Senior Associate, Manufacturing - Technical Lead

1 week ago(1/10/2018 10:38 AM)
# of Openings


The Senior Associate, Manufacturing/Technical Lead will perform various biological manufacturing unit operations which includes media/buffer preparation, fermentation, clarification and purification in a cGMP clinical manufacturing facility. Initial job responsibilities will include working with a group of manufacturing personnel responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation.



Biologics Manufacturing:

  • Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
  • Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
  • Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
  • Maintains cleanliness and orderliness of process area.
  • Maintains production area with supplies.
  • Prepares and operates bioreactor systems and TFF operations, and/or media/buffer preparation operations.
  • Performs batch record review, procedure revisions, and work order generation.
  • May be responsible for training less experienced or new operators.
  • Utilizes manufacturing knowledge to improve process operations and affect positive change.
  • Demonstrates ability to troubleshoot basic mechanical operations.


Technical Lead:

  • Leads, practices and promotes safe work habits and adheres to all safety procedures and guidelines
  • Ensuring execution of manufacturing material activities in strict accordance with standard operating procedures and cGMP
  • Manages cross functional teams to drive complex change controls and investigation close outs by determining root cause(s) and implementing appropriate Corrective and Preventative Action(s).
  • Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.
  • Conducts complex document revisions and/or document management including standard operating procedures (SOPs), batch production records, manufacturing procedures, and cross functional procedures.
  • Performs training with staff on the floor, as needed.
  • Leads cross-functional continuous improvement teams with various departmental and outside representatives (Process Development, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services).
  • Works independently with minimal supervision and direction.



  • Bachelor's Degree with 5 years of experience, or Master’s Degree with 3 years of experience.
  • 1 year in a lead or supervisor role.
  • Excellent communication and coordination skills.
  • Demonstrated ability to effectively coach and train employees.
  • Subject matter expertise in biologics manufacturing.
  • Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
  • Ability to influence in a cross-functional environment.
  • Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.


  • Minimum Bachelor’s degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.


  • Effectively uses process automation systems to operate production processes
  • Experience in reviewing and creating controlled documents.
  • Familiarity with Deviation Management Systems
  • Thorough knowledge of the cGMP regulations.
  • Demonstrated abilities for problem solving, working as a key member of a team, and motivation to complete company objectives.


  • Ability to lift over 40 pounds.
  • Ability to stand for 6 hours in a production suite.
  • Ability to gown and gain entry to manufacturing areas.
  • Ability to work flexible work hours.


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