Manufacturing Operations Manager

4 weeks ago


Harmans, Maryland, United States Catalent Inc Full time
Job Summary

Catalent is seeking a highly skilled Manufacturing Manager to lead our purification operations at our Contract Manufacturing Facility. As a key member of our team, you will be responsible for managing and improving the purification operations, ensuring staff are fully trained on cGMP manufacturing operations and documentation, and adhering to safety guidelines.

Key Responsibilities
  • Manage and improve the purification operations of Contract Manufacturing Facility
  • Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines
  • Establish a continuous improvement plan to achieve excellence in accordance with The Catalent Way (TCW)
  • Build effective teams that apply their diverse skills and perspectives to achieve common goals
  • Drive engagement and create a culture where employees are motivated to do their best
  • Ensure quality culture through the continuous pursuit of right first-time performance
  • Understand company goals and practices and apply them when resolving a variety of problems
  • Coordinate with production supervisors and project managers to execute production campaigns on-time
  • Ensure batches adhere to established Quality standards
  • Write and/or approve manufacturing documentation, including validation protocols, SOPs, and master batch records
  • Review client processes for compatibility with plant capabilities and GMP requirements
  • Work with client representatives, Process Development, and technical support to transfer manufacturing processes
  • Coordinate with other departments to schedule work in processing and support areas or work that affects processing and support areas
  • Identify and maintain relationships with quality vendors of supplies, instruments, and equipment
  • Identify processing technologies and capabilities to add to the Catalent portfolio
  • Work with QA to investigate and resolve nonconformance's
Requirements
  • Masters' degree in a Scientific, Engineering or Biotech field with 6 –8 years' experience with upstream (purification) biologic production processes under GMP compliance recommended
  • Experience with chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity)
  • Bachelor's degree in a Scientific, Engineering or Biotech field with 8 -10 years' experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance recommended
  • Associate'sDegree with 10 –12 years' experience in biologics production recommended
  • 3 years of Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict
  • One (1) year of demonstrated leadership experience (Lead role) at a Catalent site will be considered
  • Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience
  • Proficient knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
  • Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports
  • Actively pursues learning of required skills, new skills, and new equipment
  • Possesses proficient equipment understanding, including understanding equipment function and application
  • Creative thinking with the ability to multi-task
  • Commitment to ongoing professional development
  • Team player who thrives in collaborative environments and revels in team success
  • Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways
What We Offer
  • Defined career path and annual performance review and feedback process
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • 152 hours of paid time off annually + 8 paid holidays
  • Competitive salary with yearly bonus potential
  • Community engagement and green initiatives
  • Generous 401K match and Paid Time Off accrual
  • Medical, dental and vision benefits effective day one of employment
  • Tuition Reimbursement

Catalent is a global drug development and delivery leader, and we are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. If you are a motivated and experienced professional looking for a challenging and rewarding opportunity, please submit your application.



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