Director, CMC Regulatory Affairs
ORIC Pharmaceuticals job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
Reporting to the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position is responsible for leading CMC regulatory activities and supporting all of ORIC's clinical development programs for oncology products. The role involves close collaboration with cross-functional teams including regulatory affairs, regulatory operations, quality, CMC, nonclinical, and clinical departments.
Job Description
Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORIC's products.
Provide CMC regulatory support for new and ongoing clinical trials, e.g., manage/prepare CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
Lead preparation and responses for CMC-related meetings with global RAs and HAs, balancing regulatory requirements and corporate objectives.
Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans.
Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs , etc.
Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).
Qualifications
BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
At least 10+ years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and regulatory writing.
Experience in addressing CMC-related regulatory queries from global health authorities.
Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
Demonstrated success driving drug product development and managing all aspects of CMC documentation.
Excellent working knowledge and understanding of applicable global regulations required - cGMP, global regulatory guidance, compendial requirements, including FDA, EMA, ICH, WHO, USP-NF.
Prior experience as primary author of CMC sections of M2 and M3 of IND,NDA, and IMPD.
Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents.
Excellent attention to detail, and strong computer and organizational skills required.
Must be a strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
Must have a quality mindset and deliver results in an ethical and positive manner.
Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
Proven ability to manage multiple tasks and associated deadlines.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $220,000-$270,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
Director Information Technology, Development Operations
ORIC Pharmaceuticals job in San Diego, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
Reporting to the Executive Director, of IT, ORIC is seeking a strategic and hands-on IT leader to support late-stage Development functions across Clinical, Regulatory, Quality, and Drug Safety. This role will drive digital enablement and compliance for Phase 3 programs, ensuring that systems and processes meet global regulatory standards and are ready for inspection. The ideal candidate will bring deep expertise in Veeva platforms, Computer System Validation (CSV), and regulatory frameworks such as 21 CFR Part 11. By collaborating with stakeholders across Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions, you will ensure data is discoverable, interoperable, and analytics-ready.
Job Description
IT Business Partnership & Strategy
Serve as the primary IT partner for Phase 3 Development functions, aligning technology solutions with business needs.
Collaborate with Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions and teams to support digital transformation initiatives.
System Ownership & Implementation
Lead implementation and optimization of Veeva Vault applications (e.g., Quality Docs, QMS, RIMS).
Gather application business requirements and systems goals from business owners and translate them into technical requirements.
Oversee system lifecycle management, including upgrades, integrations, and vendor coordination for SAS, Box.com, and Extedo.
Collaborate with domain leaders, governance, and platform teams to ensure seamless integration of Developement systems.
Compliance & Validation
Ensure systems are validated per GxP requirements and compliant with 21 CFR Part 11.
Lead the IT GDPR compliance program.
Own CSV documentation and audit readiness for IT-supported platforms.
Inspection Readiness & Support
Partner with QA and Regulatory to prepare for health authority inspections.
Provide IT support during inspections, including system demonstrations and documentation.
Project & Change Management
Lead cross-functional projects from concept through deployment.
Manage change control processes and ensure stakeholder alignment.
Manage the UAT planning, execution, and reporting.
Qualifications
Bachelor's or Master's degree in Computer Science, Life Sciences, or related field.
8+ years of experience in IT supporting development functions in the biopharma industry.
Strong knowledge of Veeva Vault applications and their configuration.
Proven experience with CSV, GxP systems, and 21 CFR Part 11 compliance.
Familiarity with Phase 3 clinical trial operations and regulatory submission processes.
Good understanding of industry data standards (CDISC, MedDRA, HL7, etc.).
Experience in R&D data domains and lifecycle.
Excellent communication, stakeholder management, and problem-solving skills.
Preferred Experience:
Experience supporting global clinical trials and regulatory submissions.
Prior involvement in inspection readiness or direct participation in regulatory audits.
Knowledge of Quality Management Systems (QMS).
Additional Information
The anticipated salary range for candidates who will work in our San Diego location is between $200,000-$250,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
Center Manager for Plasma Donation Center
Moreno Valley, CA job
table.MiTabla { max-width: 1020px;!important
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Job Title: CENTER MANAGER
Summary:
Acts as the general manager for a Plasma Collection Center and has overall responsibility for the center's operation. Works under general occasional guidance and general oversight of regional management. Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations.
Primary Responsibilities for Role:
Responsible for meeting quarterly goals, staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals.
Create appropriate organizational environment and value systems which stimulate the morale and productivity of the work force and its leadership.
Operates the center and manages employees and operations to the highest standard of ethics and integrity.
Manages staff to ensure that training and quality goals are met and to implement operational changes and maximize center efficiency.
Directs and manages employees.
Monitor and evaluate operations. Develop action plans to maximize center efficiency and supervise the implementation of process improvements.
Manages headcount to provide for efficient staffing through high and low production intervals, providing accurate and timely projections to regional management team in advance of cyclical and seasonal or situational spikes.
Accountable for the direction of all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records.
Provides strategic direction and planning.
Other Responsibilities for Role:
Acts as a mentor to assigned team, other center staff and other centers.
Through Assistant Manager, oversees donor selection, plasma collection and shipment and records completion.
Accountable to ensure the adequate training of production employees and demonstrate how tasks are to be performed to meet company standards.
Accountable for the adequacy of inventory of all goods and supplies necessary for center operations and oversee ordering goods as needed.
Assure center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order.
Accountable for freezer management, including overseeing plasma shipments and equipment failures. Required to answer all freezer alarms and deal with them appropriately.
Submit timely and accurate reports on a daily/weekly basis or as requested.
Develop community representation with regards to all public relations and marketing campaigns to attract and retain donors.
Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).
Accountable for donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).
Directs through the management team and with Training and Quality staff to ensure that training and quality goals are met.
Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation.
Works with Divisional/Corporate management in the preparation of annual budget and manages facility to consistently achieve production targets and quality goals at the agreed-upon cost structure.
Control center donor funds and ensure that all financial records are accurate and in order.
Identifies regulatory deficiencies and in collaboration with the Center Quality Manager implements immediate corrective action.
Minimize center liability through constant risk management review. Investigates all unsafe situations and complaints and institutes corrective/preventive action.
Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises.
Assumes Regional management oversight and mentoring duties for select facilities/projects or in ROMs absence.
Performs other duties as required.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Job Requirements:
Bachelor's degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field.
Typically requires a minimum of 3 years of related work experience in clinical or general business environment.
Supervisory experience preferred but not required.
Prior management experience, preferably supervising a group of 20 or more employees.
Experience in a medical and/or cGMP regulated environment preferred.
Experience with plasma or whole blood preferred.
Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a master's degree with 2 years of experience.
Attributes:
Command of leadership, management, presentation, organizational, customer service, interpersonal communication, and computer skills. Ability to understand, assess and communicate FDA regulations. Ability to balance multiple competing priorities, ensure proper staffing levels, maintain adequate levels of plasma collection, and adhere to quality standards. Ability to control costs and maintain a budget. Ability to motivate staff to achieve established goals and standards. Ability to develop positive relationships with donors, center employees, and company employees working in different geographical locations. Developing command of and proficiency in at least one functional area, such as finance, IT, HR, or compliance. Ability to relocate preferred.
Compensation and Benefits:
This position is eligible to participate in up to 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
“We are looking to grow our teams with people who share our energy and enthusiasm for creating the best experience for our donors/customers.”
#BiomatUSA
#Indeed
#app
#LI-Onsite
#LI-BA1
#LI-RL1
Third Party Agency and Recruiter Notice:
Agencies that present a candidate MUST have an active, nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Location: NORTH AMERICA : USA : CA-Moreno Valley
Center Address: 718 22nd Ave South, Brookings, SD 57006
Contact: Alex S. Contreras,
Senior Talent Acquisition Partner
- ************** | **********************
Learn more about Grifols
Follow us on Facebook: *******************************************
Follow us on LinkedIn: *****************************************
To find more jobs with Grifols: ********************
Or Text GRIFOLS to ************
Psychiatry Account Manager - Stockton, CA
Stockton, CA job
Territory: Stockton, CA - Psychiatry
Target city for territory is Stockton - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Fremont, Stockton, Elkgrove, San Ramon, Pleasonton and Hayward.
SUMMARY:
Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!
As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas:
ESSENTIAL FUNCTIONS:
Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance.
Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior.
Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management.
Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities.
Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources.
Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university
2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience
Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually
Self-starter, with a strong work ethic and outstanding communication skills
Must be computer literate with proficiency in Microsoft Office software
Must live within 40 miles of territory boundaries
Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements
Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
Previous experience within a specialty product sales force
Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder
Documented successful sales performance
Ownership and accountability for the development and execution of fully integrated account plans
Strong analytical background, and experience using sales data reporting tools to identify trends
Experience in product launches
Previous experience working with alliance partners (i.e., co-promotions)
Strong leadership through participation in committees, job rotations, panels and related activities
TRAVEL:
Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner.
The range displayed is specifically for those potential hires who will work or reside in the state of California, if selected for this role, and may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $117,000 - $155,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis.
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.
Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
Executive Administrative Assistant
Irvine, CA job
Executive Administrative Assistant - Hybrid | Irvine, CA | Kelly at Johnson & Johnson
Join a world-class team and take the next step in your career! Kelly , in partnership with Johnson & Johnson, is seeking a talented Executive Administrative Assistant for a dynamic hybrid role in Irvine, CA. You'll play a key part in supporting leadership and streamlining office operations for one of the most respected companies in the healthcare industry.
Job Specifications
Job Type: Flexible between 20-40 hours per week.
Company: Kelly (Johnson & Johnson Assignment)
Location: Irvine, CA (Hybrid)
Pay Rate: $30.00/hr
Shift: Flexible, within business hours 7a-4p preferred due to various teams in differing time zones
Assignment Length: 1 year (potential for extension)
Roles and Responsibilities
Coordinate event logistics and provide administrative support for meetings and workshops.
Manage complex calendars for senior leaders (Two Senior Directors and their teams; coordination with global admins), schedule appointments, update calendars, and troubleshoot booking issues (including digital booking systems).
Planning events and onsite scheduling coordinating of services, meetings, gatherings, and events.
Prepare expense reports, process invoices, and support travel bookings for leaders using Concur; support domestic and international travel including visa support.
Maintain office supply inventory, organize files, and manage office storage systems.
Support around POs, payment requisitions, PO issuing, and project number creation.
Occasionally greet vendors and visitors-ensure pre-registration, prepare guest passes, escort guests, and liaise with onsite facilities and cafeteria staff for meetings/events.
Collaborate proactively with leadership, global admin teams, maintaining key spreadsheets and digital records of leaders and their locations.
Advise on healthcare compliance for expenses and events, including program/expense limits for healthcare providers.
Utilize Microsoft Office Suite (Outlook, Teams, PowerPoint, Excel) daily, as well as company-specific tools (Concur, Workday, Ariba, digital solutions).
Qualifications & Skills
High School diploma or GED required.
5+ years of office-based experience, including 2+ years as an Executive Assistant.
Advanced proficiency with Microsoft Office Suite; experience with Concur and Workday is a plus.
Strong multitasking and organizational skills within a dynamic team setting.
Exceptional verbal & written communication and interpersonal abilities.
Professional, resourceful, self-starter with strong initiative, able to “own” issues until resolved.
Open and collaborative team player, able to partner closely with leaders and coordinate with onsite teams (facilities, cafeteria, other admins).
Familiarity with healthcare provider compliance and basic PO/program management
Experience working in a fast-paced, cross-functional business environment
Ideal Candidate
Hyper-focused and self-motivated, able to partner closely with leaders, anticipate needs, manage priorities and people effectively, and leverage digital tools to keep operations smooth.
Comfortable engaging with guests and office staff, and able to manage quick event turnaround.
Company Culture At Kelly and Johnson & Johnson, you'll find a collaborative, inclusive, and innovative work environment. The team values professionalism, initiative, and mutual respect. You'll be encouraged to grow your skills, support meaningful projects, and make a real difference in the lives of others. If you thrive in a fast-paced, cross-functional setting-and are ready to anticipate needs and drive results-you'll fit right in!
Ready to discover what's next? Apply today and let Kelly connect you to your future!
Research Assistant, In Vivo Tumor Models
San Francisco, CA job
Kelly Science & Clinical is seeking an In Vivo Research Assistant for a contract opportunity with one of our clients, a synthetic biology and cell therapy biotechnology company in Menlo Park, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.
Workplace: Onsite in Menlo Park, CA
Position Title: Research Assistant, In Vivo Tumor Models
Position Type: contract
Pay rate: $30-40 per hour
Schedule: Part-time
Animal Technician - In Vivo Oncology (Mouse Models), Biotechnology Startup - San Francisco Bay Area, CA
Are you ready to drive transformative research at the frontier of cell therapy innovation? Join a pioneering biotechnology startup in Menlo Park, where your expertise with in vivo mouse models will be instrumental in shaping therapies with the potential to change the course of medicine. As an early team member, you'll collaborate closely with visionary scientists and engineering innovators, making a direct impact on the culture, direction, and scientific breakthroughs of our organization.
About the Opportunity:
We're searching for a dedicated Animal Technician with a robust background in managing and executing solid tumor studies using immunocompromised and humanized mouse models. Your hands-on skills and analytical insight will enable our platform to accelerate the design, screening, and optimization of novel cell therapies that harness the full therapeutic power of cellular engineering. You will be critical in supporting our rapid innovation cycles, where new tools and approaches are continuously tested and refined.
Mission & Environment:
Our team believes that cellular biology holds the blueprint for tackling the most challenging diseases-from cancer and viral infection to autoimmunity and aging. We apply cutting-edge synthetic biology and systems immunology to engineer next-generation cells capable of precisely and potently fighting disease. Our approach goes far beyond established paradigms, leveraging novel receptor technologies and high-throughput screens to uncover untapped avenues for therapy development.
Responsibilities
Lead day-to-day execution and management of oncology mouse model experiments.
Independently plan and coordinate study timelines in partnership with research scientists.
Serve as the main interface with vivarium partners to ensure seamless in vivo operations.
Maintain stringent protocol compliance according to all institutional and regulatory standards.
Collect, analyze, and interpret preclinical data to inform project decisions and accelerate development.
Proactive communication and collaboration to move projects forward in a fast-paced, multidisciplinary environment.
Qualifications
Minimum 3 years of hands-on in vivo research experience, ideally in cancer or related therapeutic areas within industry settings.
No formal education requirement; demonstrable expertise is key.
Flexibility to support weekend research schedules.
Exceptional process discipline and attention to detail.
Proven ability to troubleshoot challenges and implement solutions rapidly.
Strong organizational and communication skills, with reliability in managing and executing assigned responsibilities.
Collaborative spirit and a track record of contributing to impactful scientific endeavors.
Ideal Fit:
Takes pride in reliability and personal accountability.
Seeks flexibility in work hours and the possibility of full-time engagement.
Thrives in a close-knit, high-impact team with diverse skillsets.
Eager to take on new responsibilities and champion team success.
Shares a passion for advancing health through cell engineering and community-driven science.
Join us and help unlock the next era of engineered cell therapies-where your work directly contributes to solutions for today's most urgent medical challenges.
Trade Marketing Analyst
Orange, CA job
About Solaris Paper:
Solaris Paper is among the fastest-growing tissue manufacturers in the United States, with production facilities strategically located in California, Oklahoma, and Virginia. A proud member of Asia Pulp & Paper Group (APP), Solaris benefits from being part of one of the world's largest integrated paper companies, whose products reach customers in over 150 countries. The tissue finished goods division of APP, Tissues International, ranks as one of the global leaders in its sector, offering a diverse portfolio of products across 18 brands and five categories, produced in 18 converting factories worldwide.
About Our Products:
Our products include premium bath tissue, paper towels and facial tissue. Our family of brands include LoCor Towel and Tissue and Advanced Dispensing Systems, Livi VPG Select and Livi VPG towel and tissue and FIORA branded consumer towel and tissue products - one of the fastest growing consumer brands in North America.
Ensuring supply chain integrity and commitment to the Sustainable Roadmap Vision 2030 are crucial to APP's operations. Learn more about our path to operational excellence by reading our Sustainability Reports and Forest Conservation Policy at: ****************************************************
About the role:
We are seeking a detail-oriented and analytical Trade Analyst to join our Trade Marketing department. As a Trade Analyst, you will be responsible for managing the Trade Marketing lifecycle, including promotion planning, invoiced shipments, expense accruals, customer claims receipt, and claims settlement. You will work closely with cross-functional teams such as Sales, Business Operations, Marketing, and Accounting to ensure accurate and timely financials.
Job Responsibilities:
Match customer claims to approved promotional plans and facilitate the resolution of settlement issues in collaboration with the Trade Marketing team, Sales, and Brokers.
Coordinate with the Accounts Receivable team to maintain alignment between Trade Settlement and Invoicing, Cash Application, and Customer Collections
Issue customer checks as authorized through approved promotional activity.
Identify discrepancies between trade fund accruals and claims to enhance the accuracy and reliability of Trade Promotion planning and accrual
Perform ad-hoc financial analyses as needed
Build effective relationships and partner with internal customers, including Sales Directors, Trade Managers, and Accounting personnel
Collaborate with external stakeholders such as Customer Accounting Departments, Category Managers, and Brokers depending on the project requirements
Demonstrate a commitment to quality performance through personal example by adopting a customer-based approach to business support
Drive process improvements designed to increase efficiency within the function and organization
Enhance the position by thoroughly reviewing all activities performed in order to improve the quality and productivity of services provided
Basic Qualifications:
BS degree in Business, Accounting or Finance preferred
Strong organizational and communication skills
Ability to build effective relationships and collaborate with internal and external stakeholders
Intermediate Microsoft Excel Skills
Proficiency in understanding and implementing complex concepts, processes, and business structures
Excellent communication and interpersonal skills
Solaris Paper Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, or expression.
Psychiatry Account Manager - Fresno, CA
Fresno, CA job
Territory: Fresno, CA - Psychiatry
Target city for territory is Fresno - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Fresno, San Luis Obispo, Santa Barbara, Clovis, Visalia and Santa Maria.
SUMMARY:
Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!
As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas:
ESSENTIAL FUNCTIONS:
Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance.
Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior.
Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management.
Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities.
Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources.
Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university
2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience
Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually
Self-starter, with a strong work ethic and outstanding communication skills
Must be computer literate with proficiency in Microsoft Office software
Must live within 40 miles of territory boundaries
Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements
Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
Previous experience within a specialty product sales force
Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder
Documented successful sales performance
Ownership and accountability for the development and execution of fully integrated account plans
Strong analytical background, and experience using sales data reporting tools to identify trends
Experience in product launches
Previous experience working with alliance partners (i.e., co-promotions)
Strong leadership through participation in committees, job rotations, panels and related activities
TRAVEL:
Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner.
The range displayed is specifically for those potential hires who will work or reside in the state of California, if selected for this role, and may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $117,000 - $145,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis.
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.
Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
Sr. Microbiologist
Santa Rosa, CA job
NeilMed (Santa Rosa, CA) takes pride in delivering quality OTC products from development through manufacturing.
We're looking for a Senior Microbiologist to join our team and be the subject-matter expert for microbiological control across our manufacturing, QC and operations functions.
Responsibilities
Lead and execute advanced microbiology testing of raw materials, in-process samples, finished goods, packaging materials, and utilities in support of OTC drug manufacturing.
Drive and oversee the environmental monitoring program (clean-rooms, production areas, utilities) and ensure microbiological integrity of the manufacturing environment.
Investigate microbiological failures and out-of-specification (OOS) results; perform root-cause analysis and lead corrective & preventive actions (CAPA).
Develop/validate microbiological methods (e.g., microbial enumeration, microbial limits, preservative efficacy, endotoxin/bioburden, sterility if applicable) aligned with compendial standards (USP/EP) and regulatory requirements for OTC drugs.
Write and review protocols, reports, deviations, CAPAs, trend analyses, change controls and SOPs relevant to microbiology.
Collaborate closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D and Engineering to create and maintain microbiological control strategies across the product/process lifecycle.
Monitor and analyze microbial trend data and recommend improvements to facility/processes for risk mitigation and continuous enhancement.
Provide technical leadership and mentorship to junior microbiologists/technicians; promote a culture of excellence, data integrity and continuous improvement.
Support internal audits, external inspections, supplier/contract-lab evaluations as required.
Maintain strict adherence to cGMP, GLP, Good Documentation Practice (GDP), and data integrity standards in the lab and manufacturing environment.
Qualifications
Required: Bachelor's degree in Microbiology, Biology or a closely related science (Master's/PhD preferred).
5-10+ years' experience in microbiology within a pharmaceutical/OTC drug manufacturing environment (or similarly regulated manufacturing).
Hands-on experience with microbiological methods: bioburden, endotoxin, sterility (if applicable), preservative efficacy, microbial identification, environmental monitoring (air, surfaces, utilities).
Familiarity with 21 CFR 210/211, OTC monographs, FDA inspections, compendial guidelines such as USP, etc.
Proven experience with method validation, protocol/report writing, deviation/CAPA investigations, trend analysis and root-cause resolution.
Strong leadership, communication and interpersonal skills; ability to train and mentor team members and influence cross-functional stakeholders.
Strong organizational skills, meticulous attention to detail, ability to prioritize tasks and meet manufacturing-driven timelines (including some flexibility for after-hours/weekend support).
Proficiency with LIMS and statistical/data review tools; comfort working in a manufacturing laboratory environment with microbiological cultures, incubators, etc.
Preferred Skills
Experience in vertically-integrated manufacturing operations (raw material → finished goods) and understanding of upstream/downstream impact of microbiology.
Demonstrated track record supporting regulatory inspections or audits (e.g., FDA).
Experience working in an OTC or consumer health product environment.
Strong analytical and problem-solving mindset; ability to influence process improvements based on microbial trend data.
Self-starter attitude and ability to work autonomously within a cross-functional team in a fast-paced manufacturing setting.
Pay range and compensation package
We offer a competitive benefits package including medical/dental/vision.
Retirement plan.
Paid time off.
Opportunities for professional development.
50k Life Insurance Policy (paid by Neilmed).
Executive Director, Corporate Legal Counsel
San Diego, CA job
Executive Director, Corporate Legal Counsel page is loaded## Executive Director, Corporate Legal Counselremote type: Hybrid-San Diegolocations: San Diego, CAtime type: Full timeposted on: Posted Todayjob requisition id: JR000519**Salary Range**The salary range for this position is: $281,000 - $351,000.*In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.*
#J-18808-Ljbffr
Clinical Field Specialist (San Diego)
San Diego, CA job
SummaryA Day in the Life: The Clinical Field Specialist will provide education on products within the Advanced Patient Monitoring portfolio through intra-operative case coverage, coordinating one-on-one ad hoc training sessions and in-service education programs in the ICU, OR, and other acute care areas. They will also provide physicians and medical staff with clinical instructions to ensure continuity of education and technical support related to all aspects of patient outcome throughout continuum of care while anticipating and foreseeing obstacles and planning accordingly for smooth execution. We expect our CFS to advocate with clinicians to uncover other opportunities to expand the use for Advanced Patient Monitoring products. One way they have found success is by, identifying and training select hospital staff members to act as designated guide on BD products. None of this can be done, without collaborating with sales reps and managers to implement a strategic plan of action in their respective territory! Lastly, this person will be responsible for validating software and hardware updates in the field as applicable.
This position requires travel through the Arizona territory. We are looking for someone who lives in this region.Job DescriptionWe are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
This territory will cover the entire state of Arizona.
This position requires travel through the San Diego, CA territory. We are looking for someone who lives in this region.
What you will need (Required):
Minimum of 3 years of previous clinical experience in an acute care environment
Associate's degree or equivalent experience in Nursing or clinical field
Proven understanding of cardiovascular science, cardiovascular anatomy, pathology and physiology
What else we look for (Preferred):
Bachelor's degree or equivalent experience
Critical Care and/or Cardiac Clinical Experience - TVC, CV ICU or CV OR nursing experience highly preferred
Licensed as a Registered Nurse
Strong understanding of hemodynamic monitoring
Proven ability to inspire change within their hospital/organization
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
.
Primary Work LocationUSA CA - Irvine Laguna CanyonAdditional LocationsWork Shift
Auto-ApplyMedical Supply Technician
Palo Alto, CA job
Greenberg-Larraby, Inc. (GLI) is seeking a diligent and organized Medical Supply Technician to join our healthcare team. In this important role, you will be responsible for managing the inventory and distribution of medical supplies within our facility, ensuring that all departments have the necessary materials to provide optimal patient care.
Your responsibilities will include receiving, inspecting, and storing medical supplies, tracking stock levels, and preparing orders for distribution. You will work closely with clinical and administrative staff to ensure efficient supply chain operations that support our commitment to excellence in patient service.
We value your attention to detail and commitment to quality service in contributing to our patients' health and safety.
Requirements
Key Responsibilities:
Receive and inspect medical supplies upon delivery for quality and accuracy.
Organize and store supplies in designated areas to promote easy access and efficiency.
Monitor inventory levels and initiate reorders as needed to prevent shortages.
Prepare and distribute medical supplies to various departments within the facility.
Maintain accurate records of supply usage and inventory counts.
Minimum Requirements:
High school diploma or equivalent required.
Minimum of 2 years of experience in supply chain management or healthcare settings is required.
Strong organizational and time management skills.
Excellent communication and interpersonal abilities.
Ability to lift and move supplies as needed.
U.S. Citizenship required.
Apply now for immediate consideration and join our commitment to quality healthcare!
Benefits
Health Care Plan (Medical, Dental & Vision)
Retirement Plan (401k, IRA)
Life Insurance (Basic, Voluntary & AD&D)
Paid Time Off (Vacation, Sick & Public Holidays)
Family Leave (Maternity, Paternity)
Short Term & Long-Term Disability
Disclaimer:
Greenberg & Larraby, Inc. (GLI) will never send offer letters of employment unless a thorough interview process has taken place and all other internal processing has taken place.
If you receive one from an outside party and is not from the URL of our firm *************************), please do not respond. If you have further questions, please reach out to your administrator.
When you apply to our positions, upon our interest, a recruiter will call you directly and will pre-screen prior to an interview. Offers of employment are contingent upon a thorough interview process, background check, and security clearance adjudication processing as applicable.
Thank you.
Auto-ApplyLeadership Advancement Program
Chula Vista, CA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Senior Operations Management Trainee (Senior OMT)
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
Equal Employment Opportunity
Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth.
Our growth is your bright future.
Opportunities to grow as a leader are within your reach. With the incredible growth of 220+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference.
A typical day for you may include:
Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities.
Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees.
Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers.
Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management.
Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production.
Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend.
REQUIRED QUALIFICATIONS:
3-5 years of experience leading medium to large teams (20+ direct reports)
Up to 90-100% travel during the Trainee Program
Ability to walk and/or stand for the entire work shift
Willingness to travel and work at various BioLife locations across the country
Ability to work evenings, weekends, and holidays
Have a valid driver's license for the entire duration of the program
Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
Fine motor coordination, depth perception, and ability to hear equipment from a distance
Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
PREFERRED QUALIFICATIONS:
Associates or Bachelor's Degree
Experience working with SOPs, GDP, GMP, CLIA, and the FDA
Experience working in a highly regulated or high-volume retail environment
Excellent interpersonal, organizational, technical, and leadership skills
Equal Employment Opportunity
#LI-Remote
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
California - Virtual
U.S. Base Salary Range:
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsCalifornia - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
Yes
Laboratory Technician, Intern
San Diego, CA job
Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.
Group's key figures are approx. 6.7 billion Euros, over 940 laboratories across 59 countries, and about 61,000 staff.
Job Description
Eurofins BPT San Diego is seeking a motivated intern to support our Analytical Science teams by assisting with laboratory tasks and process improvement initiatives. This position is a temporary, part-time, entry-level position involved in day-to-day activities in a laboratory setting under prescribed procedures (protocols, standard operating procedures, methods, etc.).
Responsibilities include:
Generates data from a variety of laboratory techniques and analytical instrumentation such as but not limited to, pH, analytical balance, sample preparation, etc.
Participates in studies as directed. Completes the necessary tasks associated with projects in designated areas.
Carries out routine experiments and procedures in accordance with all applicable regulatory requirements as defined by protocol, method, and standard operating procedures.
Maintains clean laboratory conditions which include, but is not limited to, cleaning glassware, emptying trash, mopping floors, etc.
Adheres to schedule according to Eurofins or contracting organization's timetable and follows daily or weekly routines necessary to ensure on-time delivery.
Performs work in accordance with CGMP principals and standard operating procedures.
Completes documentation legibly, timely, and accurately according to all regulatory requirements. Maintains and completes equipment log books. Appropriately documents all movement of materials during process of receipt, transfer, disposal, or archiving and distributes those documents as required.
Communicates effectively and regularly with supervisor regarding timelines, project completion, and any issues that may arise.
Depending on area of assignment, may be required to move/transfer materials from one department to another; check-in/out materials as requested by study personnel; and examine materials received/delivered for safety, accuracy of shipment, and viability of content.
May assist in quality check of spreadsheets and other data.
Performs other related duties as required and directed
The ideal candidate will possess:
Knowledge of basic office equipment (computers, printers, faxes, copiers, etc.).
Strong attention to detail and organizational skills. Excellent customer service skills.
Ability to work independently and communicate effectively in a team environment.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Able to apply common sense understanding to carry out detailed written, oral, diagram, or scheduled instructions.
Working knowledge of Microsoft Outlook, Word, PowerPoint and Excel is required.
Flexible hours can be accommodated; however, regular and reliable attendance is a requirement of this position.
Qualifications
Must be a minimum of 18 years of age
High School diploma or equivalent
Currently enrolled in a science or engineering program preferred.
Authorization to work in the United States.
Learning Opportunities:
Hands-on experience within a real-world pharmaceutical laboratory.
Exposure to GMP/GLP principles and regulatory compliance.
Development of skills in Lean/5S mindset, scientific documentation, and team-based communication.
Confidentiality Requirement:
The intern must sign a Confidentiality Agreement prior to starting, agreeing not to disclose, share, or misuse any proprietary data, methods, or intellectual property accessed during the internship. All work products remain the property of Eurofins Advantar Laboratories.
Additional Information
Pay rate of this position is $20/h.
Position is temporary, part-time, with flexibility Monday-Friday, ranging from 8 a.m.-4:30 p.m. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Chief Scientific Officer (CSO)
San Francisco, CA job
Location: California (Onsite, Full-Time) Type: Permanent, Full-Time (Monday-Friday; occasional out-of-hours work expected) Travel: Some travel required
This is a rare opportunity to join a global biopharmaceutical company at the C-Suite level who will be directly responsible for driving the scientific innovation and strategy across the company. As Chief Scientific Officer, you will work hand-in-hand with the CEO to define and execute strategies that drive the development of transformative therapies across a portfolio of complex, high-impact platforms.
We are seeking a proven biotech leader with deep expertise in drug development-someone who thrives on solving scientific challenges and shaping programs that advance patient care. If you're ready to take the next bold step in your career and influence the trajectory of an organization and an entire field, this is your moment.
Step into a role where your vision will accelerate progress, your leadership will set the standard for excellence, and your impact will be felt globally.
Key Responsibilities
Partner closely with the CEO and executive leadership to set and execute scientific strategy.
Define and implement the organization's research priorities across preclinical and clinical programs.
Lead global scientific teams to deliver R&D programs on time and within budget.
Oversee budgets for scientific initiatives and ensure optimal resource allocation.
Build and maintain relationships with regulatory authorities, professional organizations, and external partners.
Evaluate business development opportunities, including in/out licensing and technical due diligence for acquisitions or co-development agreements.
Represent the organization on scientific and technical matters with external stakeholders, including investigators and (optionally) the investment community.
Manage collaborations with external research providers, such as CROs and independent investigators.
Essential Qualifications
PhD, PharmD, or MD in a relevant scientific discipline.
10 - 12 years of executive leadership experience leading teams throughout preclinical, clinical and commercial manufacturing within biotechnology or pharmaceuticals.
Strong background in organic chemistry; experience with peptides, polymers, and formulation development preferred.
Familiarity with global regulatory frameworks (FDA, EMA, IND/NDA filings) and ICH Good Clinical Practice.
Proven scientific credibility through publications and/or patents.
Expertise in clinical trial design, monitoring, and statistical reporting.
Ability to interpret and evaluate clinical data and prepare regulatory documentation.
Exceptional leadership, organizational, and project management skills.
Excellent communication and presentation skills for diverse audiences.
Financial management experience related to R&D budgets.
Advanced proficiency in MS Office and related tools.
Preferred Attributes
Post-doctoral training in dermatology or related discipline (not required).
Experience in a publicly traded company.
Strategic thinker with strong problem-solving skills.
Ability to foster collaboration across internal teams and external partners.
What's Offered
Competitive compensation and benefits.
Opportunity to work on cutting-edge science with global impact.
High degree of commercial exposure and collaboration with leading scientific experts.
Dynamic, fast-paced environment focused on innovation and delivery.
Associate Principal Scientist, Analytical R&D
South San Francisco, CA job
Join our Discovery Analytical Research group to drive innovation in analytical measurement technologies, enabling the discovery of new drug candidates across diverse modalities. The Discovery Analytical Research group within Analytical Enabling Capabilities (Analytical R&D) is seeking applicants for an Associate Principal Scientist position available at our research laboratories located in South San Francisco, California.
The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. A broad range of tools (e.g. high-resolution mass spectrometry, chromatography, spectroscopy) are leveraged, and new technologies are developed to influence selection of new drug candidates and enhance scalability and robustness.
Primary Responsibilities:
Enable discovery partner groups with advanced analytical methods
Represent the discovery analytical research group in project teams, provide technical guidance, and drive scientific strategy
Develop, implement, and troubleshoot advanced analytical methods (e.g., high-resolution mass spectrometry, liquid chromatography, capillary electrophoresis, ion chromatography, size exclusion chromatography, and two-dimensional techniques)
Solve complex problems and explore new measurement technologies
Collaborate in multidisciplinary teams, foster partnerships with discovery groups, and contribute to organizational goals
Support junior scientists and promote a culture of learning and innovation
Ensure high standards of data integrity and documentation
Qualifications:
Education:
Bachelor's (with 12 years), Master's (with 8 years) or Ph.D. (with 4 years) in Analytical Chemistry or related field and relevant experience
Required Experience and Skills:
Strong background and extensive hands-on experience in high-resolution mass spectrometry of large molecules (Proteins, mAb, ADC, etc.) and separation science techniques
Demonstrated scientific ability through publications in peer-reviewed journals and presentations in scientific conferences
Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
Ability to deliver complex objectives under challenging timelines in a rapidly changing environment
Ability to work in a team environment with cross-functional interactions
Preferred Experience and Skills:
Knowledge of biochemistry and organic chemistry
Experience with electronic laboratory notebook applications and good documentation practices
#EligibleforERP
Required Skills:
Analytical Chemistry, Antibody Drug Conjugates (ADC), Biologics, Chemistry, High Resolution Mass Spectrometry (HRMS), Mass Spectrometry Analysis, Protein Chemistry, Separation Sciences
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$156,500.00 - $246,300.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at *******************************************************
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic/International
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
12/15/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Auto-ApplyAdventure Therapist
Newport Beach, CA job
Newport Academy is a gender-specific, comprehensive treatment program for adolescents suffering from mental health, behavioral health and substance abuse issues. The program combines the key elements essential in effectively treating adolescent girls and boys with substance abuse and other mental health disorders. As compared with adults, adolescents have higher rates of dual diagnosis and developmental differences. Adolescent treatment needs can be challenging and often involves more comprehensive and multi-disciplinary approaches. At Newport Academy, we deliver a highly individualized, holistic approach to treatment where psychological, biological, spiritual, social and educational needs are continually assessed and revised throughout the treatment process.
Job Description
Adventure therapy staff desired at gender specific adolescent residential center treating co-occurring disorders in Orange County. Responsibilities include planning, organizing and implementing twice weekly group activities such as hiking, paddleboarding, rock climbing, ropes course and team building exercises. Adventure therapy staff is encouraged to be creative and build therapeutic activities that can address individual needs and build self esteem. Adventure therapy staff will work closely with clinical staff to best address needs of residents. Must be available for weekly staff meetings, trainings and other events. Must complete and pass trainings and background check with DCF and State Police. Experience or education in the field of Human Services, Psychology or Substance Abuse is highly encouraged. Awareness and understanding of 12 step recovery principles preferred. This job is an amazing opportunity to change lives.
Qualifications
Licensed and/or Certified Clinical Credentials required
Additional Information
Why are you interested in this position?
What makes you a unique candidate for this position?
Can you give an example of a skill or expertise that you learned/developed on the job?
Outside of your career goals what is one thing that you are driven to achieve your life?
Tell us about a mistake or bad decision that you made in your professional experience and what you learned from that experience.
What are your favorite companies or products?
What is your Myers-Briggs personality type?
Tell us something about you that we wouldn't otherwise get to know from the application process. This could be an example of your work, links, other talents, skills, or passions (that don't necessarily relate to the position!)
What is your availability to interview?
When would you be able to start?
Current employment status?
Current pay rate?
Salary expectation?
Have you ever been convicted of a crime (misdemeanor/felony)? If so, please explain.
List 3 references:
Do we have permission to contact the references listed? Yes/No
Director of Pharmacy
West Covina, CA job
JOB | Director of Pharmacy
PAY | $98-$115/hour- DOE
SCHEDULE | M-F 8am - 5pm Full Time, Direct Hire
Rx Relief is a leader in Pharmacy recruiting and is looking for a Director of Pharmacy to join our team in West Covina, CA. Rx relief has great entry-level Outpatient and Inpatient Hospital opportunities!
BENEFITS | Director of Pharmacy
Aetna - Medical, Dental, and Vision Insurance
Mental Health Wellness Program
401K Retirement savings plans matching with employer contributions
Paid Sick Time and Jury Duty Time
Flexible Spending Accounts
Commuter Flexible Spending
Career Advancement & Development opportunities
RESPONSIBILITIES | Director of Pharmacy
Maintains the confidentiality of patients/customers, staff, and their personal information at all times.
Research
Ensures the pharmacy's and employees' compliance with all applicable state and federal laws and regulations.
Ensures compliance with accepted professional standards of practice and industry standards of care.
Dispense and verify prescriptions for accuracy, proper dosage, and potential drug interactions.
Provide patient counseling on medication use, side effects, and adherence to therapy.
Coordinate with prescribers to resolve prescription issues and ensure optimal patient care.
JOB REQUIREMENTS | Director of Pharmacy
An active California Pharmacist license is required
Compounding/Specialty experience
High-volume retail Pharmacy experience preferred
RX RELIEF HIRING REQUIREMENTS :
Must be 18+ years old
Experience in infusion and IVIG.
Background and Drug Screening required
Health Screening required
Must be able to provide proof of eligibility to work in the US
Rx relief is a specialty staffing company providing supplemental pharmacy professionals for all pharmacy practice settings. ***************************************
Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Experienced Veterinary Assistant
Los Angeles, CA job
Eagle Rock Pet Care's mission is guided by kindness and compassion where our team delivers the care to each pet that they would want their own pet to receive. We use the most modern equipment, tested and reliable veterinary products, and the personal touch of tailoring the most effective treatment for pets in need.
At Eagle Rock Pet Care in Los Angeles, you'll find a close-knit team of passionate animal lovers who treat all pets like family. Our experts provide individualized vaccine programs based on age, breed, and environment. We perform regular checkups with nutritional and behavioral counseling to monitor the overall health of our clients. We are well versed in handling surgeries in our innovative surgery suite, whether that involves soft tissue surgery, orthopedic procedures, emergencies, or spays and neuters. Our state-of-the-art facility is equipped to oversee radiography and urgent care during business hours.
Our hours of operation are:
* Tuesday - Friday: 9:00AM - 6:00PM
* We are closed on Mondays and weekends
To learn more about us, click here!
Job Description
Job duties include, but are not limited to:
Animal restraint, triage of incoming patients, collection and analysis of lab samples, diagnostic imaging, management and nursing care of medical and hospitalized cases with varying degrees of stability, administration of medications, effective communication of treatment plans with clients, surgical preparation and assistance, and anesthetic management.
Must be able to withstand unpleasant odors and noises. May be exposed to bites, scratches, animal waste and potentially contagious diseases.
Whether you're looking to just be a master of your role or trying to grow into that next career move, you'll have opportunities through a variety of virtual and hands on, interactive training and continuing development.
Qualifications
We're looking for:
* A minimum of 2-year vet med experience preferred
* A high work ethic and positive attitude team member
* Ability to arrive on-time and ready to work
* Exceptional customer service skills and ability to communicate precisely
* Interpret medical records and record client history accurately
* Knowledge in preventative care, surgical procedures, and hospital flow
* Ability to restrain pets in a low-stress and safe manner
* Ability to properly set-up and process laboratory samples and tests
* Proficient in positioning and capturing radiographs, positioning for dental radiographs are a plus
* A self-starter with the desire to continue to advance one's knowledge and skillset
* Ability to receive in a professional manner constructive feedback to maintain hospital efficiency
Additional Information
Pay Range: $18 - 21/hr
We offer our staff:
* Comprehensive Benefits (health, dental, vision, liability, 401k & 401K matching program, life & supplemental insurance, HSA, & FSA)
* Employee Assistance Program
* Paid Vacation and Sick Time for ALL Employees
* Paid Bereavement Program
* Paid Parental Leave Program
* Competitive Compensation
* Continuing Education Allowance (applies to licensed/registered/certified roles)
* Tuition Assistance Program
* Access to a CVA/CVT/CVPM Partnership through Penn Foster
* Career Development Opportunities
* Referral Bonus Program for most positions!
* Additional Benefits May Also Be Available (i.e. Personal Pet Discounts, Holiday Pay, Uniform Allowance, Bonuses etc.)
Hiring eligibility may be contingent to a candidate authorizing and completing a satisfactory background check.
* Note - some benefits may only be available to or vary slightly for full time employment status vs part time status.
For additional details including our full equal opportunity statement, texting/outreach communication authorization, physical requirements of the job and more, please visit: ***********************************************************
Director, CMC Regulatory Affairs
ORIC Pharmaceuticals job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to
******************
, and follow us on
X
or
LinkedIn
.
Reporting to the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position is responsible for leading CMC regulatory activities and supporting all of ORIC's clinical development programs for oncology products. The role involves close collaboration with cross-functional teams including regulatory affairs, regulatory operations, quality, CMC, nonclinical, and clinical departments.
Job Description
Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORIC's products.
Provide CMC regulatory support for new and ongoing clinical trials, e.g., manage/prepare CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
Lead preparation and responses for CMC-related meetings with global RAs and HAs, balancing regulatory requirements and corporate objectives.
Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans.
Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs , etc.
Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).
Qualifications
BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
At least 10+ years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and regulatory writing.
Experience in addressing CMC-related regulatory queries from global health authorities.
Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
Demonstrated success driving drug product development and managing all aspects of CMC documentation.
Excellent working knowledge and understanding of applicable global regulations required - cGMP, global regulatory guidance, compendial requirements, including FDA, EMA, ICH, WHO, USP-NF.
Prior experience as primary author of CMC sections of M2 and M3 of IND,NDA, and IMPD.
Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents.
Excellent attention to detail, and strong computer and organizational skills required.
Must be a strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
Must have a quality mindset and deliver results in an ethical and positive manner.
Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
Proven ability to manage multiple tasks and associated deadlines.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $220,000-$270,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.