Promaxo jobs in Oakland, CA - 199 jobs

By Hello Promaxo / October 15, 2025 Role Promaxo is seeking an organized, hands-on Supply Chain Engineer to help scale purchasing, supplier management, and production readiness for our novel MRI-guided intervention technology. You'll partner closely with New Product Introduction (NPI) and Manufacturing teams to mature processes, qualify suppliers, and ensure parts and assemblies flow on time, at the right quality and cost-inside a fast-moving startup environment. Responsibilities * Build and maintain purchasing & supplier management processes (from RFQ through PO, receipt, and reconciliation). * Continuously assess, qualify, and develop suppliers; identify new sources to optimize cost, quality, and lead time. * Drive supplier quality: implement proactive controls, manage FACAs/SCARs, and lead cost/quality/process improvements. * Own and maintain multi-level Bills of Materials (BOMs) and associated part metadata. * Plan, perform, and manage purchasing to meet build schedules; optimize inventory levels vs. production demand. * Track and report supply-chain KPIs (OTD, PPV, supplier quality metrics) to senior leadership; escalate risks early. * Lead negotiations and day-to-day supplier interfaces; resolve part availability and fulfillment issues. * Define and improve internal operations workflows across the broader supply chain and related processes. Required Qualifications * Bachelor's degree in Industrial, Mechanical, Manufacturing, Biomedical, or Electrical Engineering, or a related field such as Supply Chain or Operations Management. * 3+ years of hands-on supply chain experience within a relevant engineering product company. * Proven ownership of purchasing and supplier management processes. * Experience with ERP/MRP systems (e.g., NetSuite, SAP, or equivalent). * Proficiency in Excel, Power BI, or data analytics tools for supplier performance and cost tracking. * Demonstrated ability to build/maintain product BOMs, track inventory, and support production schedules. * Comfortable working cross-functionally in multidisciplinary teams (ideally medical/regulated environments). Preferred Qualifications * Experience in medical device manufacturing and/or regulated quality environments (e.g., familiarity with ISO 13485, supplier qualification, and documentation best practices). * Exposure to NPI transitions (prototype → pilot → production) and supplier scaling. * Understanding of risk management principles (ISO 14971) and supplier controls in regulated manufacturing. * Knowledge of Lean Manufacturing or Six Sigma principles for continuous improvement. * Strong documentation discipline and familiarity with engineering change control (ECO/ECR). * Excellent communication and vendor negotiation skills. * Data fluency with spreadsheet/ERP tools; ability to automate dashboards or metrics reporting is a plus. Salary range: $100,000 - $150,000 Fully on-site. Send resume to: **************

table.MiTabla { max-width: 1020px;!important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. JOB TITLE: OPERATIONS MANAGER ESTIMATED SALARY RANGE: $65,280.00 - $97,920.00 per year, depending on training, education, and experience. This position is eligible to participate in up to 20% of the company bonus pool. SIGN-ON BONUS & RELOCATION ASSISTANCE! This position is eligible for an sign-on bonus of $8K and relocation assistance of up to $20K! The Operations Manager is a key member of the donor center leadership team, responsible for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance, and achievement of production goals. This role provides direct leadership to frontline staff across donor floor operations and ensures all center activities align with company standards, SOPs, and applicable regulatory requirements. Summary: Assists with operational management of a Plasma Collection Center, ensuring compliance with all applicable policies and regulations and overall performance and profitability of the center. Acts on behalf of the Center Manager in his/her absence, may manage the center alone for days at a time. This position will manage employees in centers with over 50,000 liters. Primary Responsibilities: Responsible for all aspects of the donor center when the Center Manager is not present. Collaborates with Training and Quality staff to ensure that training and quality goals are met. Coaches and leads through effective feedback to employees through the Operations Supervisor(s). Monitor and evaluate operations. Works with the Center Manager to develop action plans to maximize center efficiency and supervises the implementation of improvements. Makes critical decisions for the modifications of action plans. Responsible for all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records Partners with the Center Manager in budget preparation and oversees facility to achieve production targets and quality goals at the agreed-upon cost structure. Actively delegates, monitors, and holds responsible the operations supervisors for their performance. Direct and supervise employees. This includes creating and managing work schedules. Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises. Other Responsibilities: Assures center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order. Responsible for freezer management, including overseeing plasma shipments and equipment failures. Required to answer all freezer alarms and deal with them appropriately. Develop and implement active donor recruitment advertising campaigns to improve production levels. Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP). Directs key personnel in donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP). Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation. Controls center donor funds and ensure that all financial records are accurate and in order. Keeps Center Manager informed of any irregularities within the center and provide action plans to improve and correct center deficiencies. Minimizes center liability through constant risk management review. Investigates all unsafe situations and Situations/complaints. Develops and implements required corrective actions. Directs and monitors the performance of outside vendors. Reviews and monitor special projects for accuracy and timely completion. Works with the Center Manager in implementing the donor center's mission into the community. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Education: Bachelor's degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field. Experience: Typically requires 3+ years of related experience in clinical or general business experience. Supervisory experience preferred. Experience in a medical and/or cGMP regulated environment preferred. Experience with plasma or whole blood preferred. Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Knowledge | Skills | Abilities: Developing command of leadership, organizational, customer service, interpersonal communication, and computer abilities. Ability to understand and assess FDA regulations. Ability to maintain adequate levels of plasma collection and adhere to quality standards. Ability to motivate staff to achieve established goals and standards. May be required to relocate. Occupational Demands Form # 6: Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues. Compensation and Benefits: The estimated pay scale for the Operations Manager in Van Nuys, CA is $65,280.00 - $97,920.00 per year. Additionally, the position is eligible to participate in up to 20% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! “We are looking to grow our teams with people who share our energy and enthusiasm for creating the best experience for our donors/customers.” #BiomatUSA #CB #GrifolsJobs #app #LI-Onsite Third Party Agency and Recruiter Notice: Agencies that present a candidate MUST have an active, nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms, or they will be considered a Grifols candidate. EEO Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability . We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Location: NORTH AMERICA : USA : CA-Van Nuys Center Address: 17641 Vanowen St, Van Nuys, CA 91406 Contact: Alex Contreras, Senior Talent Acquisition Specialist - ************** | ********************** Learn more about Grifols Follow us on Facebook: ******************************************* Follow us on LinkedIn: ***************************************** To find more jobs with Grifols: ******************** Or Text GRIFOLS to ************

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834. About the Job: Title of the Position: Visual Inspection and Packing Operator At Nivagen, the Visual Inspection and Packaging Operator plays a critical role in ensuring product quality and compliance. This position is responsible for conducting manual visual inspections to verify that products meet established quality standards. Additionally, the operator will oversee the operation of leak testing machines and packaging equipment to ensure products are properly prepared for shipment. All tasks must be performed in strict adherence to company protocols and regulatory requirements, maintaining the highest standards of product quality and safety throughout the production process. Responsibilities: To perform the visual inspection of the filled containers i.e., vials (liquid and lyophilized), pre-filled syringes, cartridges and IV bags. To identify the defects i.e., fill volume inconsistencies, glass pieces, metal, colored particles, fibers, cap defects, sealing defects, label flaws, printed text matter flaws, batch coding flaws, wrong labelling, cross labelling flaws etc. and shall ensure no defective product shall be supplied to the market. Segregation of the defects and preparation of defective library and preparation of Knapp kits required for the qualification of automatic inspection machines. Preparation of the documents (including SOPs, batch records), protocols required for operation and maintenance of the VI, leak testing and packing equipment. Responsible for collection, transportation, and storage of the semi-finished products as per product storage conditions. Shall take utmost care to avoid the cross-contamination and mix-up errors. Shall be responsible for the storage of the semi-finished and finished products Collaborate effectively with cross-functional departments to ensure timely coordination and organization of all prerequisites, supporting the smooth operation of the department and ensuring the delivery of finished products that meet market needs and business demands. Qualification/validation of the equipment and area in accordance with approved protocols and preparation and readiness for the routine commercial manufacturing. To perform in process, check and controls in accordance with approved protocols, batch records, SOPs and regulatory guidelines. Collaborate closely with production staff, including operators, supervisors, and quality control teams, to ensure product quality and timely delivery, while actively participating in team meetings and training sessions as required. Prepare products for secondary packing using the correct materials and pack them according to company specifications. Ensure packaging is sealed, labelled correctly, and checked for completeness and accuracy. Collaboration with warehouse, production, in-process quality teams for timely support and product deliverables to meet OTIF. Adhere to safety guidelines, promptly report hazards or accidents, and ensure the work area remains clean and organized. Involved in daily operations, including cleaning, maintaining logs, and overseeing routine packing activities to ensure efficiency and compliance Tracking defect trends, maintaining control over defect storage, conducting periodic reviews, and implementing control and mitigation plans Managing market complaints, conducting investigations, implementing corrective actions, and preventing future occurrences. Inventory management for the consumables required for the day-to-day packing activities. Any other tasks as directed by the supervisor. Education: High school diploma or equivalent required; technical certification or degree in a related field is a plus. Experience: 1-3 years of experience in pharmaceutical manufacturing, visual inspection, or packaging Knowledge and Skills: cGMP, FDA regulations, and SOPs related to sterile and non-sterile pharmaceutical production. Strong attention to detail and ability to detect visual defects. Proficiency in operating inspection and packaging equipment. Ability to follow written instructions and complete documentation accurately. Good communication and teamwork skills. Requirements: Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents) Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Able to successfully complete a drug and background check stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties. Must comply with cleanroom protocols, gowning, and PPE requirements. The role requires strong attention to detail, the ability to identify defects or discrepancies, a basic understanding of quality control and packaging requirements, the capacity to work efficiently in a fast-paced environment while maintaining high standards, and good manual dexterity for handling delicate products. Benefits: Pay range $20.0 - $25.0 per hour (Based on Experience) Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

A leading pharmaceutical company in Santa Monica seeks a manager for their Process Execution Team. The candidate will lead a multi-disciplinary team, ensure capacity and capability in line with demand, and drive process performance while maintaining compliance with internal and external standards. Essential qualifications include a degree and significant management experience, especially in pharmaceutical supply chains. The role offers a competitive compensation package and benefits including health coverage and a retirement plan. #J-18808-Ljbffr

THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.

Job DescriptionSalary: $18 - $20 per Hour DOE The primary obligation of the Caregiver/Med Tech is to provide excellent personalized care in regard to assistance with residents activities of daily living (ADLs) to ensure each function at their highest level physically, cognitively, and socially. Direct resident care providers manage care and supervision to residents as needed, and as indicated in the resident care plan. The Caregiver/Med Tech will report to the Wellness Coordinator(s). Duties & Responsibilities: Caregiving Assist residents with activities of daily living such as bathing, grooming, toileting, hygiene, mobility, etc. Assist with incontinent care and adhere to bowel and bladder training as indicated in the residents care plan. Document resident conditions, including input and output, on a daily basis and in a timely manner. Check residents on a regular basis; Observe and report any changes in the residents condition to Wellness Coordinator and follow up with charting. Follow Wellness Coordinator direction regarding residents overall management of care. Monitor resident skin condition, look out for new rashes, skin tears, bruises, patches that are soiled or have come off, etc. Inform the Wellness Coordinator or Director of Wellness of any changes. Document all new skin conditions on residents daily chart. Follow Wellness Coordinator direction regarding residents skin care needs, i.e. prevention techniques such as continuous repositioning, use of heel protectors, etc. Report and document any unusual incidents, such as falls, behaviors, etc. directly to the administrator on duty. Call and inform the administrator on duty in case of emergency. Prepare tables and set up for all meals of the day. Escort residents to dining room. Prepare and deliver tray services if resident is unable to leave room for meals. Assist residents that are not able to eat on their own. Ensure daily laundry is maintained for each resident. Bed linens are done weekly. Ensure that residents rooms are neat, clean, and orderly. Maintain cleanliness in all common areas, living rooms, kitchens, dining areas, courtyard, activity room, beauty salon etc. Follow Wellness Coordinator direction regarding cleaning schedules and procedures. Ensure that residents are informed and may attend planned activities in the common activity areas. Spend quality time with residents, i.e. visiting residents in their room, painting nails, going on walks, outside fun, afternoon snacks & bingo etc. We are here to serve our residents; their happiness and health is our number one priority. Adhere to all safety rules and practices. Attend all regular safety, staff, and training meetings. These meetings are mandatory and failure to attend can lead to an unexcused absence. Maintain online state mandated annual caregiver training. Maintain work accounts and communication. Keep Wellness Coordinator up to date on all important matters regarding resident overall change in condition. Other duties as assigned for the operation of the company, or resident need and safety. Medication Management Administer medication directly to residents as prescribed. Supervise residents to ensure medications are taken. Document medications administered to residents on residents MARS, including medication refusal, medication holds, etc Reorder medications in a timely manner, i.e. PRN medication, narcotic medications that are not part of the monthly cycle. Record newly delivered medication on centrally stored medication logs, maintaining an accurate LIC 622. Maintain signed and updated Medication Verification Lists for each resident, i.e. residents file and emergency envelope. Keep emergency envelopes updated and maintain two copies for each resident. Maintain copies of all physician orders. Manage medication records, i.e. medication verification list, centrally stored medication record, PRN letters, and MARS for all incoming residents. Monitor residents for change of condition and communicate changes and concerns to the appropriate health care provider. Requesting specific orders, medication changes etc. Documents all changes in residents medication records. Maintain all State mandated medication training records annually. NOC Shift Specific: Wellness check at beginning of shift - check in with exiting caregiver to receive update/current status on each resident. Perform wellness check on each resident, ensuring that residents are present and well. Assist residents in night routine, i.e. tuck in routine, brushing teeth, putting on pajamas, etc. Perform bedtime medpass and continuously monitor residents throughout NOC shift, providing PRN medicine as needed. Throughout shift, check each resident every two hours Required Experience, Education, & Skills: To be able to stand for extended periods of time, bend, climb stairs, reach & grasp. Be able to respond to pagers and radios. Must be reliable, responsible, timely, efficient, well-organized, and have a strong attention to detail Excellent prioritization and time management skills, and ability to multitask Strong communication skills to work well with the Wellness Coordinator, peer staff, clients, and families Approachable, professional presentation and attitude; always willing to help and lead other caregivers to go the extra mile. Promote a team spirit and a can do attitude Deal with reasonable complaints/requests with professionalism and patience Ability to work with little supervision and maintain a high level of performance Customer-oriented and friendly Working quickly without compromising quality Knowledge of English language: able to read, write, and converse Abide by all RCG policies and procedures, including but not limited to cell phone use, privacy, uniform guidelines and professional appearance, personal conduct and residents rights Complete all required initial and scheduled training on time and with a passing score/meets expectations Work effectively individually and in a team environment. Able to perform the essential functions of the job with or without reasonable accommodations. About Rose Care Group: Rose care Group is a leading provider of comprehensive, compassionate, and personalized residential care services for the elderly in San Luis Obispo, California. Our dedicated team works tirelessly to create a comfortable, safe, and nurturing environment for our residents, ensuring that they receive the highest level of care and support.

Job DescriptionDescription: Join McAlister Institute, a 48-year beacon in San Diego's Recovery Community. We are seeking an Associate Recovery Technician who will support the Recovery & Bridge Center team in maintaining a safe, welcoming, and recovery-focused environment. This role assists with intake, screening, care coordination, and logistical support, working collaboratively to promote client stability and engagement in recovery. Benefits for YOU: 13 paid annual holidays, including your birthday; 12 paid vacation days, paid sick leave Public Service Loan Forgiveness eligibility 403(b) Retirement Plan + up to 6% Employer Match Health Insurance available the first of the month following 30 days of employment (Sharp) EAP Key Responsibilities: Support and implement the overall purpose, philosophy, values, and direction of McAlister Institute and the Recovery and Bridge Center. Assist with intake, screening, and assessment using approved tools (e.g., SBIRT, ASAM Criteria). Coordinate with law enforcement, health, and safety agencies as needed. Facilitate referrals and linkages to community resources and treatment programs. Maintain accurate records and documentation. Ensure a safe, clean, and dignified environment for all clients. Other duties as assigned. Available Shifts: 8.5 hours each shift Shift 1: 6AM - 2:30PM, Monday - Sunday Shift 2: 2PM - 10:30PM, Monday - Sunday Shift 3: 10PM - 6:30AM, Monday - Sunday Requirements: Candidates must meet one of the following: EMT background, registered SUD counselor, certified peer support specialist, associate level education in a relevant field, or two years' experience working in the SUD field. Must be CPR and First Aid certified on the date of employment or within 60 days of employment and maintain current certification throughout employment. Maintains knowledge of legal guidelines pertaining to EMTALA/COBRA and abuse/neglect reporting. Knowledgeable about harm reduction, trauma-informed care, patient-centered care, and motivational interviewing. Ability to work effectively with a diverse population, including the impoverished, unhoused, and those suffering from chronic substance use and/or mental health challenges. Exceptional interpersonal skills, written and verbal communication, adaptability, and professionalism. Exudes a calm and competent manner, able to converse with medical professionals, lay persons, as well as persons or families and defuse crisis or high intensity situations. Proficiency with software and/or equipment (Microsoft Office applications including Outlook, Word, Excel and PowerPoint). Proficient with EHR Systems (e.g., Electronic Health Records such as Welligent or SmartCare). Maintains confidentiality; listens to others without interrupting; effectively regulates emotions, especially under stress; remains open to others' ideas and tries new things. On-site position. Must possess a valid and unrestricted California Driver's License, with a good driving record, free of any major infractions. Skills include strong paperwork and computer skills, ability to maintain-up-to-date records, exceptional written and verbal communication; ability to work in a team; excellent time management skills; and organizational abilities. Must comply with all agency and contract requirements related to trainings, public health, certifications, reporting, etc. Bilingual proficiency in Spanish and English strongly preferred. Must be able to pass a drug test, background clearance, and provide a negative TB test. Must be free of probation or parole for at least one year. Equal Opportunity Employer: McAlister Institute is committed to creating a diverse environment and we are proud to be an equal-opportunity employer. All qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender, gender identity, gender expression, marital status, ancestry, medical condition (cancer and genetic characteristics), genetic information, or denial of medical and family care leave, any other non-job-related factors, and other characteristics protected by local, state, or federal anti-discrimination law covering employment. Reasonable Accommodations: McAlister Institute is committed to providing reasonable accommodation to applicants as required by the Americans with Disabilities Act (ADA) and Fair Employment and Housing Act (FEHA). Qualified individuals with disabilities who need a reasonable accommodation during the application or selection process should contact the *********************., for more information. Please include your name and position you are applying for. Work Authorization Requirement: Applicants must be legally authorized to work in the United States at the time of application. McAlister Institute does not participate in visa sponsorship programs, including H1-B visas, and will not provide sponsorship for any employment-based visas. Pre-Employment: All employment offers are contingent upon successful completion of pre-employment requirements including a criminal background investigation, which involves fingerprinting. (A felony or misdemeanor conviction may disqualify the applicant from McAlister Institute employment as we are subject to County of San Diego contractual hiring requirements). A pre-employment physical examination, and post-offer background check is required. Candidates must have at least one year clear of probation or parole, a drug test, and a negative TB test. General Information & Considerations: Placement on the pay range is based on multiple factors including, but not limited to, relevant years of experience and qualifications. Current McAlister Institute employees may receive priority consideration for positions when they meet essential qualifications. To Staffing and Recruiting Agencies: We do not solicit staffing or agency contacts for our recruitment needs. Our careers site is only for individuals seeking a job at McAlister. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes. Any such submissions will be considered unsolicited and will be ignored to prioritize our own process. We are sure you do amazing work and can give us data to support your sell. We, however, are a non-profit, and are mindful agents of our resources. We do not accept unsolicited resumes or applications from agencies. Please do not forward resumes to us, or email us individually. McAlister Institute is not responsible for any fees related to unsolicited resumes/applications.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Position Description Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Key Values / Objectives Integrity * Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. * Responsible for administering technical training and ensuring all operators are trained to perform tasks. * Operate the equipment and perform activities as required to meet production schedule. * Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) * Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Respect for People * Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. * Key liaison between operations and support functions. Basic Qualifications/Requirements: Time Commitments and Work Authorization * Minimum education: High School Diploma or GED * A valid drivers license * Must Pass a "fitness for duty" physical exam * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. * Must pass a vision exam and be free of color blindness * Must be equivalent to 20/20 correctable close vision acuity * Must be able to work a 2-2-3 schedule Additional skills/preferences: Experience with, completion of, or understanding of: * We have several levels open for Operator which are based on the experience and education you bring. * Ability to work overtime as required * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * Ability to participate in professional development opportunities (team coursework such as classes through RCCC) * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges * Computer proficiency (desktop software, MS office). * Leadership and the ability to train / educate team members * STEM degree or certifications * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Knowledge of current Good Manufacturing Practices (CGMPs) * Experience in operations or manufacturing environments. * Pharmaceutical, medical device or food processing industries * Manufacturing Execution Systems and electronic batch release. * Continuous improvement (Lean, Six Sigma methodologies) * Highly automated equipment (inspection, packaging, filling, assembly, etc) * SAP, Electronic Batch Records Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

The IT Specialist is responsible for providing technical support, system administration, and infrastructure maintenance in a GMP-compliant pharmaceutical CDMO environment. This role ensures the secure, reliable, and compliant operation of all IT systems, networks, and applications that support manufacturing, laboratory, and business operations. The IT Specialist will collaborate closely with Quality Assurance, Production, and R&D to ensure all IT solutions meet both operational needs and regulatory requirements. Key Responsibilities 1. Technical Support & Troubleshooting Provide timely end-user support for hardware, software, and network issues. Diagnose, troubleshoot, and resolve incidents via phone, email, remote tools, and in person. Escalate complex issues to senior IT staff or vendors as necessary. 2. System Administration Install, configure, and maintain workstations, servers, printers, and mobile devices. Administer Active Directory, email systems, user accounts, and permissions. Manage and maintain data backup, disaster recovery, and storage solutions. 3. GMP & Regulatory Compliance Ensure all IT systems and processes comply with GMP, FDA, and other applicable regulatory guidelines. Support Computer System Validation (CSV) activities, including documentation, change control, and periodic reviews. Maintain detailed records of system configurations, updates, and incidents in compliance with audit requirements. 4. Network & Security Monitor and maintain LAN/WAN, wireless networks, and internet connectivity. Apply security updates, patches, and antivirus protection. Assist in implementing cybersecurity best practices and incident response procedures. 5. Collaboration & Projects Partner with cross-functional teams to support IT requirements for manufacturing, laboratory, and administrative operations. Assist in planning and executing IT infrastructure upgrades, migrations, and implementations. Provide technical input during audits, inspections, and customer visits as needed. Qualifications Education & Experience: Associate's or Bachelor's degree in Information Technology, Computer Science, or related field preferred. 2+ years of experience in IT support or system administration, preferably in a pharmaceutical, biotech, or GMP-regulated environment. Skills & Competencies: Significant GMP experience Strong knowledge of Windows operating systems, Microsoft 365, and networking fundamentals. Experience with Active Directory, file permissions, and group policies. Familiarity with ERP, LIMS, MES, or other laboratory/manufacturing systems (preferred). Understanding of GMP, 21 CFR Part 11, and data integrity requirements (preferred). Excellent troubleshooting, communication, and customer service skills. Ability to handle multiple priorities in a fast-paced, regulated environment. Preferred Certifications: CompTIA A+ (IT support fundamentals) CompTIA Network+ (networking basics) HDI Support Center Analyst (HDI-SCA) or HDI Desktop Support Technician (HDI-DST) Microsoft Certified: Modern Desktop Administrator Associate ITIL Foundation (IT service management best practices) Physical Requirements Ability to lift up to 25 lbs. for equipment installation. Ability to sit or stand for extended periods. Occasional after-hours or weekend work to support system maintenance or project deadlines. Work Environment Office and manufacturing/laboratory settings with exposure to cleanroom environments. Strict adherence to company safety, security, and GMP policies is required.

The Manager, Clinical Operations works closely with the OPDC Monitoring Oversight Lead to manage monitoring oversight activities including managing Clinical Monitoring Consultants (CMC) contracted to perform monitoring oversight duties as well as escalating issues related to CRO monitoring quality. While focusing on quality and compliance, uses metrics and key performance indicators to drive monitoring oversight activities to achieve timelines and deliverables across the portfolio. Additionally, the Manager, Clinical Operations will support planning, resourcing, contracting, and budgeting of CMC resources to conduct monitoring oversight tasks. The Manager, Clinical Operations will also coordinate reporting and review of CRO related Key Performance Indicators (KPIs) Monitoring Oversight Lead. **Job** **Description** - Manage Monitoring Oversight activities in North America, and other regions as assigned - With the OPDC Monitoring Oversight Lead, plan conduct of Oversight Accompanied Visits (OAV) in the assigned region(s) - Manage, onboard, train and evaluate CMC resources to perform monitoring oversight tasks - Ensure adherence to training requirements for assigned CMCs (SOPs and study specific training) - Report status and output of OAVs and other monitoring oversight activities to OPDC Oversight Lead - Review OAV reports and manage timelines and deliverables - Oversee FSP monitoring resources in assigned region(s) as applicable - Support implementation and improvement of monitoring oversight related processes - Ensure compliance with Otsuka policies and procedures and applicable Key Performance Indicators (KPIs) - Provide oversight of required metrics across all monitoring oversight service providers and contribute to monthly reporting of monitoring oversight related KPIs to CM&O Management - Conduct Assessment Visits of CMCs to assess quality and compliance with applicable policies and procedures per the monitoring oversight job aids - Escalate significant issues related to oversight visits (e.g., site, study, CRA, etc.) in a timely manner to the Monitoring Oversight Lead, Clinical Operations management, and Study Management as applicable - Ensure compliance with clinical systems use and updates - Provide support for internal audit and regulatory inspection activities as applicable - Review study specific monitoring plans and provide feedback prior to implementation - Collaborate with CMC staffing vendors, as applicable - Manage consultant CMC contracts, budgets, and expenses to meet forecasts and support the development of annual regional monitoring oversight budget - Other monitoring oversight activities as assigned by OPDC Oversight Lead **Qualifications/** **Required** Knowledge/ Experience and Skills: - Experience managing field-based Clinical Research Associates. - Demonstrated ability to lead teams. - Proficient with on-site monitoring activities (Site Qualification Visit, Site Initiation Visit, Interim Monitoring Visit, and Close Out Visit). - Demonstrated strengths with critical thinking and analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills. - Ability to supervise, direct and lead team members as well as interact with other internal staff and external vendors. - Strong planning and organization skills with the ability to multi-task and plan activities are they relate to field monitoring operations. - Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance. - Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors and consultants. - Possess advanced computer skills (e.g., Microsoft applications, etc. - Financial management skills as applicable to oversee initiatives and system expenditures. - Ability to handle and prioritize multiple tasks. - Ability to work effectively in a team/matrix environment. - Ability to travel up to 30% including ground and air travel. Educational Qualifications - 7 years of industry experience and a minimum BA/BS Life Sciences, or equivalent college program, is required. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $107,718.00 - Maximum $161,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

As a senior leader within Medical Affairs, the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical Affairs, providing high-level guidance and operational leadership across the organization. Leveraging a deep understanding of industry trends and internal priorities, this individual will shape the development of best-in-class medical excellence capabilities aligned with Otsuka's vision, direction, and growth strategy. The Executive Director, Medical Affairs Strategy, Excellence & Operations will lead five critical teams: Strategic Planning, Business Solutions & Analytics, Vendor & Contracts Management, Governance & Procedures, and Global Medical Evidence Operations ensuring alignment with enterprise goals and medical excellence priorities. This role will champion operational rigor, foster strategic integration, and drive high-quality insights to support decision-making across the organization. Serving as a key liaison across the Global, US, and Commercial ecosystem, the Executive Director will play a pivotal role in advancing scientific and medical initiatives. Through thoughtful leadership and collaboration, this individual will shape and execute the global medical affairs strategy, optimize operational frameworks, and enable data-driven innovation across therapeutic areas. **** **Key Responsibilities Include:** **Strategic Leadership and Execution** + Serve as Chief of Staff to the VP of Medical Affairs, driving strategic alignment and operational integration across the Global Medical Affairs organization. + Sets the overall direction of Medical Excellence & Operations (MEO); make critical decisions that have impact across Global Medical Affairs therapeutic areas (TAs) and functions + Leads the development, refinement, and execution of Medical Affairs strategies and objectives in alignment with corporate goals. + Coordinates cross-functional planning, meeting cadences, budget oversight, and communication on behalf of Medical Affairs leadership. + Collaborates with cross-functional teams to align medical affairs activities with commercial and clinical development strategies + Leads Medical Excellence for Med Affairs Strategy to ensure consistent best practices across programs and drive consistent methods of strategic and tactical planning and execution. **Operational Excellence and Team Management** + Lead and manage core operational pillars within Medical Affairs Excellence & Operations Team, including: + Global Asset Strategic Planning + Business Solutions and Analytics + Vendor and Contracts management + Global Medical Evidence Operations + Governance and Procedures + Establish and implement systems, SOPs, and governance frameworks to ensure excellence, compliance, and efficiency in Medical Affairs processes (e.g., IME, ISTs, EAPs, publications, congresses) + Provide and maintain the technological infrastructure, business tools, and data analytics, including the medical information contact center, to enable Global Medical Affairs teams to operate efficiently + Oversee the department's budget, resource allocation, and vendor contracting processes (including key TA level vendors) + Will ensure assignment of Med Excellence activities/projects to Otsuka priorities + Congress Strategy/prioritization, ensure aggregation of congress plans (including meetings) and awareness cross functionally + Develop and maintain calendar of important TA meetings across programs, including congresses and internal offsite meetings (US and Global) to ensure no conflicts and adequate resourcing; will work with Administrative leads to ensure meetings are added to calendars + Develops and manages large teams driving a high-performance culture; understands the required skillset (s) needed within the medical excellence function to deliver best results + Builds relationships with key internal and external stakeholders, including industry partners **Performance Monitoring and Reporting** + Establish and track key performance indicators (KPIs) to measure Medical Affairs impact and execution + Deliver monthly and quarterly updates to Global Medical Affairs leadership and contribute to board-level reporting, as needed + Keeps abreast external environment-relevant trends and incorporates insights and best practices to inform functional decisions + Responsible for ensuring timelines and process for cross-brand initiatives, such as annual medical strategy planning, 3-year roadmaps, SMART goals **Qualifications** **Education and Experience:** + Doctorate Degree (MD (Medical Doctor), PharmD, PhD) or equivalent preferred + Minimum of 15 years' experience in the pharmaceutical or biotechnology setting within medical affairs strategy + Sr Director level medical affairs strategy experience for a minimum of 5 yrs. and experience in Medical Excellence & operations **Skills and Competencies:** + Demonstrated ability to lead and inspire high-performing teams + Strong strategic, operational, and leadership capabilities within a biotech or pharmaceutical setting + Expertise in navigating regulatory frameworks and ensuring compliance within medical affairs function + Excellent communication and interpersonal skills, with the ability to influence cross-functional teams + Strong analytical and problem-solving skills to address complex challenges within medical affairs + Ability to lead a team and influence organizational level decisions + Experience in collaborating with Medical Affairs vendors that can provide medical excellence related support + Strategic thinking acumen and record of accomplishment for operational excellence + Ability to rapidly pivot based on evolving corporate strategy and direction + Proficiency in pharma code and all guidelines concerning medical affairs activities + Excellent presentation skills and ability to communicate complex scientific information + Motivated, disciplined, pro-active individual capable of effectively managing timelines **Other Requirements:** + Ability to travel globally up to 25% for congresses, advisory board meetings, Governance meetings as business needs require **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.

Job DescriptionDescription: Join McAlister Institute, a 48-year beacon in San Diego's Recovery Community. We are seeking an Associate Recovery Technician who will support the Recovery & Bridge Center team in maintaining a safe, welcoming, and recovery-focused environment. This role assists with intake, screening, care coordination, and logistical support, working collaboratively to promote client stability and engagement in recovery. Benefits for YOU: 13 paid annual holidays, including your birthday; 12 paid vacation days, paid sick leave Public Service Loan Forgiveness eligibility 403(b) Retirement Plan + up to 6% Employer Match Health Insurance available the first of the month following 30 days of employment (Sharp) EAP Key Responsibilities: Support and implement the overall purpose, philosophy, values, and direction of McAlister Institute and the Recovery and Bridge Center. Assist with intake, screening, and assessment using approved tools (e.g., SBIRT, ASAM Criteria). Coordinate with law enforcement, health, and safety agencies as needed. Facilitate referrals and linkages to community resources and treatment programs. Maintain accurate records and documentation. Ensure a safe, clean, and dignified environment for all clients. Other duties as assigned. Shifts: Five, 8.5 hour shifts per week Shift 1: 6AM - 2:30PM, Monday - Sunday Shift 2: 2PM - 10:30PM, Monday - Sunday Shift 3: 10PM - 6:30AM, Monday - Sunday Requirements: Candidates must meet one of the following: EMT background, registered SUD counselor, certified peer support specialist, associate level education in a relevant field, or two years' experience working in the SUD field. Must be CPR and First Aid certified on the date of employment or within 60 days of employment and maintain current certification throughout employment. Maintains knowledge of legal guidelines pertaining to EMTALA/COBRA and abuse/neglect reporting. Knowledgeable about harm reduction, trauma-informed care, patient-centered care, and motivational interviewing. Ability to work effectively with a diverse population, including the impoverished, unhoused, and those suffering from chronic substance use and/or mental health challenges. Exceptional interpersonal skills, written and verbal communication, adaptability, and professionalism. Exudes a calm and competent manner, able to converse with medical professionals, lay persons, as well as persons or families and defuse crisis or high intensity situations. Proficiency with software and/or equipment (Microsoft Office applications including Outlook, Word, Excel and PowerPoint). Proficient with EHR Systems (e.g., Electronic Health Records such as Welligent or SmartCare). Maintains confidentiality; listens to others without interrupting; effectively regulates emotions, especially under stress; remains open to others' ideas and tries new things. On-site position. Must possess a valid and unrestricted California Driver's License, with a good driving record, free of any major infractions. Skills include strong paperwork and computer skills, ability to maintain-up-to-date records, exceptional written and verbal communication; ability to work in a team; excellent time management skills; and organizational abilities. Must comply with all agency and contract requirements related to trainings, public health, certifications, reporting, etc. Bilingual proficiency in Spanish and English strongly preferred. Must be able to pass a drug test, background clearance, and provide a negative TB test. Must be free of probation or parole for at least one year. Equal Opportunity Employer: McAlister Institute is committed to creating a diverse environment and we are proud to be an equal-opportunity employer. All qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender, gender identity, gender expression, marital status, ancestry, medical condition (cancer and genetic characteristics), genetic information, or denial of medical and family care leave, any other non-job-related factors, and other characteristics protected by local, state, or federal anti-discrimination law covering employment. Reasonable Accommodations: McAlister Institute is committed to providing reasonable accommodation to applicants as required by the Americans with Disabilities Act (ADA) and Fair Employment and Housing Act (FEHA). Qualified individuals with disabilities who need a reasonable accommodation during the application or selection process should contact the *********************., for more information. Please include your name and position you are applying for. Work Authorization Requirement: Applicants must be legally authorized to work in the United States at the time of application. McAlister Institute does not participate in visa sponsorship programs, including H1-B visas, and will not provide sponsorship for any employment-based visas. Pre-Employment: All employment offers are contingent upon successful completion of pre-employment requirements including a criminal background investigation, which involves fingerprinting. (A felony or misdemeanor conviction may disqualify the applicant from McAlister Institute employment as we are subject to County of San Diego contractual hiring requirements). A pre-employment physical examination, and post-offer background check is required. Candidates must have at least one year clear of probation or parole, a drug test, and a negative TB test. General Information & Considerations: Placement on the pay range is based on multiple factors including, but not limited to, relevant years of experience and qualifications. Current McAlister Institute employees may receive priority consideration for positions when they meet essential qualifications. To Staffing and Recruiting Agencies: We do not solicit staffing or agency contacts for our recruitment needs. Our careers site is only for individuals seeking a job at McAlister. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes. Any such submissions will be considered unsolicited and will be ignored to prioritize our own process. We are sure you do amazing work and can give us data to support your sell. We, however, are a non-profit, and are mindful agents of our resources. We do not accept unsolicited resumes or applications from agencies. Please do not forward resumes to us, or email us individually. McAlister Institute is not responsible for any fees related to unsolicited resumes/applications.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834. About the Job: Title of the Position: Visual Inspection and Packing Operator At Nivagen, the Visual Inspection and Packaging Operator plays a critical role in ensuring product quality and compliance. This position is responsible for conducting manual visual inspections to verify that products meet established quality standards. Additionally, the operator will oversee the operation of leak testing machines and packaging equipment to ensure products are properly prepared for shipment. All tasks must be performed in strict adherence to company protocols and regulatory requirements, maintaining the highest standards of product quality and safety throughout the production process. Responsibilities: To perform the visual inspection of the filled containers i.e., vials (liquid and lyophilized), pre-filled syringes, cartridges and IV bags. To identify the defects i.e., fill volume inconsistencies, glass pieces, metal, colored particles, fibers, cap defects, sealing defects, label flaws, printed text matter flaws, batch coding flaws, wrong labelling, cross labelling flaws etc. and shall ensure no defective product shall be supplied to the market. Segregation of the defects and preparation of defective library and preparation of Knapp kits required for the qualification of automatic inspection machines. Preparation of the documents (including SOPs, batch records), protocols required for operation and maintenance of the VI, leak testing and packing equipment. Responsible for collection, transportation, and storage of the semi-finished products as per product storage conditions. Shall take utmost care to avoid the cross-contamination and mix-up errors. Shall be responsible for the storage of the semi-finished and finished products Collaborate effectively with cross-functional departments to ensure timely coordination and organization of all prerequisites, supporting the smooth operation of the department and ensuring the delivery of finished products that meet market needs and business demands. Qualification/validation of the equipment and area in accordance with approved protocols and preparation and readiness for the routine commercial manufacturing. To perform in process, check and controls in accordance with approved protocols, batch records, SOPs and regulatory guidelines. Collaborate closely with production staff, including operators, supervisors, and quality control teams, to ensure product quality and timely delivery, while actively participating in team meetings and training sessions as required. Prepare products for secondary packing using the correct materials and pack them according to company specifications. Ensure packaging is sealed, labelled correctly, and checked for completeness and accuracy. Collaboration with warehouse, production, in-process quality teams for timely support and product deliverables to meet OTIF. Adhere to safety guidelines, promptly report hazards or accidents, and ensure the work area remains clean and organized. Involved in daily operations, including cleaning, maintaining logs, and overseeing routine packing activities to ensure efficiency and compliance Tracking defect trends, maintaining control over defect storage, conducting periodic reviews, and implementing control and mitigation plans Managing market complaints, conducting investigations, implementing corrective actions, and preventing future occurrences. Inventory management for the consumables required for the day-to-day packing activities. Any other tasks as directed by the supervisor. Education: High school diploma or equivalent required; technical certification or degree in a related field is a plus. Experience: 1-3 years of experience in pharmaceutical manufacturing, visual inspection, or packaging Knowledge and Skills: cGMP, FDA regulations, and SOPs related to sterile and non-sterile pharmaceutical production. Strong attention to detail and ability to detect visual defects. Proficiency in operating inspection and packaging equipment. Ability to follow written instructions and complete documentation accurately. Good communication and teamwork skills. Requirements: Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents) Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Able to successfully complete a drug and background check stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties. Must comply with cleanroom protocols, gowning, and PPE requirements. The role requires strong attention to detail, the ability to identify defects or discrepancies, a basic understanding of quality control and packaging requirements, the capacity to work efficiently in a fast-paced environment while maintaining high standards, and good manual dexterity for handling delicate products. Benefits: Pay range $20.0 - $25.0 per hour (Based on Experience) Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

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 ***************** Purpose: The Area Business Lead (Sales Director) is responsible for providing the leadership necessary to achieve Area level sales goals. This includes sales, sales strategy, resource allocation, and talent development. Today, the Ophthalmic team is focused on maximizing the patient impact and commercial value of IZERVAY. IZERVAY launched in September 2023 and is a complement C5 inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). IZERVAY is a Priority Brand for Astellas and has blockbuster potential. The GA market is a dynamic and rapidly evolving new category of treatment where IZERVAY is one of two options available for treatment. The Area Business Lead is responsible for leading and managing Regional Business Leaders and providing consistent and uniform direction regarding execution of sales and marketing strategies and tactics for Astellas' US products and services. Additional responsibilities include recruiting and development of field force personnel within the geography, including appropriate assessment of performance. This role has oversight and provides direction to optimally allocate key resources and inspire industry leading customer engagement across regional geographies. The ABL is accountable to maintain effective communication and relationships with key external and internal customers and accounts. Essential Job Responsibilities: Demonstrate strong, clear leadership through consistent communication and direction, and assume direct responsibility for achieving sales goals for an assigned therapeutic franchise and geography. Foster a culture of high engagement and accountability by building trust, setting clear expectations, providing coaching and development of managers. Set expectations and high standards of performance for each team member. Accurately assess the team's performance, identify and maximize talents, provide growth and development opportunities, and appropriately allocate rewards/recognition within the Sales Area. Guide and support national/area/regional business strategic plans. Track sales trends and analyze performance to ensure the area meets established goals. Develop and oversee the area's budget, allocating resources effectively. Drive sales effectiveness through execution of marketing and promotional strategies that cater to the special needs of selling in Ophthalmology (specifically) Retina environment. Ensure a high level of collaboration with matrix partners to maximize joint efforts as well as adherence to compliance standards. Work closely with Market Access to establish pull-through programs and take advantage of patient services and favorable Managed Health Care opportunities; ensure excellent coverage and customer service for key accounts in the Sales Area; and assist in ensuring adequate positioning of Astellas' products on key purchasing group's formularies in the nation. Monitor industry trends and competitor activity to guide strategic decision-making. Guide and support sales areas to recruit, train, retain and develop diverse talent to strengthen team capabilities and ensure sustainable performance. Manage and understand trends and human resource needs related to recruitment, performance management, selection, and development. Support and lead development and training initiatives across the region. Represents Astellas' Values and Behaviors by adhering to compliance policies and procedures, while promoting a culture of ethics and integrity. Ensure each Manager and Representative within each region understands, accepts, and adheres to the policies and procedures. Represent sales and collaborate across the brand while building impactful field and marketing strategies ultimately deploying and delivering within area and as needed to national team. Partner and strategize with leadership on executive exchange planning and engagements with priority accounts and/or c-suite and retina community advocates. Carry out additional responsibilities as assigned. Quantitative Dimensions: Responsible for overseeing and leading a sales area inclusive of Regional Business Leaders and Business Specialists. Direct management of Regional Business Leaders (Sales Managers). Directly responsible for providing the leadership and direction for Sales Area to achieve at least 100% goal attainment. High level of skill in developing and maintaining relationships and interacting with internal cross-functional Astellas departments and fostering a cohesive and impactful matrix team to deliver industry leading customer experience and engagement. Engaging external customers, including Key Opinion Leaders and key stakeholders including ECPs and C-Suite within accounts, to better align customer needs to the Astellas organization. Exhibit the leadership qualities and competencies essential for success in a senior leadership role. Organizational Context: Reports into the Ophthalmic Head of Sales. Leads area of regional business leaders and sales representatives.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Position Description Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Key Values / Objectives Integrity * Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. * Responsible for administering technical training and ensuring all operators are trained to perform tasks. * Operate the equipment and perform activities as required to meet production schedule. * Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) * Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Respect for People * Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. * Key liaison between operations and support functions. Basic Qualifications/Requirements: Time Commitments and Work Authorization * Minimum education: High School Diploma or GED * A valid drivers license * Must Pass a "fitness for duty" physical exam * Must pass a vision exam and be free of color blindness * Must be equivalent to 20/20 correctable close vision acuity * Must be able to work 6am to 6pm on a 2-2-3 schedule * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Additional skills/preferences: Experience with, completion of, or understanding of: * We have several levels open for Operator which are based on the experience and education you bring. * Ability to work overtime as required * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * Ability to participate in professional development opportunities (team coursework such as classes through RCCC) * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges * Computer proficiency (desktop software, MS office). * Leadership and the ability to train / educate team members * STEM degree or certifications * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Knowledge of current Good Manufacturing Practices (CGMPs) * Experience in operations or manufacturing environments. * Pharmaceutical, medical device or food processing industries * Manufacturing Execution Systems and electronic batch release. * Continuous improvement (Lean, Six Sigma methodologies) * Highly automated equipment (inspection, packaging, filling, assembly, etc) * SAP, Electronic Batch Records Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget. **** - Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs. - Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents. - Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites. - Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs. - Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments. - Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. - Participate in forecasting study expenditures and resourcing needs. - Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. - Provide timely communication of any variances in budget forecast to the Director/Associate Director. - Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. - Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned. - Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency. - Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF. - Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned. - Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities. - Represent Clinical Management in departmental and cross-functional initiatives, as assigned. - Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts. - May have supervisory responsibilities including: + Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes. + Assuring compliance with departmental, SOP, compliance, and corporate training + Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities. + Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance. - Performs other duties, as assigned. **Qualifications/ Required** Knowledge/ Experience and Skills: - Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations. - Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW). - Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management. - Strong understanding of global regulatory requirements. - Strong communication, organization, planning, analytical, problem solving, and people management skills. - Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.) - Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.). - Ability to travel up to 25%. **Educational Qualifications** Required: - Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience. Preferred: - Previous supervisory experience. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.

Director, Operation/Business Development, DMPK/GDSS Services Reports to: Executive Director, Business Development Frontage Laboratories : Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. DMPK/Global Drug Discovery Service : At Frontage, our scientific staff applies state-of-the-art techniques and best-in-class approaches to generate data for critical milestones and decision-making during drug discovery and development. The highly trained and experienced team provides broad and in-depth expertise/advice to clients on appropriate study designs, execution of studies, and interpretation of the data. We offer extensive drug metabolism and pharmacokinetic capabilities for new chemical entities and compounds in development. We provide rapid turnaround of high-quality key data sets to support critical decisions in advancing potential therapeutic agents for further development. Responsibilities : This is a hybrid business development and operations position to facilitate expansion of Frontage's DMPK/ Global Drug Discovery services in USA/China. Focus on selling DMPK and early drug discovery services for pharmaceutical and biotech companies Develop and maintain account and action planning activities to facilitate partnerships with prospective clients Develop and maintain a personal client call cycle to expand client base and realize opportunities to meet and exceed sales objectives Participate in the business development activities through assisting in proposal/protocol/report writing and managing, especially IND-enabling, DMPK studies for clients Work closely with the operations team and provide other support as needed to facilitate the business growth Recognize and communicate sales opportunities to other Frontage business units Requirements : BS/MS degree or above, experience in DMPK/drug development highly desirable 3-10 years' working experience of sales or project management in DMPK/drug discovery division of a pharmaceutical or a CRO company. Excellent interpersonal and communications skills required Very strong work ethic and comfortable with travel Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Salary Range: $120,000-$160,000