Cell Cleaner Job Description Sample
Senior Director, Protein & Cell Analysis Reagents & Global Operations
Job ID :
US - Oregon - Eugene
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Location/Division Specific Information
The Sr. Director, Protein and Cell Analysis (PCA) Reagents & Global Operations is part of the Biosciences Division (BID), which is a $2.8 billion business with 4,000+ employees across the globe. Our team serves 480,000 customers with 70,000 products in 180 countries. The majority of the business comes from academic and government funded customers, with the rest of the business from pharmaceutical, biotech, healthcare industries and the industrial market. With more than 4,000 patents, over 770,000 scientific citations and 70,000 products, BID is grounded in science.
This role will be based at our facility in Eugene, OR. Travel expectation will be approximately 25%, including both domestic and international.
How will you make an impact?
This experienced operations and business leader will provide thought partnership to the VP of Protein and Cell Analysis and her leadership team, providing leadership to the Operations Directors and Senior Managers leading the manufacturing sites in Vienna, Rockford, Eugene, Bangalore and Santa Clara. In addition, the Sr. Director will lead operations at their assigned site to ensure all functions are working at peak efficiency with proper internal communication and interfaces, developing the operations and manufacturing teams while ensuring delivery of high quality products which are in compliance with all applicable manufacturing regulations for Multi-step organic and organometallic chemistry, Mass Spec, antibody purification/conjugation and bead synthesis.
What will you do?
Become the Operations trusted partner to the VP of Protein and Cell Analysis.
Develop and cascade strategies, goals and objectives as well as strong execution mind-set well aligned with both the PCA business and BID Operations leadership teams.
Provide leadership to the Protein and Cell Analysis Operations leaders in Vienna, Rockford, Bangalore and Santa Clara. Support the team goals and initiatives to deliver maximum value to the business leaders and meet customer expectations.
Ensure solid alignment between the operations team and the needs of the Protein and Cell Analysis business to support expected growth.
Manage the complexity of the operational needs within Protein and Cell Analysis, while ensuring alignment with the supply chain, quality, PPI, procurement, EHS and business operations functions.
Lead a multi-tiered organization of operation professionals. Accurately assesses talent, identify promotional opportunities, develop succession plans, build talent pipelines and hires the best people.
Builds trust and integrity by demonstrating transparency, honest communication, delivering on commitments and being emotionally steady.
Identify and drive process improvement programs that simplify and streamline otherwise complex processes.
Develop and establish strong operating mechanisms to ensure business objectives are met
Coordinate the hiring, training, coaching and annual performance reviews of team. Facilitate and mentor the development of team members and front line leaders to be exceptional players.
Effectively use prioritization mechanisms to utilize resources across teams to complete required workload.
Drive compliance to applicable Quality System Regulations.
Establish key performance indicators that drive change and visibility to the team and leadership. Track, trend, and monitor routinely with active data analysis to target and drive results.
Monitor and manage progress on projects, ensuring key requirements and milestones are met.
Coordinate the development of action plans when corrective steps (CAPA) are required and implement these in a timely manner.
Manage budgets, schedules and key operating metrics.
Define and establish clear objectives and expectations, provide direct feedback routinely for performance management.
Identify projects and recommend appropriate course of action (e.g., discontinuation, outsource, process improvement) to maximize profitability and supply.
Execute robust Risk Management practices to maintain high probability of project success, ie, satisfaction of scope, schedule and budget.
Responsible for assessing resource needs across multiple projects and working with appropriate managers to assign resources per established priorities.
Ensure effective transfers of new products into production that meet all the Quality requirements for the classification.
Ensure site wide training is effective and that the team operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective.
This position will report directly to the Vice President of Operations for the Bioscience Division. Responsibilities require an intense focus on meeting customer (internal and external) expectations and delivering to financial commitments while fostering a culture of accountability, stringent commitment to quality, collaboration and continuous improvement.
How will you get here?
Bachelor's degree in related discipline and/or equivalent experience.
Master's Degree preferred.
Minimum of 10 years of management experience in a complex manufacturing environment.
Experience in Operations, R&D, or Engineering with expertise in managing and developing staff in a manufacturing and/or distribution operations environment is required, preferably with exposure to high volume, high mix, reagent, antibody and controls immunoassay production in an inter-disciplinary manufacturing environment.
Extensive previous experience in a diagnostic manufacturing environment with thorough knowledge of a variety of laboratory chemicals, potentially hazardous chemicals, human source materials, and reagent manufacturing activities.
Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
Knowledge, Skills, Abilities
Strong leadership ability with the capability to leverage diverse resources, respond quickly, understand the impact of changes and decisions, facilitate agreement, build collaborative relationships and focus on customer needs.
Excellent communication and interpersonal skills both written and verbal and the ability to facilitate team interactions.
Ability to work with individuals at all levels and within all functions to motivate strong results.
Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
Ability to partner with and influence key stakeholders including Finance, R&D, HR, Product Management and the Commercial team.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Research Scientist, T Cell Biology
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
DUTIES AND RESPONSIBILITIES
Seeking a highly motivated PhD with a strong background in T cell immunology, cell signaling, and gene editing; general responsibilities include but are not limited to:
Discovery lead for gene editing enhancements in engineered T cells (CARTs and TCRs)
Design and hands-on execute T cell assays including but not limited to cytotoxicity, cytokine/chemokine measurements, and proliferation
Investigate signaling pathways via RNAseq, western blotting, immunoprecipitation, ELISA, and multiplex assays to uncover novel T cell biology
Stay current on the latest scientific literature relevant to cellular therapies, genetic engineering, and T cell biology
Bring new approaches and technologies into the company
Collect, organize, interpret, and present data in group meetings and to senior management
Manage projects and efficiently with Kite colleagues and external collaborators
Contribute to a dynamic, exciting culture that embraces teamwork and innovation
REQUIRED EDUCATION AND EXPERIENCE
PhD in immunology or cell biology with 0-4 years of postdoc experience
Experience required in:
Multicolor flow cytometry (through knowledge of T cell subsets)
Molecular biology techniques (PCR, ELISA, and westerns)
Mammalian cell culture
Primary T cell assays (expansion, proliferation and cytotoxicity)
Gene editing (CRISPR, miRNAs etc.)
Current on the latest scientific literature relevant to cellular therapies, cell engineering, and T cell biology
PREFERRED TECHNICAL SKILLS
Prior experience with:
Gene editing (CRISPR, miRNA, etc.) in primary T cells
NGS and ddPCR
MSD or Luminex
Generation of retroviral/lentiviral vectors and transduction of target cells
Proficiency in the use of software to support data analysis such as FlowJo, FACSDiva, GraphPad Prism, as well as Microsoft Office (Excel, PowerPoint, Word, Outlook)
Proven ability to work and think independently and creatively; be an affable and energetic colleague and team player
Collect, organize, interpret, and present data in small and large group meetings
Contribute to a dynamic, exciting culture that embraces teamwork and innovation
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Senior Scientist, Cell Product Development
The company, a 2017 “Fierce 15” award winner, was founded in 2013, is based in Cambridge, MA and is currently expanding across the all functions within the organization. Having completed our an initial public offering (Nasdaq: RUBY), we are well capitalized to execute our vision and strategy. For more information, please visit us at www.rubiustx.comor follow us on Twitter.
- Design, develop and execute upstream and downstream process development experiments.
- Direct oversight of clinical process development projects and some people management responsibilities while maintaining a direct, active presence in the lab.
- Actively represent the Cell Product Development team in CMC teams with the potential to lead a CMC team for the right candidate.
- Document and communicate results in a timely manner.
- Ability to manage various priorities in a fast-paced and growing environment .
- Present and communicate study results at company meetings.
Experience & Qualifications
- Strong industrial upstream processing knowledge with the capability to flex to oversee downstream processing required from a small scale process development perspective.
- Industrial experience with gene and/or cell therapy process development including ownership of key process decisions.
- Understanding of regulatory guidance including process and product-related impurity clearance required
- Motivated, curious, and comfortable working with highly technical projects and personnel.
- Comfortable delivering against challenging commitments.
- Ph.D.+ 2 years, MS + 10 years in bioengineering, chemical engineering, biology, biochemistry or related field with prior stem cell differentiation experience a plus.
- Direct industrial experience managing projects including participation in strong CMC teams is expected.
- Direct prior industrial experience managing at least 1-2 direct reports is expected.
Research Associate, Cell Culture And Flow Cytometry
Kintai Therapeutics was founded by Flagship Pioneering in 2017 through its venture creation engine, which founded Seres, Moderna, Agios, Indigo and Evelo, to pioneer therapeutics from microbiome metabolites. Integrating discoveries in metabolic pathways and cross-tissue signaling networks, Kintai Therapeutics leverages proprietary chemistry to develop small molecule therapeutics for multiple therapeutic areas including metabolic, inflammatory, oncology, and infectious diseases. Kintai Therapeutics has rapidly built a deep pipeline of candidates across a range of therapeutic areas, with the potential to move quickly into the clinic. Kintai Therapeutics offers the challenge and opportunity to work at an innovative early stage company with rapid and nimble growth, combining near stage development candidates with a sustainable pipeline for long terms success. Kintai Therapeutics is poised to emerge as category defining company in the microbiome metabolite space—one that leading scientists feel should the dominant means of drugging the microbiome. The company is driven to discover and fully develop novel compounds that extend and improve the lives of individuals with a broad range of serious and potentially devastating diseases.
As a part of Kintai Therapeutics’ Research and Discovery Biology team, the successful Senior/Research Associate candidate will apply expertise in cell-based assays, data analysis, and presentation. In addition, the candidate will collaborate with Kintai Therapeutics team members across departments (e.g. Chemistry, DMPK, and Computational Biology) to develop novel assays and reach Kintai Therapeutics’ milestones.
- Culturing primary cells and cell lines
- Performing ELISA, Luminex, and Flow cytometry (analyzer and sorter)
- Learning and setting up new techniques
- Isolating cells from experimental tissues
- Collaborating closely with other team members
- Working with external vendors and CROs
- Troubleshooting, solving difficult problems, and proposing solutions related to projects
- Maintaining a detailed and organized electronic lab notebook
- Laboratory maintenance: inventory, purchasing, reagent preparation, etc.
- Bachelor’s degree in Biology, Cell Biology or related discipline with 3+ years of professional experience working in a laboratory environment, or MS degree in Biology, Immunology or related discipline
- Ability to maintain mammalian cell culture
- Experience in cell-based assays
- Ability to independently conduct laboratory experiments and evaluate and interpret data
- Experience in Molecular biology techniques (DNA/RNA extractions, quantification, qPCR)
- Agility: Ability to work in a high energy organization with evolving goals and deliverables
- Results Oriented: Self-motivated, curious, accomplishes goals with minimal oversight
- Communication: Outstanding written and verbal communication skills, ability to work well with colleagues from diverse backgrounds and cultures
- Authenticity: Ability to voice their opinion and provide insight to the broader team, even when holding a minority or “out of the box” opinion
- Ability to thrive with input from a cross-functional team while remaining the unquestioned expert in her/his area
Associate/Scientist, Cell Biology And Biochemistry
Founded in 2016, Foghorn Therapeutics discovers and develops novel drugs to treat cancer and other serious medical disorders. The company seeks to discover novel therapeutics that target chromatin remodeling complexes. Foghorn uses a proprietary platform based on revolutionary advances in mechanistic understanding of disease.
We currently seek a highly motivated, creative and collaborative researcher to join our team in a hands-on role to discover the next generation of innovative therapeutics towards unmet medical needs.
- Functional and mechanistic characterization of enzymes, substrates, multi-protein complexes, and protein-protein interactions.
- Design, development and troubleshooting of diverse biochemical and biophysical assays towards understanding mechanism and small-molecule modulation of cancer targets, including hit identification, validation and optimization
- Analysis, interpretation, documentation and presentation of data to the department and project teams
- Assessment of emerging technologies with an emphasis towards the adoption and implementation of new experimental techniques enabling drug discovery
- Contribution to group knowledge and expertise through collaboration and idea exchange with multidisciplinary teams
- BA/BS degree or MS degree in Biochemistry, Biophysics, Biology or a related field with 2-10+ years of relevant industry experience (title will be commensurate with experience)
- A solid understanding of protein biochemistry and enzymology – experience with biochemical and biophysical assay development towards understanding protein targets, their interactions with binding partners and their modulation by small-molecules.
- Experience with fluorescence-based assay techniques (e.g. HTRF, FP, AlphaLISA/AlphaScreen, quench assays) and label-free technologies (e.g. ITC, DSF, SPR, MST) is desired
- High-throughput assay development experience is preferred.
- Experience with automated liquid handling instrumentation is a plus
- Demonstrated ability to analyze, interpret and present data in a clear manner
- An interest in contributing to medicinal chemistry drug discovery efforts to evaluate compound SAR and mode of action characterization
- Team player with excellent communication and inter-personal skills
Cell Specialist Ii/Iii - Cell Bank Production
The Cell Specialist II or III will participate and lead the manufacture of HEP & HDF cell banks under direct supervision from the department manager. He/she will perform and manage all tasks required to produce cells, i.e. tissue dissociation, spinner preparation, seeding, maintenance and harvest of cells, in a class 10,000 clean room environment in a safe and timely manner.
Activities will include production/expansion of cell banks, creation of test cells, senescence of Master Cell banks, and production of range finders and G100 range finders, for a smooth translation into production. With minimal supervision, he/she will be required to multitask by working independently while supporting and working with the team with on-going cell banking priorities. This position requires a high level of technical expertise in Cell Banking, Cell Culture, and Apligraf Production, thereby providing support to ongoing manufacturing operations. Strong values and behaviors and a sense of urgency for projects supporting Apligraf production are essential and required.
This position requires a high degree of manufacturing competence with a strong understanding of quality control and quality assurance concepts and the interrelation with cGMP manufacture of cellular products. This position involves close collaboration with process development, manufacturing, quality control, and quality assurance groups.
Knowledge and experience with equipment operation is required (e.g. incubators, controlled rate freezers, centrifuges, biosafety cabinets). Compliance to Standard Operating Procedure is essential to ensure that the cell banking and tissue processing suites are in compliance and operational at all times.
Dissociation of tissue and manufacture cell banks according to established procedures
Maintenance of cell bank inventory in compliance with AATB, FDA , state and local regulations
Adherence to all protocols, policies, regulatory requirements, cGMPs, and safety guidelines
Conduct batch record reviews with team and transfer to ensure that documentation is complete and in compliance
Harmonization with QC and Cell Culture for Cell Bank testing
Review/transfer of completed batch records to Quality Assurance in a timely manner
Proficiently operate equipment according to designed procedures
Maintain required records & adherence to established guidelines for quality control procedures, cGMP and safety
Assist in maintaining databases for trending, and analyzing cell culture technical data
Provide technical and operational support and problem solving capabilities, as needed
Coordinate the implementation of corrective measures to remedy deficiencies cited in audits of the manufacturing environment
Proficiently function within a Class 100,000 and/or Class 10,000 clean room environment, ensuring personal and product safety
Cell culture of mammalian cell banks using cell culture methods that may include T-flasks, cell factories, and spinner flasks, and cryopreservation of cell banks.
Responsible for ensuring all appropriate manufacturing documents are current and updated as required and that documentation is consistently produced with a high level of accuracy and clarity
Proven technical and scientific proficiency
Ability to communicate effectively with other departments
Performs additional duties as assigned
Weekend work/coverage is required, when necessary
Demonstrated expertise in manufacturing/aseptic techniques and GMP requirements
Proven organizational and documentation skills
Problem solving abilities
Excellent communication skills
Demonstrated leadership ability
Cell counting on a hemocytometer
Basic computer skills with a working knowledge of Microsoft Word and Excel
Ability to work independently as well as in a team environment
Ability to work in a cleanroom environment for extended periods of time
EDUCATION AND EXPERIENCE
Associate's Degree or Bachelor's Degree in the biological sciences with 3+ years of experience, or 5-7 years of experience in biotechnology or related field
Experience in aseptic technique and experience working in controlled clean room protocols highly preferred
Organogenesis Inc. Corporate Headquarters - Canton, MA 02021 US (Primary)
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Construction Manager - DAS And Small Cell (King Of Prussia, PA)
Our client offers a rewarding career track managing industry leading telecom projects with a growing organization along with future growth potential, excellent employee benefits, salary plus bonus, company vehicles to their employees, etc.
- Manage project schedules in the E.PA market and ensure deadlines are met.
- Oversea DAS projects in the field.
- Supervise Field Team and subcontractors to ensure quality work and safe work environment.
- Manage project budget.
- Experienced managing telecommunications projects that include DAS, Small Cell or tower NSBs / modifications.
- Leadership experience in the field and strong organizational skills.
- Self driven and positive personality.
Research Associate/Research Scientist In Cell Culture And Discovery/Targeted Proteomics
The Moritz lab of the Institute for Systems Biology in Seattle, WA is seeking qualified Research Associates for its research at ISB.
Our current research directions include Targeted-protein quantitation using SRM, SWATH and Data dependent mass spectrometry biomarker discovery. Our projects include wellness, infectious disease, cancer, and aging biomarker development and validation in cells, tissues and blood, and complex mixture fractionation & enrichment, with a particular interest in the study of organ specific markers for markers signatures. In addition, we have at our disposal an array of mass spectrometers, including varieties of Thermo, Agilent and Sciex instruments for quantitative analysis.
The ideal candidate will have experience in mammalian and pathogenic bacterial cell culture within a BSL2 environment. The growth of mammalian cell lines and protein chemistry techniques to achieve purified protein extracts from secreted organelles or free proteins is required.
Experience in aseptic techniques and control of contamination is also required. Knowledge of biological mass spectrometry-based proteomics including liquid chromatography, computational identification of large data sets is preferred. Statistical analysis of data produced would be advantageous. We are looking for individuals with creativity, lateral-thinking, good communication skills and the willingness and ability to work as part of a larger multidisciplinary team of scientists.
ISB is an EOE (M/F/disabled/veteran status).
Gas Furnace Cell Manager
United States of America
CAI20: CCS-Indianapolis, IN 8751 Boehning Lane, Indianapolis, IN, 46219 USA
LEVEL OF RESPONSIBILITY:
This position will be responsible for oversight of production planning, staffing, and day-to-day manufacturing operations in a cost effective manner for the gas furnace assembly and fabrication departments. This position has oversight of multiple areas including salaried and hourly employees.
Provide leadership of product line assembly and or fabrication manufacturing processes.
Meet or exceed safety, quality, throughput, and productivity targets.
Lead salaried and hourly employees, develop new processes, implement cost saving initiatives, and achieve EH&S and lean initiatives goals.
Plan and allocate resources, materials and the scheduling of equipment for maximum utilization of production facilities and personnel.
Champion the use of lean initiative tools to reduce downtime, improve quality, reduce scrap and achieve labor efficiency targets
Implement product and engineering changes successfully
Model and promote adherence to environmental, health and safety policies and initiatives
Maintain working relationship with the union by following the terms of the collective bargaining agreement
LEVEL OF RESPONSIBILITY:
Responsible for several components of a project or a complex component of a larger project
Contributes to their team or department by applying their knowledge of one or more functional areas
Responsible for developing and coaching others
Directly supervises exempt and hourly employees
The ideal candidate will possess a degree with the following years of experience:
- BA/BS degree w/6-10+ years experience
- MA/MS degree with 4-7+ years experience
Strong background of supervising in a high volume assembly manufacturing setting
Ability to make suggestions and informed decisions quickly
Possess strong organizational, leadership and time management skills
Highly motivated and possesses superior follow-up and follow-through skills
Able to motivate and lead employees
Experience supervising union-represented employees
Excellent communication skills
Able to learn and use software applications including Outlook, Excel, TMS and Word
Must be willing to work first or second shift as well as required overtime
The ideal candidate will demonstrate the desire and potential for advancement
The incumbent in this role will be responsible for complying with UTC's Code of Ethics, Environmental, Health and Safety (EH&S) policy and applicable regulatory and Company rules and requirements. UTC is an Equal Opportunity Employer.
All qualified Associates who are interested in this opening are encouraged to apply. To make your interest known, please apply via the Job Connections function within the Employee Self Service (ESS) tool before the closing date.
United Technologies Corporation is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.
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United Technologies Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other federally protected class.
GMP Quality Control Cell Therapy Technician
The Marcus Center for Cellular Cures has an exciting opportunity for a GMP Quality Control Cell Therapy Technician located in The Robertson cGMP Laboratory Durham, N.C. More information about the Marcus Center and the Robertson cGMP Laboratory is located at the following link(s):
The incumbent in this position is responsible for highly complex and specialized testing of cellular products for clinical trials and commercial operations. In addition, this individual will be responsible for QC testing of the GMP facility, and projects manufactured therein, to ensure it is in control and in compliance with applicable regulations. The individual will report to the GMP QC Supervisor. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel cellular therapies.
Perform duties as dictated by standard operating procedures (SOPs) for QC and release testing of cellular product manufacturing and under G'X'P (GLP, GTP, GMP, GDP) guidelines as directed.
Perform sterility, endotoxin, cell characterization by flow cytometry, and other required testing to support in-process testing and final product release. Ship samples to outside vendors for quality control testing.
Operate QC instrumentation needed for release testing such as cell counting devices, micropipettes, Biological Safety Cabinets, flow cytometers, and endotoxin testing devices.
Serve as a resource to the GMP QC supervisor in identifying and assessing the appropriate complement of resources and support needed to successfully complete quality control related work.
Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification.
Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including universal precautions and hazardous chemical handling.
Perform routine environmental monitoring of the GMP facility. Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guidelines.
Operate instrumentation needed for environmental monitoring.
Perform Quality Control activities for the facility, including checking expiration dates for supplies and tracking maintenance schedule for equipment, including biosafety cabinets, pipettes, centrifuges and other specialized equipment.
Maintain sufficient inventory of supplies and reagents for performance of duties; clean and maintain laboratory equipment in good working order.
Maintenance of QC-related procedures, documentation, and equipment. Notification of management of any QC-related out of specification (OOS) result.
Assist in writing and review of validations, research plans and reports, SOPs, and batch records as required.
Work with GMP QC Supervisor to ensure the facility is in compliance for governing regulations.
Help to maintain orderly lab spaces. Participate in lab inspections and work with inspectors as needed
Use dexterity, knowledge, and ability to complete assigned laboratory tasks and skills, with attention to detail and compliance with all appropriate laboratory regulatory and safety requirements.
Perform other related duties incidental to the work described herein.
Good interpersonal skills. Ability to work and maintain strong relationships with the department manager, members of the GMP team and other departmental staff.
Good communication skills and the ability to work independently as well as part of team.
Attention to detail
Ability to read and understand Standard Operating Procedures.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Work requires a bachelor's degree in botany, biology, zoology or other directly related scientific field.
Work requires two years of research experience. A related master's degree may offset required years of experience on a 1:1 basis, e.g., a two year master's degree in lieu of two years of experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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