BioSpace
Associate Director, Parenteral Operations
BioSpace, Concord, North Carolina, United States, 28027
Associate Director, Parenteral Operations
Concord, NC — Lilly is investing over $1 billion to build a new, automated campus that will house warehousing, logistics, parenteral operations, medical device assembly, packaging, QC laboratories, and support teams to produce medicines for unmet patient needs. This is a leadership role focused on staffing, training, and guiding the operations group through asset delivery, process development, operations readiness, startup, and validation of parenteral operations (formulation, aseptic isolator barrier filling, and visual inspection). Travel domestically is required, with potential international travel to collaborate with other Lilly sites.
Once the facility is turned over to operations, the Associate Director is responsible for achieving annual production goals and planning 1–3 year horizons. The role emphasizes safety, quality, operational excellence, compliance, and continuous improvement, and includes leading cross-functional process teams. Direct reports include Supervisors and Operations Associates. This position offers significant growth opportunities into future leadership and technical roles.
Responsibilities
Staff, train, and lead the operations group supporting asset delivery, process development, operations readiness, startup, and validation of parenteral operations areas (formulation, aseptic isolator barrier filling, visual inspection).
Travel domestically with potential international travel to collaborate with other sites.
Lead by example to ensure safety, quality, and compliance; coach others in safety and performance standards.
Lead cross-functional process teams and supervise a group including Supervisors and Operations Associates.
Develop and execute plans to meet production goals and improve operational performance across 1–3 year horizons.
Key Objectives / Deliverables
Integrity : Lead with a safety-first mindset; promote Stop Work Authority as needed.
Excellence : Ensure consistent operations across shifts; track metrics and drive continuous improvement; contribute to initiatives such as RCA, FMEA, OSSCE.
Respect for People : Build a diverse, capable site organization; provide leadership and development for production, safety, quality, and people; serve as a primary contact for related areas.
Qualifications (Education, Experience, Training)
Bachelor's degree in a STEM or pharmaceutical-related field.
At least 7 years in the pharmaceutical industry.
Previous management or leadership experience with cross-functional collaboration.
Solid understanding of regulatory requirements (FDA, EMEA, OSHA, etc.).
Strong interpersonal, written, and verbal communication skills; ability to train and mentor others.
Time Commitments, Environment, and Travel
Ability to wear required safety equipment; work 8 hours per day with overtime as needed.
Frequent domestic travel with potential international travel to support vendor testing and site collaboration; travel up to ~20% of the year.
Preferred Attributes (Not Required)
6+ years in manufacturing/operations with 4+ years in a supervisory role.
Experience with cGMP, FDA guidelines, aseptic filling, isolator technology, and automated equipment.
Experience with SOP creation, training documentation, and equipment/start-up validation.
Familiarity with manufacturing execution systems and electronic batch release; knowledge of ASRS or AGVs; continuous improvement methodologies (lean, six sigma).
Experience with Trackwise, Veeva, QualityDocs, or Kneat for documentation and deviation/change management.
This job specification provides a general overview of requirements and may evolve. Consult your supervisor for actual responsibilities and duties.
Lilly is dedicated to helping individuals with disabilities to participate in the workforce and provides accommodations in the application process. If you require accommodations, please submit the accommodation request form. Lilly is an equal opportunity employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, sexual orientation, or other protected statuses. Our employee resource groups (ERGs) support a diverse workforce. Compensation will depend on education, experience, and location. The anticipated wage range is $123,000–$180,400, with eligibility for a company bonus and a comprehensive benefits package.
#WeAreLilly
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Once the facility is turned over to operations, the Associate Director is responsible for achieving annual production goals and planning 1–3 year horizons. The role emphasizes safety, quality, operational excellence, compliance, and continuous improvement, and includes leading cross-functional process teams. Direct reports include Supervisors and Operations Associates. This position offers significant growth opportunities into future leadership and technical roles.
Responsibilities
Staff, train, and lead the operations group supporting asset delivery, process development, operations readiness, startup, and validation of parenteral operations areas (formulation, aseptic isolator barrier filling, visual inspection).
Travel domestically with potential international travel to collaborate with other sites.
Lead by example to ensure safety, quality, and compliance; coach others in safety and performance standards.
Lead cross-functional process teams and supervise a group including Supervisors and Operations Associates.
Develop and execute plans to meet production goals and improve operational performance across 1–3 year horizons.
Key Objectives / Deliverables
Integrity : Lead with a safety-first mindset; promote Stop Work Authority as needed.
Excellence : Ensure consistent operations across shifts; track metrics and drive continuous improvement; contribute to initiatives such as RCA, FMEA, OSSCE.
Respect for People : Build a diverse, capable site organization; provide leadership and development for production, safety, quality, and people; serve as a primary contact for related areas.
Qualifications (Education, Experience, Training)
Bachelor's degree in a STEM or pharmaceutical-related field.
At least 7 years in the pharmaceutical industry.
Previous management or leadership experience with cross-functional collaboration.
Solid understanding of regulatory requirements (FDA, EMEA, OSHA, etc.).
Strong interpersonal, written, and verbal communication skills; ability to train and mentor others.
Time Commitments, Environment, and Travel
Ability to wear required safety equipment; work 8 hours per day with overtime as needed.
Frequent domestic travel with potential international travel to support vendor testing and site collaboration; travel up to ~20% of the year.
Preferred Attributes (Not Required)
6+ years in manufacturing/operations with 4+ years in a supervisory role.
Experience with cGMP, FDA guidelines, aseptic filling, isolator technology, and automated equipment.
Experience with SOP creation, training documentation, and equipment/start-up validation.
Familiarity with manufacturing execution systems and electronic batch release; knowledge of ASRS or AGVs; continuous improvement methodologies (lean, six sigma).
Experience with Trackwise, Veeva, QualityDocs, or Kneat for documentation and deviation/change management.
This job specification provides a general overview of requirements and may evolve. Consult your supervisor for actual responsibilities and duties.
Lilly is dedicated to helping individuals with disabilities to participate in the workforce and provides accommodations in the application process. If you require accommodations, please submit the accommodation request form. Lilly is an equal opportunity employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, sexual orientation, or other protected statuses. Our employee resource groups (ERGs) support a diverse workforce. Compensation will depend on education, experience, and location. The anticipated wage range is $123,000–$180,400, with eligibility for a company bonus and a comprehensive benefits package.
#WeAreLilly
#J-18808-Ljbffr