Commercial Attribute Science Senior Associate Shift
Commercial Attribute Science Senior Associate Shift
Posted on :
09-10-2024
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1 Vacancy
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Job Description
About PSC Biotech
Who we are
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
Overview
- This role will require the candidate to provide Process Development (PD) support primarily to the Forensics and Defect Laboratory at ***.
- The candidate will establish themselves as an expert in forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.
Responsibilities would include the following:
- Leads / assists forensic investigation and identification of defects arising from drug product manufacture at *** and write up of these investigations to cGMP standards.
- Be accountable for the maintenance distribution and upkeep of extensive defect panels used for the setup training and characterisation of automated / semiautomated / manual finished drug product visual inspection equipment at ****.
- Working as part of the PD laboratory team be expected to contribute to upkeep / maintenance of a GMP laboratory environment.
- Provide process development expertise for commercial drug product particle / defect identification and contribute to the maintenance of local and global particle / defect libraries.
The position will report directly to Process Development Senior Scientist.
Key Responsibilities
- Perform experiments organise data and analyse results with minimal supervision (in a GMP laboratory environment) to evaluate product impact due to process variables encountered during drug product manufacture.
- Creation Management and Maintenance of Inspection defect panels / sets.
- Execution of Knapp studies and data analysis.
- Establish experimental design develop and implement protocols obtain reproducible and reliable results and communicate data to cross functional groups.
- Ensuring all aspects of laboratory activity adheres to required policies and procedures including safety and training.
- Ensure that the laboratory and site meet the quality requirements of its customers and applicable regulations (FDA EU & international standards).
- Participate in cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organisational goals and project milestones.
- Assist in deviation and exception resolution and root cause analysis.
Requirements
Basic Qualifications
- Third level bachelor s degree in science engineering or a relevant quality discipline with 2 4 years experience in a similar role OR Associate s degree and 5 years of directly related experience.
- Experience in Working in a Laboratory Environment.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills.
Preferred Qualifications
- Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing process characterization inspection tech transfer (to commercial DP sites) or validation.
- Be familiar with advanced microscopy (scanning electron microscopy) and spectroscopy (Fouriertransform infrared spectroscopy).
- Understanding of degradation mechanisms for biologics analytical methods laboratory practices and basic statistical methods.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to crossfunctional teams to advance complex projects to completion.
#LIKV1
Knowledge/Skills: Strong Project Management and organizational skills, including ability to follow assignments through to completion. Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills. Escalate issues professionally and in a timely manner. Ensures compliance within regulatory environment. Demonstrated ability to work independently and deliver right first-time results under minimal direction. Experience participating in and leading cross-functional teams. Experience in managing multiple, competing priorities in a fast-paced environment. Relevant Experience: Bachelor s degree in a Science or Engineering discipline. 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage. #LI-XA1
Employment Type
Full Time
Key Skills
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