Pharmaceutical compliance jobs in Sacramento, CACreate job alerts

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: HVAC Service Technician We are seeking a dedicated and experienced HVAC Operator to join our team at Nivagen. In this key role, you'll be responsible for operating and maintaining our HVAC system, BMS and EMS system ensuring they function safely, efficiently, and reliably. This position is pivotal in minimizing downtime and supporting our manufacturing operations' overall productivity and efficiency. Responsibilities: • Operate and maintain HVAC system , BMS, EMS and supporting areas observing all safety procedures and regulations., • Monitor HVAC systems to detect malfunctions and necessary maintenance., • Perform routine inspection and maintenance on HVAC systems to ensure optimal operation., • Record and maintain daily logs on HVAC operations, maintenance, and safety activities., • Coordinate with the maintenance team to implement repairs and improvements., • Adhere to all environmental policies and procedures, ensuring compliance with legal regulations., • Should have knowledge on the clean room classification , AHU zoning , pressure balancing and other operation related to AHU and its area of supply., • Preventative maintenance of HVAC systems, • Prepare the SOP / EOP for the system., • Ability to lean other system and operate them., • Follow Good documentation practices Education/Experience: • High School Diploma or equivalent, • HVAC Systems & Components: Knowledge of heating, ventilation, air conditioning, refrigeration systems, and related components (furnaces, heat pumps, etc.)., • Electrical & Mechanical Expertise: Proficiency in wiring, circuit boards, motors, and other mechanical systems used in HVAC., • Troubleshooting & Diagnostics: Ability to efficiently diagnose and resolve HVAC system issues using diagnostic tools., • Installation, Repair, & Maintenance: Skilled in installing, repairing, and maintaining HVAC components and systems., • Customer Service & Communication: Strong skills in explaining issues and maintaining professional client relationships., • Energy Efficiency & Sustainability: Awareness of energy-efficient HVAC systems and eco-friendly practices., • Safety & Compliance: Knowledge of building codes, safety regulations, and adherence to industry standards (e.g., OSHA, EPA)., • Valid driver's license and acceptable driving record, • 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, • Pay range $25.0 - $30.0 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 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.

Job Description Job Summary: We have an exciting opportunity to join an independent pharmacy in East Sacramento that is on the cutting edge of retail pharmac services. We are looking for individual(s) who are interested in working in a community pharmacy setting as a goal. This is not a position for individual(s) who are simply looking for a job. We offer an environment that is focused on maximization of your knowledge and skills while affording the opportunity to learn and expand your abilities as a pharmacist. We are a specialized fastpaced, dynamic environment, serving the community in multiple facets of services which provides you with the ability to work at the top of your pharmacy license. The Staff Pharmacist is a front-line position serving as a representative of the business providing the products and services offered by the company. The Staff Pharmacist will creatively deploy technology and human resources to accomplish the objectives of the organization which include dispensing drugs prescribed by providers and provide information about medications and their use to patients, advise providers on the selection, dosage, interactions, and side effects of medications, provide point of care testing, immunizations, and pharmacist prescribed therapies where applicable. Duties are not limited to those listed as the position has a wide scope of duties at times dependent on customer needs and organization priorities. Ideal Candidate: Is self-driven, punctual and reliable, with a positive attitude. You must be personable, enjoy working in a public facing environment. You must be able to quickly assess situations and make prioritization decisions rapidly as it relates to what order functions must be completed to ensure efficient workflow. You must have the ability to assess verbal and non-verbal communications with customers and team members to determine the correct path toward completion of tasks and resolution of issues. You must be a team player and have a natural ability and willingness to assume responsibility for assisting in all areas of business operations. You must have the ability to deploy and manage human and technology resources across the organization to obtain company objectives. Work Hours: Store hours are Monday through Friday 9am-6pm, Saturday 9am-1pm, Closed Sunday. Working hours will be assigned based on Part-time or Full-time employment and will float across the open hours of the business to ensure adequate coverage for the demands of the business. Working hours will not solely be during the open business hours as duties will require employees to be on the clock prior to and after store business hours. Supervisory Responsibilities: • Direct daily pharmacy operations, • Ensures compliance with all regulatory aspects of the pharmacy, • Performing administrative duties, • Assists in managing inventory and purchasing, • Precepts pharmacy interns, • Assists the Pharmacist-In-Charge (PIC) for the pharmacy, • Reviews prescriptions to ensure accuracy, to ascertain the needed ingredients, and to evaluate their suitability. Provides information and advice regarding drug interactions, side effects, dosage, and proper medication storage., • Assesses the identity, strength, or purity of medications. Compounds and dispense medications prescribed by providers by calculating, weighing, measuring, and mixing ingredients, or overseeing these activities., • Maintains records such as pharmacy files, patient profiles, charge system files, inventories, and controlled substance records., • Plans, implements, and maintains procedures for mixing, packaging, and labeling pharmaceuticals according to policy and legal requirements to ensure quality, security, and proper disposal., • Provides specialized services to help patients manage conditions such as diabetes, asthma, smoking cessation, high blood pressure, HIV and STI treatment and prevention, travel health., • Offers health promotion and prevention activities by, for example, training people to use devices such as blood pressure and diabetes monitors., • Advises customers on the selection of medication brands, medical equipment, and health care supplies., • Collaborates with other health care professionals to plan, monitor, review, and evaluate the quality and effectiveness of drugs and drug regimens, providing advice on drug applications and characteristics., • Analyzes prescribing trends to monitor patient compliance and to prevent excessive usage or harmful interactions., • Orders and purchases pharmaceutical supplies, medical supplies, and drugs, maintaining stock and storing and handling it properly., • Performs point of care testing, interprets results, and prescribes medications on patients for all permissible disease testing as allowed by California law under Pucci’s collaborative practice agreement., • Performs immunizations and other therapeutic injections., • Identifies strengths, weaknesses, opportunities, and threats for the organization., • Strong patient service skills., • Excellent knowledge of chemistry and specific drug interactions., • Strong knowledge of medical and biological terminology., • Doctor of Pharmacy (PharmD) degree, • California Pharmacist License, • CPR Certification, • Prolonged periods sitting at a desk and working on a computer., • Prolonged periods of standing and bending., • Must be able to lift up to 15 pounds at times.Company DescriptionOur philosophy has always been to place great emphasis on individualized and personal care. Each patient deserves the greatest level of respect, care and attention, and it is our goal to consistently be there for our patients. We take great pride in getting to know each patient on a personal basis, understanding their health concerns and needs, and providing them with the necessary knowledge and information to help them enjoy long, healthy and fulfilling lives. We are looking for employees who share in this philosophy and want to be part of family owned and operated business.Our philosophy has always been to place great emphasis on individualized and personal care. Each patient deserves the greatest level of respect, care and attention, and it is our goal to consistently be there for our patients. We take great pride in getting to know each patient on a personal basis, understanding their health concerns and needs, and providing them with the necessary knowledge and information to help them enjoy long, healthy and fulfilling lives. We are looking for employees who share in this philosophy and want to be part of family owned and operated business.

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: Quality Assurance QMS Lead-Parenteral (Full Time) At Nivagen as Quality Assurance QMS Lead you will be responsible for supporting the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with regulatory requirements and industry standards. This role involves analyzing quality data, managing documentation, coordinating audits, and driving continuous improvement initiatives to ensure the highest standards of product quality and regulatory compliance within the pharmaceutical industry. Responsibilities: • Responsible for collecting and analyzing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of CAPA., • Leads, mentors, and coaches' operations and support personnel on the Change control, deviation management system and CAPA program., • To drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence., • Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems., • Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions., • Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner., • Act as a site instructor for Change control, Deviation Management and CAPA courses., • Coaches lead investigators on technical writing., • Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures., • Supports and initiates deviations, trends, or other technical investigations, as applicable., • Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding., • Works with the network deviation program mentor to benchmark and replicate best practices. Education/Experience: • A Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology or Related Sciences from an accredited institution is preferred, • A minimum of Three or More years of experience in in in-process quality assurance or a related role within a pharmaceutical or GMP-regulated environment, or equivalent experience in related fields, is necessary Knowledge, Skills, and Abilities: • Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations, • Proficiency in handling of electronic Quality Management systems (QMS)Experience in conducting root cause investigations, and execution of change management, investigating of deviation/non-conformance., • Ability to communicate effectively with customers to carry out requirements., • Ability to work under time pressure, exert good judgment in special situations, make decisions independently under minimum supervision, and problem solve., • Ability to influence team interactions and lead initiatives., • Demonstrated strong oral and written communication and interpersonal skills., • Demonstrated knowledge and understanding of manufacturing process and Quality Systems., • This involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards, • Occasional travel may be required for audits, supplier evaluations, or training, • Flexibility is required as work hours and starting times may vary to provide coverage on different shifts to meet business needs., • Overtime and weekend work may be required., • Individuals must be available via cell phone (on-call)., • Must live or be willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range $75,000-$85,000 per Year / $35/hr. (for hourly basis), • Relocation assistance available, • Annual bonus Eligibility (Based on yearly company and personal performance), • Medical, dental and vision coverage, • Paid time off plan 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.

Job DescriptionJob Title: Clinical Research Coordinator Job Description The Clinical Research Coordinator will play a pivotal role in patient-facing activities, including screening, recruitment, and managing source documentation. The role requires documenting in Electronic Medical Records (EMR) and ordering labs. You will work in collaboration with a team responsible for specimen collection and processing, allowing you to focus on managing patient interactions without data entry responsibilities. Your main responsibilities will involve screening, consenting, and enrolling patients in oncology trials, and following them through their therapy course. Responsibilities • Screen, consent, and enroll patients in oncology trials., • Follow patients through their therapy course and ensure protocol compliance., • Spend most of the time in the clinic, seeing patients with doctors and attending patient visits., • Ensure questionnaires are completed and research procedures outside the clinical norms are done., • Work with clinic staff to schedule appointments such as EKGs or vitals., • Interact with nursing staff and medical assistants., • Collaborate with clinical staff to obtain insurance authorizations., • Work with infusion nurses to schedule appointments., • Maintain an enthusiastic attitude.Essential Skills, • Clinical research experience., • Pre-screening patients., • Oncology knowledge., • Chart review skills., • Patient recruitment experience., • Minimum 2 years of Clinical Research Coordinator experience with acute Therapeutic Area experience., • CRC: 4+ years of oncology CRC experience., • Bachelor's degree.Additional Skills & Qualifications, • Patient study enrollment experience., • Ability to read protocols and identify side effects., • Exceptional organizational skills., • Experience in managing oncology patients., • Ability to assist patients with various aspects of study participation.Work Environment The work environment involves participating in pharmaceutical-sponsored trials, acting as one of the sites for Phase I, Phase II, and occasionally Phase III trials. You will collaborate with the Investigator Davis Oncology department, managing INDs and progress reports to the FDA. The clinical group is divided into disease teams, with clinical staff working in the cancer center and data management staff working in a different center. The position requires working Monday to Friday from 8 AM to 5 PM with some flexibility based on the clinic schedule. Office visits are required daily, and the position is on-site. Job Type & Location This is a Contract to Hire position based out of Sacramento, California. Pay and Benefits The pay range for this position is $30.00 - $40.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Sacramento,CA. Application Deadline This position is anticipated to close on Sep 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

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: Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that manufacturing processes, equipment, utilities, and systems in the sterile pharmaceutical production environment meet all regulatory requirements, industry standards, and company specifications. The role involves independently working and supporting the validation lifecycle from installation through qualification and routine re-validation activities, ensuring that the company's sterile manufacturing processes are in compliance with cGMP (current Good Manufacturing Practices) and other regulatory guidelines such as FDA, EMA, and ISO standards. Responsibilities: • Qualification of Equipment and Systems:, • Perform or oversee the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment and systems., • Qualification of equipment in sterile manufacturing facility (e.g., aseptic processing, sterile filling, isolators, autoclave sterilization)., • Ensure compliance with regulatory requirements for equipment qualification and validation., • Knowledge of validation equipment like Kaye validator, temperature and RH data loggers etc., • Validation Documentation and Protocols:, • Prepare and review validation reports to ensure they meet regulatory and company requirements., • Maintain traceability of validation activities and ensure all validation records are accurately documented, maintained, and stored., • Process Validation and Cleaning Validation:, • Conduct and manage process validation studies to confirm the sterility and quality of pharmaceutical products., • Work with cross-functional teams (e.g., production, quality control, engineering) to optimize manufacturing processes and ensure consistency and repeatability., • Support the development and implementation of new processes, ensuring that they are validated per regulatory requirements., • Knowledge of cleaning validation will be an added advantage Education/Experience: • Bachelor's degree or Diploma in Pharmaceuticals, or a related field., • Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, with a focus on sterile manufacturing (e.g., aseptic processing, sterile filling, isolator, autoclave sterilization)., • Strong understanding of cGMP, FDA, EMA, ISO standards, and other relevant regulatory requirements., • Experience with equipment validation (e.g., filling machines, autoclaves, and HVAC systems) and process validation., • Excellent technical writing and documentation skills., • Strong attention to detail and ability to manage complex technical documentation., • Ability to work cross-functionally and manage multiple priorities., • Familiarity with data analysis tools and software used for validation testing and reporting (e.g., Excel, Validation Master Plans, LIMS systems)., • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Cleanroom and sterile production areas with controlled environments., • Competitive salary, • 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 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.

Job Description Now Hiring: Specialty Pharmaceutical Sales Representative – Bio-Pharmaceuticals Atlantic Management Resources is proud to partner with a dynamic, fast-growing bio-pharmaceutical start-up dedicated to transforming patient care and closing critical treatment gaps. This is an incredible opportunity for a driven, results-oriented sales professional with a proven track record of success in pharmaceutical sales and relationship building. Join a company that’s shaping the future of patient health with an innovative therapy and breakthrough solution. Key Responsibilities: * Build and maintain strong, lasting relationships with physicians, office staff, and key stakeholders. * Engage healthcare professionals through consistent in-person visits and group presentations to deliver clinically relevant, compliant product information. * Execute company-approved marketing strategies and develop territory business plans to maximize sales performance. * Collaborate with sales and leadership teams to develop business strategies that exceed goals and enhance overall team success. * Deliver impactful presentations and facilitate speaker programs aligned with corporate messaging and industry compliance. Qualifications: * Bachelor’s degree * 2+ years of branded pharmaceutical sales experience * Strong track record of consistently exceeding sales goals in physician-targeted roles * Exceptional communication, negotiation, and problem-solving skills * Passion for healthcare and a commitment to improving patient outcomes — especially in children’s health * Dermatology or Pediatrics experience a plus Compensation & Benefits: * Base salary: $110,000 – $130,000 (commensurate with experience) * Bonus potential: $35,000 – $40,000+ * Comprehensive benefits package including: * Strong car allowance + mileage reimbursement * Robust health plan * 401(k) with match * Stock options

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. 3900 Duckhorn Drive, Sacramento, CA 95834 About the Job: Title of the Position: QA Specialist As a Quality Assurance (QA) Specialist, you will play a critical role in ensuring that all products, processes, and documentation meet established quality standards, regulatory requirements, and company policies. Your responsibilities will include maintaining compliance with cGMP, GLP, and other industry regulations, safeguarding product integrity, and supporting continuous improvement initiatives. You will manage Quality Management Systems (QMS), review critical documentation, oversee training programs, and ensure adherence to organizational quality objectives. Responsibilities: • Responsible for collecting and analysing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of CAPA., • Leads, mentors, and coaches operations and support personnel on the Change control, deviation management system and CAPA program., • To drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence., • Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems., • Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions., • Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner., • Act as a site instructor for Change control, Deviation Management and CAPA courses., • Coaches lead investigators on technical writing., • Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures., • Supports and initiates deviations, trends, or other technical investigations, as applicable., • Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding., • Effective implementation of electronic Quality Management system (eQMS) across organizations. Education/Experience: • Bachelor's degree in a relevant field such as Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline., • Strong knowledge of cGMP, GLP, and quality standards such as ISO 9001., • Proficiency in managing Quality Management Systems (QMS)., • Familiarity with laboratory instruments and analytical methods., • Experience with document control processes and regulatory audits., • Excellent attention to detail and strong organizational skills., • Effective communication and interpersonal skills for collaboration across departments., • Strong analytical and problem-solving abilities., • Ability to work independently and as part of a team in a fast-paced environment., • Legally authorized to be employed in the United States, • Pay range $25.0 per hour to annual salary of $70,000, • 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 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.

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: Quality Assurance Manager-Parenteral (Full Time) At Nivagen as Quality Assurance manager you will be responsible for overseeing and managing all QA activities related to the manufacturing of sterile injectable (parenteral) products. This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (e.g., FDA, EMA, MHRA). The QA Manager will lead a team in managing quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close collaboration with production, QC, regulatory affairs, and engineering teams to ensure consistent product quality and continuous improvement. Responsibilities: • Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness., • Provide triage support across departments to address moderate quality issues, ensuring timely escalation to management when necessary., • Review and approve deviations, including the associated investigation reports, and corrective/preventative actions., • Review and approve change controls for appropriateness, completeness and alignment with quality, validation, and regulatory expectations., • Review and approve sampling protocols, risk assessments, and master batch records., • Author, review and approve SOPs as appropriate for both Operations and Quality., • Assist with additional tasks, including (but not limited to) Master Data management / approval, GMP area walkthroughs, product changeover activities., • Participate in internal audits, support regulatory inspections or customer audit activities, as needed., • Maintain and update quality-related documents, records, and reports within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance., • Assist in the development or assignment of training to key stakeholders related to QMS., • Contribute to the preparation of Periodic Quality Reviews., • Assume responsibility for any additional quality-related activities delegated to the hub, ensuring effective management in alignment with Quality standards. Education/Experience: • Candidates with a Bachelor's degree must have at least 10 years of relevant experience; those with a Master's degree require 5+ years of experience., • Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations, • Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards., • Proactive approach and strong critical thinking skills., • Must be able to work in a team environment within own team and interdepartmental teams., • Excellent communication and interpersonal skills., • Experience in quality administered systems., • Strong organizational skills and attention to detail., • Experience with regulatory compliance and documentation., • Ability to mentor and review the work of other colleagues., • This role is primarily day shift, Monday – Friday, with 24/7 support of manufacturing as quality issues arise., • Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements., • Collaboration skills and the ability to independently engage with a wide range of colleagues, and management to gather the input and background knowledge needed to complete assignments., • Must be able to gown for entering controlled areas., • Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc.)., • Flexibility is required as work hours and starting times may vary to provide coverage on different shifts to meet business needs., • Overtime and weekend work may be required., • Individuals must be available via cell phone (on-call)., • Pay range $85,000-$95,000 per Year / $40/hr. (for hourly basis), • Relocation assistance available, • Annual bonus Eligibility (Based on yearly company and personal performance), • Medical, dental and vision coverage, • Paid time off plan 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.

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: Lab Technician As a Lab Technician at Nivagen you will be responsible for supporting the laboratory operations by conducting routine tests, preparing samples, maintaining laboratory equipment, and ensuring compliance with Good Laboratory Practices (GLP) and regulatory standards. The technician will work closely with chemists, scientists, and other technical staff to ensure the smooth and accurate testing of pharmaceutical products. Responsibilities: • Analyze assigned samples using various instruments, primarily HPLC., • Maintain laboratory logbooks and usage/consumption logs., • Clean and maintain all laboratory areas., • Adhere to and comply with cGLP and cGMP standards., • Operate laboratory instruments as per SOPs., • Management of chemicals, reagents, standards, HPLC columns, etc., • Contact service engineer when necessary to calibrate laboratory instruments., • Handle the disposal of chemicals and samples, • Prepare and review SOPs., • Prepare and review COAs., • Prepare other documents related to analytical activities, including protocols, templates, reports, specifications, and STPs., • Develop analytical methods under the guidance of supervisor. Education/Experience: • Experience in assisting to prepare reports., • Pay range $20 to $22 an hour, • Yearly bonus and stock options 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 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.

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: Lab Technician As a Lab Technician at Nivagen you will be responsible for supporting the laboratory operations by conducting routine tests, preparing samples, maintaining laboratory equipment, and ensuring compliance with Good Laboratory Practices (GLP) and regulatory standards. The technician will work closely with chemists, scientists, and other technical staff to ensure the smooth and accurate testing of pharmaceutical products. Responsibilities: • Reviews Data, • Perform Internal Audits, • Analyze assigned samples using various instruments, primarily HPLC., • Maintain laboratory logbooks and usage/consumption logs., • Clean and maintain all laboratory areas., • Adhere to and comply with cGLP and cGMP standards., • Operate laboratory instruments as per SOPs., • Management of chemicals, reagents, standards, HPLC columns, etc., • Contact service engineer when necessary to calibrate laboratory instruments., • Handle the disposal of chemicals and samples, • Prepare and review SOPs., • Prepare and review COAs., • Prepare other documents related to analytical activities, including protocols, templates, reports, specifications, and STPs., • Develop analytical methods under the guidance of supervisor. Education/Experience: • Experience in preparing reports., • Proficiency in Microsoft Office., • Pay range $24 to $28 an hour, • Yearly bonus and stock options 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 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.

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 3050 Fite Circle, Suite 100, Sacramento, CA 95827 About the Job: Title of the Position: Senior Chemist (Full Time) At Nivagen as a Senior Chemist you will be responsible to leads projects, ensuring accurate results, innovative solutions, and optimized processes. This role involves collaborating with engineering, production, and quality assurance teams to support product development, testing, and compliance. Responsibilities: • Communicate with CMO regarding analytical activities., • Handle product deficiencies., • Ensure adherence to FDA guidelines and regulations., • Responsible for maintaining cleanliness of lab areas., • Guide team regarding analytical method development on instruments like HPLC and GC., • Ensure compliance with quality system., • Train new personnel., • Prepare analytical budget for the lab., • Plan analyses in accordance with production schedule., • Develop analytical methods., • Perform PDR-related activities and documentation, • Investigate OOT and OOS results., • Prepare and review SOPs., • Prepare and review COAs., • Prepare other documents related to analytical activities, including protocols, templates, reports, specifications, and STPs., • Review validation protocols, reports, and datasheets. Education/Experience: • Bachelor's degree in Chemistry, Biochemistry, or a related field (Master's or Ph.D. preferred)., • Proficiency in advanced analytical techniques such as spectroscopy, chromatography (HPLC, GC), and other instrumentation., • In-depth understanding of chemical properties, reaction mechanisms, and regulatory guidelines (e.g., FDA, EPA, OSHA)., • Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS)., • Strong problem-solving, communication, and project management skills., • Pay range $75,000-$85,000 per Year, • Yearly bonus and stock options 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 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.

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: Engineering Project Lead The project lead should have a strong understanding of Pharmaceutical Projects of Sterile products like vials, PFS, Cartridges, and IV bags. Should have firm hands-on Experience in the execution of the sterile project, Concept Designing, and Basic Engineering for Pharma Projects. Well-versed with relevant guidelines like cGMP, GSP, GLP, ISO, etc. Self-Starter, motivator, team player. He/she will be independently dealing with the Vendors Suppliers, internal stakeholders apart from Project Management, Scheduling, Master Planning, Project Progress Reports, and Management Reporting activities. Knowledge of site execution, installation & commissioning is mandatory. Responsibilities: • Assist the Project Director with the handling of project-related tasks., • Coordination of multidisciplinary engineering projects throughout its life cycle - from proposals to final project handovers within scheduled and agreed timeframe., • Ensure that the proper engineering procedures, methods, and technical solutions are used throughout the project, • Coordinate or supervise the daily activities of the project team, including contractors and suppliers, • Manage the planning and execution of all critical success factors within the project such as scope, time, cost, and quality, • Review of vendor proposals against Standards and Guidelines and develop deviation and correction reports for communication with suppliers/contracts., • Coordinate with city and county regarding facility design and approval of Pharma facilities in accordance with local rules and regulations., • Review of Consultant designs to ensure better compliance with cGMP Education: Minimum 8 to 10 years of professional experience in the field of pharmaceutical projects or process design with a pharmaceutical company Or Engineering/consulting firm. • Sterile Manufacturing and packing, • Review and implementation of clean Utility, • Review and execution of HVAC system for sterile Plants, • Setting up a greenfield project for a pharmaceutical company Functional: • Knowledge of Sterile formulation engineering, • Knowledge of USFDA, cGMP, GLP, ISPE, ISO, • Good Command over AutoCAD, • Project Management, • Result oriented, • Innovative thinking, • Time Management, • Problem-solving ability & High level of self-motivation, • Strong interpersonal relationship skills, • Valid driver's license and acceptable driving record, • Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents), • Competitive Salary (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 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.

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: QC Chemist As a QC chemist at Nivagen you will be responsible for conducting analytical tests on pharmaceutical products, ensuring that they meet regulatory standards such as those set by the FDA and ICH. This role involves performing tests on raw materials, intermediates, and finished dosage forms to guarantee product safety, efficacy, and quality in compliance with Good Manufacturing Practices (GMP) and other regulatory standards. Responsibilities: • Operate and maintain analytical instruments such as GC, GC-MS, LC-MS, UPLC, and HPLC, which are equipped with UV-Vis, PDA, and CAD detectors., • Ensure proper calibration and regular maintenance of laboratory equipment to guarantee accuracy and precision in results., • Assist in developing and validating analytical methods for new products, ensuring compliance with regulatory guidelines, including those from ICH and FDA., • Perform qualitative and quantitative analyses on raw materials, in-process materials, and finished products using validated methods to ensure compliance with required specifications., • Conduct stability studies on products following ICH guidelines, adhering to stability protocols, and documenting results for regulatory submissions., • Investigate deviations and out-of-specification (OOS) results, conduct root cause analysis, and implement corrective and preventive actions (CAPA) to address and prevent recurrence., • Ensure all testing adheres strictly to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory standards., • Implement ICH Q2 (R1) guidelines for method validation and participate in internal and external audits to maintain laboratory compliance., • Collaborate with R&D, production, and quality assurance teams to support product development and commercialization efforts, and provide assistance during regulatory inspections. Education/Experience: • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field., • Proficiency in analytical techniques (HPLC, GC, FTIR, UV-Vis, Dissolution Testing, etc.)., • Strong understanding of pharmaceutical regulations (FDA and ICH)., • Experience with GMP, GLP, and GDP requirements., • Ability to troubleshoot analytical issues and conduct root cause analysis., • Strong communication and documentation skills., • Excellent attention to detail and organizational skills., • Familiarity with FDA, ICH guidelines, including ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients) and ICH Q10 (Pharmaceutical Quality System)., • Knowledge of stability testing guidelines, including ICH Q1A., • Ability to stand and work for extended periods in a laboratory environment., • Pay range $75,000-$85,000 per Year, • 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 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.

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: Lab Technician As a Lab Technician at Nivagen you will be responsible for supporting the laboratory operations by conducting routine tests, preparing samples, maintaining laboratory equipment, and ensuring compliance with Good Laboratory Practices (GLP) and regulatory standards. The technician will work closely with chemists, scientists, and other technical staff to ensure the smooth and accurate testing of pharmaceutical products. Responsibilities: • Analyze assigned samples using various instruments, primarily HPLC., • Maintain laboratory logbooks and usage/consumption logs., • Clean and maintain all laboratory areas., • Adhere to and comply with cGLP and cGMP standards., • Operate laboratory instruments as per SOPs., • Management of chemicals, reagents, standards, HPLC columns, etc., • Contact service engineer when necessary to calibrate laboratory instruments., • Handle the disposal of chemicals and samples, • Prepare and review SOPs., • Prepare and review COAs., • Prepare other documents related to analytical activities, including protocols, templates, reports, specifications, and STPs., • Develop analytical methods under the guidance of supervisor. Education/Experience: • Experience with standard laboratory equipment, such as pipettes, graduated cylinders, and balances., • Experience with laboratory techniques related to measuring, weighing, and handling of samples., • Experience with HPLC is highly desired., • Familiarity with handling chemicals, especially the safety precautions and documents (SDS) related to such., • Proficiency in Microsoft Office., • Knowledge of chemistry and pharmaceuticals, as well as the terms and concepts related to such., • Pay range $25 to $28 an hour, • Yearly bonus and stock options 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 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.

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: Microbiologist (Full Time) At Nivagen as a Microbiologist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. Position Summary As a Microbiologist you will play a critical role in the success of our operations. This position is integral to our commitment to excellence, as it involves developing and validating microbiological test methods, maintaining detailed records, and preparing reports, protocols, and standard operating procedures (SOPs). Your expertise will directly contribute to Quality and affordable medication. Collaboration is key in this role. You will work closely with cross-functional teams to meet project objectives and timelines and identify opportunities for process improvements. Your proactive approach and innovative mindset will help us enhance efficiency and effectiveness within our microbiology laboratory and reinforce our dedication to quality and compliance. Additionally, in this influential role you will be a mentor, providing training and guidance to microbiology staff, fostering an environment of continuous learning and professional growth. Joining Nivagen as a Microbiologist means being part of a visionary team dedicated to expanding access to quality, affordable medication. If you are passionate about quality, service, and innovation, and are eager to make a difference in people's lives, we invite you to bring your expertise and enthusiasm to our dynamic team. Duties and Responsibilities • Conducts microbiological testing of primary packaging materials, raw materials, in process sample, finished products, and environmental samples using various techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing., • Develops and validates microbiological test methods in accordance with compendial and regulatory requirements., • Maintains accurate and detailed records of all microbiological testing and analysis performed. Prepares and reviews reports, protocols, and SOPs related to microbiological activities., • Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures. Participate in internal and external audits as needed., • Microbiology-related projects, including method transfers, validations, and investigations., • Collaborates with cross-functional teams to achieve project objectives and timelines., • Provides training and mentorship to microbiology staff., • Shares knowledge and expertise to promote continuous learning and development within the microbiology team., • Identifies opportunities for process improvements and optimization within the microbiology laboratory., • Implements best practices and innovative solutions to enhance efficiency and effectiveness., • Performs a variety of Microbiology testing to assess the strength, identity, and purity of test samples and/or materials. Knowledge and Skills • Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions., • Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement., • Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives., • Resourcefulness: Secures and deploys resources effectively and efficiently., • Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems., • Ensures Accountability: Holds self and others accountable to meet commitments and objectives., • Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations. People: Our people define who we are as a company. We believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth. By prioritizing the well-being and development of our employees, we create an environment where everyone can thrive and contribute their best. Quality: Quality stands at the core of our mission. It reflects our commitment to excellence in every medication we produce. We adhere to the highest standards of quality control and continuously strive to improve our processes to ensure that our products meet the needs of those we serve. Our dedication to quality is unwavering and is evident in every aspect of our work. Service: We are here to serve others. Every interaction with our patients, providers, employees, and other stakeholders comes from a place of service. We are committed to delivering exceptional service and ensuring that every experience with our company is positive and impactful. Our service-oriented approach helps us build strong, lasting relationships and fulfill our mission of improving healthcare outcomes. Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care. Innovation drives us to find better ways to serve our patients, improve our products, and streamline our operations. We are committed to staying ahead of industry trends and leveraging cutting-edge technology to enhance the value we provide. In summary, our core values—People, Quality, Service, and Innovation—are integral to everything we do. They guide our actions, shape our culture, and inspire us to achieve excellence in all our endeavors. By staying true to these values, we ensure that we fulfill our mission and make a positive impact on the lives of those we serve. Experience and Qualifications • Bachelor's degree in microbiology, Biology, or related field required; Master's degree preferred., • Minimum of 3 years of experience in a microbiology laboratory required., • Previous experience in a pharmaceutical or compounding environment preferred., • Experience with compendia testing: United States Pharmacopeia, and regulatory requirements (Food and Drug Administration and cGMP) preferred., • Pay range $70,000 - 85,000 per Year, • 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 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. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Job Description Job Title: Pharmacist (Specialty) Pay: $60-$68 an hr | Bi-weekly Job Type: Onsite in Sacramento CA 95834 Participate in decisions regarding the pharmaceutical services within assigned scope including: * Assessing the patient's general pharmaceutical needs * Planning for the pharmaceutical services provision * Participating in the overall plan of care * Participating in the overall quality assessment and improvement plan * Receive physician prescription orders and evaluate the appropriateness of these orders for dosage, drug choice, potential drug interactions, route of administration and stability * Supervise the filling, receiving, compounding, and dispensing activities involved in providing finished product to the patient * Ensure that the patient chart is complete for allergies, height, weight, current and past medical history, clinical laboratory results and concurrent medications (including over-the-counter or home remedy medications) * Ensure that when necessary, laboratory tests have been ordered and the results are obtained and discussed with the nurse and the physician * Provide patient counseling, education, and monitoring * Ensure safety of patients and personnel by exercising good pharmacy practice in the process of drug therapy instructions to the patient * Determine remaining doses on hand to manage inventory and avoid waste * Provide clinical interventions * Assess responses to therapy, patient compliance, and ongoing review of drug regimens; report and manage adverse events * Assist the physician, nurse and patient with clinical and technical support * Document all communication with physicians, nurses and patients in the patient chart * Assist in the maintenance and upkeep of all necessary paperwork required by state and federal agencies as well as the Joint Commission * Assist the Pharmacy Manager in implementing new procedures * Assist in the training and supervision of Pharmacy Technicians, Pharmacy Interns and other pharmacy personnel * Participate in Performance Improvement Projects * Assist in providing in-service programs to nursing and pharmacy personnel on any aspect of drug therapy * Attend and/or complete education and training programs * Review literature and other materials pertinent to the practice of pharmacy * Complete all competency/skills assessment requirements * Participate in on-call schedule * Perform other tasks as determined by the Pharmacist-In-Charge Pharmacist Qualifications: • Required: Bachelor’s degree or advanced degree (Pharm.D), • Required: Current state’s Pharmacist license, • Years of experience required: At least 2+ years of experience., • Disqualifiers: having a bad attitude, • Benefits are available to full-time employees after 90 days of employment and include health, optical, dental, life, and short-term disability insurance. If you are interested in this position, please apply OR submit your resume to: Saw Hlaing | | 412-790-5425

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: Sterile Manufacturing Associate The Sterile Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs. This role plays a critical part in ensuring the integrity and quality of sterile drug products manufactured at Nivagen. The position requires a high degree of attention to detail, adherence to gowning and aseptic techniques, and the ability to follow precise procedures. Responsibilities: • Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection., • Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions., • Comply with all gowning requirements and environmental control procedures to maintain sterile conditions., • Follow batch production records (BPRs), standard operating procedures (SOPs), and material handling protocols., • Support execution of media fills, process validations, and cleanroom qualification activities., • Participate in room and equipment sanitization activities, ensuring compliance with established cleaning frequencies., • Complete all training in a timely manner and maintain qualification for aseptic operations., • Accurately record all activities in cGMP documentation, ensuring data integrity., • Assist with investigations, deviations, CAPAs, and continuous improvement initiatives., • Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs. Education/Experience: • High School diploma or GED required; Associate's or Bachelor's degree in Life Sciences or related field preferred., • Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred., • Strong understanding of aseptic technique, cleanroom behavior, and contamination control., • Ability to read and follow SOPs, batch records, and manufacturing instructions precisely., • Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods., • Detail-oriented with strong documentation and communication skills., • Ability to work independently and as part of a collaborative team., • Valid driver's license and acceptable driving record., • Legally authorized to be employed in the United States., • This role is an onsite role and requires daily commuting to and from the facility., • This role requires work in a controlled cleanroom environment with strict gowning and hygiene protocols., • Fulltime Employment, • $28 - $40 per hour (Based on Experience), • Annual Bonus eligibility, • Medical, Dental and Vision coverage, • PTO plan Nivagen Pharmaceuticals affords 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.

Job Description Contract Attorney or Paralegal - 340B Program (Remote) Remote (Any State License Accepted) Employment Type: Contract (Set your own hours for a project) About the Role: We are seeking a highly skilled and detail-oriented Contract Attorney or Paralegal with expertise in the 340B Drug Pricing Program to join our team on a remote, contract basis. This role will provide critical legal and regulatory support to ensure compliance with 340B program requirements, assist with audits, and help navigate complex legal issues related to pharmaceutical pricing and healthcare regulations. The ideal candidate will have a strong background in healthcare law, contract review, and regulatory compliance, with specific experience in the 340B program. Key Responsibilities: • Provide legal analysis and guidance on 340B program compliance, including eligibility, contract pharmacy arrangements, and regulatory changes., • Review, draft, and negotiate contracts related to the 340B program, including agreements with covered entities, contract pharmacies, and third-party administrators., • Assist with internal and external audits, including preparing documentation, responding to inquiries, and ensuring compliance with 340B program requirements., • Monitor and interpret federal and state regulations, guidance, and policies related to the 340B program and healthcare compliance., • Collaborate with internal stakeholders, including legal, compliance, and pharmacy operations teams, to address legal and regulatory risks., • Conduct legal research and prepare memoranda on issues related to the 340B program, healthcare law, and pharmaceutical pricing., • Support dispute resolution efforts, including responding to HRSA (Health Resources and Services Administration) inquiries or allegations of non-compliance., • Stay up-to-date on industry trends, litigation, and enforcement actions related to the 340B program. Qualifications: • For Attorneys: Juris Doctor (JD) degree from an accredited law school and active bar membership in good standing in any U.S. state., • For Paralegals: Paralegal certification or equivalent experience, with a strong background in healthcare law or regulatory compliance., • Minimum of 3-5 years of experience working with the 340B Drug Pricing Program, healthcare compliance, or pharmaceutical law., • In-depth knowledge of 340B program regulations, HRSA guidelines, and related federal and state laws., • Experience drafting, reviewing, and negotiating contracts, particularly in the healthcare or pharmaceutical industries., • Strong analytical skills with the ability to interpret complex regulations and provide actionable recommendations., • Excellent written and verbal communication skills, with the ability to communicate legal concepts to non-legal stakeholders., • Self-motivated and able to work independently in a remote environment., • Proficiency with Microsoft Office Suite and legal research tools (e.g., Westlaw, LexisNexis). Preferred Qualifications: • Experience working with covered entities (e.g., hospitals, clinics, federally qualified health centers) or contract pharmacies., • Familiarity with Medicaid drug rebate programs and other pharmaceutical pricing regulations., • Prior experience supporting 340B program audits or dispute resolution processes. Why Join Us? • Fully remote position with flexible hours., • Opportunity to work on impactful projects within the healthcare and pharmaceutical industries., • Collaborative and supportive team environment.

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

Job 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., • 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., • 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., • 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 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.

Job DescriptionCompany Description EVERSANA has partnered with Calliditas Therapeutics for this Direct Hire opportunity. Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product, TARPEYO, has been approved by the FDA as the first treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. Additionally, Calliditas plans to initiate clinical trials with NOX inhibitor product candidates in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Reasons to join the Calliditas Therapeutics Team • Be a part of a global leader in IgA- Nephropathy, • Rare Disease product launch - TARPEYO Is indicted as a treatment for a rare, progressive autoimmune disease, • Fast paced small company environment DIRECT HIRE - Calliditas Therapeutics The "Rare Disease Account Manager" is responsible for developing and implementing a business plan to maximize territory sales for TARPEYO. The business plan will align with the direction from commercial leadership and with all company guidelines, policies, and directives. As a Rare Disease Account Manager, you will: • Deliver sales performance, brand KPIs, financial targets, marketing objectives, etc. to meet or exceed expectations, • Effectively promote and educate targeted physicians and their practices including, physician colleagues, RNs, NPs, PAs, MAs and office staff on Calliditas Therapeutics' product(s) using company approved resources, sales materials and promotional activities/initiatives as identified by sales leadership, • Achieve sales goals while adhering to ethical sales practices, compliance guidelines and promotional regulations, • Develop and execute a call plan that achieves set metrics and optimizes reach, coverage and frequency to key customers, • Effectively handle objections and concerns while moving the customer to logical and reasonable calls to action, • Continuously build knowledge of customer, territory, market dynamics, product, competitors and disease state, • Share market intelligence to optimize brand strategy and execution, • Effectively communicate product value proposition to customers, • Develop and maintain superior relationships with key decision makers and influencers (MDs, RNs, NPs, PAs, PharmDs, MAs, office staff, etc.) within target physician offices and hospitals., • Deliver brand messaging in person and virtually to ensure comprehensive coverage of the territory, • Travel as needed throughout territory (may include overnights), • Report and submit sales calls, reports, activities and territory expenses timely and accurately as defined by sales leadership #LI-CG1 Qualifications Hiring Criteria/Requirements: • Bachelor's degree from an accredited College/University is required, • A minimum of five years successful pharmaceutical sales experience - with at least 2 of these years in specialty and/or hospital sales, • Experience in nephrology or rare/orphan (specialty product) experience is required, • Proficiency in working with specialty drugs via a HUB distribution model is preferred, • Launch experience, • Proven track record of successful performance – must have documentation - national awards, • Excellent presentation skills – ability to proactively identify customer’s style / behavior and quickly adapt selling approach, • Demonstrates in-depth scientific, therapeutic, product, and competitor; recognized as an expert resource by all relevant stakeholders, • Strong business acumen and proficient use of business tools; possesses strategic and critical thinking capabilities, • Experience working territory alone yet collaborating and partnering with a team, • Ability to sell both "face to face" and virtually via Zoom/Teams/teleconferencing, • Builds collaborative partnerships and operates effectively in a matrix environment, • Offers innovative ideas and solutions to maximize business opportunities to address challenges, • Influences others and is viewed as a credible and respected role model and resource among peers, • Consistently displays positive attitude through challenges and change, • Approximately 60% (dependent on geography) travel expectation - overnight travel is required in this role, • Meet all requirements for health care industry representative (HCIR) credentialing to gain entry into facilities and organizations that are in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases Additional Information Calliditas Therapeutics is committed to providing competitive salaries and benefits for all employees. The anticipated base salary range for this position is $155,000 to $185,000 and is not applicable to locations outside of the U.S. The base salary range represents the low and high end of the salary range for this position. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). Calliditas Therapeutics reserves the right to modify this base salary range at any time.