... technologies Understanding of regulatory documents required to support product development ... electronic batch records
60 Aequor Technologies Electronics Jobs Hiring Near You
... technologies Understanding of regulatory documents required to support product development ... electronic batch records
Works with CROs to develop electronic systems, establish processes and plans, mitigation strategies ... Topics include but are not limited to team communication, computer software and IT training, ...
Works with CROs to develop electronic systems, establish processes and plans, mitigation strategies ... Topics include but are not limited to team communication, computer software and IT training, ...
... technologies Understanding of regulatory documents required to support product development ... electronic batch records
... technologies Understanding of regulatory documents required to support product development ... electronic batch records
Contract QA Specialist,
Somerset, NJ · On-site
Experience with Process / Method validation or Equipment / Facility Qualification is a big plus Experience in using electronic Quality Management System, ERP system, MS Office applications Excellent ...
Contract QA Specialist,
Somerset, NJ · On-site
Experience with Process / Method validation or Equipment / Facility Qualification is a big plus Experience in using electronic Quality Management System, ERP system, MS Office applications Excellent ...
... technologies Understanding of regulatory documents required to support product development ... electronic batch records
... technologies Understanding of regulatory documents required to support product development ... electronic batch records
Some electronics design and analysis experience, including power supplies, motor control, digital controls and sensor conditioning * Microsoft office: Word, Excel, PowerPoint * Flexible and well ...
Some electronics design and analysis experience, including power supplies, motor control, digital controls and sensor conditioning * Microsoft office: Word, Excel, PowerPoint * Flexible and well ...
Test Development Engineer
Irvine, CA · On-site
Some electronics design and analysis experience, including power supplies, motor control, digital controls and sensor conditioning * Microsoft office: Word, Excel, PowerPoint * Flexible and well ...
Test Development Engineer
Irvine, CA · On-site
Some electronics design and analysis experience, including power supplies, motor control, digital controls and sensor conditioning * Microsoft office: Word, Excel, PowerPoint * Flexible and well ...
Clinical publisher
West Chester, PA · On-site
The Clinical Publisher will be on-the-job trained on Client internal standard processes and systems involved with electronic document management. Essential Duties & Responsibilities: * Performs ...
Clinical publisher
West Chester, PA · On-site
The Clinical Publisher will be on-the-job trained on Client internal standard processes and systems involved with electronic document management. Essential Duties & Responsibilities: * Performs ...
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: Facilitating the electronic ...
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: Facilitating the electronic ...
Process Improvement Lead
Weston, FL · Hybrid
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: * Facilitating the ...
Process Improvement Lead
Weston, FL · Hybrid
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: * Facilitating the ...
... electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate 20% Attain qualification for all assigned ...
... electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate 20% Attain qualification for all assigned ...
... electronic validation lifecycle management system) Apply statistical methods (e.g., Cpk/Ppk, DOE, SPC, MSA, hypothesis testing) to support process capability studies, validation sample sizing, and ...
... electronic validation lifecycle management system) Apply statistical methods (e.g., Cpk/Ppk, DOE, SPC, MSA, hypothesis testing) to support process capability studies, validation sample sizing, and ...
Quality Specialist II PIPELINE
Weston, FL · On-site
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: Facilitating the electronic ...
Quality Specialist II PIPELINE
Weston, FL · On-site
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: Facilitating the electronic ...
... electronic validation lifecycle management system) Apply statistical methods (e.g., Cpk/Ppk, DOE, SPC, MSA, hypothesis testing) to support process capability studies, validation sample sizing, and ...
... electronic validation lifecycle management system) Apply statistical methods (e.g., Cpk/Ppk, DOE, SPC, MSA, hypothesis testing) to support process capability studies, validation sample sizing, and ...
Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements Generate complete, accurate, and concise laboratory documentation using electronic systems ...
Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements Generate complete, accurate, and concise laboratory documentation using electronic systems ...
Quality Specialist II PIPELINE
Weston, FL · On-site
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: Facilitating the electronic ...
Quality Specialist II PIPELINE
Weston, FL · On-site
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: Facilitating the electronic ...
Process Improvement Lead
Weston, FL · Hybrid
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: * Facilitating the ...
Process Improvement Lead
Weston, FL · Hybrid
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs through the supply chain. Full track and trace will be achieved by: * Facilitating the ...
Logistics Associate I
Fremont, CA · On-site
$23.50 - $31.75/hr
Ability and willingness to maintain accurate and factual hard-copy and electronic records. Demonstrated ability and willingness to work and participate effectively in a team environment. Operate ...
Logistics Associate I
Fremont, CA · On-site
$23.50 - $31.75/hr
Ability and willingness to maintain accurate and factual hard-copy and electronic records. Demonstrated ability and willingness to work and participate effectively in a team environment. Operate ...
Research Associate I
Waltham, MA · On-site
... electronic notebook is preferred -Provide oral presentation in group meetings as needed -Must be able to carry out experiments and interpret data independently -Strong communication skills -Must be a ...
Research Associate I
Waltham, MA · On-site
... electronic notebook is preferred -Provide oral presentation in group meetings as needed -Must be able to carry out experiments and interpret data independently -Strong communication skills -Must be a ...
Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements Generate complete, accurate, and concise laboratory documentation using electronic systems ...
Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements Generate complete, accurate, and concise laboratory documentation using electronic systems ...
Aequor Technologies Jobs Information
What makes Aequor Technologies an attractive place to work?
Aequor Technologies is a cutting-edge biotechnology company that has established itself as a leader in the field of bioluminescence and fluorescence technologies. The company's workplace is characterized by a culture of innovation, collaboration, and open communication, where employees are encouraged to think creatively and work together to drive scientific breakthroughs. Joining Aequor Technologies offers opportunities for professionals to contribute to groundbreaking research, develop new skills, and advance their careers in a dynamic and supportive environment.
What are the most popular job types at Aequor Technologies?
What are the most popular jobs at Aequor Technologies?
What are the most popular categories at Aequor Technologies?
Full-time
Re-posted 23 days ago
Job description
About the Job
The CMC Dossier Sciences department within client R&D Global CMC Development organization has
critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to
enable advancement of company's product development through clinical phases to market authorization.
We are seeking qualified individuals to join the team, which focus on supporting client's innovative
pipeline of Mammalian products.
Main Responsibilities:
Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory
documents
Lead, coordinate, and manage CMC dossier preparation and development processes.
Drive alignment between dossier strategy and CMC activities as a core CMC team
member, ensuring data supports expedited pathways to clinic and patients
Lead CMC sub team (Dossier Subgroup or Submission Taskforce) for authoring, review,
comment resolution, and approval of CMC dossiers
Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IB/BP,
BLA/NDA/MAA/JNDA, Information Requests from Health Authorities).
Ensure consistent information presented throughout CMC dossiers and with other modules
(e.g., clinical and preclinical) and between CMC dossiers
Contribute to the elaboration/improvement of the submission templates and authoring
guides in close collaboration with CMC functions, GRA CMC and Digital teams.
Support M&A, in licensing due diligence activities by assessing the CMC dossiers content
Experience:
5 + years of professional experience in CMC development
Proven track record in authoring CMC dossiers
Understanding of current pharmaceutical environment including digital transformation,
economic and regulatory challenges
Soft and technical skills:
Agility to embrace digital transformation and AI/ML applications
Knowledge of at least one aspect of CMC development for Biologics: Cell line
development, Formulation, DS/DP aseptic manufacturing, Analytical development, and
Process and Method validations
Comfortable working in digital-first environments with ability to quickly adopt new
technologies
Understanding of regulatory documents required to support product development
milestones, consultation meetings with agency, site inspections, or written responses to
Agency's information requests
Knowledge of CMC dossier structures required for clinical trial and market authorization
submissions
Leadership capabilities: Ability to lead cross-functional teams with internal and/or external
partners
Strong team spirit with assertiveness: Ability to represent CMC Dossier Sciences and
contribute to cross-company projects
Facilitator skill to resolve issues and move project forward
Agility in priorities, readiness to adopt a TRT culture and embrace continuous digital
innovation
Proficiency in leveraging with digital tools (e.g., Vault RIM, Word and adobe)
Education:
MS or PHD or an equivalent level degree in life sciences in one of the areas of
biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology,
biotechnology, biochemistry or related degree)
In depth and superior knowledge in pharmaceutical development is mandatory
Languages:
Excellent oral and written English communication skills
Experience (nice to haves):
Experience working with agile/scrum methodologies in pharmaceutical development
CMC knowledge and experience in Cell/Gene Therapeutics
Experience with data integration platforms
Soft and technical skills:
Understanding of AI/ML applications in pharmaceutical development
Knowledge of digital quality management systems and electronic batch records
About Aequor Technologies
Sourced by ZipRecruiter
Aequor Technologies, located in Piscataway, New Jersey, is an established IT consulting and solutions company that operates primarily in the United States. The company, founded in 1998, specializes in providing high-value, cost-effective IT services and solutions for a variety of industries, including health care, life sciences, manufacturing, and media and entertainment. They offer a wide array of services including IT consulting, application development, infrastructure management, and strategic staffing solutions. Its mission is to facilitate its clients in their pursuit of achieving business objectives through effective and efficient use of technology. Aequor Technologies is a significant player in its field, boasting several accomplishments including repeated recognition as one of the fastest growing privately-held companies in the U.S. by Inc. 5000.
Industry
Recruiting and staffing services
Company size
201 - 500 Employees
Headquarters location
Piscataway, NJ, US
Year founded
1998