Director, Clinical Pharmacology | Columbia, SC

Reports, Notebooks, and Certificates of Analysis (C of A's). The QCM II will be assigned a specific area (determined by upper management) and become the Subject matter Expert (SME). This areas include but not limited to: microbial identification, probiotics, Environmental Monitoring (EM) risk evaluator, etc.

The QCM will be responsible for submitting sample to contract labs as necessary with appropriate documentation. The QCM will follow Current Good Manufacturing Practice (c GMP) documentation guidelines to record all procedures in a timely fashion. The analyst will be responsible for reporting the results of analyses on finished product Certificates of Analysis (COAs). The QCM will

be responsible for the documentation of all routine and non-routine microbiological testing performed on raw materials, finished products, and special request samples weather performed in-house or by the certified contract laboratory.

(S)he will initiate Investigation reports for out of specification (OOS) laboratory data when necessary. The QCM will perform evaluation/ validation testing on Nutramax Laboratories, Inc. finished products and raw materials following Standard Operating Procedures (SOPs), in-house test methods, and industry guidelines. (S)he will be responsible for the execution of Evaluation Protocols as well as Evaluation/ Validation Reports and Summaries, following Current

Good Manufacturing Practice (c GMP) documentation guidelines, to be presented to QC and Upper Management.

The QCM II will provide assistance in ensuring the lab and company current policies align with current USP, ISO, FDA, and NSF requirements. The QCM II will support the validation of manufacturing processes and equipment through environmental sampling and microbiological testing. The QCM II will participate in the proficiency testing program. The QCM II will provide guidance and methodologies for current and new microbiological processes. The QCM will be knowledgeable of the collection of Environmental Monitoring (EM) samples, following QCM SOPs, as needed to meet the needs or goals of the company.

(S)he will be familiar with the operation of both the APC Airborne Particle Counter and the SAS Air Sampler and will be proficient in the use and handling of media plates for EM sampling. The QCM IIs responsible for the scrutiny, documentation, and interpretation of EM results. (S)he must communicate EM trends and findings to QC, Manufacturing, or Packaging Management, as appropriate. The QCM II will support the validation of manufacturing processes and equipment through environmental sampling and microbiological testing. The QCM will provide input for the improvement of existing SOPs, test methods, and other protocols and policies throughout the Micro Laboratory.

(S)he will also be involved in implementing new procedures within the laboratory and the authoring of new SOPs, as appropriate. The QCM will have a good understanding of all equipment and methods used throughout the QCM Laboratory, including but not limited to the following instrumentation: Laboratory Balances, Biolumix Rapid Microbiology Systems, Autoclave, Incubators, Stomacher, Microscope, and the Bio-Safety Hood. This individual will be required to troubleshoot his or her own analyses or experiments, and to draw conclusions with sound scientific judgment.

The QCM will also assist other analysts in the Laboratory with troubleshooting as problems arise with instrumentation or with other microbiological analyses. The QCM will assist in developing and executing test methods for the analysis and QC testing of microbiological media (Growth Promotion) for suitability and the interpretation of growth (organism identification) from samples and controls. The QCM will assist in gathering information and data for product or situation investigations relevant to the QCM Laboratory or to Quality Control (QC) as a whole.

The QCM will assist in training new laboratory personnel. All training performed under the supervision of the QCM will be documented in accordance with established SOPs and the Nutramax Laboratories, Inc. training program. The QCM will maintain a safe working environment and will ensure that all equipment used in the testing procedures is calibrated and properly maintained. The QCM will provide assistance, as needed, to the QC Chemistry Laboratory with any chemistry application of which (s)he is knowledgeable and trained. Regular attendance is required Must be able to effectively communicate with other department and function within a team environment.

Performance of other duties may be required for meeting company goals. Minimum Requirements : The QCM II will have four or more years of laboratory experience in a c GMP facility, including experience with the proper operation of laboratory instrumentation, troubleshooting, and the generation and revision of SOPs. Effective interpersonal skills and the ability to interact with all levels of personnel are required. Education and Experience : A Bachelor of Sciences (B. S. ) or Bachelor of Arts (B.

A. ) degree in Microbiology or a related science or a combination of experience and education deemed equivalent is required for the QCM position. Supervisory Responsibilities: None Job Posted by Applicant Pro

of ESA species; and 3) research involving coral disease, diagnosis and treatment.

Extensive experience in molecular biology, biochemistry, metagenomics, functional genomics, or related fields with an ability to troubleshoot any number of issues with different types of assays (e.

g. microbiology, molecular and analytical chemistry) and different assay platforms is expected to be part of this work. The work requires the incumbent to design experiments, analyze the data and prepare written reports. The work requires the incumbent to exhibit scholarship through the ability to search, read, and understand primary scientific literature and contribute in technical and scholarly aspects

to discussions with the team lead or PI as part of establishing daily and long-term goals and objectives within each of the laboratory's projects. The incumbent is expected to work with the Program PI, display a high degree of initiative, independence and responsibility, while monitoring the day-to-day aspect of all ongoing projects in the laboratory, in essence serving as a first-line resource for the junior staff and students to assist in meeting project objectives in a timely manner while ensuring safe and efficient functioning of the laboratory.

This includes managing the day-to-day operations, operating as part of a team for brainstorming and developing new projects, assisting in

selection of appropriate or best assays to address the research questions at hand and helping troubleshoot issues as they arise.

The incumbent is expected to be highly organized with a keen ability to multi-task and manage multiple projects effectively, perceptive with attention to detail, and a passion for science. Participate both technically and intellectually in the preparation of research proposals, presentations and make oral or poster presentations when appropriate; provide written reports of research findings; and assist in meeting annual end of the year accomplishments reporting requirements. The research is primarily laboratory based but does have a portion of work that involves field missions to investigate coral and environmental conditions at specific locations domestically and occasionally internationally.

This requires the willingness to travel and coordinate field logistics (from experimental design to shipping). The incumbent will function as a member of an interdisciplinary research team to collaboratively develop projects, proposals, combining research analyses and developing reports and manuscripts. Duties continued: • Determine and execute improved technologies and bioassays by applying scientific knowledge, techniques, instrumentation and methods necessary to achieve project goals.

• Plan and perform experiments, collect, record and analyze data • Independently perform root cause analysis for method investigations • Apply open-source and vendor-developed software for data analysis • Draw inferences/conclusions from experimental data; document findings in the form of records and reports which may be used for presentations or publications; and communicate effectively both orally and in writing. • Monitor team progress in achieving objectives to ensure quality standards and goals are met. • Functions as a team member with other scientists both within and outside the agency or at other organizations in supporting discovery and applied biological research efforts.

• Assist the Program manager with oversight of the day-to-day routine laboratory operations; ensuring equipment is serviced and operational and the laboratory is safe and orderly. Assist in the design and implementation of laboratory protocols and practices, and in the training of new employees. • This work requires occasional night, early morning and weekend duty to conduct extended duration experiments or to assist in the maintenance of the culture facility in the absence of assigned personnel.

Emergency situations with storms and/or power outages also may require staff to assist others if coral facility staff is not available or additional help is needed. • Willingness to travel for field operations nationally and occasionally internationally participating in field logistics and carrying out fieldwork to meet mission objectives. • Keep accurate written records of all methods, procedures, and experimental results, document observations of unusual or abnormal appearance, and prepare data reports. • Assist in ordering and maintaining laboratory supplies and equipment including chemicals, biological materials, liquid nitrogen, etc.

as assigned by the team lead or PI. • Performs other duties as assigned that support the overall objectives of the program. Qualifications: • Master's degree or Ph. D. in one of the biological sciences (at a minimum). • At least 7 years of experience related to molecular biology, cellular biology, experimental design, and assay development. • Knowledge and expertise in biochemistry, molecular and cell biology, and/or related fields such as molecular microbiology, genomics, or toxicology. • Demonstrated laboratory experience in at least two of the following areas: -Molecular biology (i.

e. isolation of genomic and c DNA clones, sequencing, genomic DNA mapping, PCR amplification, DNA and RNA preparation, q PCR, oligonucleotide and RNA fragments analysis) -Microbiology (e. g. aerobic and anaerobic bacterial culture, algal isolation and culture, conducting bacterial water quality analyses) -Protein chemistry (e. g. MALDI-TOFMS, ELISA, HPLC, western Blot and SDS-PAGE); plant biotechnology (e. g. chlorophyll measurements, photosynthetic condition assays, plant cell culture) -Environmental toxicology -Diagnostic assay development • Additional expertise in bioinformatics, genomics, transcriptomics, metagenomics and/or proteomics is recommended but not required.

• Proficiency in data analysis tools and statistical applications. • Reliability and the ability to learn quickly • Problem solving and troubleshooting abilities • Flexibility and adaptability • Teamwork and interpersonal skills • Excellent written and verbal communications CSS is predominantly a Federal Contractor and is subject to following the terms of Executive Orders. CSS requires all Employees (Direct, Indirect, government, state, and commercial), including employees working from home/remotely, to be fully vaccinated against COVID-19 or have an approved exemption.

Exceptions to the COVID-19 vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the CSS HR Department. CSS is an Equal Opportunity/Affirmative Action Employer who provides equal employment opportunities to all employees and applicants for employment without regards to race, color, religion, interaction, gender identity, interactionual orientation, pregnancy, national origin, age, disability, veteran status or genetic information.

In addition to federal law requirements, CSS complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

associated with oncology clinical trials, and with basic researchers on the design and execution of clinical correlative studies.

The Operations Manager will provide technical expertise to ensure that the TSL meets the needs of HCC members and supports the research mission of MUSC.

The Operations Manager will be responsible for ensuring that the TSL operates in compliance with institutional policies, federal regulations, and NCI guidelines. The Operations Manager of HCC's TSL is a key scientific position within the Center, and as such, requires a highly motivated and experienced individual with a strong commitment to excellence in cancer research. The successful candidate will

have the opportunity to support the strategic direction of the TSL and play a critical role in supporting the research mission of HCC. Entity Medical University of South Carolina (MUSC - Univ) Worker Type Employee Worker Sub-Type Classified Cost Center CC001337 HCC Shared Resources Pay Rate Type Salary Pay Grade University-08 Pay Range $63,707 - $90,789 - $117,870 Scheduled Weekly Hours 40 Work Shift Job Description DUTIES/RESPONSIBILITIES: 35% Management and Consultation Responsible for overseeing the day-to-day operations of the TSL, including personnel management, budget planning and oversight, equipment maintenance, and quality control.

Collaborate and consult with research faculty

at MUSC and abroad for TSL in support of grant submissions and manuscript preparations; Performs initial review of investigators request for services and advises investigators in development and conduct.

Assigns hands-on conduct of experiments to TSL staff and oversees their work products. This includes, but is not limited to, data analysis and preparation of data for presentation and/or publication. Manage activities and responsibilities of the TSL; including hiring, training and supervising all staff, fellows, postdocs and/or students; Prepare and submit budgets, billing and invoicing records for services provided by TSL; Advises TSL Director and HCC administrators in long-term planning of the shared resource instrumentation and operations, financial management of the shared resource, staffing needs, and overall direction of the facility.

35% Provide Technical Expertise & Data Analysis Serves as liaison between investigators, research staff, and TSL staff to train users, and to design, execute, and troubleshoot experiments; Develop and provide a portfolio of biomarker assays to be used for correlative studies in oncology Phase I/II clinical trials; Investigate literature for new trends and oversee and evaluate current and new assays/techniques; Assist with writing relevant sections of clinical trial, grant applications and manuscripts; including the methods, results, correlative science write-ups, training and other relevant sections in the preparation of clinical trials and grants; Develop hypothesis-driven correlative studies associated with Clinical Trials Office to ensure that clinical outcomes are correlated with laboratory measurement; Provide project management for studies that utilize resources available through other Shared Resources; Assist innovative investigator initiated clinical trials with Medical Oncology faculty; 25% Facility Administration and Outreach: Responsible for day-to-day operations and interfacing with the HCC SR Administrative Manager and HCC Associate Director of Shared Resources to help oversee all aspects of shared resource management (e.

g. operations, cost-effectiveness and usage, monitoring user satisfaction, policy development); Manages all technical, administrative and fiscal actions associated with the TSL, including but not limited to monthly billing, maintaining utilization statistics by Principal Investigators and service. Generates quarterly reports: instrumentation usage, cost recovery, and quality assurance.

Communicates with HCC and MUSC leaders and vendors to maintain instrumentation and service contracts; Develops and delivers presentations to HCC and MUSC leadership faculty and external stakeholders. Maintains contact with facility users to target needs suitable for a range of research interests; Promotes facility through various methods (presentations, posters, social media, promotional videos, etc. ) to increase awareness of services and instrumentation with the goal of increasing usage; Participates in campus committees (HCC Research Committee and Cores Committee, etc.

); Represents facility in professional societies and at professional conferences/meetings; Actively participates in the preparation of the CCSG application to the NCI, HCC External Scientific Advisory Board (ESAB) Site Visits, and NCI Site Visits; Provides information on clinical studies, publications, research support, and other information needed to fulfill P30 Cancer Center Support Grant requirements; Participation in HCC-related activities that foster interdisciplinary collaborations including: supporting new research projects in collaboration with other HCC Research Program members; attendance at HCC Research Program meetings, HCC Research Committee meetings, sponsored conferences, and seminars; authorship of cancer-related manuscripts with other program members, etc; Build, maintain, and expand robust training programs 5% Ensure Compliance Ensure compliance: The TSL Operations Manager will ensure that the TSL operates in compliance with institutional policies, federal regulations, and NCI guidelines.

This may involve developing and implementing policies and procedures, ensuring appropriate training for TSL staff, and ensuring that equipment and facilities are maintained in accordance with regulatory requirements.

MUSC Minimum Training and Experience Requirements: A bachelor's degree and four years relevant program experience. MUSC Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes.

(Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs.

unassisted. (Infrequent) Ability to lift objects, up to 15 lbs. from floor level to height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs. unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities.

(Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent) Additional Job Description Minimum Requirements: A bachelor's degree and four years relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position.

(Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms.

(Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs. unassisted. (Infrequent) Ability to lift objects, up to 15 lbs. from floor level to height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs. unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand.

(Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas.

(Infrequent) If you like working with energetic enthusiastic individuals, you will enjoy your career with us! The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, interaction, national origin, gender identity, interactionual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http: //www. uscis. gov/e-verify/employees

(GC), Infra-Red (IR) Spectrophotometers, Ultra Violet-visible (UV-VIS) Spectrophotometers, Particle Size Analyzers, KF Titrators, and similar. Monitor lab systems and document Out of Tolerance events. Write and review instrument and equipment standard operating procedure documents.

Execute Good Manufacturing Practices compliance protocols for instrument validation. Train and mentor junior Instrumentation Specialists. Well established industry leader offers a competitive compensation package, bonuses, full medical benefits, 401(k) retirement plan, generous vacation time, numerous career development opportunities, and more! For complete details contact Christopher Moreno at: (609) 584-xyz

X ext 264 Or submit resume online at: Or email to: Please reference #42876235 when responding. Diedre Moire Corporation Diedre Moire Corporation, Inc. Diedremoire_dot_com WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, interaction, national origin, handicap, disability or marital status.

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