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
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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
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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
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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
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Learn more about Grifols
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Neuroscience Account Manager - Psychiatry - East Bay, CA
Oakland, CA job
Territory: East Bay, CA - Neuroscience
Target city for territory is Oakland - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Oakland, Vallejo, Davis, Brentwood, Livermore, Fremont & Milpitas.
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 Neuroscience Account Manager, you lead the promotion of our psychiatry portfolio to Psychiatrist and Institutional Accounts such as community mental health centers and hospitals, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Neuroscience 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
4+ 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
Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network
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:
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 calling on customers at a variety of call points, including offices, community mental health centers and hospitals
Sales experience with buy & bill/injectable products
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 qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $135,000 - $175,000 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
Santa Rosa, 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.
CTM/ Senior CTM
San Diego, CA job
Clinical Trial Manager/ Senior Clinical Trial Manager
San Diego Metropolitan Area
Salary: $150,000-$180,000
A clinical-stage cell therapy company based in San Diego is expanding its clinical operations team. Focused on developing treatments for autoimmune diseases and hematological cancers, the company uses a unique approach to cell therapy, harnessing Natural Killer (NK) cells that target B cells.
The team has been a pioneer in cell therapies, with one of the first IND filings for Lupus using cell therapy. Now advancing several indications, the company is working to streamline manufacturing and distribution to improve access to novel treatments. Their CEO brings over 20 years of experience in biotech and venture capital, including leadership roles in notable life sciences companies, while the CMO has an extensive background in clinical research from leading pharmaceutical firms. This role offers the opportunity to contribute to the ongoing development of therapies at the intersection of cell therapy and auto-immunology.
Primary Responsibilities
Take the lead in reviewing work completed by members of the clinical development team.
Lead or assist in revising study-related documents, such as informed consent forms, laboratory manuals, pharmacy manuals, case report forms (CRFs), and other tools essential for study execution.
Provide assistance with site recruitment, initiation, payments, and close-out activities.
Contribute to the training of new clinical site staff and offer additional training for protocol amendments.
Coordinate with in-house teams to ensure timely collection of regulatory documents as required.
Offer daily guidance to clinical sites, including interpretation of protocols and adherence to protocol safety standards.
Lead or assist in training staff within the clinical development group.
Work with the CPM to prepare and update trial progress reports for the Clinical Development team.
Support the tracking and summarization of patient treatment, response, and survival data for ongoing studies.
Perform other tasks as assigned.
Qualifications
Bachelor's degree with 7-10 years of experience in clinical research.
Bachelors degree required
experience in cell therpay and/or auto immune inidations is prefered
Skills & Competencies
Proficiency in MS Word, Excel, PowerPoint, and Outlook.
Strong written and verbal communication skills, with excellent organizational and multitasking abilities.
Understand and follow job-specific systems and processes as outlined in the company's SOPs, and seek clarification from a supervisor if any requirements are unclear.
Consistently maintain corporate confidentiality.
Registered Dental Assistant
San Jose, CA job
Registered Dental Assistant - Join a Community-Centered Dental Care Team Be Part of a Mission That Matters For more than 50 years, AACI has proudly served the diverse communities of Santa Clara County with compassion, integrity, and respect. We are dedicated to supporting individuals and families from all cultural backgrounds, ensuring each person feels acknowledged, heard, and valued. If you're looking for a workplace that champions inclusively and provides the stability and support you deserve, AACI is the place for you. Why AACI?
12 Paid Holidays, Floating Holiday, Vacation, and Sick Leave
Four comprehensive health plan options with 95% of premiums covered
403(b) retirement plan with a 3% employer match
Ongoing opportunities for professional growth and development
About the Role AACI is seeking a skilled and caring Registered Dental Assistant (RDA) to join our dental team and contribute to an exceptional patient experience. This role is ideal for someone who thrives in a dynamic environment, values community-focused care, and is passionate about improving oral health outcomes. Key Responsibilities
Prepare treatment rooms and sterilize instruments in accordance with established protocols
Review and update patient health histories; accurately document treatment provided
Provide patient education on oral hygiene, plaque control, and post-treatment care
Fabricate temporary crowns, bridges, night guards, and bleach trays
Monitor supply inventory and collaborate with the integrated care team
Ensure compliance with all dental care guidelines, regulations, and infection control standards
Qualifications
Active California Registered Dental Assistant license
Minimum of 1 year of experience as a RDA
Experience with EPIC electronic health records and Microsoft Office
Bilingual skills in Spanish, Mandarin, or Vietnamese highly preferred
Salary Range: $29.50 - $34.24 per hour If you're ready to make a meaningful impact and grow in your dental career, we invite you to apply today. Submit your application at and join a team that truly cares. Copyright 2025 Jobelephant.com Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency jeid-073e8ee2ad4544d2aa870b4de170be34
Study Start Up Specialist
San Mateo, CA job
Study Start-Up Specialist
Type: Full-Time, Permanent
Compensation: 75,000 - 90,000 annually + bonus + benefits
Are you passionate about clinical research and want to play a key role in bringing innovative therapies to patients?
We are partnered with a sponsor that is seeking a Study Start-Up Specialist to join our dynamic team and support the initiation of clinical trials across North America.
Responsibilities:
Identify and evaluate potential research sites through feasibility assessments.
Engage with site staff to foster collaboration and ensure readiness for study initiation.
Organize and support contract negotiations.
Prepare and submit regulatory documents to IRBs and other authorities.
Conduct Site Initiation Visits (SIVs) and train site staff on protocols and procedures.
Coordinate study supplies and ensure timely delivery.
Track and report progress to ensure timely start-up of studies.
Communicate effectively with internal teams, vendors, and research sites.
Assist with audits, process improvements, and other clinical operations tasks.
Qualifications:
Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or related field.
Minimum 1 year of experience as a Clinical Research Assistant or similar role.
Working knowledge of ICH GCP guidelines.
Strong organizational and communication skills.
Ability to manage multiple priorities and work in a fast-paced environment.
Travel: 20 - 30% travel
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.
Senior Manufacturing Test Software Engineer (Python)
San Francisco, CA job
Manufacturing Test Engineering Manager (or Senior/Lead Test Engineer)
Red Oak Technologies is partnering with our client, a leader in LiDAR sensor technology, to identify a highly skilled Manufacturing Test Engineering Manager. We are open to considering strong Senior or Lead-level Test Engineers who are ready to take on team leadership responsibilities while continuing to code daily.
This role is fully onsite in San Francisco, CA.
Position Overview
The Manufacturing Test Engineering Manager will be a hands-on technical leader responsible for developing and maintaining production test software for high-volume LiDAR sensor manufacturing. The ideal candidate will have strong Python development skills, proven experience in test engineering for electro-mechanical assemblies, and the ability to mentor and guide a team while contributing individually on a daily basis.
The role requires close collaboration with cross-functional teams to improve test coverage, reduce test time, and ensure production readiness as new products move from development into manufacturing.
Key Responsibilities
Develop, maintain, and improve production test software using Python for LiDAR sensor and sub-assembly manufacturing.
Serve as a working manager, providing technical leadership while contributing hands-on daily.
Mentor and train Test Engineers on both technical and soft skills.
Establish team priorities, KPIs, and work goals aligned with product development schedules and company objectives.
Collaborate with cross-functional teams on software development, verification, and validation for new product introductions.
Drive continuous improvement initiatives, including test time reduction, data quality enhancements, and production process optimization.
Apply software engineering best practices, including coding standards, code reviews, source control management, CI/CD pipelines, and test automation.
Communicate project updates, risks, and recommendations to management and stakeholders.
Ensure timely completion of team deliverables and proactively address constraints or delays.
Support contract manufacturing facilities with occasional travel (less than 10%).
Work full-time onsite in San Francisco, CA.
Qualifications and Skills
Strong proficiency in Python development (minimum 5 years).
Experience with CI/CD infrastructure, GitLab, Jenkins, and SQL database design.
Strong skills in debugging, programming, data collection, and data analysis.
Experience using project tracking tools such as Jira, Confluence, or equivalents.
Proven ability to deliver results in a fast-paced engineering environment.
Excellent organizational skills with the ability to manage multiple concurrent projects.
Demonstrated people management or technical leadership experience (3+ years preferred).
Experience working with high-precision electro-mechanical assemblies.
Preferred: Experience developing test software for high-volume production and test equipment.
Education
BS in Computer Science, Mechatronics, Mechanical Engineering, or a related technical field required.
MS degree preferred.
Additional Information
Background screening is conducted by the client. The Manufacturing group has zero tolerance for misdemeanor or felony theft or robbery offenses.
This position is within an electrical component manufacturing environment (not medical devices).
About Red Oak Technologies
Since 1995, Red Oak Technologies has been a trusted partner in the technology industry, specializing in identifying and placing highly skilled contract, permanent, and project-based professionals. We value diversity and welcome applicants from all backgrounds and experiences.
Red Oak Core Values:
Relationships First | Exceptional Quality and Service | Unwavering Integrity and Trust | Be Easy To Do Business With | Respect Everyone
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.
Staff Software Engineer
Santa Clara, CA job
Staff Software Engineer - SaaS Healthcare Solutions Location: Santa Clara, US
Exo is seeking an experienced Staff Software Engineer to lead the design and development of scalable, cloud-based SaaS healthcare applications. This hands-on role combines deep technical involvement (80% coding and code review) with strategic architecture responsibilities (20% requirements analysis, system design, production support, and team mentorship). The ideal candidate will have extensive experience building distributed systems and SaaS platforms, with a strong background in healthcare technology.
Key Responsibilities
Write high-quality, maintainable code and conduct thorough code reviews, providing technical guidance to engineering teams
Design scalable, fault-tolerant distributed systems for SaaS healthcare applications and lead development of critical system components
Collaborate with Product Managers and stakeholders to translate business requirements into technical specifications and architectural designs
Lead incident response, troubleshoot complex production issues, and optimize system performance across distributed environments
Ensure solutions meet HIPAA, cybersecurity, and medical device regulations while supporting QMS requirements
Design and implement integrations with EMR systems, medical imaging platforms, and healthcare protocols (DICOM, HL7, FHIR)
Evaluate and recommend technologies, frameworks, and architectural patterns to support business objectives
Work closely with cross-functional global teams including Product Managers, Project Managers, and Support Engineering teams
Required Qualifications and Skills
Bachelor's degree in Computer Science, Software Engineering, or related field
10+ years of software development experience with proven track record in senior technical
roles
5+ years of experience architecting and building SaaS applications at scale
3+ years of hands-on experience with distributed systems design and implementation
Expert-level proficiency in Python and JavaScript/TypeScript
Extensive experience with AWS services (EC2, S3, RDS, Lambda, EKS, etc.)
Proficiency with Terraform and Ansible for CI/CD automation
Deep understanding of microservices, event-driven architectures, and distributed data
management
Experience with both relational (PostgreSQL, MySQL) and NoSQL (MongoDB, Redis) databases
Experience with message brokers (Apache Kafka, RabbitMQ, AWS SQS/SNS) and containerization (Docker, Kubernetes)
Knowledge of RESTful APIs, GraphQL, and API gateway patterns
Experience with DICOM standards, HL7, FHIR, and EMR system integrations (preferred)
Experience with Active Directory, SSO, LDAP, OAuth, and OpenID Connect (preferred)
Salary: 160-200K
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
Phlebotomist
Escondido, CA job
Sterling Medical is currently seeking a Full time Phlebotomist to provide services at the Escondido (CBOC) VA Community Based Outpatient Clinic located in Escondido, CA.
Hours:
Monday through Friday
7:30 A.M to 4:00 P.M
Qualifications:
Must have knowledge of legal requirements of blood drawing, fluid sample handling and relevant medical equipment and material. This position also requires the ability to use computers to enter patient information, excellent communication skills, and attention to detail. The Phlebotomist must be able to properly identify patients and use correct phlebotomy methods (venipuncture, skin puncture) to obtain patient samples. The Phlebotomist is relied on to preserve patient health and the quality of samples.
The Phlebotomist must have a National Phlebotomy License or a California Phlebotomy License
Minimum one-year experience
Duties include:
The Phlebotomist must be able to properly identify patients and use correct phlebotomy methods (venipuncture, skin puncture) to obtain patient samples. The Phlebotomist is relied on to preserve patient health and the quality of samples.
Provide guidance and direction to patients and personal support persons for navigating the VA health care system and administrative functions in VA. Provide scheduling services in accordance with VA policies and guidance.
This position also requires the ability to use computers to enter patient information, excellent communication skills, and attention to detail
Who We Are
Sterling Medical Corporation is a leader in health care professional staffing. For over 30 years, Sterling Medical has matched qualified health care providers with federal facilities throughout the nation as well as overseas.
How to Apply
Please submit your Resume via *************************** or please contact Isela Boyett at ************ X350
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.
Scientist I, Neuroscience
Mountain View, CA job
PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
Visit our website to learn more about our company and culture!
Site: **************
Summary: The Scientist I, Neuroscience is responsible for planning and performing scientific experiments that contribute to PTC's research and drug discovery activities. The incumbent works cross-functionally with internal departments, and external resources as appropriate, as part of PTC's discovery science project teams.
The Scientist I, Neuroscience supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
.Job Description:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
With guidance from the advisor plans, initiates, directs and executes scientific research and experiments and interprets and communicates results as part of multi-disciplinary team(s). This includes performing analyses of primary research literature.
Presents findings internally to cross-functional teams.
May provide scientific advice to research leadership on projects and areas of expertise.
Abides by all safety and regulatory guidelines.
Maintains a detailed laboratory notebook.
Performs other tasks as assigned
Interviews and contributes to the evaluation of candidates.
Abides by all safety requirements.
May Participate in the development and writing of patent applications
Contributes to general lab needs such as:
Equipment maintenance.
Capital equipment purchases.
Troubleshoot
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Experience working with and/or establishing differentiated iPSCs is required.
Excellent sterile technique and ability to establish and maintain various cell culture systems including primary and immortalized cell systems.
Working knowledge of molecular biology (for example: RT-PCR, qPCR, RNAseq) and gene editing techniques required.
Experience in protein quantification end analysis methods such as Western blot, ELISA, MSD
Strong desire to work in a dynamic environment where innovation and initiative are expected.
* Minimum level of education and years of relevant work experience.
Ph.D. in scientific discipline preferably in Neuroscience, Molecular Biology or Biochemistry with 1-2 years' post-doctoral or Industry experience
* Special knowledge or skills needed and/or licenses or certificates required.
Exercises independent judgement within defined procedures and practices.
Demonstrates technical proficiency, collaboration with others within a fast-paced, matrixed, team environment consisting of internal and external team members.
Possesses detailed and expert knowledge of scientific principles and concepts.
Demonstrate ability to work effectively in a multi-disciplinary team environment.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Demonstrate ability to work on complex problems to produce experimental data across one or more projects.
Proficiency with Microsoft Office preferably MS Excel and MS PowerPoint or similar, and familiarity with basic statistical analytical methods
Excellent verbal and written communication and skills.
Analytical thinker with excellent problem-solving skills.
Demonstrates an understanding of the strategic alignment of his/her work with corporate goal(s) and demonstrates the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
Experience designing and conducting cell-based studies of compound activity as well as mechanism of action studies.
* Travel requirements
Up to 10%
Office/Laboratory based position
Expected Base Salary Range
$111,400 - $140,300. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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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
Leadership 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
Director, CMC Regulatory Affairs
Oric Pharmaceuticals, Inc. 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.