About PSC Biotech Who are we?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 PropositionEmployees 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:This position will be the key technical leader interface
with the External Partner for the Large
Molecule Vaccines External Manufacturing (ExM) organization. This individual will create, lead and execute Change
Controls within the organization. This role is critical to the organization’s ability to
support in-line commercial product technology transfers of vaccine drug
substance to External Partner, and support of our in-line products.RequirementsRole Function:The primary focus of the Technical Specialist is as
followsTechnical support of vaccine drug substance and/or drug
product processes to EP, including but not limited to person-in-plant support,
directly within the EP manufacturing facility:review manufacturing documents including batch record
check, standard operating procedures, job aids, and protocolsprocess troubleshooting,support manufacturing investigations, andreview analytical resultsSupport Water Runs, Equipment shakedown runs, Engineering
Runs, and Process Performance Qualification (PPQ).Collaborate across multiple technical functions within
the organisation and the EP team to ensure the successful support and
commercial manufactureAuthor process change control documentation, technical
communications, and process risk management.Provides technical oversight, management, and planning
support for complex partnership models. Provides technical guidance to the External Partner,
assess viability of technology in proposed process configurations, verify
adherence to required standards, and ensure deliverables are technically
sound. Leads team for identification and assessment of partner
risks and develops mitigations plans. Provides manufacturing process support to External
Partner(s) to resolve production issues and to provide guidance on process and
capacity optimization. Support/Coordinate/Manage investigations, with
appropriate interface with other impacted manufacturing sitesProvides a technical review of External Partner process
change requests, deviations, and Master Batch Record changes. Minimizes duplication of efforts between
External Partner and systems.Drive and support Continuous process verification and
process performance monitoring program for all products under his/her
responsibilityIn concert with Operations, Quality, and Regulatory,
ensures that External Partner(s) are inspection ready for all new product
introductions and transfers.Understands the true regulatory requirements and partners
with Operations, Quality, and the External Partner to develop more efficient
ways to meet these requirements. Collaborates with External Partners to achieve business
goals and to establish a common culture. Education Requirements:A Bachelor’s degree in Engineering or applicable Science
is required. An advanced degree in
Engineering, Science, or Business is preferred. Skill Requirements:Minimum of 2 to4 years post-bachelor’s degree experience
in pharmaceutical manufacturing, engineering, and/or technical support of
operations is requiredAdvanced problem-solving skills and experience leading
teams to resolve complex business or technical issues is requiredExcellent leadership, collaboration, change management,
interpersonal, analytical skills, collaboration, and engagement as a team
player with dependable interpersonal and communication skills (both verbal and
written) is required. Experience in leading cross-functional teams in support
of manufacturing operations at internal sites or External Partner(s) is
preferredCreative, innovative, thinks outside of the box,
self-motivated, applies problem-solving skills, and solid base in engineering
fundamentals and process troubleshooting is preferredTravel Requirements: >25% for partner assignments outside of primary location. Travel and flexibility in partner assignment
location is required; assignments may require short term travel
assignments. #LI-BR1