Goal templates — Manufacturing Operations / Production Supervision (Upstream Processing) — M1

1. Oversees daily operations of a single upstream shift, planning, scheduling and supporting daily production tasks (seed expansion, bioreactor/fermenter operation, cell culture harvest) on single-use and stirred-tank platforms (HyPerforma S.U.B, Biostat STR, Xcellerex XDR, wave bioreactors) to ensure schedule adherence and 'Right First Time' execution.  [source: JFM responsibility (M1)]
   Specific:    Deliver: "Oversees daily operations of a single upstream shift, planning, scheduling and supporting daily production tasks (seed expansion, bioreactor/fermenter operation, cell culture harvest) on single-use and stirred-tank platforms (HyPerforma S.U.B, Biostat STR, Xcellerex XDR, wave bioreactors) to ensure schedule adherence and 'Right First Time' execution."
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Limited scope; resolves routine production, equipment and documentation issues using established practices, escalating non-standard deviations. May impact short-term shift goals and unit budget."
   Relevant:    Advances the Manufacturing Operations / Production Supervision (Upstream Processing) · Manufacturing Operations / Production Supervision (Upstream Processing) mandate for a M1 — Manager (Team Lead).
   Time-bound:  ⟨date⟩

2. Directly supervises a team of manufacturing associates performing processing of bulk intermediates and drug substances, distributing workload, assigning tasks and confirming associates understand task requirements.  [source: JFM responsibility (M1)]
   Specific:    Deliver: "Directly supervises a team of manufacturing associates performing processing of bulk intermediates and drug substances, distributing workload, assigning tasks and confirming associates understand task requirements."
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Limited scope; resolves routine production, equipment and documentation issues using established practices, escalating non-standard deviations. May impact short-term shift goals and unit budget."
   Relevant:    Advances the Manufacturing Operations / Production Supervision (Upstream Processing) · Manufacturing Operations / Production Supervision (Upstream Processing) mandate for a M1 — Manager (Team Lead).
   Time-bound:  ⟨date⟩

3. Ensures staff maintain compliance to SOPs, batch records, GMP and aseptic/cleanroom expectations during routine cell culture and fermentation, including gowning, cleaning and Good Documentation Practices at time of execution.  [source: JFM responsibility (M1)]
   Specific:    Deliver: "Ensures staff maintain compliance to SOPs, batch records, GMP and aseptic/cleanroom expectations during routine cell culture and fermentation, including gowning, cleaning and Good Documentation Practices at time of execution."
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Limited scope; resolves routine production, equipment and documentation issues using established practices, escalating non-standard deviations. May impact short-term shift goals and unit budget."
   Relevant:    Advances the Manufacturing Operations / Production Supervision (Upstream Processing) · Manufacturing Operations / Production Supervision (Upstream Processing) mandate for a M1 — Manager (Team Lead).
   Time-bound:  ⟨date⟩

4. Ensures timely execution and review of batch documentation and logbooks within the shift, initiates deviations and completes ERP orders, monitoring critical process parameters (pH, dissolved oxygen, viable cell concentration, viability) via Vi-Cell and Cedex Bio readings.  [source: JFM responsibility (M1)]
   Specific:    Deliver: "Ensures timely execution and review of batch documentation and logbooks within the shift, initiates deviations and completes ERP orders, monitoring critical process parameters (pH, dissolved oxygen, viable cell concentration, viability) via Vi-Cell and Cedex Bio readings."
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Limited scope; resolves routine production, equipment and documentation issues using established practices, escalating non-standard deviations. May impact short-term shift goals and unit budget."
   Relevant:    Advances the Manufacturing Operations / Production Supervision (Upstream Processing) · Manufacturing Operations / Production Supervision (Upstream Processing) mandate for a M1 — Manager (Team Lead).
   Time-bound:  ⟨date⟩

5. Troubleshoots routine production and equipment issues on the floor using established practices, escalating non-standard deviations to senior management.  [source: JFM responsibility (M1)]
   Specific:    Deliver: "Troubleshoots routine production and equipment issues on the floor using established practices, escalating non-standard deviations to senior management."
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Limited scope; resolves routine production, equipment and documentation issues using established practices, escalating non-standard deviations. May impact short-term shift goals and unit budget."
   Relevant:    Advances the Manufacturing Operations / Production Supervision (Upstream Processing) · Manufacturing Operations / Production Supervision (Upstream Processing) mandate for a M1 — Manager (Team Lead).
   Time-bound:  ⟨date⟩

Objective 1: Oversees daily operations of a single upstream shift, planning, scheduling and supporting daily production tasks (seed expansion, bioreactor/fermenter operation, cell culture harvest) on single-use and stirred-tank platforms (HyPerforma S.U.B, Biostat STR, Xcellerex XDR, wave bioreactors) to ensure schedule adherence and 'Right First Time' execution.  [source: JFM responsibility (M1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Oversees daily operations of a single upstream shift, planning, scheduling and supporting daily production tasks (seed expansion, bioreactor/fermenter operation, cell culture harvest) on single-use and stirred-tank platforms (HyPerforma S.U.B, Biostat STR, Xcellerex XDR, wave bioreactors) to ensure schedule adherence and 'Right First Time' execution."
  KR2. Evidence at this level's scope bar: "A single team" — ⟨target⟩ by ⟨date⟩

Objective 2: Directly supervises a team of manufacturing associates performing processing of bulk intermediates and drug substances, distributing workload, assigning tasks and confirming associates understand task requirements.  [source: JFM responsibility (M1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Directly supervises a team of manufacturing associates performing processing of bulk intermediates and drug substances, distributing workload, assigning tasks and confirming associates understand task requirements."
  KR2. Evidence at this level's autonomy bar: "Manages within established goals" — ⟨target⟩ by ⟨date⟩

Objective 3: Ensures staff maintain compliance to SOPs, batch records, GMP and aseptic/cleanroom expectations during routine cell culture and fermentation, including gowning, cleaning and Good Documentation Practices at time of execution.  [source: JFM responsibility (M1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Ensures staff maintain compliance to SOPs, batch records, GMP and aseptic/cleanroom expectations during routine cell culture and fermentation, including gowning, cleaning and Good Documentation Practices at time of execution."
  KR2. Evidence at this level's complexity bar: "Day-to-day delivery and people issues" — ⟨target⟩ by ⟨date⟩

Objective 4: Ensures timely execution and review of batch documentation and logbooks within the shift, initiates deviations and completes ERP orders, monitoring critical process parameters (pH, dissolved oxygen, viable cell concentration, viability) via Vi-Cell and Cedex Bio readings.  [source: JFM responsibility (M1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Ensures timely execution and review of batch documentation and logbooks within the shift, initiates deviations and completes ERP orders, monitoring critical process parameters (pH, dissolved oxygen, viable cell concentration, viability) via Vi-Cell and Cedex Bio readings."
  KR2. Evidence at this level's impact bar: "Team output and health" — ⟨target⟩ by ⟨date⟩

Objective 5: Troubleshoots routine production and equipment issues on the floor using established practices, escalating non-standard deviations to senior management.  [source: JFM responsibility (M1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Troubleshoots routine production and equipment issues on the floor using established practices, escalating non-standard deviations to senior management."
  KR2. Evidence at this level's decision rights bar: "Owns team execution, hiring input, performance" — ⟨target⟩ by ⟨date⟩

1. Area: Oversees daily operations of a single upstream shift, planning, scheduling and supporting daily production tasks (seed expansion, bioreactor/fermenter operation, cell culture harvest) on single-use and stirred-tank platforms (HyPerforma S.U.B, Biostat STR, Xcellerex XDR, wave bioreactors) to ensure schedule adherence and 'Right First Time' execution.  [source: JFM responsibility (M1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Functional expert in upstream unit operations (seed expansion, bioreactor/fermenter operation, cell counting, aseptic technique) applying established SOPs, batch records, ERP orders and GMP to a single shift or unit."
   Target:   ⟨target⟩   Due: ⟨date⟩

2. Area: Directly supervises a team of manufacturing associates performing processing of bulk intermediates and drug substances, distributing workload, assigning tasks and confirming associates understand task requirements.  [source: JFM responsibility (M1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Functional expert in upstream unit operations (seed expansion, bioreactor/fermenter operation, cell counting, aseptic technique) applying established SOPs, batch records, ERP orders and GMP to a single shift or unit."
   Target:   ⟨target⟩   Due: ⟨date⟩

3. Area: Ensures staff maintain compliance to SOPs, batch records, GMP and aseptic/cleanroom expectations during routine cell culture and fermentation, including gowning, cleaning and Good Documentation Practices at time of execution.  [source: JFM responsibility (M1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Functional expert in upstream unit operations (seed expansion, bioreactor/fermenter operation, cell counting, aseptic technique) applying established SOPs, batch records, ERP orders and GMP to a single shift or unit."
   Target:   ⟨target⟩   Due: ⟨date⟩

4. Area: Ensures timely execution and review of batch documentation and logbooks within the shift, initiates deviations and completes ERP orders, monitoring critical process parameters (pH, dissolved oxygen, viable cell concentration, viability) via Vi-Cell and Cedex Bio readings.  [source: JFM responsibility (M1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Functional expert in upstream unit operations (seed expansion, bioreactor/fermenter operation, cell counting, aseptic technique) applying established SOPs, batch records, ERP orders and GMP to a single shift or unit."
   Target:   ⟨target⟩   Due: ⟨date⟩

5. Area: Troubleshoots routine production and equipment issues on the floor using established practices, escalating non-standard deviations to senior management.  [source: JFM responsibility (M1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Functional expert in upstream unit operations (seed expansion, bioreactor/fermenter operation, cell counting, aseptic technique) applying established SOPs, batch records, ERP orders and GMP to a single shift or unit."
   Target:   ⟨target⟩   Due: ⟨date⟩

Internal process
  - "Oversees daily operations of a single upstream shift, planning, scheduling and supporting daily production tasks (seed expansion, bioreactor/fermenter operation, cell culture harvest) on single-use and stirred-tank platforms (HyPerforma S.U.B, Biostat STR, Xcellerex XDR, wave bioreactors) to ensure schedule adherence and 'Right First Time' execution."  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M1)]
  - "Directly supervises a team of manufacturing associates performing processing of bulk intermediates and drug substances, distributing workload, assigning tasks and confirming associates understand task requirements."  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M1)]
  - "Ensures staff maintain compliance to SOPs, batch records, GMP and aseptic/cleanroom expectations during routine cell culture and fermentation, including gowning, cleaning and Good Documentation Practices at time of execution."  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M1)]
  - "Ensures timely execution and review of batch documentation and logbooks within the shift, initiates deviations and completes ERP orders, monitoring critical process parameters (pH, dissolved oxygen, viable cell concentration, viability) via Vi-Cell and Cedex Bio readings."  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M1)]
  - "Troubleshoots routine production and equipment issues on the floor using established practices, escalating non-standard deviations to senior management."  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M1)]

Role calibration
  - Meets the scope bar: "A single team"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Scope)]
  - Meets the autonomy bar: "Manages within established goals"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Autonomy)]
  - Meets the complexity bar: "Day-to-day delivery and people issues"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Complexity)]
  - Meets the impact bar: "Team output and health"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Impact)]
  - Meets the decision rights bar: "Owns team execution, hiring input, performance"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Decision rights)]
  - Meets the leadership bar: "Direct people management of one team"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Leadership)]