
*Candidates cannot begin an assignment without successful drug & background clearances, including employment & education verification. *One year contract assignment in Durham, NC Responsible for investigation of manufacturing atypical events occurring during the vaccine formulation, filling, and lyophilization process. Specifically, will lead the investigation of atypical events to determine root cause, will develop corrective actions to prevent reoccurrence, and will ...
Jun 18 - Durham

My name is Myesha O and I represent The Fountain Group. We are a national staffing firm and are currently seeking Quality Shop Floor Specialist for a prominent client of ours. This position is located in Holly Springs, NC. Details for the positions are as follows: Duties *There are two shifts available: *2nd shift position - 3pm - 11pm. Employee will train on 1st shift. Some weekend work may be required* ...
Jun 17 - Holly Springs

Responsible for maintenance of quality procedures and systems related to Quality Assurance oversight of site wide KPI’s and Metrics. Provides technical support for the US FCC site in cGMP compliance related matters for deviations and change controls, including assurance that all aspects comply with cGMP’s, legal, regulatory requirements, and the Quality Manual requirements. Responsibilities: • Ensures that all aspects of USFCC operations comply with the requirements of the Quality manual and meets ...
Jun 15 - Holly Springs

*This is a 3rd shift position - 11pm - 7am. Employee will train on 1st shift. Some weekend work may be required* QA Shop Floor resource for primary manufacturing. Responsibilities: • Duties will include on floor batch record review concurrent to completion of manufacturing operations in real time. • Perform routine quality audits in QC and Manufacturing. • Support quality systems related to QA for in-process sampling and controls, and all aspects of shop floor QA. • Act as quality ...
Jun 15 - Holly Springs

Summary: This role facilitates the import/export process for active ingredients and formulated product. Essential Duties and Responsibilities include the following. Other duties may be assigned. Originates all active ingredient, turn-key orders and other materials as required Monitors order status from origination to delivery and communicates to Fulfillment Group Facilitates the entire import/export process to ensure compliant, timely, and accurate inventory movements, which includes shipment ...
Jun 14 - Raleigh

A Quality Assurance or Compliance Engineer at ProPharma Group will be responsible for the quality processes for our Clients. This position provides Quality oversight of operations and data review for accuracy, completeness, and conformance to current Good Manufacturing Practices (cGMP) and company quality standards. Quality Assurance / Compliance Engineers will provide consulting services for quality related issues and cGMP compliance in the pharmaceutical, biotechnology, or medical ...
Jun 14 - Raleigh

*Candidates cannot begin an assignment without successful drug & background clearances, including employment & education verification. *1 year contract assignment* Seeking a highly talented individual with expertise in prototype instrument development for a diagnostic program. Job Requirements -Bachelor's degree in life-sciences or related field from four year college or university. -Minimum of 5 years clinical trials ...
Jun 13 - Durham

Please note that this is a 5 month contract assignment. Candidates cannot start an assignment until background check and drug test is completed* Tests and interprets results for raw materials, active pharmaceutical ingredients, finished pharmaceutical products, and stability samples. Interprets compendial and internal monographs, NDAs and Laboratory Quality Standards Job Requirements BS/MS in science, preferably in Chemistry or ...
Jun 12 - Wilson

$5000 Hiring Incentive for Qualified Candidates! Covance is seeking Clinical Research Associates / CRA / Monitors with cardiovascular / coronary artery disease therapeutic experience for a special hypercholesterolaemia project. Positions are home-based and urgently needed in the following locations: Raleigh, Dallas, Boston, Chicago, Minneapolis, NYC, Florida, and California. Our Clinical Research Associates /CRAs / Monitors manage all aspects of site monitoring responsibilities for ...
Jun 12 - Raleigh

The Drug Safety Specialist will be responsible for project start up, safety plan development, triage, case processing, writing narratives, report generation, reconciliation, and study close out. The Drug Safety Specialist will perform comprehensive database searches in response to both internal and external queries. The DSS will be involved in data entry, including QC of the case reports. The Drug Safety Specialist will perform remediation for non-compliance with Adverse Event (AE) reporting ...
Jun 12 - Raleigh

We have a Contract opportunity with a prominent client for a QC Chemist in Wilson, NC. Duties · Support operations by providing analytical testing for materials and products, including data. · Perform dissolution, assay, content uniformity, related compounds/impurity analytical testing using HPLC and UV. · Testing is performed in a GMP environment, primarily testing solid oral dosage forms (tablets and capsules). · Generate GMP documentation in support ...
Jun 10 - Wilson

Responsibilities: • Support functions of the Microbiology and Virology group as assigned, including, one or more of the following: • Stock and track media for the labs • Stock and track consumables in all labs • Perform all Interior and Exterior Cleaning Equipment PMs for all labs. • Gather and coordinate pipette Calibration each month Perform and update 6S Audits in all labs Supports all 6S improvements projects for the labs Archive lab test results data, protocols, etc. • Clean and organize labs • ...
Jun 7 - Holly Springs

Responsibilities: • Support operations by providing analytical testing for materials and products, including data. • Perform dissolution, assay, content uniformity, related compounds/impurity analytical testing using HPLC and UV. • Testing is performed in a GMP environment, primarily testing solid oral dosage forms (tablets and capsules). • Generate GMP documentation in support of the testing performed. Requirements: • Entry level to several years will be considered. • Testing ...
Jun 7 - Holly Springs

Seeking Scientist with at least 2 years experience performing pronuclear microinjection and blastocyst transfer surgery for the development of transgenic mice to perform similar duties at a major developer of innovative therapeutic pharmaceuticals. Work along side our industry recognized, Ivy League personnel in this high growth position. Top base salary to $70,000 and added incentives including extensive perquisites and significant upside potential stock participation. For complete details ...
Jun 7 - Durham

please contact me at [email removed] • Evaluate manufacturability of parts and assemblies, suggesting and implementing improvements • Monitor, measure and review manufacturing processes, implementing new techniques • Develop, oversee and revise manufacturing procedures and meet quality programs and requirements • Research, propose and implement manufacturing processes and capital expenditures which realize cost reductions, capacity increases, quality improvements and ...
Jun 7 - Raleigh

Utilize your vast clinical knowledge to guide drug discovery strategies and focus the resources and efforts of a major pharmaceutical company. Shall develop strategies for global pharma projects to improve the analysis, selection and internal promotion of drug development programs to move evidence-based medicine into sustainable therapeutic solutions. Drive clinical-to-preclinical backward collaboration in an effort to more effectively select targets and entities at the basic science, pre-clinical, ...
Jun 7 - Research Triangle Park

At Workforce Integration - Wi? - we know people are the key to successful organizations. So we have concentrated on getting people down to a Science. Ask us Wi? Medical Lab Technologist– contract to possible hire Requirements MUST have at least a Bachelor’s Degree in a Medical, Clinical or Life Science related field 1-3 years of experience in a Clinical Laboratory a MUST MUST be able to provide college transcripts or proof of degree (IF your degree was obtained outside of the US you must provide ...
Jun 6 - Durham

Process Associate | Lab Assistant Long-term contract Durham, NC [email removed] | 646.790.8355 Perform the emptying, gathering, washing, and restocking of QC lab glassware to storage. Operate Steris and Miele lab glassware washers. Restock QC lab supplies. Require experience and proficiency with MS Word, Excel, and PowerPoint. Must work efficiently and within established time frames and effectively function within a team environment. Excellent communication and follow-through skills required. ...
Jun 6 - Durham

As a Pharmaceutical Sales Representative, you will have the opportunity to regularly call on health care professionals (primary care physicians, clinics, hospitals and pharmacies) within a specific geographic area. Day-to-day responsibilities consist of supporting the promotional efforts behind Forest products, which includes organizing, tracking and distributing FDA regulated sample products to health care professionals. You will maintain a current and competent level of knowledge on the product ...
Jun 5 - Durham

As a Pharmaceutical Sales Representative, you will have the opportunity to regularly call on health care professionals (primary care physicians, clinics, hospitals and pharmacies) within a specific geographic area. Day-to-day responsibilities consist of supporting the promotional efforts behind Forest products, which includes organizing, tracking and distributing FDA regulated sample products to health care professionals. You will maintain a current and competent level of knowledge on the product ...
Jun 5 - Durham

The laboratory technician prepares and weighs samples for testing and analysis. May setup and conduct tests, assays, and other protocols under the direction of a laboratory services manager, researcher, or scientist. Follow Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLPs). Ensure all laboratory equipment and work areas are clean, sterile, and in proper working order. May be responsible for calibration of instruments and also involved in media prep. Job Requirements Complete ...
Jun 4 - Holly Springs

My client is a public Pharmaceutical company located in RTP, NC Associate Director, Business Relationship Management Overview: The Associate Director, Business Relationship Management (BRM), Research & Development team is responsible for creating and maintaining the strategic partnership between the Research & Development (R&D) department needs and technology delivery. The position serves as the primary point of contact and internal consultant for business stakeholders and is responsible for ...
Jun 3 - Durham

Seeking scientist with 2+ years of experience designing and developing formulations of new topical and transdermal products. Required Experience: *** Pre-formulation, formulation, process, and stability studies *** Drug Delivery by way of creams, foams, gels, lotions, ointments, and transdermal patches *** In vitro skin flux study, transdermal patch physical property testing, and rheology testing Grow within a top company. Offering: starting salary up to $125,000, several medical and dental ...
May 31 - Raleigh

Develop a marketing and sales strategy for a line of central nervous system therapeutics. Required experience: *** Development and execution of strategies for KOL relationships *** Evaluation of current marketing strategy and tactical effectiveness *** Development and execution the commercial medical education strategy *** Promoting the product externally with press, customers, and partners *** Track record of successful Product Launches Starting salary to $180,000 as well as ...
May 31 - Raleigh

Seeking 3+ years developing pulmonary and nasal drug delivery techniques and development projects. Shall *** Conduct preformulation characterization of physical, chemical, and mechanical properties. *** Formulation of dry powder dose inhalers, metered dose inhalers, nasal sprays, and nebulizers. *** Support manufacturing processes including scale-up, tech transfer, and process optimization. *** Test and store container closure systems. We offer a competitive salary, growth potential and ...
May 31 - Research Triangle Park

Associate Director of Regulatory Affairs Global leader in the development and production of life saving pharmaceuticals seeks an Associate Director of Regulatory Affairs to lead regulatory activities in the development of pipeline products as well as the maintenance of marketed products. The Associate Director of Regulatory Affairs will: Lead regulatory strategies for early to late development of commercial products with a goal of obtaining favorable outcome Provide leadership to project teams ...
May 31 - Raleigh

our client in RTP, NC is looking for a Scientist with a statistical background using softmax, jmp, and PLA tools. This is a long term consulting position. If interested, please apply to this ad or send your resume and contact details with the job # and job title in the subject line to [email removed] The Analytical Technology group in RTP, NC has an opportunity for Scientist II with a technical background in analytical method validation and proven project leadership. The Analytical Technology ...
May 25 - Durham

The Bench Scientist/Chemist II will be part of a multidisciplinary team of chemists and other scientists involved in developing medicines to treat skeletal muscle disorders. The Bench Scientist/Chemist II will design synthetic routes, synthesize, and purify novel chemical entities using state-of-the art laboratory equipment. Bench Scientist/Chemist II will learn practical medicinal chemistry principles and techniques and be exposed to a broad range of preclinical drug discovery concepts outside ...
May 23 - Durham

Clinical Data Project Manager - Group Leader Highly regarded, global pharmaceutical leader seeks a Clinical Data Project Manager to lead multiple clinical data management teams supporting clinical protocols, data analysis ensuring compliance with regulatory requirements. The Clinical Data Project Manager will also: Lead clinical data project teams in the design and development of databases, applications and documentation to meet requirements for collection, archiving and documentation ...
May 22 - Raleigh

RESPONSIBILITIES: • Perform timely data review with a high focus on data quality and integrity to ensure accuracy, completeness, cGMP compliance, and neatness of analytical documentation and real time documentation in a GMP environment • Reviews executed protocols for accuracy, completeness, cGMP compliance, and neatness of analytical documentation • Verify calculations and documented information such as reagent expiry, reference standard tracking, instrument calibration, logbook entries, control ...
May 19 - Holly Springs

Description The Analytical Support Associate will support document creation and review related to analytical methods, deviation reports and change controls generated in the Manufacturing Science and Technology (MS&T) and Quality Control analytical laboratories. Responsibilities: • Review and approve various documents from the Quality Control Department related to method SOPs, method qualification and validation • Support deviations, change controls and corrective actions involving MS&T analytical ...
May 19 - Holly Springs

Seeking a protein expert to lead a team focusing on the development of methods for characterizing proteins and protein based therapeutics. Shall be responsible for hands on method development and team leadership as well as IND and BLA contributions. Requires PhD and hands on development experience with Liquid chromatography - Mass Spectrometry and two dimensional Gel Electrophoresis for characterizing proteins Highly visible associate director level position with a leader in the scientific ...
May 17 - Research Triangle Park

Hands on team leadership opportunity to develop protein purification and characterization processes to support biologics manufacturing of Monoclonal Antibodies, Enzymes, Growth Factors, PEGylated Proteins and Cytokines derived from mammalian cell lines Will: *** Develop new purification procedures to be transferred and scale up to clinical and commercial manufacturing *** Evaluate transferred processes, validate existing procedures, ensure viral validation, and train manufacturing team on new ...
May 17 - Research Triangle Park

Looking for a qualified SAS Programmer (home based) Requirements include but are not limited to the following: BA/BS degree in computer science, statistics, biostatistics, mathematics or related field. MA/MS degree is desirable 5+ years of programming and clinical research or related experience Must have database management, SAS or PL/SQL programming experience Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills ...
May 15 - Cary

Seeking 3+ years experience developing and validating analytical methods in support of the development of manufacturable pharmaceutical products. Candidate must possess: *** Experience in API characterization. *** Hands-on use of HPLC, GC, particle size, dissolution, droplet size, AA, DSC-TGA, DVS, MS, XRD, and NIR. *** Previous exposure to analyzing inhaled, nasal, topical, transdermal, oral, parenteral, and novel dosage forms. *** Familiarity with cGMP guidelines and analytical regulatory ...
May 13 - Raleigh

Seeking MS and 3+ years experience in analytical methods development and validation to support preformulation, formulation, and product development. Must be familiar with: *** Analysis of novel dosage forms *** High Performance Liquid Chromatography (HPLC) *** Gas Chromatography (GC) *** Liquid Chromatography-Mass Spectrometry (LC-MS) *** Microelectrophoresis Join a passionate and talented team in a rapidly growing company while earning a competitive salary plus bonuses and excellent ...
May 13 - Durham

Responsibilities: **This is position requires frequent 3pm - 11pm shift coverage. The employee will primarily work M-F, 8am - 5pm, but must have the ability to cover 3pm - 11pm for weeks at a time. Please make sure candidates have this availability!** • Perform batch record review concurrent to completion of manufacturing operations in real time. • Perform routine quality audits in Manufacturing. • Support quality systems related to QA for in-process sampling and controls, and all aspects of shop ...
May 11 - Holly Springs

The successful candidate will provide timely data collection and analysis support for the flu cell culture (FCC) manufacturing process. Routine job responsibilities are to: • Collect and compile electronic and paper-based process data. • Analyze process data using graphical and numerical methodologies. • Generate figures and summary tables of process data for routine monitoring and reporting. • Contribute to the preparation of technical reports on process performance. • Contribute to deviation ...
May 11 - Holly Springs

Description This position will support the organization of the QC Biochemistry laboratory at the Flu Cell Culture facility in Holly Springs, NC. Primary responsibilities for this position include GMP testing support for biochemistry assays (SDS-PAGE, Threshold, SRD and UV/Vis spectrometry), stability testing, laboratory data review and some participation in method validation and transfer. The QC Analyst I may be identified as a Subject Matter Expert (SME) for biochemistry assays within the ...
May 11 - Holly Springs

Description This position will support the organization of the QC Biochemistry laboratory at the Flu Cell Culture facility in Holly Springs, NC. Primary responsibilities for this position include method validation and transfer for biochemistry assays (SDS-PAGE, Threshold, SRD, and UV/Vis spectrometry). Responsibilities: Primary Functions: • • Subject Matter Expert for biochemistry assays (SDS-PAGE, Threshold, and UV/Vis spectrometry) • • Author SOPs, protocols and technical reports ...
May 11 - Holly Springs

Responsibilities: • Supports the implementation of necessary Novartis V&D Quality processes, systems, and procedures regarding self-inspections and general compliance at Holly Springs, N.C. • Act as lead auditor during self-inspections (including all prep, day of and follow up activities • Complete general compliance activities including but not limited to regulatory gap assessments and SOP revisions • Reports monthly KPI/KQI’s for self-inspections. Requirements: • Must have experience leading, ...
May 11 - Holly Springs

Description • To provide detailed QC plan to support SAP production plans and MRP requirements for a production or quality segment, and then to ensure QC control within segment on daily and weekly basis. Responsibilities: These roles will cover QC/QA (Primary and Secondary). • The role is a member of the site Supply Chain Team, working together with other site supply chain functions (Site Product Planners, Schedulers, Artwork and Data Controllers) and specific cross-functional segment team. o Works ...
May 11 - Holly Springs

Contact me for confidential job description [email removed] • Mentor and provide technical guidance to the engineering staff • Continue to refine our mechanical development process. • Generate ideas and solutions for new products as well as engineering support for current products. • Comply with regulatory requirements, including company design control procedures. • Review and analyze, including formal reports when necessary, such things as product concepts and needs, ...
May 9 - Raleigh

Lead the development of preclinical and clinical strategies based on the discovery of molecular biomarkers to drive the creation of novel oncology therapeutics Shall: *** Prioritize and evaluate predictive biomarkers and companion diagnostics to optimize clinical development *** Collaborate with scientific experts to establish accurate and reliable criteria for proof of mechanism and integrate study results into the clinical development strategy *** Determine the role of predictive biomarkers ...
May 9 - Raleigh

We are looking for Sr. level candidates, this role can be remote or onsite based on experience. Relocation is available! Summary of role Oversee statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians Function as Biostatistics Project Leader for multiple protocols, projects, or NDA projects, including coordinating with other divisions and ...
May 9 - Durham

Seeking 3+ years experience developing powdered dosage and particle dosage forms. Shall *** Conduct physico-chemical characterization of drug substances, excipients and dosage forms. *** Apply techniques such as cascade impaction, moisture sorption isotherm, bulk density, surface area, particle size analysis. *** Support scale-up, tech transfer, and process optimization. *** Contribute to regulatory submissions We offer a competitive salary, growth potential and an excellent benefits ...
May 7 - Research Triangle Park

Lead teams focused on developing and optimizing the clinical development for novel oncology therapeutics through the use of predictive biomarkers and companion diagnostics. Shall: *** Provide clinical and scientific input into Discovery Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology POC, nonclinical toxicology, biomarker strategy and IND enabling studies, to develop optimal translational medicine approaches ...
May 2 - Raleigh

My client is a profitable public Pharmaceutical company in RTP, NC Senior Manager, Digital Marketing -- New position based on major growth! You will be the key person for developing digital marketing strategies for branded, non-branded, and corporate strategic imperatives. This position will manage the execution of digital marketing programs, all marketing-related technologies and will help drive how the corporation leverages online marketing assets. Additionally, the selected individual ...
Apr 30 - Durham

Title: Clinical Operations Lead--Work From Anywhere Company: Pharmaceutical Company Location: Midwest Status: Full-time consulting engagement, 40 hours/week Length: Long-term assignment: initial term 6 months Our client is a multinational pharmaceutical company, headquartered in the US, whose goal is to ensure that people everywhere have access to innovative treatments and quality health care. Through working in partnership with everyone from patients to health care providers and managed care ...
Apr 29 - Raleigh

Summary: Responsible for directing regulatory / registration activities for designated US EPA products. Providing advice and support on technical matters (i.e. crop science, product chemistry, toxicology, environmental fate, and or ecological effects). Develops and manages product registration and regulatory requirements successfully. Interacts with internal and external partners; providing strategic regulatory guidance. Essential Duties and Responsibilities include the following. Other ...
Apr 23 - Raleigh