...this opportunity you should have a BS/BA/BEng in Life Sciences or related field. 2+ years of relevant cGMP manufacturing/engineering/scientific experience in a Drug Substance Biotech facility and a deep Technical knowledge of the Downstream Process.
#IRELIM #LI-Onsite...
...establishing the transfer of methodology from R&D
To be considered for this opportunity you must hold a third level qualification in a scientific/technical discipline. Previous experience working in a regulated QC Laboratory testing environment would be a distinct advantage....
...track record working as part of a successful team
To be considered for this opportunity you should have a BS/BA in a business or scientific discipline and 6-7 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management...
...You demonstrate an ability to work within a successful team
To be considered for this opportunity you should hold a BSc/BEng in scientific discipline or related field with 3+ years of relevant work experience in pharmaceutical or related industry or equivalent combination...
...and utilize computerized systems for daily performance of tasks
To be considered for this opportunity you should have a BS/BA in a scientific discipline or related field and minimum 5+ years relevant experience. Relevant experience may be substituted for education...
Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. Process Sciences support the following areas: Upstream Sciences, Downstream Sciences, Analytical...
...Perform additional duties as requested.
Education and Experience:
Principal Quality Systems Specialist: Requires BS/BA in scientific discipline or related field and 8 years of industry/relevant experience or equivalent combination of education and experience.
Senior...
...format of regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements, scientific advice) to ensure compliance with applicable regulations and guidelines governing the development, licensure, and marketing of drugs...
...supporting productive team environments toward a common objective
To be considered for this opportunity you should have a BS/BA in scientific discipline and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial External Manufacturing) or...
...techniques
• Assisting in validation of methods
To be considered for this opportunity you should have a third level qualification in a scientific/technical discipline and 5 years+ hands-on work experience in a regulated QC laboratory-testing.
#LI-Onsite #REGNQC #JOBSIEST...
...ICH guidelines and global regulatory
Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another
Aptitude to comprehend, analyze...
...might include, but is not limited to, the following:
Carries out small-scale process studies and investigations
Assists in the scientific evaluation of samples generated from lab scale studies
Develops and writes protocols for small-scale process studies
Tabulates...
...regulatory requirements.
* Monitoring and trending metrics associated with site quality systems.
Education and Experience:
* BS/BA in scientific discipline or related field
* 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or...
...experience in equipment and process validation activities.
* Good project management and communication skills.
* Ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximize productivity and yields is an essential...
...skills, via multiple communication types, in a steady paced environment
Strong writing and proofreading skills in a technical and scientific capacity.
Ability to organize and author technically complex information into laymen suitable documentation.
Ability to...
...encourage safe practices and promptly report any safety concerns
~Continue to maintain knowledge and experience in line with technical and scientific progress for product(s) of responsibility in alignment with Annex 16 requirements.
~Communication and education of personnel in GMP...
...Your new company
Here in Hays we have a fantastic long-term opportunity for a Microbiology Shift Lead for our Scientific Testing Services client in their state-of-the-art product testing microbiology laboratory. The company is a leading contract laboratory services provider...
€40k - €50k per annum
...Control Operations. Seeking a candidate with min 9-12 months GMP industry experience (essential) along with a degree qualification in a Scientific discipline. A candidate with previous GMP food related background will also be considered. Excellent opportunity for a candidate...
...products, as well as a provider of related services, for the consumer, pharmaceutical, and medical device markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease, and improve the quality of life of patients and their loved...
...manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings
Respond to regulatory queries and interact with regulators
Therapeutic Area Knowledge
Understand disease states, competitive...
...technology transfer of products for clinical supply and successful regulatory approval of new product submissions;
- Provide strong scientific leadership for ongoing marketed commercial products providing technical support and expertise to troubleshoot and lead...
...out tasks related to the administration of site supplier approval process.
Experience and Education:
~ Bachelors Degree in a scientific/technical discipline required
~3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical...
...Qualification Requirements:
• Level 8 Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline) required.
• Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance...
...language skills and full fluency in English
Educational/work background in a health care, medical affairs, clinical development, scientific or medical communications field to understand national health care systems and organizational hierarchies.
Bachelor’s degree, diploma...
...NU) to accommodate business needs
Qualifications Education:
~ A minimum of a Bachelor’s degree in Engineering or relevant scientific/technical field is required. Advanced degree is preferred.
Experience and Skills:
Required:
A minimum of 6 years of...
...manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings
Respond to regulatory queries and interact with regulators
Understand disease states, competitive landscapes, and regulatory...
...skills, via multiple communication types, in a steady-paced environment.
Strong writing and proofreading skills in a technical and scientific capacity.
Ability to organize and author technically complex information into laymen suitable
documentation.
Ability to...
...clinical development (5+ year preferred)
~ Strong knowledge of ICH GCP
~ Early Phase (Phase 1) experience preferred
~ Advanced scientific degree
~ Strong leadership and networking skills
~ Vendor management and contracting experience
~ Demonstrated high-level, end...