Location: Rock Hill, SC
Company: Piedmont Medical Center
Biotech/Pharmaceutical jobs refer to career opportunities within industries that focus on developing drugs and medical technology derived from living organisms and cellular and biomolecular processes. These roles occupy a diverse ecosystem ranging from research and development (R&D) to regulatory affairs, manufacturing, and sales. Key characteristics include a strong emphasis on innovation, stringent regulatory environments, the need for advanced degrees or expertise in life sciences, and a commitment to improving patient health outcomes. As these fields are constantly evolving with the advancement of science, professionals often engage in ongoing learning and adaptation to new scientific discoveries and medical needs.
(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
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Biotech/Pharmaceutical jobs involve roles in the development, manufacturing, and commercialization of medicinal products and innovative therapies. These positions often require a strong foundation in life sciences, and employees work in various settings, including laboratories, manufacturing facilities, and corporate offices. Characterized by rigorous research and adherence to strict regulatory standards, this sector offers roles ranging from research scientists and clinical trial managers to quality assurance specialists and regulatory affairs coordinators. Employees in this field contribute to advancing medical science and improving patient healthcare, often engaging in cross-disciplinary collaboration and operating at the forefront of technology and innovation.
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.
