Location: Morrisville, NC
Company: Intellectt
of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.
Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate.
Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities. Author and/or revise procedures/methods, as appropriate.
Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.
Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented. Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability to learn and retain technical information Proactively
address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Mathematical and scientific reasoning ability Basic understanding of instrument operations and troubleshooting skills in multiple techniques Ability to identify aberrant/out of spec data and limited interpretation of data expected Excellent written and verbal communications skills with internal and external customers
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.
the incumbent will act as a primary technical lead interfacing with customers, writing protocols and communicating with the Microbiology Manager and other internal stakeholders to ensure incoming projects are ready to execute. Primary duties include performing microbiological method development and verification, testing of raw materials and sterile and non-sterile medical dosage forms, and general support activities within the Microbiology group in the Quality Control Department.
An individual in this role functions as a microbiology technical lead, interacts with external and internal customers for project support, and mentors or provides technical guidance to junior analysts. Responsibilities
also include coordinating, performing and/or supporting instrument/equipment qualification activities, as well as associated maintenance and calibration programs.
The individual will author and/or revise procedures/methods, as appropriate. II. Essential Functions: Plan and perform method development/validation, routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance. Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct
of project activities and to assure project timeline understanding and deliverable are met, as appropriate.
Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities. Author and/or revise procedures/methods, as appropriate. Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable. Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented.
Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. III. Position Requirements: Education or Equivalent: Bachelor's degree in chemistry or closely related physical science. Experience: : Education: Bachelors of Science in Microbiology or closely related discipline, 8+ years of microbiology laboratory experience - OR- Masters Degree in Microbiology or closely related discipline, 5+ years of Microbiology experience Industry experience as a microbiologist, strong leadership and project management skills, and previous supervisory experience are desirable.
Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability to learn and retain technical information Proactively address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Mathematical and scientific reasoning ability Basic understanding of instrument operations and troubleshooting skills in multiple techniques Ability to identify aberrant/out of spec data and limited interpretation of data expected Excellent written and verbal communications skills with internal and external customers -------------------------------------------------------------------------------------- Thanks & Regards Kiran comear Senior Recruiter Email: xyz X@ Desk Number: 732-412-xyz X Ext 259 Direct Number: 732-398-xyz X Website: Address: 517 Route 1 South, Suite 1115 Iselin, NJ 08830 In my absence, you may contact Kowshik Lead 732-627-xyz X xyz X@
routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.
Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate. Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities.
Author and/or revise procedures/methods, as appropriate. Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.
Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented. Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability
to learn and retain technical information Proactively address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Education & Experience: Bachelors of Science in Microbiology or closely related discipline, 8+ years of microbiology laboratory experience - OR- Masters Degree in Microbiology or closely related discipline, 5+ years of Microbiology experience
- Site Lead (HR Title: Staff Biologist) to join our growing bat biology program.
You will lead bat studies using mist-net and acoustic survey techniques for projects in the renewable energy, transportation, and other development projects across the eastern United States.
A key element of your job will be to independently supervise environmental survey crews in the field. In addition, you will write reports, lead habitat backssments, and assist with other environmental surveys (e. g. avian surveys, wetland delineations, species-specific surveys). Applicants with additional relevant skills (e. g. wetland determinations, additional endangered species experienced) will receive top
consideration. This position offers the possibility of temporary or regular full time status with the flexibility of working remotely from anywhere within the Indiana bat range.
Lodging and travel expenses will be covered. What you will accomplish Lead mist-net and acoustic surveys for bats. Collect field data for bats, other wildlife, and other natural resources. Supervise a small crew while conducting environmental fieldwork. This includes: independently assigning and directing the activities of others on behalf of SWCA, often in remote areas without immediate guidance from senior managers, to ensure quality and on-time delivery; ensuring that employees understand their responsibilities
and delegated tasks and being held accountable if crew members under your supervision are not performing their activities correctly, productively, and safely; serving as a conduit of communication between employees and senior managers, including communicating issues to relevant senior managers; receiving and resolving complaints from employees in the field; andmonitoring team productivity and offering timely performance guidance, including determining when corrective action is needed and delivering appropriate feedback.
Track target species via radio-telemetry. Lead habitat backssments and site characterization studies. Prepare reports describing survey methodologies and results for clients and regulatory agencies.
Assist with Endangered Species Act compliance coordination. May mentor junior staff, as appropriate. May conduct biological data/literature searches and reviews. May conduct wetland and stream delineations. Use topographic maps, aerial photographs, GPS units, and other maps and tools to determine exact locations of project areas, habitat types, and associated landforms. Drive 4WD vehicles in rugged terrain. Experience and qualifications for success Minimum Qualifications: Hold a Federal Fish and Wildlife Section 10(a)(1)(A) permit for listed bat species to include, at a minimum, Indiana bat, gray bat, and northern long-eared bat.
Minimum of B. A. or B. S. in Biology, Ecology, Natural Resource Management, or a related field. Minimum 2 years of demonstrated field experience with bat species of the eastern and central U. S. and appropriate survey techniques. Ability to work in a dynamic team environment in a variety of field conditions. Must have proof of current rabies vaccination. Ability and willingness to travel; extensive travel and night work will be required during the summer months. Preferred Qualifications: Hold a 10(a)(1)(A) permit for Ozark big-eared bats and/or Virginia big-eared bats in addition to the species listed above.
Preference will be given to candidates with demonstrable skillsets and experience in addition to bat surveys, such as: wetland delineation, avian survey techniques, and botanical survey experience. Experience conducting manual review of acoustic survey data. Experience preparing scientific reports and environmental permitting documentation. Interest in using your experience to put your own stamp on a fast growing bat program. Ability to conduct fieldwork for long hours in inclement weather conditions.
Ability to walk up to 10 miles per day, often in rugged terrain. May have to carry equipment and/or supplies, weighing up to 40 pounds. SWCA Environmental Consultants is a growing employee-owned firm, providing a full spectrum of environmental services. With offices across the United States, SWCA is one of the largest environmental compliance firms and ranks among Engineering News-Record's Top 200 Environmental Firms. SWCA is committed to salary equity and salary transparency for all its employees. In alignment with this commitment, SWCA posts good faith pay ranges in all its advertised job postings to promote pay equity and transparency.
An employee in this Chicago, Illinois-based position can expect an hourly pay rate of $24.15/hr. -$31.50/hr. Actual pay within this range may depend on experience, qualifications, geographic location, client requirements where applicable, and other factors permitted by law. Regular-status employees are also eligible for performance bonuses. Candidates are also encouraged to consider SWCA's Total Rewards package, which includes a competitive Benefits package, forward-thinking workplace flexibility, outstanding corporate culture, award-winning career development, and more.
EOE - women, minorities, individuals with disabilities and veterans are encouraged to apply If you would like to contact SWCA regarding the accessibility of our website or need assistance completing the online application process due to a disability, please email or call. This contact information is for disability accommodation requests only. All other inquiries will not receive a response. #LI-LC1#ind-s Connect With Us! Not ready to apply? Connect with us for general consideration.
