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Descripción del trabajo
Job Description
About PSC Biotech
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 cloud-based 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 like-minded 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 diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house 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:
Our Small Molecule API Chemical Technical Operations Unit is seeking a highly motivated individual to fill an open position to support drug substance tech transfer and commercial manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in API manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the small molecule line of business at our company.
This position reports to the Director, Chemical Technical Operations, External Manufacturing API Technology. The Technical Lead will be responsible for the management of the technical interface between client and External Partners (EP). The technical lead will provide process support to External Partners for existing supply products to resolve production issues, evaluate and manage process change requests, proactively assess, and manage process / technical risks, and provide guidance on process improvement and capacity optimization. The technical lead will also provide oversight of External Partners during New Product Introductions and Technical Transfers, proactively identifying process / technical risks as part of pre-execution activities, providing on-site support during execution, and supporting post-execution activities.
Responsibilities include:
* Work with external partners to achieve business goals and to establish a common culture that benefits our company, external partners, and patients.
* Lead and act as the primary interface on technical issues between Chemical Technical Operations and external partner API manufacturers.
* Responsible for technical transfer activities, as applicable, through review of GMP documentation (eg: Master Batch Records, change control, protocols, reports, qualifications, etc.)
* Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
* Develop solutions to complex technical issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products.
* Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities.
* Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners.
* Ensure that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory.
* Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
Education Minimum Requirement:
* Bachelor’s degree in Chemistry, Chemical / Biochemical Engineering, Pharmaceutical Science or other related science or engineering field.
Required Experience and Skills:
* Experience in API chemical manufacturing in an API manufacturing facility.
* Knowledge of GMPs in API manufacturing. A Minimum of 7 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations or Technical Operations.
* Experience in Quality Risk Assessments, deviation management and change control.
* Strong analytical problem-solving skills, root cause analysis, and risk assessment / mitigation.
* Experience in Tech Transfers.
* Ability to work independently as well as excellent organizational skills.
* Strong professional and interpersonal communication skills.
* Accomplishment oriented (self-motivated and persistent), possess a "business owner" mentality, possess the ability to influence without authority, and demonstrate the ability to effectively operate in an ambiguous / changing environment.
* Must be able to multi-task and work within tight deadlines.
* Proven collaboration and team building skills.
* Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation skills to work outside boundaries as a norm.
* Excellent command of English (both written and oral).
* Travel will be a requirement of this position (Person in Plant support during Technical Transfers at External Partners).
Preferred Experience and Skills:
* Project management experience.
* Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.
* Experience in ADC manufacturing.
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