer (in/out), and lifecycle products of multiple dosage forms (solids, non-solids, semi-solids, nasals, inhalation, etc.). Coordinating agency (e.g. FDA) submission documentation requirements, quality investigations, process change management, and project communications during development/ transfer/ launch/ life-cycle projects. Mentoring junior process engineers and share best practices within Technical Services to continuously grow talent and enhance productivity. Key Responsibilities: 1. Consult as Process and Formulation Champion on cGMP/ FDA/ Hikma quality requirements and execute process registration (ANDA, NDA, PAS, etc.)/ scale-up/ validation and commercial production for 3rd Party/ CMO & in-house products during project selection, process development, filing, transfer, evaluation, launch and life-cycle phase. * Lead as Hikma's Technical Services representative for in-house process flow & equipment requirements for different products (solids, non-solids, nasals, inhalation, etc.) and spearhead 3rd Party/ CMO site visits, process and equipment requirements, and other technical considerations during project selection, and execution. * Drive gap and risk assessments including statistical data analysis for process scale-up, and process design/ improvement initiatives (e.g. PAT, DOE) during development/ registration/ transfer and lead mitigation and implementation activities. * Lead strategy development for filing and validation (e.g. lot sizes, number of lots, sampling plan etc.) and drive requirements (e.g. protocols, batch records, etc.) for registration scale-up, evaluation, transfer, and process validation batch production. * Create and/ or review documentation (e.g. Master Manufacturing Formula/ batch records, protocols/ reports, technical justifications for matrix approach etc.), and master data for production of batches for registration/ filing/ scale-up, evaluation, and process validation * Travel to 3rd party locations as lead representative of Process Transfer - Technical Services during registration/ evaluation/ scale-up/ process transfer/ validation/ commercial lot manufacturing to provide subject matter expertise and technical support on process and quality requirements of Hikma to mitigate risks during commercial production. 2. Lead process development, registration, and FDA filing tasks with R&D and project teams from 3rdparty/ CMO and Hikma to establish robust control strategy for future commercial process. * Collaborate with stakeholders (e.g. Product Development, Production etc.) during development, pilot lot production, registration, etc. to optimize or develop product formulation, and process flow, and resolve complex issues relating to CPPs, CQAs, AQL, analytical methods/ testing, quality deviations and other process risks. * Collaborate with Analytical Development, Quality labs etc. to set-up testing requirements for in-process controls, release and stability; influence in establishing product specifications based on process and data trends. * Co-lead with Product Development to generate development/ registration QbD reports and ensure robust documentation of development history/data prior to process validation/ PPQ. * Collaborate with Drug Regulatory Affairs (DRA) at 3rd Party/ CMO and Hikma to author/ or review documentation required for product filing (ANDAs, NDAs, PAS, CRLs, and other FDA correspondences) to support timely approvals. * Leverage lessons from registration scale batches and coordinate with Production/ Engineering team to drive procurement or modification of key manufacturing equipment to support commercial production. 3. Lead the planning and execution of process transfers and scale-up/ evaluation, process validation/ PPQ and commercial production/ CPV of new and existing products (3rd Party/ CMO, Transfer (In/ Out) Buy-ins, Inter-site etc.) following Hikma requirements; drive resolutions to complex process problems and influence teams to adopt solutions to meet commercialization/ product launch timelines/ deliverables. * Lead as a process champion/ point of contact for process validation (process design, PPQ, & CPV) / commercial production at Hikma * Lead proactive planning and strategies for the scale-up/ transfer/ validation lot manufacturing including commercial lot size determination, no. of lots for validation, documentation etc. to support product launch goals * Lead functional and cross-functional investigations in collaboration with Quality function of 3rd Party and Hikma to determine root causes, assess product impact, determine path forward, and develop/ implement CAPAs. Influence organizational partners to support these initiatives. * Lead process improvement/ optimization, CAPA, and other process changes during commercial manufacturing/ CPV stage. Influence organizational partners to support execution of these initiatives. * Coordinate with Quality/ Change Management, Drug Regulatory Affairs (DRA) etc. to lead the implementation of critical process changes (e.g. API/ raw materials, process parameters, batch size optimization etc.). * Lead the development of response strategies and corrective actions to resolve process quality/ product stability deviations on commercially marketed products in coordination with Quality, DRA, etc. * Support Life-Cycle Operations to plan and perform continuous process verification (CPV) or re-validation. 4. Mentor and develop other members of the Technical Services department and promote knowledge transfer within Technical Services. Act as a subject matter expert on core technologies and/or process engineering/ validation topics. * Identify and proactively create opportunities to mentor Process Engineer(s) on equipment/ process technologies, validation strategies, quality investigations/ CAPA, conflict management etc. * Lead knowledge sharing of best practices, quality and safety incidents, new process technologies, etc. within Technical Services organization. * Drive documentation to standardize best practices, and author Work Instructions, SOPs, etc. to support process documentation requirements under Hikma's quality management system. * Support Technical Services management to resolve complex challenges related to process/ equipment, validation, quality investigations etc. * Other duties as assigned 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: * B.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of six (6) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or nine (9) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering. * Alternatively, a M.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of four (4) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or seven (7) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering. * Alternatively, a Ph.D. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of two (2) year experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or three (3) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering. * Expert implementation knowledge of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including FDA, cGMP, DEA, OSHA and other applicable regulatory and company guidelines. * Expert knowledge of pharmaceutical formulation development, processing equipment, quality by design, and cGMP production with emphasis on scale-up/ optimization and validation. * Demonstrated ability to develop, scale-up, and/or validate pharmaceutical processes for unique and challenging dosage forms (e.g. tablets, capsules, combination products (nasals, dry powder inhalation etc.), creams/ ointments, soft gels, transdermal etc.); Demonstrate strong learning agility towards process technologies that are outside of previous experience. * Ability to travel (domestically and internationally) to external organizations/ companies for multiple days to support project deliverables. * Attention to detail to documentation to ensure quality and accuracy. * Conflict Management: Demonstrated ability to work with professionals/ teams with differing perspectives from external/ contract organizations from different regions (domestic and international) and achieve mutually acceptable solutions. * Experimental Methodology: Demonstrated ability to design complex experiments to support pharmaceutical development/process transfer/validation. * Complex Problem Solving: Expert knowledge of and ability to apply investigative techniques to uncover problem areas, determine root causes, and drive corrective actions at both the individual and cross-functional team level. * Situational leadership: Demonstrated ability to independently work with no or minimal supervision to make strategic decisions and execute tactical tasks of high complexity. * Teamwork: Demonstrated ability to be an influencing participant on teams of high complexity, and to lead/facilitate teams on tasks of high complexity. 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: Columbus, OH, US, 43228 Nearest Major Market: Columbus

As a family company, we serve people and communities. When you work at Meijer, you're provided with career and community opportunities centered around leadership, personal growth and development. Consider joining our family - take care of your career and your community! Meijer Rewards Weekly pay Scheduling flexibility Paid parental leave Paid education assistance Team member discount Development programs for advancement and career growth Please review the job profile below and apply today! The person selected for this position will be responsible for having basic pharmacy knowledge to provide customer service, to process and fill prescriptions, to provide third party functions, to manage inventory, and to provide clinical services. What You'll be Doing: Customer service. Communicating with patients in person and via telephone; assisting patients with product selection; obtaining medication prices (internally and from competitors) pursuant to patient requests. Processing and filling prescriptions. Using pharmacy computer system for prescription data entry & third party adjudication; pulling correct products from the shelf; counting and labeling prescriptions appropriately at fill station; receiving new prescriptions from patients, selling prescriptions to patients at the Will Call station. Third-party functions. Inventory management. Updating balance on hand (BOH); product ordering; looking up Meijer codes; checking-in and putting away orders; processing vendor charge backs (VCBs)/transfers/salvage. Clinical services. This job profile is not meant to be all inclusive of the responsibilities of this position; may perform other duties as assigned or required. What You Bring with You (Qualifications): Enrolled in an accredited pharmacy school. Pharmacy Intern License (state specific). Positive attitude. Excellent communication skills. Neat and legible penmanship. Organizational skills. Prioritization skills. Team-oriented mindset. Timeliness & dependability. Basic math skills. Drive to stay current and competent in all pharmacy-related functions. Excellent customer service skills. Empathy. Professional appearance. Understanding of the importance of patient confidentiality. Understanding of all patient care services available at Meijer Pharmacy. Knowledge of Third Party Help; prescription split billing. Knowledge of health screening tests available; knowledge of immunizations available; ability to perform health screening tests and immunizations after proper training and state-specific authorization; knowledge of MTM platforms and working under a pharmacist to perform these services when applicable & allowed. Knowledge of brand/generic medication names; knowledge of applicable medical/pharmacy terminology; knowledge about various dosage forms; ability to perform pharmaceutical calculations. Knowledge of MP6.

Job Description Primary Function Provides a positive patient experience with fair, friendly, empathetic, courteous, and quick service. Dispensary Agents are expected to be trained and competent to work in all areas of the dispensary. Essential Duties and Responsibilities Reception Enthusiastically greet every person coming through the door. Provide exceptional service for new patients, answering any questions they may. Verify patient/caregiver eligibility on Medical Marijuana Patient Registry Calculate patient's remaining day supply allotment. Maintain accurate records of patient's identification and registration documents, manage scheduling patient traffic flow, and respond to patient and caregiver inquiries. Ensure that all visitors coming into the store have signed the applicable visitor log. Maintain an organized environment and facility appearance. Comply with current policies and procedures and applicable state and local laws. Obtain the appropriate documentation from each patient and caregiver at every visit, ensuring validity of his or her identification, registration, and recommendation in the State's Patient Registry and within the store's POS system. Communicate with staff to maintain a steady patient traffic flow to maximize sales and patient satisfaction. Monitor patient intake and store's general customer service email, respond to and resolve patient requests, complaints, or compliments in person, through email, and on the phone requesting supervisor support as needed. Maintain organization of desk space and waiting room through daily upkeep and light cleaning Maintain a positive attitude while representing the Buckeye Relief/Amplify brand. Budtending Educate patient on medical cannabis, dose, dosage forms, and devices. Educate patient on the rules and regulations of the Medical Marijuana Control Program. Advise customers on suitable cannabis products based on their needs, preferences, budgets, and reactions to different strains of cannabis. Work closely with reception to maintain a steady patient traffic flow to maximize sales and patient satisfaction. Ensure that the dispensary is always clean and well-organized. Educate customers on the safe use of their selected cannabis products. Ensure the safety and satisfaction of both the patients and employees. Greet patients in welcoming manner. Maintain in-depth knowledge of products and strains in the store, as well as industry-wide product knowledge. Maintain in-depth knowledge of the current medical cannabis law, industry trends, and regulations, and communicate changes to staff and patients. Cashier Verify patient/caregiver identity by checking the patient's MMCP Registry Card and photo-ID. Retrieve the correct patient's order from the will-call area. Review the entire order with patient at the register for accuracy, ensuring all items in the order match what is in the patient's cart in the POS. Complete sales on a cash register, collects payment, and make change for cash customers. Resolve customer issues and answers questions. Balance cash drawer by counting cash at beginning and end of work shift. Maintain a safe and clean working environment by complying with procedures, rules, and regulations. Order Processing and Fulfillment Enthusiastically answer all incoming phone calls to the store to address any and all questions and to triage to a "tele-'tender" to assist patients calling to place a pre-order. Verify patient/caregiver eligibility on Medical Marijuana Patient Registry Calculate patient's remaining day supply allotment and ensures patient's order will not result in oversale. Build patient pre-orders submitted online and kiosk orders submitted in-store, using barcoding to ensure proper product selection. Print order labels and affix to correct products. Perform "tech-check-tech" before order is bagged (i.e. a budtender performs final accuracy checks on orders prepared by another budtender). Take inventory of cannabis products and communicates with inventory team to ensure that the fulfillment area is adequately stocked. Place completed orders in the will-call area and marks them in POS as ready for pickup. Prioritize workflow to ensure patient orders are ready when promised. Maintain a safe and clean working environment by complying with procedures, rules, and regulations. Qualifications and Education Requirements At least 21 years of age. Possess a high-school diploma or equivalent. Pass an FBI/BCI Background check. 1-2 years customer service experience strongly preferred. Previous cannabis industry experience, health-care experience, or hospitality experience is preferred but not required.

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit **************** Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Job Description Position: Key Account Manager Company: Azurity Pharmaceuticals Location: Ohio Valley- Detroit, Nashville, Columbus, Cincinnati About Azurity Pharmaceuticals Azurity Pharmaceuticals is a midsize, specialty pharmaceutical company dedicated to providing innovative and high-quality medicines that meet the unique needs of patients. We are driven by a commitment to access, innovation, and patient-focused solutions. Position Summary The Key Account Manager (KAM) will be a pivotal, field-based commercial leader responsible for developing and managing strategies to maximize utilization of Azurity's diverse portfolio of innovative medicines within assigned Integrated Delivery Networks and large Health Systems.This role requires a sophisticated understanding of the evolving healthcare landscape, with a particular emphasis on building strategic relationships to identify unmet needs within the four key therapeutic areas: Anti-infective, Gastroenterology, Respiratory, and Oncology. The KAM will drive strategic engagement with high-level IDN decision makers to co-create long-term value that aligns to Azurity's commitment to providing high-quality, user-friendly formulations for overlooked patients is met. Key Responsibilities Portfolio Access Strategy & Execution (60%) Develop and execute comprehensive IDN Account Business Plans that meet both company and customer objectives, focusing on growth, market access, and integration of Azurity's multi-therapeutic portfolio (Anti-infective, Gastroenterology, Respiratory, and Oncology). Develop and sustain customer stakeholder maps that align both internal and external teams to the current strategy as well as future growth opportunities. Engage in economic discussions and negotiations with health systems, helping clients understand the value proposition and financial impact. Needs assessment and solutions: Understand client needs and challenges to develop and present tailored solutions and customized services. Conduct in-depth analysis of IDN performance data, utilization trends, and barriers to develop targeted pull-through strategies. Clearly articulate the unique clinical and economic value proposition of Azurity's specialized dosage forms (e.g., oral solutions, suspensions, unique delivery systems) to IDN C-suite and D-suite stakeholders. Key Stakeholder Engagement & Relationship Management (25%) Establish and maintain strong, strategic relationships with key IDN stakeholders at each level to ensure long-term sustainable growth of Azurity's portfolio. Facilitate clinical pull-through of system strategy by partnering with Azurity's Field Sales team, market access, and medical affairs to educate providers on patient formulary status and patient clinical benefits across targeted therapeutic areas. Serve as the voice of the IDN customer internally, providing actionable market intelligence to inform internal strategies, launch planning, and future growth opportunities. Internal Collaboration (15%) Work cross-functionally with Market Access/Strategic Accounts, Commercial Sales, Medical Affairs, and Marketing to ensure successful execution of account plans and seamless coordination of service delivery at the highest level. Conducting strategic reviews with Azurity senior leadership to assess strategy deployment performance and ensure teams have clarity on resource needs, achievements, and barriers. Act as the subject matter expert on IDN market dynamics within the Anti-infective, Gastroenterology, Respiratory, and Oncology markets to provide valuable insights and advice to clients. Qualifications • Bachelor's degree required; advanced degree (MBA, MPH, PharmD) preferred. • 5+ years of experience in pharmaceutical market access, key account management, managed markets, or related field. • Strong understanding of U.S. payer, PBM, and specialty pharmacy landscape. • Proven track record of building relationships and negotiating access agreements with payer decision-makers. • Excellent communication, presentation, and analytical skills. • Ability to work independently in a fast-paced, remote environment while collaborating across a matrix organization. • Willingness to travel up to 30% domestically. #LI-Remote Physical & Mental Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to sit for long periods of time While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear May occasionally climb stairs and/or ride elevators The employee must occasionally lift and/or move up to 25 pounds Employee must be able to manipulate keyboard, operate a telephone and hand-held devices Other miscellaneous job duties as required Benefits We Offer: Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent. Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan. Fuel Your Success: * Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you. Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of. Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. * Excludes Sales, Manufacturing, and some Operations positions* Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%. Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date. Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge. Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays. Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications. Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work. The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here. The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).

may be performed remotely with travel to the Boston area as needed. Praxis is seeking a skilled and driven Process Engineer to partner closely with our Contract Manufacturing Organizations (CMOs) to validate and optimize drug product manufacturing processes-primarily oral dosage forms. You'll play a key role in ensuring readiness for future commercial production and maintaining appropriate supply levels. The right candidate brings hands-on engineering expertise, excels in leading day-to-day CMO communication, and serves as a trusted point of contact for seamless knowledge transfer between Praxis and our manufacturing partners. Primary Responsibilities: Ability to understand varied formulation processes and transfer drug product processes for industrialized execution by authoring scale up spreadsheets and process manuals. Efficient use of technologies and applications to gather, analyze and archive large data packages that can support regulatory filings. Review relevant documentation from CMOs and lab partners including instructions, procedures, batch records, non-conformances, in-process controls, bulletin of analysis, developmental reports. Work alongside Quality Assurance to ensure all proper regulations and standards are followed in all our processes being executed by third parties. Adhere to industry guidelines, standards and laws including being well-versed in cGMPs. Travel required - PIP at CMOs (US and worldwide) Qualifications and Key Success Factors: Advanced degree in chemical engineering, pharmaceutical sciences or other relevant engineering field, MS or equivalent a plus. Pharmaceutical industry experience required, e.g. process operations knowledge of sifting, milling, blending, roller compaction, tableting, coating among others. 8 years' with a BS degree or 6 years' with an MS degree of applied experience in CMO management, drug product manufacturing, or comparable positions that handle diverse environments, reviewing Manufacturing and Executed Batch records, operating procedures, non-conformances, change controls, and fostering business partner relationships. Excellent written and visual communication skills with an ability to build relationships internally and externally Self-motivated and able to contribute to a productive and collaborative team environment Highly organized and detail-oriented with a passion to deliver quality results Compensation & Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together! To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience. Annualized Base Salary$145,000-$167,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** As a Manufacturing Scientist II, you will lead and/or implement activities for the development of new and established manufacturing processes of solids, liquids, and semi-solid dosage forms. Project management skills will be applied to implement the scaling up manufacturing processes, supporting new product validations and post approval qualifications activities. This will require the writing, approval, and routing documents within a manufacturing setting. You will be the primary technical representative on client projects and will work closely work with internal and external project teams of analytical, quality, and project management representatives. Supporting process development and commercial activities will be required. Leads technical/scientific project activities and discussions to lead strategies and technical solutions that meet client needs and expectations. Investigates, creates, and validates new scientific and equipment methodologies for a diverse scope of projects. Using experimental design, established formulation processes for the following phases of product scale-up, registration, and validation. Creates processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Leads problem solving activities as necessary with independent judgement. Makes decisions that require choosing between multiple options or may develop new options to resolve moderately complex problems. Coaching Scientist I and Scientist II's will be required to provide guidance on assigned projects. Specific coaching in the areas of project pathways as projects may require selecting proper excipients, equipment, and process parameters on a supervisory level. Communicates up and down the internal management track to provide accurate and detailed progress of projects that focuses on timely completion of activities and critical turning points. + Time bound outlines to complete activities for the validation of new products and manufacturing processes of solids, liquids, and semi-solid dosage forms. + Leverage current leadership skills to provide support, mentoring and guidance to internal team members and clients for product and process development activities performed in commercial manufacturing areas. + Lead client calls as primary technical representative and provide scientific justification for the project decisions and recommendations. + Own the review and planning of all technical aspects of the project which includes prioritization of multiple projects or tasks to meet the appropriate timeline achievements. + Integrate risk-based approach during the scale up and commercialization of processes and develop appropriate mitigation strategies. + Draft quality batch production records, protocols, and reports to support product development, validation activities, and routine commercial batches. + Support routine manufacturing operations in order to assure timely release of products with appropriate quality attributes and providing stewardship for commercial products of responsibility. + Lead with project leadership skill required for daily meetings + Work independently within the Technical Services Department and work as team member within the department + Managing work independently with standard work planning and abilities to meet timelines established for projects. + Proficiencies of Leadership, Trust, Diversity and Focused behaviors are required for the position. + Quality attitude to be exemplified daily with standard work. + Outstanding team dynamics and idea generation is promoted. **How will you get here?** Education Bachelor's degree in chemical engineering (or other engineering field), chemistry, pharmacy, or other related science or technical field is required. Experience + Minimum of one (1) to three (3) years of experience in a manufacturing environment. + Experience in product or process development, including scale-up and technology transfer processes for both immediate and controlled release dosage forms preferred. + Project Management experience preferred Knowledge, Skills, Abilities + Understanding of Good Manufacturing Practices (GMP) and regulatory compliance. + Lead projects of moderate to high complexity in scope and compliance-related challenges to implementing processes to meet changing regulations. + Proficiency using Microsoft (MS) Office applications. + Good critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients. + Self-starter, mature, independent, and detailed oriented. + Ability to work in a fast-paced, results oriented, and structured environment. + Experience leading projects related to process development including scale-up production activities. + Effective time management, multi-tasking and prioritization skills to effectively run multiple projects. + Lead by example. + Courages and assumes challenges in a risk based approaches. + Transparent and knowledgeable in presenting project updates daily. + Diligent in team meetings and discussions. + Collaborate across multiple departments to reach goals and objectives. + Inclusive with communication styles and ideas. + Conscientious to fellow peers with work load requirements. + Coordinate and lead weekly meetings with customers. + Fast and focused execution of tasks will be required at time. + Build helpful ideas to increase production efficiencies. + Technical skill information transferred to supporting departments. + Participate and support audit participation and interaction for regulatory agencies. + Develop and transform learning to peers with technical and mechanical result oriented aptitudes. + Written communication skills expected and presentation will be expected. Equivalent combinations of education, training, and meaningful work experience may be considered. **Physical Requirements:** Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically, manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. At Thermo Fisher Scientific, each one of our 100,000 outstanding minds has a unique story to tell. Join us and chip in to our unusual mission-enabling our customers to make the world healthier, cleaner and safer. Apply today: **************************** Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual Orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Job Summary: The Manufacturing Science and Technology Engineer will be critical in supporting the manufacturing processes of oral solid dosage forms. This position involves ensuring efficient and compliant production, troubleshooting technical issues, and driving continuous improvement initiatives. Key Responsibilities: Process Support: Provide technical support for the manufacturing of oral solid dosage forms, ensuring processes are efficient, compliant, and meet quality standards. Technology Transfer: Collaborate with cross-functional teams to facilitate the transfer of new processes and products into commercial manufacturing. Troubleshooting: Identify and resolve technical issues related to equipment, processes, and materials to minimize production downtime. Continuous Improvement: Lead and participate in continuous improvement projects to enhance process efficiency, product quality, and cost-effectiveness. Documentation: Author and review technical documents, including batch records, standard operating procedures (SOPs), and technical reports. Compliance: Ensure all manufacturing activities comply with regulatory requirements, Good Manufacturing Practices (GMP), and company policies. Data Analytics: Analyze process data to identify trends, optimize processes, and support decision-making. Collaboration: Work closely with Manufacturing, Quality Assurance, Quality Control, Supply Chain, Process Development and other departments to ensure seamless operations and new improvement/technology installation. Qualifications: Education: Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field. Experience: Minimum of 5-10 years of experience in pharmaceutical manufacturing, with a technical focus on oral solid dosage forms. Technical Skills: Strong understanding of OSD manufacturing processes, equipment, and technologies. Proficiency in data analysis and process optimization. Familiarity with JMP stats software and coding in JSL, SQL, JAVA, HTML, and/or Python is desired. Problem-Solving: Excellent troubleshooting and problem-solving skills. Communication: Strong written and verbal communication skills. Ability to work effectively with both technical and non-technical teammates. Regulatory Knowledge: Familiarity with GMP, FDA regulations, and other relevant industry standards.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders. Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. **Responsibilities and Accountabilities:** **Strategic Leadership:** + Define and implement global CMC regulatory strategies with a strong focus on North American requirements. + Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU. **Policy & Advocacy:** + Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. + Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. **Cross-Functional Collaboration:** + Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. + Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions. **External Engagement:** + Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. + Lead advocacy initiatives for innovative technologies and precedent-setting projects. **Operational Excellence:** + Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). + Ensure consistency and quality in dossier preparation across regions. **Expected Key Accountabilities from Global Regulatory Aspects** + Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. + Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. + Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities. + Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. + Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. + Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects. + Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. + Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. + Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. + Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions. + Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility. **Required** + Advanced degree in Chemistry, Engineering or equivalent degree (PhD, PharmD, MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotech industry, with significant exposure to North American regulatory requirements. + Proven track record in developing and implementing global CMC strategies and influencing regulatory policy. + Strong knowledge of FDA, ICH and global guidelines; prior experience in ICH initiatives highly desirable. + Expert technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and an in-depth knowledge of global regulatory CMC submission requirements, with a strong understanding of the application of ICH and other guidance. + Exceptional communication and leadership skills; ability to influence internal and external stakeholders. + Experience representing companies in trade associations and industry forums. + Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope. + Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral + dosage forms) is required. + Demonstrated track record for successful interactions with global health authorities related to CMC submissions. + Ability to navigate a global organization and to act globally and regionally as appropriate. + Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders in high impact situations. + Proven leadership skills is preferred. **Salary Range** $170,450 - $267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Regulatory CMC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Part time Shift: Other (United States of America) Hours per week: 0 Job Information Exemption Status: Non-Exempt Under the supervision of a registered pharmacist, will assist in the non-judgmental aspects of preparing medications for dispensing and assist in clinical pharmacy operations. Will provide services to patients from birth to death. Education Qualifications High School Diploma / GED Required Completion of a vocational training program. Preferred Experience Qualifications 1 year Experience as a pharmacy technician in any pharmacy practice setting. Preferred Skills and Abilities Excellent customer service skills (Required proficiency) Knowledge of specialty disease states and medications. (Preferred proficiency) Knowledge of pharmacy reimbursement and PA process. (Preferred proficiency) Knowledge of medical and pharmaceutical knowledge. (Preferred proficiency) Licenses and Certifications National Technician Certification recognized by the Kansas State Board of Pharmacy is required. Must also be registered with the Kansas Board of Pharmacy. What you will do In addition to pharmacy tech 1 essential duties and responsibilities, must meet qualifications to check the work of other technicians when applicable (Tech-Check-Tech). Manipulate and re-package hazardous and non-hazardous dosage forms following procedure. Specialized training & competency in hazardous and non-hazardous sterile compounding as assigned. Competency in at least one decentralized pharmacy space (OR, ED, etc.) in addition to basic central pharmacy operations or the assigned area. Specialty Technicians: Serves as a liaison between physician clinic staff, specialty pharmacy, and other stakeholders to develop and maintain a strong and collaborative partnership between the businesses. Identifies opportunities for the Stormont Vail Specialty Pharmacy to partner with prescribers in the development of new initiatives and avenues of service. Complies with HIPAA/HITECH regulations. Specialty Technicians: Ensures accuracy of prescription and patient data entered into various systems; verifying patient, drug, quantities, directions, days' supply, supplies, insurance, and physician data. Reviews all pertinent medical documentation from physician offices and other healthcare facilities, and clarifies prescription orders with pharmacist and/or clinician as appropriate. Works with payers to resolve insurance related issues, assists patients with financial assistance as needed. Required for All Jobs Complies with all policies, standards, mandatory training and requirements of Stormont Vail Health Performs other duties as assigned Patient Facing Options Position is Patient Facing Remote Work Guidelines Workspace is a quiet and distraction-free allowing the ability to comply with all security and privacy standards. Stable access to electricity and a minimum of 25mb upload and internet speed. Dedicate full attention to the job duties and communication with others during working hours. Adhere to break and attendance schedules agreed upon with supervisor. Abide by Stormont Vail's Remote Worker Policy and will review and acknowledge the Remote Work Agreement annually. Remote Work Capability On-Site; No Remote Scope No Supervisory Responsibility No Budget Responsibility No Budget Responsibility Physical Demands Balancing: Occasionally 1-3 Hours Carrying: Occasionally 1-3 Hours Climbing (Ladders): Rarely less than 1 hour Climbing (Stairs): Occasionally 1-3 Hours Crawling: Rarely less than 1 hour Crouching: Occasionally 1-3 Hours Driving (Automatic): Rarely less than 1 hour Driving (Standard): Rarely less than 1 hour Eye/Hand/Foot Coordination: Frequently 3-5 Hours Feeling: Frequently 3-5 Hours Grasping (Fine Motor): Frequently 3-5 Hours Grasping (Gross Hand): Frequently 3-5 Hours Handling: Frequently 3-5 Hours Hearing: Frequently 3-5 Hours Kneeling: Rarely less than 1 hour Lifting: Occasionally 1-3 Hours up to 50 lbs Operate Foot Controls: Rarely less than 1 hour Pulling: Occasionally 1-3 Hours up to 10 lbs Pushing: Occasionally 1-3 Hours up to 10 lbs Reaching (Forward): Frequently 3-5 Hours up to 10 lbs Reaching (Overhead): Frequently 3-5 Hours up to 10 lbs Repetitive Motions: Frequently 3-5 Hours Sitting: Occasionally 1-3 Hours Standing: Frequently 3-5 Hours Stooping: Occasionally 1-3 Hours Talking: Frequently 3-5 Hours Walking: Frequently 3-5 Hours Physical Demand Comments: The employee is occasionally required to lift up to 50 pounds, with frequent lifting and/or carrying of objects weighing up to 10 pounds. Clarity of vision at 20 inches or less and the ability to identify and distinguish colors is essential. Working Conditions Burn: Rarely less than 1 hour Chemical: Rarely less than 1 hour Combative Patients: Occasionally 1-3 Hours Dusts: Rarely less than 1 hour Electrical: Rarely less than 1 hour Explosive: Rarely less than 1 hour Extreme Temperatures: Rarely less than 1 hour Infectious Diseases: Occasionally 1-3 Hours Mechanical: Rarely less than 1 hour Needle Stick: Occasionally 1-3 Hours Noise/Sounds: Occasionally 1-3 Hours Other Atmospheric Conditions: Rarely less than 1 hour Poor Ventilation, Fumes and/or Gases: Rarely less than 1 hour Radiant Energy: Rarely less than 1 hour Risk of Exposure to Blood and Body Fluids: Occasionally 1-3 Hours Risk of Exposure to Hazardous Drugs: Occasionally 1-3 Hours Hazards (other): Rarely less than 1 hour Vibration: Rarely less than 1 hour Wet and/or Humid: Rarely less than 1 hour Stormont Vail is an equal opportunity employer and adheres to the philosophy and practice of providing equal opportunities for all employees and prospective employees, without regard to the following classifications: race, color, ethnicity, sex, sexual orientation, gender identity and expression, religion, national origin, citizenship, age, marital status, uniformed service, disability or genetic information. This applies to all aspects of employment practices including hiring, firing, pay, benefits, promotions, lateral movements, job training, and any other terms or conditions of employment. Retaliation is prohibited against any person who files a claim of discrimination, participates in a discrimination investigation, or otherwise opposes an unlawful employment act based upon the above classifications.

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Manufacturing Project Manager position summary: We are seeking a skilled Manufacturing Project Manager with hands-on experience in solid dosage form pharmaceutical manufacturing to join our team. The ideal candidate will have a strong technical background in process design, optimization, and troubleshooting for solid oral dosage forms, including granulation, spray drying, tablet compression, and coating operations. This role will support both day-to-day manufacturing activities and capital or process improvement projects to enhance product quality, process robustness, and operational efficiency. Key Responsibilities: Provide technical support for the manufacturing of solid dosage forms, ensuring processes operate safely, efficiently, and in compliance with cGMP regulations Lead or support process improvement and scale-up projects for granulation, spray drying, compression, and coating operations Conduct process investigations, identify root causes, and implement corrective/preventive actions to resolve manufacturing issues Develop and optimize process parameters to achieve consistent product quality and yield Prepare and review process documentation including batch records, SOPs, validation protocols/reports, and change control documents Collaborate with cross-functional teams (R&D, Quality, Validation, Maintenance, and Production) to ensure successful technology transfer and process validation Support equipment qualification and process validation activities for new or modified equipment/processes Analyze production data, generate reports, and recommend process or equipment improvements to enhance performance and efficiency Ensure compliance with all safety and regulatory requirements within the manufacturing environment Qualifications: Bachelor's degree (or higher) in Chemical Engineering, Pharmaceutical Sciences, Mechanical Engineering, or related field Minimum 3 years of hands-on experience in solid dosage form manufacturing (pharmaceutical industry required) Strong knowledge of granulation, spray drying, tablet compression, and tablet coating processes Familiarity with cGMP, FDA, and EMA regulatory requirements Excellent problem-solving, analytical, and communication skills Proven ability to work independently and in cross-functional teams within a fast-paced manufacturing environment Proficiency with process data analysis tools and process control systems preferred Onsite requirement in Indianapolis, IN Preferred Qualifications: Experience with fluid bed granulation and/or spray drying systems Direct involvement in tablet compression and film coating process development or troubleshooting Exposure to process validation, technology transfer, and scale-up activities For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. *Verista is an equal opportunity employer. National (US) Range$85,000-$136,225 USD Benefits Why Choose Verista? High growth potential and fast-paced organization with a people-focused culture Competitive pay plus performance-based incentive programs Company-paid Life, Short-Term, and Long-Term Disability Insurance. Medical, Dental & Vision insurances FSA, DCARE, Commuter Benefits Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account 401(k) Retirement Plan (Employer Matching benefit) Paid Time Off (Rollover Option) and Holidays As Needed Sick Time Tuition Reimbursement Team Social Activities (We have fun!) Employee Recognition Employee Referral Program Paid Parental Leave and Bereavement Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. For more information about our company, please visit us at Verista.com

Job Title: Principal Scientist, Drug Product Design (Remote) Reports to: Senior Director, Drug Product Design About Us: At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged, it's celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you! The Role: We're looking for a passionate and curious, Principal Scientist to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a Principal Scientist at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It's a role where your curiosity will fuel both your personal growth and the success of the team. What You'll Do: * Dive deep into drug product manufacturing process development, process technical transfer, and GMP manufacturing of biologics, always looking for ways to improve efficiency, reduce risk, and innovate. * Identify, review contracts, and maintain relationships with existing and future drug product manufacturers. * Provide technical oversight for drug product manufacturing activities (including person-in-plant responsibilities), bringing fresh perspectives to manufacturing process development and technical transfer that challenge the status quo. * Collaborate with cross-functional teams and external clients to ensure technical success and uninterrupted supply of drug product. Represent the Drug Product Design function on internal teams and external partnerships. * Keep up with the latest trends and developments in GMP drug product manufacturing and use your knowledge and experience to inspire and influence both internal and external stakeholders. * Travel: 10-25% to manufacturing sites for client products. Who You Are: * A recognized expert in drug product manufacturing of sterile dosage forms, including frozen, liquid, and lyophilized formulations in vials, pre-filled syringes, and cartridges. * A curious problem-solver with knowledge of analytical techniques for product and process characterization enabling continuous learning and growth in a dynamic environment. * Someone who is experienced with Quality Management Systems and other GxP systems to support GMP manufacturing. * A self-starter who is comfortable with ambiguity and thrives in environments where curiosity and experimentation are encouraged. * Excellent communicator, both verbally and in writing, able to gain alignment and advance project goals in multi-company collaborations * Knowledgeable of global regulatory expectations for the development and manufacturing of biologic drug products and biosimilars. Why Join Us: * Growth Opportunities: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow. * Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life, with hybrid work schedules in many of our various locations. * Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged. * Innovative Projects: You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. * A Place for Big Ideas: We don't just talk about thinking outside the box-we throw the box away. If you've got ideas, we want to hear them. Are You Still Curious? If you've read this far, then chances are you've got a curious mind, just like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads you and how it will shape the future of Just-Evotec. Let your curiosity guide your career. #BeCurious and explore the endless possibilities at Just-Evotec! The base pay range for this position at commencement of employment is expected to be $145,000 to $170,000; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Commercial Manufacturing Validation. This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. Job Duties and Responsibilities Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. Lead/support technical transfers activities from a validation and compliance perspective. Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. Lead author for applicable sections in regulatory submissions. Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). As needed, work as a member of SMPA's cross-functional product development teams. Perform other duties as assigned. Key Core Competencies Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. Must have strong analytical, problem solving, and statistical analysis capabilities. Ability to work effectively in a global cross-functional team environment. Ability to work across locations and time zones. Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. Excellent written and oral communication skills. Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. Education and Experience Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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 continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Process Engineer - Technical Services. In this role, you will be responsible for Leading the Registration/ Process Validation (Process Design, Process performance qualification, & Continuous Process Verification)/ Process transfer of in-house products (on-site development/ transferred or procured filings/ re-launch etc.) and champion cross coordination with multiple groups and alignment with Hikma's quality/ compliance requirements. Leading the transfer of 3rd party/ CMO products (externally contracted for development/ manufacturing/ testing, Buy-ins, Site Transfers (in/ out), life-cycle) from R&D to Commercial Operations as a Process Champion from Hikma. Developing and executing production strategies (e.g batch record documentation, GMP systems set-up etc.) for evaluation, scale-up, process validation, site transfer (in/out), and lifecycle products of multiple dosage forms (solids, non-solids, semi-solids, nasals, inhalation, etc.). Coordinating agency (e.g. FDA) submission documentation requirements, quality investigations, process change management, and project communications during development/ transfer/ launch/ life-cycle projects. Mentoring junior process engineers and share best practices within Technical Services to continuously grow talent and enhance productivity. Key Responsibilities: 1. Consult as Process and Formulation Champion on cGMP/ FDA/ Hikma quality requirements and execute process registration (ANDA, NDA, PAS, etc.)/ scale-up/ validation and commercial production for 3rd Party/ CMO & in-house products during project selection, process development, filing, transfer, evaluation, launch and life-cycle phase. Lead as Hikma's Technical Services representative for in-house process flow & equipment requirements for different products (solids, non-solids, nasals, inhalation, etc.) and spearhead 3rd Party/ CMO site visits, process and equipment requirements, and other technical considerations during project selection, and execution. Drive gap and risk assessments including statistical data analysis for process scale-up, and process design/ improvement initiatives (e.g. PAT, DOE) during development/ registration/ transfer and lead mitigation and implementation activities. Lead strategy development for filing and validation (e.g. lot sizes, number of lots, sampling plan etc.) and drive requirements (e.g. protocols, batch records, etc.) for registration scale-up, evaluation, transfer, and process validation batch production. Create and/ or review documentation (e.g. Master Manufacturing Formula/ batch records, protocols/ reports, technical justifications for matrix approach etc.), and master data for production of batches for registration/ filing/ scale-up, evaluation, and process validation Travel to 3rd party locations as lead representative of Process Transfer - Technical Services during registration/ evaluation/ scale-up/ process transfer/ validation/ commercial lot manufacturing to provide subject matter expertise and technical support on process and quality requirements of Hikma to mitigate risks during commercial production. 2. Lead process development, registration, and FDA filing tasks with R&D and project teams from 3rdparty/ CMO and Hikma to establish robust control strategy for future commercial process. Collaborate with stakeholders (e.g. Product Development, Production etc.) during development, pilot lot production, registration, etc. to optimize or develop product formulation, and process flow, and resolve complex issues relating to CPPs, CQAs, AQL, analytical methods/ testing, quality deviations and other process risks. Collaborate with Analytical Development, Quality labs etc. to set-up testing requirements for in-process controls, release and stability; influence in establishing product specifications based on process and data trends. Co-lead with Product Development to generate development/ registration QbD reports and ensure robust documentation of development history/data prior to process validation/ PPQ. Collaborate with Drug Regulatory Affairs (DRA) at 3rd Party/ CMO and Hikma to author/ or review documentation required for product filing (ANDAs, NDAs, PAS, CRLs, and other FDA correspondences) to support timely approvals. Leverage lessons from registration scale batches and coordinate with Production/ Engineering team to drive procurement or modification of key manufacturing equipment to support commercial production. 3. Lead the planning and execution of process transfers and scale-up/ evaluation, process validation/ PPQ and commercial production/ CPV of new and existing products (3rd Party/ CMO, Transfer (In/ Out) Buy-ins, Inter-site etc.) following Hikma requirements; drive resolutions to complex process problems and influence teams to adopt solutions to meet commercialization/ product launch timelines/ deliverables. Lead as a process champion/ point of contact for process validation (process design, PPQ, & CPV) / commercial production at Hikma Lead proactive planning and strategies for the scale-up/ transfer/ validation lot manufacturing including commercial lot size determination, no. of lots for validation, documentation etc. to support product launch goals Lead functional and cross-functional investigations in collaboration with Quality function of 3rd Party and Hikma to determine root causes, assess product impact, determine path forward, and develop/ implement CAPAs. Influence organizational partners to support these initiatives. Lead process improvement/ optimization, CAPA, and other process changes during commercial manufacturing/ CPV stage. Influence organizational partners to support execution of these initiatives. Coordinate with Quality/ Change Management, Drug Regulatory Affairs (DRA) etc. to lead the implementation of critical process changes (e.g. API/ raw materials, process parameters, batch size optimization etc.). Lead the development of response strategies and corrective actions to resolve process quality/ product stability deviations on commercially marketed products in coordination with Quality, DRA, etc. Support Life-Cycle Operations to plan and perform continuous process verification (CPV) or re-validation. 4. Mentor and develop other members of the Technical Services department and promote knowledge transfer within Technical Services. Act as a subject matter expert on core technologies and/or process engineering/ validation topics. Identify and proactively create opportunities to mentor Process Engineer(s) on equipment/ process technologies, validation strategies, quality investigations/ CAPA, conflict management etc. Lead knowledge sharing of best practices, quality and safety incidents, new process technologies, etc. within Technical Services organization. Drive documentation to standardize best practices, and author Work Instructions, SOPs, etc. to support process documentation requirements under Hikma's quality management system. Support Technical Services management to resolve complex challenges related to process/ equipment, validation, quality investigations etc. Other duties as assigned 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: B.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of six (6) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or nine (9) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering. Alternatively, a M.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of four (4) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or seven (7) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering. Alternatively, a Ph.D. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of two (2) year experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or three (3) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering. Expert implementation knowledge of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including FDA, cGMP, DEA, OSHA and other applicable regulatory and company guidelines. Expert knowledge of pharmaceutical formulation development, processing equipment, quality by design, and cGMP production with emphasis on scale-up/ optimization and validation. Demonstrated ability to develop, scale-up, and/or validate pharmaceutical processes for unique and challenging dosage forms (e.g. tablets, capsules, combination products (nasals, dry powder inhalation etc.), creams/ ointments, soft gels, transdermal etc.); Demonstrate strong learning agility towards process technologies that are outside of previous experience. Ability to travel (domestically and internationally) to external organizations/ companies for multiple days to support project deliverables. Attention to detail to documentation to ensure quality and accuracy. Conflict Management: Demonstrated ability to work with professionals/ teams with differing perspectives from external/ contract organizations from different regions (domestic and international) and achieve mutually acceptable solutions. Experimental Methodology: Demonstrated ability to design complex experiments to support pharmaceutical development/process transfer/validation. Complex Problem Solving: Expert knowledge of and ability to apply investigative techniques to uncover problem areas, determine root causes, and drive corrective actions at both the individual and cross-functional team level. Situational leadership: Demonstrated ability to independently work with no or minimal supervision to make strategic decisions and execute tactical tasks of high complexity. Teamwork: Demonstrated ability to be an influencing participant on teams of high complexity, and to lead/facilitate teams on tasks of high complexity. 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.

Title: Certified Pharmacy Tech II Department Org: Pharmacy - 110130 Employee Classification: B5 - Unclass Full Time AFSCME HSC Bargaining Unit: AFSCME HSC Primary Location: HSC H Shift: 1 Start Time: 0600 End Time: 1430 Posted Salary: $22.62 - $26.07 Float: True Rotate: True On Call: False Travel: False Weekend/Holiday: True Job Description: The Certified Pharmacy Technician II is responsible for performing tasks involving the dispensing, reconciliation, distribution and charging of drugs. This position assists the pharmacist in maintaining quality pharmacy services in compliance with laws set forth by the Ohio State Board of Pharmacy to ensure in proper storage, compounding, packaging, labeling, and record keeping associated with drugs. The technician will collaborate and communicate with patients, caregivers, health care professionals and the public. Minimum Qualifications: • Must hold current and unrestricted registration with the Ohio State Board of Pharmacy as a Certified Pharmacy Technician. • Technician certification required by Pharmacy Technician Certification Board (PTCB) or equivalent • 2 years' experience. • Ability to communicate and interact effectively, professionally and courteously with other health care professionals, patients and members of the University community. • Knowledge of metric system, along with names, strength and dosage forms of medications, and common medical abbreviations. • Strong computer skills. • Must provide excellent customer service and present a positive public image. • Must be able to withstand pressure due to work volume, interruptions, pace, job variety with an expected degree of accuracy. Preferred Qualifications: • Recent relative pharmacy experience preferred. • Knowledge of purchasing and inventory management skills preferred. • Knowledge of charging and billing preferred. Conditions of Employment: To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. Pre-employment health screening requirements for the University of Toledo Health Science Campus Medical Center will include drug and other required health screenings for the position. Equal Employment Opportunity Statement: The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation. The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect. The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact HR Compliance at ************************ or ************ between the hours of 8:30 a.m. and 5 p.m. or apply online for an accommodation request. Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the UToledo Main Campus.

As a Manufacturing Scientist II, you will lead and/or implement activities for the development of new and established manufacturing processes of solids, liquids, and semi-solid dosage forms. Project management skills will be applied to implement the scaling up manufacturing processes, supporting new product validations and post approval qualifications activities. This will require the writing, approval, and routing documents within a manufacturing setting. You will be the primary technical representative on client projects and will work closely work with internal and external project teams of analytical, quality, and project management representatives. Supporting process development and commercial activities will be required. Leads technical/scientific project activities and discussions to lead strategies and technical solutions that meet client needs and expectations. Investigates, creates, and validates new scientific and equipment methodologies for a diverse scope of projects. Using experimental design, established formulation processes for the following phases of product scale-up, registration, and validation. Creates processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Leads problem solving activities as necessary with independent judgement. Makes decisions that require choosing between multiple options or may develop new options to resolve moderately complex problems. Coaching Scientist I and Scientist II's will be required to provide guidance on assigned projects. Specific coaching in the areas of project pathways as projects may require selecting proper excipients, equipment, and process parameters on a supervisory level. Communicates up and down the internal management track to provide accurate and detailed progress of projects that focuses on timely completion of activities and critical turning points. * Time bound outlines to complete activities for the validation of new products and manufacturing processes of solids, liquids, and semi-solid dosage forms. * Leverage current leadership skills to provide support, mentoring and guidance to internal team members and clients for product and process development activities performed in commercial manufacturing areas. * Lead client calls as primary technical representative and provide scientific justification for the project decisions and recommendations. * Own the review and planning of all technical aspects of the project which includes prioritization of multiple projects or tasks to meet the appropriate timeline achievements. * Integrate risk-based approach during the scale up and commercialization of processes and develop appropriate mitigation strategies. * Draft quality batch production records, protocols, and reports to support product development, validation activities, and routine commercial batches. * Support routine manufacturing operations in order to assure timely release of products with appropriate quality attributes and providing stewardship for commercial products of responsibility. * Lead with project leadership skill required for daily meetings * Work independently within the Technical Services Department and work as team member within the department * Managing work independently with standard work planning and abilities to meet timelines established for projects. * Proficiencies of Leadership, Trust, Diversity and Focused behaviors are required for the position. * Quality attitude to be exemplified daily with standard work. * Outstanding team dynamics and idea generation is promoted. How will you get here? Education Bachelor's degree in chemical engineering (or other engineering field), chemistry, pharmacy, or other related science or technical field is required. Experience * Minimum of one (1) to three (3) years of experience in a manufacturing environment. * Experience in product or process development, including scale-up and technology transfer processes for both immediate and controlled release dosage forms preferred. * Project Management experience preferred Knowledge, Skills, Abilities * Understanding of Good Manufacturing Practices (GMP) and regulatory compliance. * Lead projects of moderate to high complexity in scope and compliance-related challenges to implementing processes to meet changing regulations. * Proficiency using Microsoft (MS) Office applications. * Good critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients. * Self-starter, mature, independent, and detailed oriented. * Ability to work in a fast-paced, results oriented, and structured environment. * Experience leading projects related to process development including scale-up production activities. * Effective time management, multi-tasking and prioritization skills to effectively run multiple projects. * Lead by example. * Courages and assumes challenges in a risk based approaches. * Transparent and knowledgeable in presenting project updates daily. * Diligent in team meetings and discussions. * Collaborate across multiple departments to reach goals and objectives. * Inclusive with communication styles and ideas. * Conscientious to fellow peers with work load requirements. * Coordinate and lead weekly meetings with customers. * Fast and focused execution of tasks will be required at time. * Build helpful ideas to increase production efficiencies. * Technical skill information transferred to supporting departments. * Participate and support audit participation and interaction for regulatory agencies. * Develop and transform learning to peers with technical and mechanical result oriented aptitudes. * Written communication skills expected and presentation will be expected. Equivalent combinations of education, training, and meaningful work experience may be considered. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically, manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. At Thermo Fisher Scientific, each one of our 100,000 outstanding minds has a unique story to tell. Join us and chip in to our unusual mission-enabling our customers to make the world healthier, cleaner and safer. Apply today: **************************** Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual Orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Manufacturing Project Manager position summary: We are seeking a skilled Manufacturing Project Manager with hands-on experience in solid dosage form pharmaceutical manufacturing to join our team. The ideal candidate will have a strong technical background in process design, optimization, and troubleshooting for solid oral dosage forms, including granulation, spray drying, tablet compression, and coating operations. This role will support both day-to-day manufacturing activities and capital or process improvement projects to enhance product quality, process robustness, and operational efficiency. Key Responsibilities: Provide technical support for the manufacturing of solid dosage forms, ensuring processes operate safely, efficiently, and in compliance with cGMP regulations Lead or support process improvement and scale-up projects for granulation, spray drying, compression, and coating operations Conduct process investigations, identify root causes, and implement corrective/preventive actions to resolve manufacturing issues Develop and optimize process parameters to achieve consistent product quality and yield Prepare and review process documentation including batch records, SOPs, validation protocols/reports, and change control documents Collaborate with cross-functional teams (R&D, Quality, Validation, Maintenance, and Production) to ensure successful technology transfer and process validation Support equipment qualification and process validation activities for new or modified equipment/processes Analyze production data, generate reports, and recommend process or equipment improvements to enhance performance and efficiency Ensure compliance with all safety and regulatory requirements within the manufacturing environment Qualifications: Bachelor's degree (or higher) in Chemical Engineering, Pharmaceutical Sciences, Mechanical Engineering, or related field Minimum 3 years of hands-on experience in solid dosage form manufacturing (pharmaceutical industry required) Strong knowledge of granulation, spray drying, tablet compression, and tablet coating processes Familiarity with cGMP, FDA, and EMA regulatory requirements Excellent problem-solving, analytical, and communication skills Proven ability to work independently and in cross-functional teams within a fast-paced manufacturing environment Proficiency with process data analysis tools and process control systems preferred Onsite requirement in Indianapolis, IN Preferred Qualifications: Experience with fluid bed granulation and/or spray drying systems Direct involvement in tablet compression and film coating process development or troubleshooting Exposure to process validation, technology transfer, and scale-up activities For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. *Verista is an equal opportunity employer. National (US) Range$85,000-$136,225 USD Benefits Why Choose Verista? High growth potential and fast-paced organization with a people-focused culture Competitive pay plus performance-based incentive programs Company-paid Life, Short-Term, and Long-Term Disability Insurance. Medical, Dental & Vision insurances FSA, DCARE, Commuter Benefits Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account 401(k) Retirement Plan (Employer Matching benefit) Paid Time Off (Rollover Option) and Holidays As Needed Sick Time Tuition Reimbursement Team Social Activities (We have fun!) Employee Recognition Employee Referral Program Paid Parental Leave and Bereavement Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. For more information about our company, please visit us at Verista.com