Pharmaceutical Jobs in Usa
1,143 positions found — Page 53
ANEUVO is developing breakthrough neuromodulation devices and bioelectronic medicine to treat diseases and injuries that are incurable with conventional pharmacological agents. We are building a cohesive team with complementary and multidisciplinary expertise to develop and bring our products to market.
We are currently looking for a detail-oriented and reliable Production Operator / Technician to join our manufacturing team in producing high-quality medical devices. You will be responsible for operating equipment, assembling components, inspecting products, and ensuring adherence to strict regulatory standards such as ISO 13485 and FDA cGMP.
Key Responsibilities:
- Operate and monitor production equipment according to SOPs (Standard Operating Procedures)
- Assemble medical device components manually or using automated tools
- Perform in-process inspections and testing to ensure product quality
- Maintain accurate records of production output, defects, and downtime
- Follow Good Manufacturing Practices (GMP), cleanroom protocols, and safety guidelines
- Participate in root cause analysis and continuous improvement activities
- Support equipment maintenance, calibration, and troubleshooting
- Collaborate with quality, engineering, and warehouse teams to meet production goals
Qualification:
- High School diploma or GED required; Associate degree or technical certification preferred
- 3 to 5 years of experience in a manufacturing environment, preferably medical device or pharmaceutical
- Basic knowledge of GMP, ISO 13485, and cleanroom standards
- Ability to read technical drawings, work instructions, and production schedules
- Strong attention to detail and manual dexterity
- Ability to stand for long periods and lift up to 30 lbs
- Comfortable working in controlled environments
Preferred Qualification:
- Experience with medical device assembly
- Familiarity with electronic batch records (EBR) and ERP systems
- Ability to work effectively in a team-oriented, fast-paced environment
- Good written and verbal communication skills
What we offer:
- A unique opportunity to drive a revolution in medical practices and to significantly improve the health condition of patients
- A unique environment for you to exercise your talents and be impactful
- Medical, dental and vision insurance
- Employee stock options
Last but not least, we are a small team and thus everyone plays a critical role - your voice will be heard clearly and loudly! Come join us and build the future, today.
Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA 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 Empowering Experts.
Job Title: QA Validation Specialist (Contract)
Duration: 10 months
Location: Irvine, CA (onsite)
Rate: $38–40/hr.
This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.
RESPONSIBILITIES:
- Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
- Authors/approves and executes qualification protocols and reports.
- Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
- Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
- Qualification of Vendors Selected.
- Input to the development of the URS/FRS/DDS.
- Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
- May present qualification studies to Regulatory and Client Auditors as required.
- Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
- Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
- Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
- Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
- Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
- Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
- Other responsibilities and special projects will be assigned based on business and customer needs.
QUALIFICATIONS:
- Bachelor’s degree in Sciences
- 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
- Strong working knowledge of cGMP and regulatory standards for validation.
- Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
- Demonstrated experience with qualification of commercial processing a packaging equipment.
- Proven track record of managing projects from start to finish on time and on budget.
What happens next:
Once you apply, you’ll proceed to 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 our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. If you are interested in building a new frontier in genetic medicine, we welcome you to apply.
Job Description: Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytical Development
Position Overview: The Research Associate III/ Senior Research Associate in Assay Development and Bioanalytical Development will play a critical role in the development, qualification, and validation of bioanalytical methods to support our RNA editing programs. The successful candidate will work under the guidance of an assay development scientist to develop custom assays for the analysis of samples, including AAVs, cells, and tissues. This role also involves drafting key documents such as Standard Operating Procedures (SOPs) and method development reports.
Key Responsibilities:
- Method Development, Qualification, and Validation:
- Support the development, qualification, and validation of bioanalytical methods in accordance with regulatory guidelines.
- Develop, optimize, and execute robust bioanalytical methods for the characterization, release, and stability testing of Amber's gene therapy.
- Sample Analysis:
- Support drug absorption, distribution, metabolism, and excretion studies.
- Perform analysis of AAVs, cells, and tissues to support various stages of research and development.
- Lead efforts to streamline and optimize sample storage and processing, as well as establishing and maintaining critical reagent stocks and cell banks.
- Documentation Reporting:
- Draft and review key documents such as SOPs, method development, and sample analysis reports.
- Maintain accurate and detailed records of all experiments and analyses.
- Collaboration & Communication
- Collaborate with manufacturing and preclinical teams to support pipeline needs.
- Communicate and present findings clearly to internal stakeholders.
Qualifications:
- B.A./B.S. or M.S. in Molecular Biology, Biochemistry, Analytical Chemistry, or a related field.
- 3+ years of experience in bioanalytical and assay development in the biotechnology or pharmaceutical industry.
- Demonstrated strong proficiency in a wide range of molecular biology techniques such as molecular cloning, DNA/RNA extractions, RT-qPCR, ddPCR, and ELISA.
- Experience with cell-based assays and detection methods such as fluorescence, luminescence, and ECL.
- Hands-on experience using laboratory automated systems (e.g., liquid handlers, extraction robotics, etc.).
- Background in RNA-based therapies is highly desirable.
- Experience writing SOPs and reports supporting IND filings (e.g. development, qualification sample analysis reports, etc.)
- Knowledge of FDA and ICH guidelines for method development, qualification, and validation.
- Prior history in compiling and analyzing data and generating reports that are routinely presented to project teams.
- Ability to work effectively in a collaborative, fast-paced environment.
Preference will be given to those who display:
- High motivation, with a strong work ethic and dedication to generating impact.
- Attention to detail, with the ability to extract deep insights from data.
- Ability to go from ideation to data in an independent fashion.
- Long-term personal vision with defined career goals.
- Team-oriented thinking.
- Demonstrated excellence in small team environments, including a “no task is too small” attitude.
If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.
Please apply directly through LinkedIn.
Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.
The Planet Group is seeking a Copy Editor/Fact Checker (AMA) to join one of our well-known global pharmaceutical clients.
- Pay: $46-48.18/hr depending on experience (W2 and benefit options)
- Duration: 6 mo to start (potential to go longer)
- Location: Remote to start but must be local to Irvine, CA
Copy Editor/Fact Checker Responsibilities:
- Edit and proofread copy for assigned and other brands as needed
- Fact check annotated copy using provided references, ensuring acceptable sources are used
- Collaborate and communicate with Editorial Director and team members to maintain quality and meet goals
- Prioritize and manage workload, meetings, and various tasks to ensure all deliverables are met with excellence; ability to handle multiple jobs and prioritize as needed
- Able to independently navigate and complete editorial tasks by understanding requirements and choosing the most effective approach, rather than relying solely on instructions or frequent supervision
- Able to conduct all types of reviews and have a firm understanding of what the job needs for each round
- Able to communicate well cross-functionally with Agency teams when needed
- Thoroughly understand assigned brands and product categories
- Demonstrate a drive to ensure adherence to client and brand guidelines
- Contribute ideas/feedback for improving process and minimizing error
- Offer guidance and training to junior team members and freelancers to ensure integrity of editorial process
- Proactively offer and provide help to others to ensure all work moves through the department efficiently
- Create/maintain brand style guides and bibliographies in a timely manner
- Understand and execute AMA style and varying editorial styles per brand needs
Copy Editor/Fact Checker Qualifications:
- Any College degree required
- At least 5 years medical editing and fact checking experience in a pharma ad agency/medical education environment
- Agency Experience is a must
- Must have been in a senior level role for a minimum of 5 years
- Experience working with Oncology brands or neurotoxins would be a great plus, but not necessary
- Demonstrated ability to work independently with a motivated, self-starting attitude
- Ability to creatively adapt to changing deadlines, providing recommendations as needed
- Knowledge of current AMA style and FDA guidelines governing pharmaceutical products/devices
- Solid ability to use MS Office (including Outlook, Teams, and Word), Adobe Acrobat, and/or ProofHQ
- Fact checking is a must!
- Must be able to work Pacific time zone hours
Location: Remote
Length: 11 month contract
Compensation: $125-$145/hr
Job Summary
A clinical-stage precision oncology biotechnology company is seeking a Director, Biostatistics to lead statistical strategy and execution across its oncology development programs. The organization focuses on developing targeted therapies for molecularly defined solid tumors, with a pipeline spanning early- through late-phase clinical development.
The Director will serve as the statistical lead across cross-functional teams and play a key role in clinical development planning, study design, regulatory interactions, and submissions. This individual will oversee internal and external biostatistics resources, ensure high-quality and timely deliverables, and represent the biostatistics function internally and externally, including interactions with regulatory agencies and key opinion leaders.
Key Responsibilities
- Provide strategic statistical leadership for oncology clinical programs from Phase 1 through regulatory submission.
- Contribute to Clinical Development Plans, study protocols, and Statistical Analysis Plans (SAPs).
- Oversee design, analysis, and interpretation of clinical trial data, including interim analyses and Clinical Study Reports (CSRs).
- Establish and maintain statistical standards and methodologies across clinical, translational, and pharmacology datasets.
- Manage and mentor biostatistics staff, programmers, consultants, and vendors to ensure high-quality statistical outputs (TFLs, analyses, datasets).
- Review and approve key study documents including protocols, SAPs, CRFs, CSRs, and publications.
- Represent biostatistics in cross-functional discussions and regulatory interactions.
- Translate scientific questions into rigorous statistical approaches and clearly communicate results to diverse stakeholders.
- Ensure compliance with regulatory expectations and stay current with evolving statistical methodologies and industry standards.
- Ph.D. or M.S. in Statistics or related field.
- 12+ years of biostatistics experience in pharmaceutical drug development, including 8+ years in oncology.
- Extensive hands-on experience developing complex protocols and SAPs and performing analyses from early-phase through submission.
- Direct involvement in multiple NDA/BLA submissions with successful oncology approvals.
- Deep expertise in clinical trial design and advanced statistical methodologies, including time-to-event analyses.
- Proven leadership experience in cross-functional environments with strong communication and organizational skills.
Estimated Min Rate: $125.00
Estimated Max Rate: $145.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:
Job Title: Biocompatibility & Toxicology Director
Salary Range: $120,000.00 - $150,000.00
Location: Onsite - Rush, NY
Canyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, packaging, and biological and analytical testing.
Canyon Labs is seeking an experienced Biocompatibility & Toxicology Director to lead our biological safety and toxicology programs supporting sustaining and new medical device products and pharmaceuticals.
Key Responsibilities
- Lead biocompatibility, and safety programs, as well as strategy development aligned with ISO 10993 and global device and pharma regulatory requirements.
- Oversee study designs, GLP/GMP protocols, reports for standard and complex studies
- Serve as senior scientific SME, interpreting safety data and advising on testing strategies for drugs and investigational devices.
- Manage and mentor department staff, supporting onboarding, training, performance development, and team leadership.
- Interface with clients, CROs, vendors, and regulatory agencies to support submissions, audits, and technical discussions.
- Oversee budgets, resource planning, and cost-saving initiatives including in-house testing capabilities.
- Collaborate with cross-functional teams including R&D, Regulatory, Analytical Chemistry, and Quality to ensure timely project execution.
Qualifications
- Advanced degree in Toxicology or related field (PhD and/or DABT) preferred with 10+ years of relevant experience including management of personnel.
Canyon Labs offers several benefits as part of your total compensation, including but not limited to:
- Paid Time Off, Sick Time, and Paid Holidays
- Medical, Dental and Vision Insurance
- Long term disability insurance, life insurance
- 401(k) with company match up to 4%
At Canyon Labs, we are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws.
Clinical Research Associate - Oncology
- Must have 1.8 years of onsite monitoring experience
- Must have experience in Oncology
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
What You Will Be Doing:
- Serve as the primary point of contact between investigational sites and the sponsor
- Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
- Ensure site compliance with ICH-GCP, SOPs, and regulations
- Maintain up-to-date documentation in CTMS and eTMF systems
- Support and track site staff training and maintain compliance records
- Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
- Support subject recruitment and retention efforts at the site level
- Oversee drug accountability and ensure proper storage, return, or destruction
- Resolve data queries and drive timely, high-quality data entry
- Document site progress and escalate risks or issues to the clinical team
- Assist in tracking site budgets and ensuring timely site payments (as applicable)
- Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
You are:
- A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
- Eligible to work in United States without visa sponsorship
- A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experienced monitoring oncology trials required.
- Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- A clear communicator, problem-solver, and collaborative team player
- Willing and able to travel up to 50% for on-site monitoring visits
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Qualifications
- Bachelor’s degree or higher in a relevant discipline with at least 3 years of applicable bioprocess experience.
- Experience with process purification of biomolecules (mAbs, vaccines, etc…) from harvest to drug substance
- Familiarly working in GxP cross matrix organizations
- Lab-scale purification process development and troubleshooting experience with standard downstream equipment (e.g. AKTAs, Repligen TFF, etc…)
- Direct hands on experience and knowledge of templated processes such as mAbs, pDNA, mRNA etc.
- Proficient expereine with data analysis tools such as Minitab, JMP, KNIME etc.
- Working knowledge of PAT applications development and implementation from bench scale to pilot (FlowVPE, IVI Raman etc…)
- Experience with HTS instrumentation for protein purification and process development.
- Working knowledge of GxP/ICH/Quality compliance systems of the biopharmaceutical industry
Job Description
We are looking for a Downstream Scientist to support our pharmaceutical client in Andover, MA. This person will lead, develop, and qualify purification techniques for biologics at both pilot and bench scale. This role involves hands-on execution of purification processes using a variety of unit operations including precipitation, depth filtration, tangential flow filtration (TFF), and chromatography. The scientist will support technology transfer, process troubleshooting, and continuous improvement initiatives.
Key Responsibilities:
- Lead and execute purification processing using precipitation, depth filtration, TFF, and chromatography.
- Develop and characterize purification processes for monoclonal antibody (mAb) programs, including second-generation process development.
- Independently plan, design, and execute downstream experiments to support technology transfer of mAb programs.
- Operate and maintain downstream equipment such as AKTAs and Repligen TFF systems, and analytical tools including SoloVPE, Stunner, and Raman spectroscopy.
- Analyze data, prepare technical reports, and present findings to internal teams.
- Support manufacturing investigations and troubleshoot purification processes.
- Drive continuous improvement initiatives including 5S, TPM, and operational excellence.
- Plan and execute critical material production campaigns independently.
- Collaborate cross-functionally with project teams to ensure alignment and effective communication.
- Familiarity with mRNA Lipid nano particle formulation and Final Drug Product (FDP) processes
Kelly® Science & Clinical is seeking a Process Engineering Manager for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Colorado Springs, CO facility. 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.
Workplace: Onsite in Colorado Springs, CO
Position Title: Process Engineering Manager, Oral Dosage Forms
Position Type: Direct hire
Salary: $125,000-140,000
Are you ready to drive innovation and success in pharmaceutical manufacturing? We are seeking a dynamic Principal Investigator to serve as a technical authority in process development, scale-up, and technology transfer. If you thrive in collaborative, fast-paced environments and are passionate about advancing life-changing therapies, this is your opportunity to make a significant impact.
Responsibilities
Strategic Process Development & Scale-Up
- Spearhead the development and scale-up of robust, scalable manufacturing processes across a wide spectrum of drug products
- Design and lead process characterization and optimization studies, defining critical process parameters and proven acceptable ranges
- Champion Quality by Design (QbD) strategies and advanced statistical methodologies, ensuring seamless progression from laboratory concepts to pilot-scale execution
Technology Transfer Leadership
- Serve as the technical lead for all technology transfer activities, bridging R&D, global manufacturing sites, and client partners
- Develop and implement comprehensive transfer protocols and process equivalence strategies to ensure flawless execution
- Lead high-performing, cross-functional teams through knowledge transfer, process mapping, and documentation best practices
Pilot Plant & cGMP Operations Management
- Oversee cGMP-compliant pilot plant operations, supporting clinical and commercial production, validation, and process improvement
- Drive continuous improvement projects—maximizing efficiency, quality, and yield
- Provide expert troubleshooting and manage deviations, ensuring on-time project delivery
Capital Projects & Facility Optimization
- Lead equipment qualification and validation for cutting-edge process installations
- Direct facility expansion and modification projects to support innovation and new technology implementation
- Optimize facility workflows to enhance operational excellence and scalability
Quality Assurance & Regulatory Compliance
- Ensure strict adherence to cGMP (21 CFR 210/211) and data integrity (21 CFR 11) regulations
- Develop and execute robust process validation strategies in accordance with global regulatory standards
- Lead investigations, implement corrective/preventive actions, and maintain perpetual audit readiness
Project Management & Client Engagement
- Manage multiple, high-profile client technology transfer programs—delivering on time and within budget
- Serve as the primary technical liaison for clients, providing strategic insight and technical guidance
- Develop detailed project plans, risk assessments, and contingency strategies to de-risk tech transfer activities
- Mentor cross-functional teams, fostering a culture of excellence and innovation
Qualifications
Education:
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field; advanced degree (MS/PhD) preferred
Experience:
- 8+ years’ experience (Bachelor’s), 5+ years (MS), or 3+ years (PhD) in pharmaceutical process development, technology transfer, and scale-up within a CDMO or CRO environment
- Demonstrated success managing complex, cross-functional projects in a regulated setting
Technical Mastery
- Deep expertise in pharmaceutical process engineering, manufacturing technologies, process validation, and equipment qualification
- Comprehensive understanding of cGMP, quality systems, and regulatory compliance
- Proven skills in process automation, risk management, and project execution
Leadership & Collaboration
- Recognized leadership in guiding technical teams and cross-functional project groups
- Outstanding client relationship management and communication abilities
- Strategic thinker with a results-driven mentality, adept at navigating complex challenges and inspiring teams
Why Join Us?
- Work alongside industry leaders and innovators
- Participate in high-impact projects accelerating life-saving therapies to market
- Competitive salary, comprehensive benefits, and opportunities for continued professional growth
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 our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
Our pharmaceutical client is seeking a Principal Scientist who will be responsible for evaluating and interpreting analytical results, as well as developing, validating, and transferring analytical methods for APIs, intermediates, and raw materials. If you are someone who wants to be apart of a highly technical environment with a lot of growth, this role may be the one for you!
Responsibilities:
- Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
- Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
- Perform analytical chemistry assays based on new and existing methodologies
- Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
- Write technical reports to document analytical methods
- Maintain laboratory notebooks documenting work
- Maintain compliance with GMP SOPs and DEA regulations
- Transfer documented analytical methods to the QC and Process Support Group departments
- Set up new or existing analytical methods for compound identification, purity and potency testing.
- Coordinate off-site testing as necessary
- Conduct testing of analytical samples for the Chemical Development Department as needed.
- Qualify reference materials.
- May also perform other duties as required.
Qualifications:
- Ph.D. in Chemistry or related field with minimum 6 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 14 years of experience in lab environment, pharmaceutical experience preferred.
