Technical Specialist
Technical Specialist
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Job Description
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 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.
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.
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 inline commercial product technology transfers of vaccine drug substance to External Partner and support of our inline products.
Requirements
Role Function:
The primary focus of the Technical Specialist is as follows
Technical support of vaccine drug substance and/or drug product processes to EP including but not limited to personinplant support directly within the EP manufacturing facility:
- review manufacturing documents including batch record check standard operating procedures job aids and protocols
- process troubleshooting
- support manufacturing investigations and
- review analytical results
- Support 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 manufacture
- Author 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 sites
- Provides 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 responsibility
- In 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 postbachelor s degree experience in pharmaceutical manufacturing engineering and/or technical support of operations is required
- Advanced problemsolving skills and experience leading teams to resolve complex business or technical issues is required
- Excellent 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 crossfunctional teams in support of manufacturing operations at internal sites or External Partner(s) is preferred
- Creative innovative thinks outside of the box selfmotivated applies problemsolving skills and solid base in engineering fundamentals and process troubleshooting is preferred
Travel 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.
#LIBR1
Minimum of 2 to4 years post-bachelor s degree experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is required >25% for partner assignments outside of primary location . Travel and flexibility in partner assignment location is required; assignments may require short term travel assignments. Technical support of vaccine drug substance and/or drug product processes to EP
Education
Minimum of 2 to4 years post-bachelor s degree experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is required >25% for partner assignments outside of primary location . Travel and flexibility in partner assignment location is required; assignments may require short term travel assignments. Technical support of vaccine drug substance and/or drug product processes to EP
Employment Type
Full Time
