Quality Sr. Scientist (Quality Assurance)
Senior scientist job in Sanford, NC
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
• The correct title for this position is Quality Sr. Scientist (Quality Assurance).
• Primarily focused on laboratory testing in a GMP area, with a focus on execution of test methods in support of assay validation.
Responsibilities may include:
• Providing Quality Review/Oversight of site GMP documentation related to the operation of a vaccine manufacturing facility to ensure compliance with global regulatory agencies and Pharmaceutical quality standards.
• Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
• Displays strong investigative or technological orientation with independence for design of projects/studies.
• Organizes and provides written and/or oral presentations of work with minimal input.
• Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance.
• Responsible for final authorization/approval/release of documentation/equipment/processes.
• Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility.
• Plans and leads projects to ensure their timely completion.
• Provide guidance/coaching to junior colleagues.
Qualifications
WORK EXPERIENCE/SKILLS:
• MINIMUM: 5 - 8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
DESIRABLE: EDUCATIONAL BACKGROUND:
• MINIMUM: BS/BA Degree in Science/related field or other appropriate education/experience in biotech or pharmaceutical industry.
DESIRABLE:
• University Degree in the field of Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry or Pharmacy or other appropriate education and experience in biotech or pharmaceutical industry is preferred.
Additional Skills:
• 5 - 8 years quality experience.
• GMP required
• Minimum BS/BA required
Additional Information
For more information, Please contact
Best Regards,
Atul Soni
************** Ext.4554
Morristown, NJ 07960
Senior Applied AI Scientist
Senior scientist job in Parkton, NC
**Meet the Team** Splunk, a Cisco company, is building a safer, more resilient digital world with an end‑to‑end, full‑stack platform designed for hybrid, multi‑cloud environments. Join the Foundational Modeling team at Splunk, where we advance the state of AI for high‑volume, real‑time, multi‑modal machine‑generated data - including logs, time series, traces, and events. We combine deep AI research expertise with the scale and operational excellence of Splunk and Cisco's global engineering capabilities. Our work spans networking, security, observability, and customer experience - designing and deploying foundation models that enhance reliability, strengthen security, prevent downtime, and deliver predictive insights across Splunk Observability, Security, and Platform at enterprise scale. You'll be part of a culture that values technical excellence, impact‑driven innovation, and cross‑functional collaboration - all within a flexible, growth‑oriented environment.
**Your Impact**
+ Lead the research, design, and deployment of large‑scale foundation models for machine‑generated data - primarily time series, augmented with logs traces, and events.
+ Optimize distributed training and inference pipelines to maximize accuracy, performance, and efficiency at scale.
+ Work closely with engineering, product, and data science to ensure solutions meet defined technical requirements and deliver tangible business impact.
+ Mentor team members and contribute directly to model architecture reviews, experimental design, and production rollout processes.
+ Stay current with AI/ML developments and integrate relevant advancements into ongoing projects and technical plans.
**Minimum Qualifications:**
+ PhD in Computer Science, or related quantitative field, plus 1+ years of industry research experience.
+ Proven track record in at least one of the following areas: large language modeling for both structure and unstructured data, deep learning‑based time series modeling, advanced anomaly detection, and multi-modality modeling.
+ Solid proficiency in Python and deep learning frameworks (e.g., PyTorch, TensorFlow)
+ Experience translating research ideas into production systems.
**Preferred Qualifications:**
+ Deep Learning for Time Series & Forecasting - Proven expertise designing and deploying architectures such as temporal transformers, temporal convolutional networks, and spatial‑temporal models.
+ Advanced Anomaly Detection - Experience creating robust, scalable approaches (statistical, deep learning, or hybrid) for high‑volume, real‑time time series data.
+ Multi‑Modal AI Modeling - Strong track record fusing logs, time series, traces, tabular data, and graphs for foundation models tackling complex operational insights.
+ Probabilistic Forecasting & Uncertainty Quantification - Skills in Bayesian deep learning and probabilistic models to capture and communicate predictive uncertainty.
+ Large‑Scale Training & Optimization - Experience optimizing model architectures, distributed training pipelines, and inference efficiency to minimize cost and latency while preserving accuracy.
+ MLOps & Continuous Learning - Fluency in automated retraining, drift detection, incremental updates, and production monitoring of ML models.
+ Strong Research Track Record - Publications in top AI/ML conferences or journals (e.g., NeurIPS, ICML, ICLR, AAAI, CVPR, ACL, KDD) demonstrating contributions to state‑of‑the‑art methods and real‑world applications.
**Why Cisco?**
At Cisco, we're revolutionizing how data and infrastructure connect and protect organizations in the AI era - and beyond. We've been innovating fearlessly for 40 years to create solutions that power how humans and technology work together across the physical and digital worlds. These solutions provide customers with unparalleled security, visibility, and insights across the entire digital footprint. Simply put - we power the future.
Fueled by the depth and breadth of our technology, we experiment and create meaningful solutions. Add to that our worldwide network of doers and experts, and you'll see that the opportunities to grow and build are limitless. We work as a team, collaborating with empathy to make really big things happen on a global scale. Because our solutions are everywhere, our impact is everywhere.
We are Cisco, and our power starts with you.
**Why Cisco?**
At Cisco, we're revolutionizing how data and infrastructure connect and protect organizations in the AI era - and beyond. We've been innovating fearlessly for 40 years to create solutions that power how humans and technology work together across the physical and digital worlds. These solutions provide customers with unparalleled security, visibility, and insights across the entire digital footprint.
Fueled by the depth and breadth of our technology, we experiment and create meaningful solutions. Add to that our worldwide network of doers and experts, and you'll see that the opportunities to grow and build are limitless. We work as a team, collaborating with empathy to make really big things happen on a global scale. Because our solutions are everywhere, our impact is everywhere.
We are Cisco, and our power starts with you.
**Message to applicants applying to work in the U.S. and/or Canada:**
The starting salary range posted for this position is $174,500.00 to $226,500.00 and reflects the projected salary range for new hires in this position in U.S. and/or Canada locations, not including incentive compensation*, equity, or benefits.
Individual pay is determined by the candidate's hiring location, market conditions, job-related skillset, experience, qualifications, education, certifications, and/or training. The full salary range for certain locations is listed below. For locations not listed below, the recruiter can share more details about compensation for the role in your location during the hiring process.
U.S. employees are offered benefits, subject to Cisco's plan eligibility rules, which include medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, paid parental leave, short and long-term disability coverage, and basic life insurance. Please see the Cisco careers site to discover more benefits and perks. Employees may be eligible to receive grants of Cisco restricted stock units, which vest following continued employment with Cisco for defined periods of time.
U.S. employees are eligible for paid time away as described below, subject to Cisco's policies:
+ 10 paid holidays per full calendar year, plus 1 floating holiday for non-exempt employees
+ 1 paid day off for employee's birthday, paid year-end holiday shutdown, and 4 paid days off for personal wellness determined by Cisco
+ Non-exempt employees** receive 16 days of paid vacation time per full calendar year, accrued at rate of 4.92 hours per pay period for full-time employees
+ Exempt employees participate in Cisco's flexible vacation time off program, which has no defined limit on how much vacation time eligible employees may use (subject to availability and some business limitations)
+ 80 hours of sick time off provided on hire date and each January 1st thereafter, and up to 80 hours of unused sick time carried forward from one calendar year to the next
+ Additional paid time away may be requested to deal with critical or emergency issues for family members
+ Optional 10 paid days per full calendar year to volunteer
For non-sales roles, employees are also eligible to earn annual bonuses subject to Cisco's policies.
Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components, subject to the applicable Cisco plan. For quota-based incentive pay, Cisco typically pays as follows:
+ .75% of incentive target for each 1% of revenue attainment up to 50% of quota;
+ 1.5% of incentive target for each 1% of attainment between 50% and 75%;
+ 1% of incentive target for each 1% of attainment between 75% and 100%; and
+ Once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation.
For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay 0% up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.
The applicable full salary ranges for this position, by specific state, are listed below:
New York City Metro Area:
$199,700.00 - $292,800.00
Non-Metro New York state & Washington state:
$174,500.00 - $260,500.00
* For quota-based sales roles on Cisco's sales plan, the ranges provided in this posting include base pay and sales target incentive compensation combined.
** Employees in Illinois, whether exempt or non-exempt, will participate in a unique time off program to meet local requirements.
Cisco is an Affirmative Action and Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, genetic information, age, disability, veteran status, or any other legally protected basis.
Cisco will consider for employment, on a case by case basis, qualified applicants with arrest and conviction records.
Scientist 1, Chemistry Development
Senior scientist job in Parkton, NC
Scientist 1, Chemistry Development
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Research & Development
Level of Experience: Entry-Level
Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)
Workdays/hours: M - F 8 am - 5 pm
Job Description:
Client Technologies and Innovation, located in Research Triangle Park NC, seeks a research associate to work as a member of an R&D team that is involved in identifying, developing, and testing new technologies for a range of medical devices, including surgical and drug-device combination devices. Specifically, the team is focused on the chemical and materials aspects of these devices.
Under the supervision of a senior scientist, the candidate will design and execute studies aimed at assessing the viability of technologies.
They will also help develop processes, including mixing and coating methods, stability testing, elution testing, and other means of evaluating these technologies.
The successful candidate must have experience with basic lab techniques and analytical instrumentation, and also be capable of learning/establishing new experimental tools. Experience with translating technologies/processes from concept to pilot scale is highly desired.
Additional experience with test method development using medical prototypes, working knowledge of polymeric materials, formulation development, coating methods, reagent drying processes, and drug or material stability testing are also valuable assets.
The candidate should have excellent communication and interpersonal skills, the ability to identify and resolve experimental challenges proactively, and a strong desire to gain experience in the process of developing medical technologies.
The candidate should be able to plan and conduct scientific experiments and should be able to effectively analyze, interpret, and present experimental results while collaborating with team members from a variety of backgrounds.
The candidate should also be able to adapt to changing requirements that may arise in a dynamic work environment and will be expected to contribute intellectually in areas not directly related to his or her field.
Requirements
Hands-on laboratory experience working with various chemicals/materials. Experience in common chemistry lab procedures and tools.
Understanding of a range of instrumentation and analytical characterization tools (e.g. familiarity with spectroscopic methods such as fluorescence, UV, IR; and/or separation and characterization tools such as HPLC/UPLC are a plus).
Good written and verbal technical communication skills
Ability to design, execute, and appropriately document experiments
Ability to effectively interpret and present scientific data
Demonstrated ability to work in a multi-disciplinary team
Desired skills
Experience working with polymeric materials and/or dry powder systems
Experience assembling OEM components and device prototypes to configure a desired test method
Hands-on experience in the development and characterization of drug formulations for therapeutics, such as those involving microparticles, nanoparticles or hydrogels
Experience in dry-down processes (e.g. lyophilization/vacuum drying, spray drying).
Past experience or willingness to work occasionally with biological specimens (e.g. tissues) for lab-scale testing
Education:
A B.S. or M.S. in Chemistry, Pharmaceutics/Pharma sciences, Chemical Engineering, biomedical engineering, or a related scientific discipline is required. Prior work experience (e.g., 1-3 years desirable) in a medical device, diagnostics, or pharmaceutical R&D organization is a plus.
Bench Scientist
Senior scientist job in Sanford, NC
IRI believes in commitment, integrity and strategic workforce solutions.
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.
Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.
Job Description
The incumbent will assist the Manufacturing Science and Technology (MSAT) organization supporting biological therapeutics. The incumbent responsibilities will include the following:
• Support lab or pilot-scale experiments involving conjugation of antigens to a carrier protein
• Execution of lab or pilot-scale purifications using Tangential Flow Filtration (TFF), Normal Flow Filtration (NFF), and/or column chromatography, as needed
• Preparation of equipment, solutions, consumable materials, etc. as needed to support experiment execution
• Preparation of technical reports and presentations to communicate results to scientists and management, as required.
Qualifications
• Bachelor's degree or graduate degree in Chemistry, Chemical Engineering or related biotechnology field
• Industrial experience is preferred
• Experience with operating and monitoring of Tangential Flow Filtration (TFF), Normal Flow Filtration (NFF), and chromatography systems is desired
• Experience with conjugation chemistry is highly desired
Additional Information
Warm Regards
Ricky Bansal
732-429-1925
Sr Associate Scientist - Standards & Controls
Senior scientist job in Sanford, NC
Use Your Power for Purpose
The position will support the Pfizer Sanford, NC Quality Operations department by performing activities supporting standards & controls and continuous improvement projects. At a minimum, the position should be able to execute work independently, work with various groups across the organization and be able to lead investigations utilizing operational excellence tools and techniques. Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; analyzing, interpreting, and trending results; and creating, reviewing and approving documentation.
The individual should be able to demonstrate the following:
Acting safely, knows and follows all Environmental Health and Safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely.
Recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting documentation management, reviewing content to ensure compliance to regulations and Pfizer policy and standards.
Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines.
Ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues.
Applies discipline's principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals.
Method 1, yellow belt trained and can apply tools to solve issues (including technical issues).
Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development.
Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail-oriented behavior.
Good judgment and correct decision making based on Pfizer procedures, policy, and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network.
Represents Quality Control on site and network teams/forums that support sustaining or improving site or network operations; influences and negotiates with business lines and shares information obtained with team; acts as change agent for improvements.
Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
Delivery on high business impact projects/activities/changes.
Able to identify and seek out external resources to build or enhance understanding of documentation concepts/improvements and compliance; supports training of staff; mentoring and coaching junior colleagues.
What You Will Achieve
Responsible for knowing, understanding, and acting in accordance with Pfizer's values.
Performs tasks associated with maintaining cGMP compliant process for QC.
Perform documentation management for QC Labs and related areas, including:
Tracking document requests.
Assessment of document to current standards including current site document templates.
Author support.
Collaboration with Doc Control, Training, and QA to approve documents.
Support regulatory audits, as required.
Provide expertise for troubleshooting and resolution of issues related to business processes, equipment, facilities, utilities, and human performance.
Assess potential impact of changes to qualified systems resulting from investigational CAPAs.
Identify and implement documentation best practices to continuously improve the site performance.
Represent QC on site or network teams as necessary.
The position requires execution and management of multiple initiatives at the same time and good communication skills to keep customers, peers, and area management up to date with progress of all such efforts.
Responsible for reporting issues to management and participating in issue resolution.
Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
May initiate, manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines.
Trains junior colleagues and may develop training plans and/or oversee training activities.
Responsible for assessing existing QC situations and suggesting continuous improvements to increase compliance and innovation.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 3 years of experience; OR a master's degree with 0+ years of experience.
Manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
Understanding of cGMP and Safety regulations.
Strong organizational and communication skills.
Team based collaborative problem solving.
Strong understanding of cGMP, Data Integrity and ALCOA principles.
Experience with project management.
Physical/Mental Requirements
Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.
Intellectual capability to perform complex mathematical problems and perform complex data analysis.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Quality Assurance and Control
Auto-ApplyPrincipal Research Scientist I
Senior scientist job in Rex, NC
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.
**Summary**
This position is in the New Proteins & Technology group, within the Protein Discovery Department, and will report to the New Proteins &Technology Associate Director. We are seeking a highly motivated and experienced individual with a PhD and a strong background in pharmaceuticals across a variety of disease areas. The individual within this position will work with other members of the New Protein and Technology group, across the Global Protein Discovery department, and other cross-functional teams to develop and move projects forward using both internal and external resources that best suit the project in question.
The successful candidate will be responsible for conducting comprehensive evaluations of proteins and opportunities both within Grifols' therapeutic areas of interest and also those that fall outside the company's primary therapeutic areas. This will involve a deep understanding of protein function and disease pathobiology, as well as the ability to apply this knowledge to the identification and development of novel therapies using those proteins.
The individual will be responsible for steering the direction of these projects, involving active participation in and leadership of the research design and execution of projects. Accomplishing this will involve detailed data analysis and interpretation from a variety of sources (cell-based and biochemical assays, in vivo studies, omics data, protein purification). Experience writing grants and working with biomedical intelligence platforms is a plus. Furthermore, the individual will be tasked with participating in and performing lab activities to support these projects when the need arises.
The position requires excellent communication skills to effectively identify, establish, and maintain collaborations with external expert partners, as well as present findings to the internal teams. The ability to work in a fast-paced environment and adapt to changing priorities is essential. This role offers the opportunity to contribute to cutting-edge research and make a significant impact on our therapeutic pipeline.
**Primary responsibilities for role:**
+ Responsible for developing functional area objectives in support of departmental objectives/corporate goals.
+ Represents the functional area on a cross-functional team
+ Identifies and requests needed resources within or across functional areas.
+ Independently writes and critically edits procedures or technical reports of a complex nature, assimilating information across functional areas, suitable for regulatory submission or external publication.
+ Directs resources in the preparation of procedures or technical reports of a complex nature suitable for regulatory submission or external publication.
+ Communicates technical and project results and critical information to technical and/or non-technical audiences.
+ Develops creative, novel programs to meet corporate objectives and open new business opportunities.
+ Capable of leading others in problem-solving efforts.
+ Contributes to the development of new principles or concepts.
+ Independently designs, executes, and interprets results for novel and scientifically complex study programs.
+ Mentors others in experimental design.
+ Capable of directing others in study execution.
**Additional Responsibilities**
+ Maintains laboratory facilities in accordance with company policies and industrial best practices.
+ Provides support for research and developmental studies, clinical or commercial manufacturing as needed.
+ Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations.
**Knowledge, Skills, and Abilities:**
+ Capable of developing resource plans to achieve identified objectives/goals.
+ Advanced ability to set and meet deadlines, multitask, as well as to identify, request, and prioritize resources across functional area based on project needs.
+ Demonstrates advanced critical judgment and strategic thinking in representing functional area concerns on cross functional teams.
+ Experienced in identifying projects risks.
+ Must demonstrate advanced ability to produce, oversee, and/or deliver written and oral presentations for technical and leadership audiences.
+ Independently applies sound scientific principles in development of innovative solutions to complex technical problems.
+ Advanced ability to creatively apply scientific principles in problem solving in potentially novel areas.
+ Advanced ability to apply standardized root cause analysis, investigation tools and methodologies.
+ Recognized and consulted as an expert in professional field within functional area or externally.
+ Broad knowledge and expertise of modern scientific technologies commonly used in functional area.
+ Evidence of patent and/or publication record in peer-reviewed journals.
+ Proficient with the use of MS Office software.
**Education & Experience:**
+ Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology)
+ A Bachelor's degree with at least 12 years of experience
+ A Master's degree with at least 10 years of experience
+ A PhD with at least 8 years of experience
**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's degree with 6 years of experience, or a Master's degree with 2 years of experience.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols 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 in a manner consistent with the requirements of applicable state and local laws.**
Learn more about Grifols (**************************************
**Req ID:** 536556
**Type:** Regular Full-Time
**Job Category:** R & D
Senior/Statistical Scientist - Global Medical Affairs
Senior scientist job in Parkton, NC
California, US residents click here (******************************************************************************************************************************************* . **The job details are as follows:** Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are
You are a detail-oriented person who has a strong understanding of clinical trial and registry design. You are able to effectively communicate complex biostatistics and collaborate strategically with colleagues and external partners. You are thoughtful and excited to part of a company that is forward thinking and innovative.
The Senior/Statistical Scientist, Global Medical Affairs will contribute to all biostatistical and programming activities related to various company-sponsored Phase 3b/4 clinical trials and registries and other real-world evidence generation. Individual will lead development of the statistical analysis plan, ensure data integrity and quality of collected data and execution/programming of the statistical analysis plan. Communicate and collaborate in a highly matrixed organization to disseminate study results for publication into abstracts, posters and manuscripts.
+ Act as the lead project statistician for assigned phase 3b/4 clinical trials, leading the development and implementation of statistical methodologies and ensuring the integrity and accuracy of data analysis
+ Conduct comprehensive statistical design, including sample size estimation and randomization specifications.
+ Develop statistical analysis plans and perform data analysis to drive evidence-based decision making
+ Collaborate with data management, clinical development and medical strategy personnel to align on phase 3b/4 clinical trial objectives, streamline processes, and ensure the successful achievement of trial goals
+ Ensure data integrity and quality as received from the electronic data capture or external vendor data working with the data manager to identify and resolve issues as identified
+ Execution of the statistical analysis plan at interim analyses and database lock, ensuring high-quality outputs (tables and figures)
+ Coordinate with the Medical Affairs team and other stakeholders to provide biostatistical resources for investigator-sponsored clinical studies and address internal/external investigator queries of UT clinical databases
+ Provide expert input, conduct thorough reviews, and grant approval for submitted investigator-sponsored clinical studies, external investigator queries of UT databases, abstracts, manuscripts, and posters, ensuring scientific validity and compliance with regulatory standards
+ Collaborate with HEOR to support and execute real world evidence studies using data including, but not limited to administrative claims, specialty pharmacy shipments and electronic health records as requested
+ Communicate highly technical statistical concepts to non-statisticians, translate clinical questions into statistical analyses, and facilitate understanding across multidisciplinary teams
+ Discuss and resolve issues or concerns related to statistical analyses with external investigators and internal colleagues, fostering a collaborative problem-solving environment
+ Develop and maintain a deep understanding of cardiopulmonary, respiratory and transplant therapeutics areas, staying abreast of latest research and trends to inform statistical strategies
Minimum Requirements
Senior Statistical Scientist, Global Medical Affairs
+ Master's Degree in statistics or related field with 6+ years of relevant experience or,
+ Doctor of Philosophy (PhD) in statistics or related field with 2+ years of pharmaceutical experience in clinical development
+ Ability to apply a wide range of statistical skills and adapt them to suit what is needed
+ Ability to work flexibly and multi-task as needed across a broad spectrum of statistical study-related activities
+ Proficient with SAS (base programming, macro language, SAS/GRAPH)
+ Proficient with graphing software (SAS, Excel, R, etc.)
+ Ability to identify data quality or analytical issues and proposing solutions for resolution
+ Proficient working in a PC/Windows environment
+ Ability to manage workload and prioritize appropriately to ensure timely communication of deliverables
+ Excellent verbal and written communication skills
Minimum Requirements
Statistical Scientist, Global Medical Affairs
+ Master's Degree in statistics or related field
+ 3+ years of relevant experience with Master's Degree or PhD (preferred)
+ Ability to apply a wide range of statistical skills and adapt them to suit what is needed
+ Ability to work flexibly and multi-task as needed across a broad spectrum of statistical study-related activities
+ Proficient with SAS (base programming, macro language, SAS/GRAPH)
+ Proficient with graphing software (SAS, Excel, R, etc.)
+ Good understanding of clinical development and regulatory processes
+ Proficient working in a PC/Windows environment
+ Ability to manage workload and prioritize appropriately to ensure timely communication of deliverables
+ Excellent verbal and written communication skills
Preferred Qualifications
+ Knowledge of cardiopulmonary, respiratory and transplant therapeutic areas
Job Location
This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Bench Scientist
Senior scientist job in Sanford, NC
Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity.
To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com
Job Description:
• The incumbent will join the Manufacturing Science and Technology (MSAT) organization supporting biological therapeutics and vaccines.
• Within MSAT, the candidate will work in the Purification Group, which develops processes for isolation and purification of recombinant proteins, polysaccharides, bioconjugates, and other biologics
The incumbent responsibilities will include the following:
• Execution of lab or pilot-scale purifications using column chromatography, Tangential Flow Filtration (TFF), and/or Normal Flow Filtration (NFF), as needed.
• Preparation of equipment, solutions, consumable materials, etc. as needed to support experiment execution
• Preparation of technical reports and presentations to communicate results to scientists and management, as required.
Qualifications
Requirement:
• Bachelor's degree or graduate degree in Chemistry, Chemical Engineering or related biotechnology field. Industrial experience is preferred.
• Experience with operating and monitoring of Tangential Flow Filtration (TFF), Normal Flow Filtration (NFF), and chromatography systems is desired
• Experience with conjugation chemistry is highly desired.
Additional Information
All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP!
I look forward to hearing from you!
Scientific Associate I
Senior scientist job in Holly Springs, NC
Seqirus is the new global company created from the combined strength and expertise of bio CSL and the influenza vaccines business formerly owned by Novartis.
Job Description
Provide support on analytical projects of varying size and demonstrate awareness of broader project objectives
Support vaccines and other biological products.
Analyze information and standard practices using existing procedures to solve routine problems, and be accountable for self-development to enhance contribution.
Major Accountabilities:
Analytical assay execution in support of vaccine process and product development programs, e.g. HPLC/UPLC, gel electrophoresis, ELISA etc.
Self-development to enhance contribution
Solve complex problems using analytical thinking gained through formal education, experience and sound judgmen
Partner with diverse team members from various functions, countries and members at various levels in the organization.
Reviews laboratory documentation
Understand business drivers and be able to work under tight deadlines.
Able to work under tight deadlines.
Perform tasks under limited supervision and able to execute experiments independently.
Data collection and reporting with knowledge of GLP/GMP environments.
Qualifications
Hands on experience on HPLC/UPLC, electrophoresis, immunoassay and other protein analysis methods are required for the position
Ability to work under limited supervision and take scientific direction from scientists.
BS Degree in Scientific Discipline
Internship or Academic experience preferred
Additional Information
All your information will be kept confidential according to EEO guidelines.
Scientific Associate I
Senior scientist job in Holly Springs, NC
Provide support on analytical projects of varying size and demonstrate awareness of broader project objectives Support vaccines and other biological products. Analyze information and standard practices using existing procedures to solve routine problems, and be accountable for self-development to enhance contribution.
Major Accountabilities:
Analytical assay execution in support of vaccine process and product development programs, e.g. HPLC/UPLC, gel electrophoresis, ELISA etc.
Self-development to enhance contribution
Solve complex problems using analytical thinking gained through formal education, experience and sound judgmen
Partner with diverse team members from various functions, countries and members at various levels in the organization.
Reviews laboratory documentation
Understand business drivers and be able to work under tight deadlines.
Able to work under tight deadlines.
Perform tasks under limited supervision and able to execute experiments independently.
Data collection and reporting with knowledge of GLP/GMP environments.
Qualifications
Hands on experience on HPLC/UPLC, electrophoresis, immunoassay and other protein analysis methods are required for
the position
Ability to work under limited supervision and take scientific direction from scientists.
BS Degree in Scientific Discipline
Internship or Academic experience preferred
Additional Information
All your information will be kept confidential according to EEO guidelines.
Sr Engineer / Scientist 2 (Downstream)
Senior scientist job in Holly Springs, NC
**What You'll Do** - Develops site technical training programs for new processes and procedures - Collaborates with cross-functional teams to support commercial and clinical manufacturing campaigns, including on-floor support - Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
- Serves as subject matter expert (SME) to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes
- As technical SME, provides supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required
- Identifies opportunities to improve systems and practices and provides direction to local and global cross-functional teams
- Leads one or more projects spanning multiple departments and cross-functional areas
- Provides engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
- Leads process sub-teams throughout the phases of TT
- Develops project plans, timelines, and communication forums to ensure a smooth transfer
- Leads troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
- Leads the execution of all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports
- Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)
- As technical SME, leads generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
- Generates and executes process training and consults on topics related to manufacturing and process
- Leads and facilitates technical risk assessments for new manufacturing processes
- Provides interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
- Leads and coordinates analysis of manufacturing process performance and reporting to manufacturing management
- Supports development of longer-term Large-Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team
- Delivers documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects
- Other duties, as assigned
**Basic Requirements**
- Bachelor's degree in in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or
- PhD with 5 years of experience
- Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
- Experience with facilitating and training others on RCA and risk assessment
- Project Management experience
**Preferred Requirements**
- Experience working in a Good Manufacturing Practices (GMP) environment
- Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
- Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections
- Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings
**WORKING CONDITIONS & PHYSICAL REQUIREMENTS**
- Ability to discern audible cues
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _2 weeks ago_ _(12/1/2025 11:57 AM)_
**_Requisition ID_** _2025-36262_
**_Category_** _Process Sciences_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_
Sr Engineer / Scientist 2 (Downstream)
Senior scientist job in Holly Springs, NC
What You'll Do
• Develops site technical training programs for new processes and procedures • Collaborates with cross-functional teams to support commercial and clinical manufacturing campaigns, including on-floor support • Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
• Serves as subject matter expert (SME) to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes
• As technical SME, provides supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required
• Identifies opportunities to improve systems and practices and provides direction to local and global cross-functional teams
• Leads one or more projects spanning multiple departments and cross-functional areas
• Provides engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
• Leads process sub-teams throughout the phases of TT
• Develops project plans, timelines, and communication forums to ensure a smooth transfer
• Leads troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
• Leads the execution of all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports
• Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)
• As technical SME, leads generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
• Generates and executes process training and consults on topics related to manufacturing and process
• Leads and facilitates technical risk assessments for new manufacturing processes
• Provides interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
• Leads and coordinates analysis of manufacturing process performance and reporting to manufacturing management
• Supports development of longer-term Large-Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team
• Delivers documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects
• Other duties, as assigned
Basic Requirements
• Bachelor's degree in in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or
• PhD with 5 years of experience
• Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
• Experience with facilitating and training others on RCA and risk assessment
• Project Management experience
Preferred Requirements
• Experience working in a Good Manufacturing Practices (GMP) environment
• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
• Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections
• Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
• Ability to discern audible cues
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Auto-ApplySr Engineer / Scientist 2 (Downstream)
Senior scientist job in Holly Springs, NC
What You'll Do
• Develops site technical training programs for new processes and procedures • Collaborates with cross-functional teams to support commercial and clinical manufacturing campaigns, including on-floor support • Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
• Serves as subject matter expert (SME) to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes
• As technical SME, provides supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required
• Identifies opportunities to improve systems and practices and provides direction to local and global cross-functional teams
• Leads one or more projects spanning multiple departments and cross-functional areas
• Provides engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
• Leads process sub-teams throughout the phases of TT
• Develops project plans, timelines, and communication forums to ensure a smooth transfer
• Leads troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
• Leads the execution of all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports
• Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)
• As technical SME, leads generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
• Generates and executes process training and consults on topics related to manufacturing and process
• Leads and facilitates technical risk assessments for new manufacturing processes
• Provides interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
• Leads and coordinates analysis of manufacturing process performance and reporting to manufacturing management
• Supports development of longer-term Large-Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team
• Delivers documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects
• Other duties, as assigned
Basic Requirements
• Bachelor's degree in in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or
• PhD with 5 years of experience
• Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
• Experience with facilitating and training others on RCA and risk assessment
• Project Management experience
Preferred Requirements
• Experience working in a Good Manufacturing Practices (GMP) environment
• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
• Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections
• Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
• Ability to discern audible cues
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Auto-ApplySr Engineer/Scientist 2 (Upstream)
Senior scientist job in Holly Springs, NC
The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations. FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: ***************************************************
Job Description
What You'll Do
* Develops site technical training programs for new processes and procedures
* Collaborates with cross-functional teams to support commercial and clinical manufacturing campaigns, including on-floor support
* Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
* Serves as subject matter expert (SME) to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes
* As technical SME, provides supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required
* Identifies opportunities to improve systems and practices and provides direction to local and global cross-functional teams
* Leads one or more projects spanning multiple departments and cross-functional areas
* Provides engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
* Leads process sub-teams throughout the phases of TT
* Develops project plans, timelines, and communication forums to ensure a smooth transfer
* Leads troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
* Leads the execution of all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports
* Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)
* As technical SME, leads generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
* Generates and executes process training and consults on topics related to manufacturing and process
* Leads and facilitates technical risk assessments for new manufacturing processes
* Provides interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
* Leads and coordinates analysis of manufacturing process performance and reporting to manufacturing management
* Supports development of longer-term Large-Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team
* Delivers documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects
* Other duties, as assigned
Basic Requirements
* Bachelor's degree in in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or
* PhD with 5 years of experience
* Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
* Experience with facilitating and training others on RCA and risk assessment
* Project Management experience
Preferred Requirements
* Experience working in a Good Manufacturing Practices (GMP) environment
* Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
* Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections
* Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
* Ability to discern audible cues
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).
Auto-ApplySenior Applied AI Scientist
Senior scientist job in Parkton, NC
Meet the Team Splunk, a Cisco company, is building a safer, more resilient digital world with an end‑to‑end, full‑stack platform designed for hybrid, multi‑cloud environments. Join the Foundational Modeling team at Splunk, where we advance the state of AI for high‑volume, real‑time, multi‑modal machine‑generated data - including logs, time series, traces, and events. We combine deep AI research expertise with the scale and operational excellence of Splunk and Cisco's global engineering capabilities. Our work spans networking, security, observability, and customer experience - designing and deploying foundation models that enhance reliability, strengthen security, prevent downtime, and deliver predictive insights across Splunk Observability, Security, and Platform at enterprise scale. You'll be part of a culture that values technical excellence, impact‑driven innovation, and cross‑functional collaboration - all within a flexible, growth‑oriented environment.
Your Impact
* Lead the research, design, and deployment of large‑scale foundation models for machine‑generated data - primarily time series, augmented with logs traces, and events.
* Optimize distributed training and inference pipelines to maximize accuracy, performance, and efficiency at scale.
* Work closely with engineering, product, and data science to ensure solutions meet defined technical requirements and deliver tangible business impact.
* Mentor team members and contribute directly to model architecture reviews, experimental design, and production rollout processes.
* Stay current with AI/ML developments and integrate relevant advancements into ongoing projects and technical plans.
Minimum Qualifications:
* PhD in Computer Science, or related quantitative field, plus 1+ years of industry research experience.
* Proven track record in at least one of the following areas: large language modeling for both structure and unstructured data, deep learning‑based time series modeling, advanced anomaly detection, and multi-modality modeling.
* Solid proficiency in Python and deep learning frameworks (e.g., PyTorch, TensorFlow)
* Experience translating research ideas into production systems.
Preferred Qualifications:
* Deep Learning for Time Series & Forecasting - Proven expertise designing and deploying architectures such as temporal transformers, temporal convolutional networks, and spatial‑temporal models.
* Advanced Anomaly Detection - Experience creating robust, scalable approaches (statistical, deep learning, or hybrid) for high‑volume, real‑time time series data.
* Multi‑Modal AI Modeling - Strong track record fusing logs, time series, traces, tabular data, and graphs for foundation models tackling complex operational insights.
* Probabilistic Forecasting & Uncertainty Quantification - Skills in Bayesian deep learning and probabilistic models to capture and communicate predictive uncertainty.
* Large‑Scale Training & Optimization - Experience optimizing model architectures, distributed training pipelines, and inference efficiency to minimize cost and latency while preserving accuracy.
* MLOps & Continuous Learning - Fluency in automated retraining, drift detection, incremental updates, and production monitoring of ML models.
* Strong Research Track Record - Publications in top AI/ML conferences or journals (e.g., NeurIPS, ICML, ICLR, AAAI, CVPR, ACL, KDD) demonstrating contributions to state‑of‑the‑art methods and real‑world applications.
Why Cisco?
At Cisco, we're revolutionizing how data and infrastructure connect and protect organizations in the AI era - and beyond. We've been innovating fearlessly for 40 years to create solutions that power how humans and technology work together across the physical and digital worlds. These solutions provide customers with unparalleled security, visibility, and insights across the entire digital footprint. Simply put - we power the future.
Fueled by the depth and breadth of our technology, we experiment and create meaningful solutions. Add to that our worldwide network of doers and experts, and you'll see that the opportunities to grow and build are limitless. We work as a team, collaborating with empathy to make really big things happen on a global scale. Because our solutions are everywhere, our impact is everywhere.
We are Cisco, and our power starts with you.
Why Cisco?
At Cisco, we're revolutionizing how data and infrastructure connect and protect organizations in the AI era - and beyond. We've been innovating fearlessly for 40 years to create solutions that power how humans and technology work together across the physical and digital worlds. These solutions provide customers with unparalleled security, visibility, and insights across the entire digital footprint.
Fueled by the depth and breadth of our technology, we experiment and create meaningful solutions. Add to that our worldwide network of doers and experts, and you'll see that the opportunities to grow and build are limitless. We work as a team, collaborating with empathy to make really big things happen on a global scale. Because our solutions are everywhere, our impact is everywhere.
We are Cisco, and our power starts with you.
Message to applicants applying to work in the U.S. and/or Canada:
The starting salary range posted for this position is $174,500.00 to $226,500.00 and reflects the projected salary range for new hires in this position in U.S. and/or Canada locations, not including incentive compensation*, equity, or benefits.
Individual pay is determined by the candidate's hiring location, market conditions, job-related skillset, experience, qualifications, education, certifications, and/or training. The full salary range for certain locations is listed below. For locations not listed below, the recruiter can share more details about compensation for the role in your location during the hiring process.
U.S. employees are offered benefits, subject to Cisco's plan eligibility rules, which include medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, paid parental leave, short and long-term disability coverage, and basic life insurance. Please see the Cisco careers site to discover more benefits and perks. Employees may be eligible to receive grants of Cisco restricted stock units, which vest following continued employment with Cisco for defined periods of time.
U.S. employees are eligible for paid time away as described below, subject to Cisco's policies:
* 10 paid holidays per full calendar year, plus 1 floating holiday for non-exempt employees
* 1 paid day off for employee's birthday, paid year-end holiday shutdown, and 4 paid days off for personal wellness determined by Cisco
* Non-exempt employees receive 16 days of paid vacation time per full calendar year, accrued at rate of 4.92 hours per pay period for full-time employees
* Exempt employees participate in Cisco's flexible vacation time off program, which has no defined limit on how much vacation time eligible employees may use (subject to availability and some business limitations)
* 80 hours of sick time off provided on hire date and each January 1st thereafter, and up to 80 hours of unused sick time carried forward from one calendar year to the next
* Additional paid time away may be requested to deal with critical or emergency issues for family members
* Optional 10 paid days per full calendar year to volunteer
For non-sales roles, employees are also eligible to earn annual bonuses subject to Cisco's policies.
Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components, subject to the applicable Cisco plan. For quota-based incentive pay, Cisco typically pays as follows:
* .75% of incentive target for each 1% of revenue attainment up to 50% of quota;
* 1.5% of incentive target for each 1% of attainment between 50% and 75%;
* 1% of incentive target for each 1% of attainment between 75% and 100%; and
* Once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation.
For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay 0% up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.
The applicable full salary ranges for this position, by specific state, are listed below:
New York City Metro Area:
$199,700.00 - $292,800.00
Non-Metro New York state & Washington state:
$174,500.00 - $260,500.00
* For quota-based sales roles on Cisco's sales plan, the ranges provided in this posting include base pay and sales target incentive compensation combined.
Employees in Illinois, whether exempt or non-exempt, will participate in a unique time off program to meet local requirements.
Bench Scientist
Senior scientist job in Sanford, NC
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
• The incumbent will join the Manufacturing Science and Technology (MSAT) organization supporting biological therapeutics and vaccines. Within MSAT, the candidate will work in the Purification Group, which develops processes for isolation and purification of recombinant proteins, polysaccharides, bioconjugates, and other biologics.
• Execution of lab or pilot-scale purifications using column chromatography, Tangential Flow Filtration (TFF), and/or Normal Flow Filtration (NFF), as needed.
• Preparation of equipment, solutions, consumable materials, etc. as needed to support experiment execution.
• Preparation of technical reports and presentations to communicate results to scientists and management, as required.
Qualifications
Able to execute experimental protocols, interpret data, and communicate results from experimental studies conducted at lab, pilot, or commercial scales.
Additional Information
Best Regards,
Anuj Mehta
************
Biology Scientist
Senior scientist job in Parkton, NC
Biology Scientist
Duration : 6 Months
Total Hours/week : 40.00
1
st
Shift
Client: Medical Device Company
Job Category: Healthcare
Level of Experience: Mid-Level
Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)
Workdays/hours: M - F 8am - 5pm
Job Description:
The Life Science Innovation group at client Technologies and Innovation is seeking a highly talented associate to join our team for a 6-month contingent position.
The associate will join a multi-disciplinary team developing molecular diagnostic solutions to address current and future healthcare needs in the infectious disease space.
The associate will be responsible for the formulation, organization, and quality control of assay raw materials, amplification master mixes, buffers, and consumables.
The associate will apply good laboratory practice and analytical skills to lead the overall reagent inventory, and material output and works with other team members to resolve technical challenges during assay development.
Duties and Responsibilities
Supports the management of reagent and material inventory, and initiates resupply orders as needed.
Receives, aliquots, and labels incoming raw materials and processes CoA's in accordance with Quality Policy.
Monitors freezers and refrigerators to ensure proper storage conditions are maintained.
Prepares various molecular biology reaction buffers and assists in optimization and re-formulation of buffers to meet product development requirements.
Formulates and lyophilizes master mixes for Nucleic Acid Amplification Tests (NAATs).
Utilizes a broad range of practical techniques in molecular biology and chemistry for material formulation.
Supports the development and/or adaptation of relevant Standard Operating Procedures (SOPs).
Maintains familiarity of molecular diagnostics methodologies and demonstrates this knowledge within responsibility areas.
Provides technical input based on experience to colleagues and provides support to other functional groups.
May assist with product quality investigations.
Knowledge and Skills
Skilled with a variety of complex laboratory procedures and instruments.
Proven ability to formulate Master mixes for DNA/RNA amplification methodologies
Skilled in Microsoft Excel to aid in generating various formulations.
Proven ability to work effectively within a team, under direction, and independently.
Excellent oral and written communication skills.
Experience working in BSL-2 environment is highly desired.
Experience in execution of molecular biology methods including qPCR, DNA quantitation/characterization, DNA extraction and purification is preferred
Job Requirements and Experience
B.A./B.S. in Chemistry, Biology, Biochemistry, Microbiology, Biotechnology, or related field
Minimum of 2 years of relevant academic, clinical, or industry lab work required.
Work experience in a laboratory requiring meticulous technique in the formulation of contamination-free, molecular grade buffers and amplification master mixes.
Learning agility and timely execution of tasks is required
Experiences with GLP/GMP standards are a plus
Familiarity of lyophilization processes, and the application of lyophilization to molecular biology reagents are a plus
Scientist - Matrix Biology
Senior scientist job in Parkton, NC
California, US residents click here (******************************************************************************************************************************************* . **The job details are as follows:** **Who We Are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: **UTHR** ) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
**How you'll contribute**
We are looking for our missing puzzle piece, an extracellular matrix (ECM) enthusiast who is looking to apply that expertise to a scale with impact that could change the world? This position will advance progress towards the generation of a functional engineered lung, with a specific focus on the role of the lung scaffold during cellular repopulation, including cell-matrix interactions, matrix changes during culture, and the impact of matrix properties on cellular repopulation. Interested? We can't wait to meet you - let's chat soon!
+ Characterize the stability of matrix components, identify relevant degradation profiles, and mitigate degradation of key components, as appropriate
+ Identify potential process changes or storage conditions to mitigate stability concerns, and contribute to the evaluation and implementation of changes to process or storage conditions
+ Analyze recellularization outcomes to understand the role of the ECM scaffold in the biology of regeneration in engineered lung constructs
+ Evaluate and optimize scaffold ECM stability from decellularization through recellularization and terminal pulmonary function assessments
+ Determine the proper chemical conditions for ECM stability, ECM component supplementation and adsorption, and ECM-cell interactions
+ Analyze matrix composition, turnover, and cell-derived matrix deposition in engineered tissues, interpret these findings, and provide insightful and actionable methods to improve or stabilize the function of the engineered tissues which may include supplementation with bioactive matrix or matrix-associated molecules
+ Assess the mechanical function of the scaffold at the organ (pulmonary mechanics) and tissue (interstitial, alveolar, and microvascular integrity) levels and develop methods to promote the proper organization and function of the matrix molecules to achieve optimal regeneration of native organ function
+ Evaluate the consistency of findings between in vitro assays and large-scale recellularization studies, adjusting or developing new assays as necessary
+ Independently integrate analyses from experiments across multiple sub-teams to determine key factors which drive outcomes, as needed
+ Develop new techniques, laboratory procedures, and/or protocols to support lung scaffold recellularization and characterization efforts, as needed
+ Proficiently perform complex scientific tasks and independently make complex technical or scientific decisions
+ Proficiently analyze data, potentially utilizing sophisticated or in-depth analyses, and through such analyses, identify novel data trends
+ Evaluate new technologies or methods, applying scientific insights to the process. Coordinate tech transfer with academic & industrial collaborators.
+ Develop and implement novel, impactful, and/or complex experimental plans. Generate insightful complex hypotheses and conclusions. Apply scientific knowledge and literature evidence to experimental planning.
+ Prepare and present regular reports on research strategy and progress
+ Independently contribute to focused research areas through maintenance and continued development of knowledge using past and current scientific literature as well as collaborative thinking
+ Commit to supporting individual, group, and departmental goals to achieve key objectives
+ Appropriately document performance and methods
+ Help maintain smooth operations of the lab, including maintaining lab supplies, monitoring equipment and providing lab support
+ Perform other duties as assigned
**For this role you will need**
Minimum Requirements
+ Masters degree with 6+ years of related industry or academic faculty-level experience or a PhD with 2+ years of related industry or academic faculty-level experience
+ 5+ years of experience and comfort developing, optimizing ,and performing analytical assays, evaluating and interpreting data, and optimizing and troubleshooting analytical assays
+ Experience includes proficiency with at least 4 of the following analytical tools in support of research efforts: histology, immunohistochemistry, image analysis, SEM/TEM, biochemistry, ELISA, Western Blot, and/or proteomics/glycomics, mechanical testing
+ Experience with statistical analysis utilizing JMP, GraphPad Prism, R or other comparable program
+ Proficiency and experience developing, optimizing ,and performing analytical assays, evaluating and interpreting data, and optimizing and troubleshooting analytical assays
+ Proficient in applying Design of Experiments (DOE) principles and advanced statistical methods for experimental planning and data interpretation
+ Familiarity with material and device biocompatibility evaluation and associated regulatory requirements
Preferred Qualifications
+ Doctor of Philosophy (PhD) in protein/cell biology, biomaterials, biotechnology, biomedical engineering, biomechanics, or related field
+ Performs and interprets results of uniaxial mechanical testing
+ Experience with MatLab and/or Python
+ Comparative Proteomic Quantitation/Comparative Analysis Program(s)
+ Previous regenerative medicine or tissue engineering experience involving cellular and matrix or scaffold interactions
+ Experience/knowledge in one or more of the following: - Mechanical characterization of biomaterials, Chemical modifications of extracellular matrix, - Immunological techniques (IHC, ELISA), - Accelerated degradation study of biomaterials, product or prototype characterization of proteins, and/or - Protein detection, western blot or ELISA especially as applied to ECM component or degradative products
+ Contribution to regulatory filing(s) in support of clinical candidate development
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Bench Scientist (Microbiology)
Senior scientist job in Sanford, NC
Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity.
To find out more about Real Staffing Group please visit
http://www.RealStaffingGroup.com
Job Description
• Will assist with cell bank production operations and associated ongoing projects.
• Individual will support cell bank operations by executing activities ranging from cell bank production, execution of protocol studies in a lab setting, as well as general daily support including document preparation and review.
• Good lab safety awareness and a good foundation in biology or microbiology.
• Experience working within a GMP framework with particular regard to manufacturing environments
Qualifications
Preference would be for an individual with a BS in Biology/Microbiology (or similar).
• Lab experience (or small scale fermentation experience) is a very strong preference.
• Need someone that wouldn't need to necessarily be taught the basics of GMP and GLP (i.e., good documentation practices, basic Micro lab skills, etc.).
• So, a minimum of at least 2-5 years of experience would probably be ideal. If the person has sound lab experience, but not necessarily within the industry, I would not necessarily discount them.
Additional Information
All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP! I want to know more about your preferences.
If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!
Sr Engineer/Scientist 2 (Upstream)
Senior scientist job in Holly Springs, NC
The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations. FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: ***************************************************
**Job Description**
**What You'll Do**
+ Develops site technical training programs for new processes and procedures
+ Collaborates with cross-functional teams to support commercial and clinical manufacturing campaigns, including on-floor support
+ Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
+ Serves as subject matter expert (SME) to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes
+ As technical SME, provides supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required
+ Identifies opportunities to improve systems and practices and provides direction to local and global cross-functional teams
+ Leads one or more projects spanning multiple departments and cross-functional areas
+ Provides engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
+ Leads process sub-teams throughout the phases of TT
+ Develops project plans, timelines, and communication forums to ensure a smooth transfer
+ Leads troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
+ Leads the execution of all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports
+ Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)
+ As technical SME, leads generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
+ Generates and executes process training and consults on topics related to manufacturing and process
+ Leads and facilitates technical risk assessments for new manufacturing processes
+ Provides interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
+ Leads and coordinates analysis of manufacturing process performance and reporting to manufacturing management
+ Supports development of longer-term Large-Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team
+ Delivers documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects
+ Other duties, as assigned
**Basic Requirements**
+ Bachelor's degree in in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or
+ PhD with 5 years of experience
+ Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
+ Experience with facilitating and training others on RCA and risk assessment
+ Project Management experience
**Preferred Requirements**
+ Experience working in a Good Manufacturing Practices (GMP) environment
+ Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
+ Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections
+ Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings
**WORKING CONDITIONS & PHYSICAL REQUIREMENTS**
+ Ability to discern audible cues
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**EEO Information**
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
**ADA Information**
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _2 days ago_ _(12/11/2025 11:40 AM)_
**_Requisition ID_** _2025-36361_
**_Category_** _Process Sciences_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_