Senior Manager Manufacturing Process Support
Senior Manager Manufacturing Process Support
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$ 124320 - 170940
1 Vacancy
Job Description
Our purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
JOB SUMMARY:
The Senior Manager Manufacturing Process Support is responsible for product technology transfer compliance process systems training and process optimization oversight while supporting the sites manufacturing deliverables and batch success goals. The Senior Manager Manufacturing Process Support will lead a team of supervisors and managers ensuring that manufacturing operations are enabled to deliver batches on time and in full (OTIF) while maintaining the highest standards of quality and compliance.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
Supporting Manufacturing & Site Deliverables
- Drive batch success by ensuring technical readiness process reliability and operational efficiency.
- Partner with Manufacturing Quality and MSAT to proactively remove roadblocks troubleshoot issues and streamline workflows.
- Ensure manufacturing operations are fully enabled to execute batches on time and in full (OTIF) by optimizing scheduling resources and technical support.
- Implement strategies to reduce deviations improve cycle times and enhance process reliability.
Technology Transfer & System Ownership
- Act as System Owner for technology transfers ensuring seamless integration of new processes and equipment into manufacturing.
- Lead crossfunctional collaboration between MSAT Engineering and Manufacturing to ensure successful transfer validation and scaleup of new products.
- Own and optimize process control strategies to ensure efficient and compliant of manufacturing processes.
CAPA Change Control & Compliance Oversight
- Initiate track and own Manufacturingrelated CAPAs and Change Requests (CRs) to support continuous improvement and regulatory compliance.
- Conduct risk assessments and deviation investigations ensuring corrective actions are effective sustainable and prevent recurrence.
- Ensure GMP compliance and regulatory alignment proactively addressing quality risks before they impact batch .
Training & Team Development
- Lead and develop a team of supervisors and managers fostering a culture of technical excellence accountability and continuous improvement.
- Oversee training programs ensuring Manufacturing teams are proficient in SOPs best practices and regulatory requirements.
- Ensure training effectiveness through ongoing assessments upskilling programs and handson coaching for the operations team.
Manufacturing Floor Support & Troubleshooting
- Provide realtime handson support to Manufacturing teams during production runs troubleshooting technical issues and deviations.
- Ensure proper performerverifier alignment confirming only trained and qualified personnel are executing critical process steps.
- Serve as a technical escalation point ensuring rapid issue resolution to minimize batch disruptions.
CrossFunctional Collaboration & Continuous Improvement
- Work closely with Engineering Quality Supply Chain and MSAT to drive operational excellence and process optimization.
- Develop and implement continuous improvement initiatives to increase throughput reduce waste and enhance process efficiency.
- Lead efforts to improve facility fit process monitoring and manufacturing control strategies to support longterm operational success.
SKILLS
- Communicates complex ideas anticipates potential objections and guides/persuades others often at senior levels to adopt a different point of view.
- Assimilates feedback from other teams to achieve successful work processes within the function/group.
QUALIFICATIONS
Required:
- BS/BA degree with 10 years of industry experience orMasters degree with 8 years of industry experience. Equivalent education and experience may substitute for stated requirements.
- 3 years experience in a leadership role
- Proven expertise in technology transfer compliance management process troubleshooting and team leadership.
- Strong understanding of GMP regulations batch requirements and process control strategies.
- Ability to drive batch success and manufacturing excellence through crossfunctional collaboration and proactive issue resolution.
- Excellent leadership skills with experience mentoring and developing supervisors and managers.
- Strong project management skills with the ability to manage multiple priorities in a fastpaced manufacturing environment.
COMPENSATION:
$124320 $170940
Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visitwww.agcbio.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.
Required Experience:
Senior Manager
Employment Type
Full-Time
