Pharmaceutical Sciences Journal Jobs in Usa

Senior Scientist

Kelly Science and Clinical, is currently seeking a Senior Scientist (Protein Mass Spectrometry) for a long-term engagement at one of our Global pharma clients in Spring House, PA. This role is a fully benefitted position. This role you will be eligible for Medical, Dental, 401K, paid time off, including holiday, vacation and sick/personal time.

Schedule: On-site Monday through Friday 8am to 5pm

Length of assignment: Until the end of 2026 will likely to extend

Pay: $45-50 an hour Depending on experience

You will be required to provide your own laptop

• Responsibilities:Intact protein mass analysis using LC/MS platforms- QC analysis and high throughput analysis for biologics (mAbs, multispecifics antibodies, Fabs, scFv, fusion proteins)
• Data analysis, documentation, and reporting – ELNs, etc.
• Lab instrument maintenance – General ESI source cleaning and routine calibration
• Prepare HPLC solvents and replenish as needed
• Prepare general buffers and reagents for enzymatic digestions and assays etc
• MS Lab-specific supply maintenance – inventory and ordering
• Chemical inventory for EHS
• Additional Duties:
• Support assay development and validation as needed.
• Assist in drafting and executing peer-reviewed posters, manuscripts, tech reports, and patent filings.
• Attend in-house seminars to support team goals.
• Requirements: Experience with mass spectrometry is required.
• Previous experience handling and working with proteins using general protein biochemistry techniques including but not limited to aliquoting and pipetting is required.
• Pharmaceutical experience working with antibodies is preferred.
• Experience with automated liquid handlers is preferred. Pharmaceutical experience working with antibodies is preferred.
• Candidate must be highly organized, independent, and very detail oriented.
• Education requirements: Ph.D. with 0-2 years’ experience, or MS with 3-5 years’ experience, or a B.S. with 10+ years in an analytical chemistry discipline

What happens next

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

Helping you discover what’s next in your career is what we’re all about,

#P1

Position Summary

Meet has partnered with a growing pharmaceutical manufacturing organization supporting sterile injectable and biopharmaceutical products. The company is seeking a Senior Validation Engineer to lead and execute validation activities across manufacturing operations.

This individual will ensure that facilities, utilities, equipment, computerized systems, and processes are designed, installed, qualified, and maintained in a validated state in compliance with FDA, EU GMP, ICH, and other global regulatory requirements. The role will also provide technical leadership and subject matter expertise in aseptic processing, cleanroom environments, and contamination control strategies.

Key Responsibilities

Validation & Qualification

• Lead and execute DQ, IQ, OQ, and PQ activities for aseptic filling lines and isolators/RABS, autoclaves, SIP/CIP systems, lyophilizers, sterile filtration systems, cleanrooms, and classified areas
• Author, review, and approve validation protocols; support execution, interpret data, and generate final reports
• Develop and maintain Validation Master Plans (VMPs)
• Support process validation, cleaning validation, and aseptic process simulations (media fills)
• Lead validation of critical utilities including Water for Injection (WFI), clean steam, HVAC systems, and compressed gases (CDA, nitrogen)
• Perform environmental qualification and airflow visualization (smoke studies)
• Validate computerized systems in accordance with GAMP 5 and 21 CFR Part 11
• Ensure data integrity compliance in alignment with ALCOA+ principles
• Support automation and control systems validation (PLC, SCADA, etc.)
• Ensure compliance with FDA cGMP (21 CFR Parts 210/211) and EU GMP Annex 1
• Support regulatory inspections, customer audits, and audit responses

Technical Leadership & Continuous Improvement

• Act as a Subject Matter Expert (SME) in validation and sterile manufacturing environments
• Lead change controls, deviations, CAPAs, and risk assessments (e.g., FMEA)
• Drive continuous improvement initiatives to enhance compliance, efficiency, and operational robustness

Qualifications

• Bachelor’s degree in Engineering or related Life Sciences field
• Strong technical writing and documentation skills
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)

Experience

• 3+ years of hands-on validation experience within sterile injectable pharmaceutical or biopharmaceutical manufacturing environments

Do you want to work at one of the top 100 hospitals in the nation?

Life is full of choices, and whom you work for is one of life's most important decisions. ChristianaCare has earned national recognition for excellence. Choose an organization that provides career advancement and the opportunity to impact health.

Our amazing Pharmacy Team dispenses approximately 8,000,000 individualized patient doses per year, as well as 262,000 retail/mail order prescriptions. We provide medications that are safe and efficacious.

Come and join us in the ChristianaCare Pharmacy - Dedicated to getting the right drug to the right patient at the right time!

ChristianaCare is seeking a detail‑oriented and patient‑focused Medication History Technician to join our team. In this critical role, you will collect and confirm precise home medication details shared by patients and their caregivers, helping ensure medication safety from the moment of admission. Your work will directly support pharmacists and physicians in delivering high‑quality, coordinated care.

This position is full time day/evening shift rotation. Every other weekend required; holidays as required.

Principal Duties and Responsibilities:

• Interview patients, caregivers, and other sources to acquire accurate and complete home medication histories.
• Ask clarifying questions regarding medication names, dosages, frequency, and last used to ensure accurate data collection.
• Enter collected information into the EMR following established procedures to produce admission medication reconciliation documentation.
• Generate medication history reports for pharmacist review and subsequent physician use.
• Collaborate closely with inpatient pharmacy staff and other care providers to support medication‑related needs.
• Navigate the ED tracking board to determine appropriate patient selection.
• Update or build medication records within the EMR with accuracy and attention to detail.
• Apply good clinical judgment when assessing medication lists; identify inconsistencies or concerns and communicate them to the pharmacist.
• Verify medication information using external sources when necessary (pharmacies, provider offices, etc.).
• Coordinate with charge nurses and patient nurses to determine optimal times for patient interviews.
• Demonstrate strong knowledge of both brand and generic medications, common dosages, dosage forms, and typical administration schedules.
• Communicate effectively with patients of all education levels in a fast‑paced Emergency Department setting.
• Assess the completeness of medication lists, including drug name, dose, frequency, indication, and time of last dose.
• Acquire accurate histories of PRN medications, including frequency and indications.
• Determine patient medication adherence prior to admission.
• Build rapport with patients and families to acquire reliable histories or identify alternative information sources when needed.
• Prompt patients for overlooked medications, including over-the-counter items such as herbals, vitamins, pain relievers, cold remedies, inhalers, patches, creams, eye drops, and more.
• Acquire and document medication allergy histories and associated reactions.
• Assist in orienting and training new pharmacy personnel.branded

Education and Experience Requirements:

• High School diploma or equivalent required; Associate or Bachelors degree preferred
• Previous hospital or retail pharmacy experience preferred
• Pharmacy Technician Certification Board certification (PTCB) required
• Applicants enrolled in, or graduate of a 4-year bachelor program in the following health science majors are encouraged to apply and will be required PTCB certification in 1 year of employment: Applied Molecular Biology and Biotechnology Biology, Chemistry, Exercise Science, Health Behavior Science, Human Physiology, Medical Diagnostics, Medical Diagnostics Pre-PA, Medical Laboratory Science, Nutrition, Nutrition and Dietetics, Nutrition and Medical Sciences, Nursing, Occupational Therapy, Physical Therapy, Physician Assistant or Sports Health
• Computer experience preferred (e.g., window-based programs)

ChristianaCare Offers:

Incredible Work/Life benefits including medical/dental/ vision insurance coverage on your first day of employment, paid PTO, retirement plans, twelve weeks of paid parental leave, annual membership to , access to backup care services for dependents through , retirement planning services, financial coaching, fitness and wellness reimbursement, and great discounts through several vendors for hotels, rental cars, theme parks, shows, sporting events, movie tickets and much more.

If you 're inspired to make a difference, we invite you to become a ChristianaCare caregiver!

Christiana Care Health System is an equal opportunity employer, firmly committed to prohibiting discrimination, whose staff is reflective of its community, and considers qualified applicants for open positions without regard to race, color, sex, religion, national origin, sexual orientation, genetic information, gender identity or expression, age, veteran status, disability, pregnancy, citizenship status, or any other characteristic protected under applicable federal, state, or local law.

QC Supervisor

Kelly® Science & Clinical is seeking a QC Supervisor for a direct-hire position at a cutting-edge client in Fort Collins, CO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Location:Ft. Collins, CO (onsite)

Shift: 1st or 2nd

Salary: $100-105,000 + Benefits

Essential Duties & Responsibilities

• Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items.
• Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
• Escalate and communicate items which arise per the timelines specified in the department escalation strategy.
• Execute all business and department goals and initiatives on time.
• Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments.
• Issue all Certificates of Analysis within 2 business days of last test completion.
• Generate, monitor and report weekly team and analyst KPIs.
• Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples.
• Strive to balance workload across all sites and teams to ensure adequate resource allocation.
• Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time.
• Provide assistance, training and leadership for direct reports through utilization of the OTD resources.
• Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix.
• Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals.
• Create and revise developmental plans to help employees grow their skills and advance their careers.
• Monitor and discuss progress of employee’s performance, growth and development in one on ones utilizing the career ladder and KPIs.
• Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates.
• Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days).
• Support and execute all potential 3-day field alert investigations and actions expeditiously.
• Submit document change requests for all document updates and minimize document revisions for routine updates where possible.
• Ensure all samples logged into the LIMS system are submitted correctly.
• Identify, and complete cost savings initiatives and facilitate continuous improvement.
• Participate in leadership development activities and take an active role during department and company activities.
• Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained.
• Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues.
• Conduct and coordinate laboratory investigations, and all associated actions.
• Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports.
• Participate in project teams, company and department meetings, third party audits, and regulatory audits.
• Monitor departmental spending to stay within the established budget.
• Demonstrate leadership aptitude in technical functions and people management.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Accountable for meeting departmental and compliance timelines.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Participate in the interview and selection process for candidates, as required.
• Perform other duties as required by business demands.

Knowledge, Skills & Abilities

• Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality.
• Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively
• Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Knowledge in analytical method validation and instrument qualification.
• Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department.
• Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices.
• Knowledge of analytical troubleshooting and product investigation.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,.
• Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use.
• Ability to coordinate activities to assure customers’ needs are met in terms of sample analysis cycle time.

Education & Experience

• Bachelor’s degree in science, preferably in Chemistry or Biochemistry, or Microbiology.
• 6+ years’ experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting.
• Supervisory or team lead experience is preferred.

What Happens Next

Once you apply, you’ll move forward to next steps if your background aligns with the role. If not, no worries — you’ll remain in our network, giving our Science & Clinical recruiting team access to your profile, helping open the door to future opportunities.

Key Responsibilities

• Document Leadership and Authoring:
• Provides medical writing leadership for clinical programs
• Acts as a medical writing subject matter expert and collaborates with the Clinical Science team to deliver on clinical documents including clinical study protocols and protocol-related documents (e.g. informed consent forms), clinical study reports, DSURs, Investigator’s Brochures, IND clinical summaries/overviews, and CTD components (e.g. Module 2 summaries)
• Partners with the regulatory function to ensure timely completion of high-quality regulatory documents including health authority meeting requests, briefing packages, responses to requests for information, and other documents as required for submissions
• Vendor Management: Provides guidance to external writers on prioritization, content and timeline development, and process management to support clinical development and regulatory activities
• Process Improvement:
• Develops medical writing best practices
• Partners with the Quality Assurance team to develop new and update existing Standard Operating Procedures for Medical Writing processes and all clinical documents to ensure compliance with ICH requirements

Position Requirements

• Master’s degree in a life science discipline from an accredited college or university; PharmD or PhD preferred
• Minimum of 8+ years of scientific or medical writing experience at a biotech/ pharmaceutical company or clinical research organization setting
• Expert knowledge of standard clinical regulatory document types and associated regulatory requirements (e.g. ICH guidance, FDA, EMA, Health Canada, Asia-Pacific regulations, etc.)
• Prior writing experience in Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator’s Brochures, IND clinical summaries/overviews, CTD clinical summaries, and partnering with external investigators to support Investigator Initiated Study Trials
• Expert ability of Microsoft Office Suite, Adobe Acrobat, collaborative review management systems (e.g. SharePoint) and documents management (e.g. Veeva RIM)
• Experience in resource planning and management experience of contractors
• Excellent organization skills with a passion for delivering quality results
• Detail-oriented mindset with excellent verbal and written communication skills
• Self-motivated and able to work collaboratively
• Ability to “roll up sleeves” in a start-up environment and a positive can-do attitude
• Must be willing to work onsite at least 4 days a week

The American Academy of Arts and Sciences seek a detail-oriented undergraduate history student to support award-winning historian Jacqueline Jones with research for a 250th anniversary history of the Academy. The research assistant will support the historian with literature reviews, archival research, and other research tasks as needed.

Archival materials are in the Boston area, and the research assistant will have access to space in the Academy’s Cambridge headquarters as needed. To ensure data security and system compatibility, the assistant will use an Academy-provided laptop (PC) and MS Office suite to perform duties.

Minimum Qualifications:

• 2 years of undergraduate study in history
• Experience with archival research
• Proficiency with MS Word and MS Excel
• Authorized to work for any employer in the U.S. (sponsorships not available)

Preferred Qualifications:

• Demonstrated ability to manage tasks and meet deadlines with minimal supervision.
• Interest in U.S. and/or transatlantic history and institutions

Duration:

• Through calendar year 2026.

Application Instructions

Please send queries and submissions (cover letter and CV) to Robert Townsend, Director of Humanities, Arts, and Culture programs, at

Location and Work Environment

This is a hybrid role in Cambridge, MA.

About the Academy

Founded in 1780, the Academy is both an honorary society that recognizes and celebrates the excellence of its members and an independent research center convening leaders from across disciplines, professions, and perspectives to address significant challenges.

The Academy membership encompasses over 6,000 members and reflects the full range of disciplines and professions: math and physical sciences, biological sciences, the social sciences, humanities and the arts, journalism, business and philanthropic leaders, educational, scientific, and cultural administrators as well as public affairs and public policy.

Summary

Our client, a Fortune 500 Medical Device company, has engaged GForce Life Sciences to source a skilled Clinical Site Lead (CSL). The CSL will oversee clinical study site maintenance, data collection, and field monitoring to ensure compliance with protocols, regulations, and Good Clinical Practices. Responsibilities include managing essential documents, resolving data discrepancies, reviewing adverse events, and coordinating site initiation. The role requires analytical problem-solving, process optimization, and continuous quality improvement. The CSL will monitor site performance, identify areas for improvement, and provide solutions to management.

Job Duties

• Monitors clinical studies at sites in an assigned territory (and others as requested) to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.
• Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects.
• Reviewing data and source documentation from investigational sites for accuracy and completeness
• Ensuring adverse events and protocol deviations are reported in an efficient manner
• Ensuring that device complaints and malfunctions are reported according to the client’s Policies and Procedures
• Resolving and/or facilitating resolution of problems including identification of cause and actions to prevent reoccurrence
• Coordinates with study teams, field clinical engineers or designee and specialists.
• Enroll sites into new and ongoing clinical studies
• Facilitate enrollment of study subjects via site coordinators
• Facilitate resolution of data queries and action items at clinical sites
• Promptly reports the findings of monitoring visits according to the client’s processes.
• Collaborates with in-house teams to ensure complete submission of study documents.
• Trains site personnel to ensure compliance with the study protocol and local regulations.

Requirements

• Bachelor’s Degree - Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
• 10+ years of clinical trial monitoring experience required.
• Familiarity with cardiac, vascular, and/or neuromodulation technologies.
• Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.

Preferred Qualifications

• A general familiarity with cardiac, vascular, and/or neuromodulation technologies.
• Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or accredited institution

Term & Start

• Remote with travel to sites in SoCal
• 50-75% travel (depending on clinical trials)
• 12-month contract (extension probable)
• Benefits available (Medical, Dental, Vision, 401k)

Role Title - Quality Control Analyst III, Analytical

Department- QC

Reports to- QC Manager, Analytical

FLSA -Exempt

Salary Range: $80k- $90k

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

COMPANY DESCRIPTION

Polaris Pharmaceuticals, Inc., an affiliate of the Polaris Group ( ), is a therapeutic protein drug manufacturer located in Vacaville, California. Polaris has a cGMP facility producing biological study drugs to support all Polaris Group clinical trials at various stages in the USA, Europe, and the Asian-Pacific region.The lead project of the company is now in clinical trials for patients with different types of cancer including mesothelioma, sarcoma, and glioblastoma. Polaris is seeking candidates to help with the production of this protein drug as well as the production of products for our clients and partners.

ROLE SUMMARY

The Quality Control Analyst, under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples compliant with cGMP guidelines. The Analyst works independently on assays that he/she has mastered. This position requires willingness to undergo training on more advanced analytical methods and always employs laboratory safety policies. The Analyst will be responsible for the timely completion of assignments. Good record keeping, organizational, written, and verbal communication skills are essential. The analyst must be willing to work overtime as required.

ROLE RESPONSIBILITIES

• Performs, under direct or minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
• Reviews test data for accuracy, data integrity, system suitability, and conformance against defined criteria/specifications.
• Provides technical support with troubleshooting of test methods, as needed.
• Identify and contribute to OOS/OOE/OOT investigations related to testing performed.
• Initiate and author deviation and laboratory investigations.
• Maintains the laboratory in an inspection-ready state.
• Develops and maintains proficiency in a broad range of trained test methods.
• Train analysts on test methods and procedures.
• Responsible for authoring Change Control records and leading the revision of written procedures as assigned.
• Holds self and others responsible to abide by department and company policies and practices.
• Adheres to cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements.
• Manage reagent and equipment inventory for assigned areas of responsibilities.
• Responsible for sampling and testing of incoming raw materials

SKILLS

• Strong working knowledge of cGMP regulations, including 21CFR 210 & 211, USP, EP, and ICH.
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Works independently as well as in a team environment.
• Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Strong documentation skills a must. The analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers.

The analyst must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation. Experience with Protein analytics, SDS-PAGE, separations technology for HPLC, Chromatography Data Systems (CDS) software such as OpenLab, subvisible particles testing (USP ), and CCIT preferred. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

QUALIFICATIONS

B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). Minimum of 5 years of relevant laboratory experience is desired.

About the Role

The Chief Scientific Officer - Early Drug Development will formulate and lead the company's global early-stage R&D strategy, establishing the R&D roadmap from target validation to proof-of-concept (POC).

Responsibilities

• Lead the drug chemistry team and the biology team.
• Establish a global R&D layout and talent echelon for innovative drugs of Qilu.
• Plan and make decisions regarding the innovative drug pipeline, including cutting-edge technology fields such as small molecules, large molecules, ADCs, and small nucleic acids.
• Establish strategic partnerships with the global academic community, research institutions, and biotechnology companies to introduce cutting-edge technologies.
• Research on leadership mechanisms and formulate biomarker strategies to provide a solid scientific basis for R&D decisions.

Qualifications

• Possess a doctoral degree in life sciences or a related medical field.
• Over 20 years of research and development experience in multinational pharmaceutical companies or top biotech firms.

Required Skills

• Profound biological knowledge in core disease areas such as oncology, metabolism, autoimmunity, or the central nervous system.
• Deep understanding of emerging therapeutic modalities.
• Complete R&D success experience from the laboratory to the clinic.
• Led and advanced at least five innovative drug projects into the clinical stage and successfully completed POC.
• Outstanding scientific insight and strategic decision-making ability to predict industry trends and transform them into the company's R&D advantages.
• Outstanding leadership with the charisma and influence to inspire, attract, and retain top scientific talents.

Preferred Skills

• Experience in establishing and managing global R&D teams.
• Strong network within the academic and biotechnology communities.

Pay range and compensation package

Competitive salary and comprehensive benefits package commensurate with experience.

首席科学官 - 早期药物研发

工作职责：

• 制定并领导公司全球早期研发战略，确立从靶点验证到POC的概念验证的研发路线图。
• 统领药物化学团队、生物学团队，构建齐鲁创新药物全球研发布局与人才梯队。
• 主导创新药物管线的规划与决策，包括小分子、大分子、ADC、小核酸等前沿技术领域。
• 作为公司科学领域的最高代表，与全球学术界、研究机构及生物技术公司建立战略合作，引进前沿技术。
• 领导机制研究与生物标志物策略的制定，为研发决策提供坚实的科学依据。

任职要求：

• 拥有生命科学或医学相关领域的博士学位，20年以上在跨国药企或顶尖生物技术公司的研发经验。
• 具备深厚的肿瘤、代谢、自身免疫或中枢神经系统等核心疾病领域的生物学知识，并对新兴治疗模式有深刻理解。
• 拥有从实验室到临床的完整研发成功经验，曾主导推进至少5个创新药物项目进入临床阶段并成功完成POC。
• 卓越的科学洞察力与战略决策能力，能够预见行业趋势并转化为公司的研发优势。
• 出色的领导力，具备激发、吸引和保留顶尖科学人才的人格魅力与影响力。
• 具体岗位职级将根据候选人综合资质确定。

Job Title: QA Consultant (GxP)

Location: San Diego, CA (On-site)

Position Type: Contract / Consultant

Department: Quality Assurance

Reports To: Site Quality Head / Director, QA

Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed

About Us

Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need.

Position Summary

The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions.

You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams.

Key Responsibilities

Support concurrent activities for legacy Quality systems during QMS integration and system migration phases.

Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems.

Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls.

Operate and support legacy Quality systems during the transition to new platforms.

Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records.

Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA).

Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records.

Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS).

Support continuous improvement efforts for events within EDMS and LMS.

Work with document owners to ensure timely periodic review of procedures.

Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools.

Generate and trend quality metrics, communicating findings to leadership.

Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans.

Review and approve paper-based quality documentation and electronic quality records.

Promote a culture of quality, teamwork, and accountability with a patient-first mindset.

Align daily activities with department goals and company values.

Ability to lift up to 20 pounds as needed.

Qualifications

Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).

Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).

Technical Skills:

Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.

Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.

Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio.

Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).

Competencies:

Exceptional written and verbal communication skills.

Strong attention to detail and ability to manage multiple projects simultaneously.

Proven ability to work independently and collaboratively in a fast-paced, dynamic environment.

Experience developing training materials and delivering training to employees.

Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents.