Work Schedule
12 hr shift/nights
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)
Job Description
Location/Division Specific Information
St. Louis MO/ Drug Substance Division (Biologics)
Discover Impactful Work:
This candidate willbe responsible foroverseeing all activitiesof the teams responsible forcleaning and sanitizing the manufacturing facility cleaning of primary secondary and ancillary equipment and assembly of production related manufacturing tanks vessels and supply assemblies in support of the manufacture of Commercial and Clinical Biologics.This individual will be accountable forthe Safety Quality Deliver Cost and Engagementmetricsassociated with the Production Support departmentand ensuring that all work performed in the departmentare followingstandard cGMP documented practicesper the assigned shift.This individual willbe responsible forfollowing Current Good Manufacturing Practices (cGMPs).
A day in the Life:
- Able to complete all Department functions such asmaintainingsuite supplies equipmentlogbooksand datain accordance withsite SOPs and policies.
- Documentation of all activities to meetcGMPrequirements. Dailylogbookreview tasks and databases.
- Forecast and resolve supply and raw material deficiencies.Identifyand resolve scheduling conflicts with one week outlook.
- Identifydeviations aid in investigations/root cause analysis and provide input on major/critical deviations.
- Representmanufacturingteam at tier meetings.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines.
- Utilizes manufacturing process knowledge and investigational skills toidentifyand resolve manufacturing issues and drive continuous improvement in process operations.
- Provides feedback on document revisions and/or document management including batch production records and manufacturing procedures.
- Maintainsafeand clean work environment by educating and directing personnel to ensure compliance with established policies and procedures.
- Coordinates training with team either in class or on the floor as needed.
- Helps build cross-functional relationships and enhances relationships with team members.
- Provides frequent feedback and coaching to others on ways to improve performance.
- Complete production plan by scheduling and assigning personnel prioritizing tasks supervising progress revising schedules resolving problems and reporting results.
- Lead shift exchanges and daily huddles forteamas. Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on various techniques.
Keysto Success:
Education:
- HS Diploma/ GEDbachelorsdegree preferred
Experience:
- 5 yearsrelevantwork experience
- 2 yearssupervisory/leadershipexperience preferred (pharmaceutical industrypreferred)
- Experience in cGMP environment preferred
Knowledge Skills Abilities
Knowledge
- Knowledge of cGMP practices aseptic techniques or chemical concepts- preferred
Skills
- Critical thinking and problem-solvingcapabilities
Abilities
- Critical evaluation of processes including foresight and thinking ahead.
- Able to read write and communicate in English
- Able to understand and carry out instructions
- Able to work in an environment of change
- Able to work independently and as part of a team
- Able to recognize problems developing not just occurring
- Seeks and welcomes feedback and responds to coaching.
Physical Requirements / Work Environment
- Be willing to wear a full gowning suit whichincludesbodysuit gloves hair & beard nets face covers and safety glasses. (These items are prohibited: makeup jewelry nail polish cologne / perfume scentedlotionsor hair care products etc.)
- Able to adhere to clean room gowning requirements including wearing Tyvek Nitrile and/or Latex gloves
- Ability to lift minimum of 25lbsindependently
- Ability to standwalk reach stoop kneel and/ or crouch for 80% of the shift
Relocation assistance is NOT provided
Must be legally authorized to work in the United States without sponsorship now or in the future.
Must be able to pass a comprehensive background check which includes a drug screening.
Required Experience:
Manager
Work Schedule12 hr shift/nightsEnvironmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (...
Work Schedule
12 hr shift/nights
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)
Job Description
Location/Division Specific Information
St. Louis MO/ Drug Substance Division (Biologics)
Discover Impactful Work:
This candidate willbe responsible foroverseeing all activitiesof the teams responsible forcleaning and sanitizing the manufacturing facility cleaning of primary secondary and ancillary equipment and assembly of production related manufacturing tanks vessels and supply assemblies in support of the manufacture of Commercial and Clinical Biologics.This individual will be accountable forthe Safety Quality Deliver Cost and Engagementmetricsassociated with the Production Support departmentand ensuring that all work performed in the departmentare followingstandard cGMP documented practicesper the assigned shift.This individual willbe responsible forfollowing Current Good Manufacturing Practices (cGMPs).
A day in the Life:
- Able to complete all Department functions such asmaintainingsuite supplies equipmentlogbooksand datain accordance withsite SOPs and policies.
- Documentation of all activities to meetcGMPrequirements. Dailylogbookreview tasks and databases.
- Forecast and resolve supply and raw material deficiencies.Identifyand resolve scheduling conflicts with one week outlook.
- Identifydeviations aid in investigations/root cause analysis and provide input on major/critical deviations.
- Representmanufacturingteam at tier meetings.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines.
- Utilizes manufacturing process knowledge and investigational skills toidentifyand resolve manufacturing issues and drive continuous improvement in process operations.
- Provides feedback on document revisions and/or document management including batch production records and manufacturing procedures.
- Maintainsafeand clean work environment by educating and directing personnel to ensure compliance with established policies and procedures.
- Coordinates training with team either in class or on the floor as needed.
- Helps build cross-functional relationships and enhances relationships with team members.
- Provides frequent feedback and coaching to others on ways to improve performance.
- Complete production plan by scheduling and assigning personnel prioritizing tasks supervising progress revising schedules resolving problems and reporting results.
- Lead shift exchanges and daily huddles forteamas. Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on various techniques.
Keysto Success:
Education:
- HS Diploma/ GEDbachelorsdegree preferred
Experience:
- 5 yearsrelevantwork experience
- 2 yearssupervisory/leadershipexperience preferred (pharmaceutical industrypreferred)
- Experience in cGMP environment preferred
Knowledge Skills Abilities
Knowledge
- Knowledge of cGMP practices aseptic techniques or chemical concepts- preferred
Skills
- Critical thinking and problem-solvingcapabilities
Abilities
- Critical evaluation of processes including foresight and thinking ahead.
- Able to read write and communicate in English
- Able to understand and carry out instructions
- Able to work in an environment of change
- Able to work independently and as part of a team
- Able to recognize problems developing not just occurring
- Seeks and welcomes feedback and responds to coaching.
Physical Requirements / Work Environment
- Be willing to wear a full gowning suit whichincludesbodysuit gloves hair & beard nets face covers and safety glasses. (These items are prohibited: makeup jewelry nail polish cologne / perfume scentedlotionsor hair care products etc.)
- Able to adhere to clean room gowning requirements including wearing Tyvek Nitrile and/or Latex gloves
- Ability to lift minimum of 25lbsindependently
- Ability to standwalk reach stoop kneel and/ or crouch for 80% of the shift
Relocation assistance is NOT provided
Must be legally authorized to work in the United States without sponsorship now or in the future.
Must be able to pass a comprehensive background check which includes a drug screening.
Required Experience:
Manager
View more
View less