Senior Operations Manager (424)

Location
Cincinnati, Ohio, United States
Posted
Aug 16, 2019
Ref
424
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Equal Opportunity Employer

Purpose of the Position:

This position is responsible for managing the Oligonucleotide Manufacturing and Supply Chain Unit, along with serving as the Continuous Improvement Champion for the Cincinnati Avecia site. Objectives for this position include:

Ensuring safe, compliant, and on-time receipt and release of materials, production, and shipment of product to the customer.

Developing and implementing systems and procedures for oligo products to optimize efficiencies and reduce risks while meeting all relevant regulatory requirements.

Supporting and facilitating the acceptance and compliant implementation of new processes, technology, and products, into production in a timely fashion.

Fostering a continuous improvement culture and developing, aligning, and driving continuous improve policies, practices, and training.

Key Job Responsibilities:

Manage the planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing compounds and technologies.

Manage the Unit's Supply Chain team and processes

Work in close collaboration with the Engineering, Process Development, QC and QA teams.

Ensure that departmental systems comply with Company and industry regulatory requirements for quality, safety, and environment.

Develop, implement, and monitor departmental objectives and schedules including setting priorities and performance expectations while ensuring alignment with expected deliverables and Company goals.

Supervise activities of line management/supervisors and technical support staff as appropriate.

Organize and lead, cross-functional and departmental continuous improvement activities in an effort to improve efficiencies and effectiveness.

Assist with developing and managing the departmental budget to meet company objectives.

Job Knowledge Required:

B.S. Degree required. A degree in a relevant technical field highly preferred.

10+ years of mid-level managerial experience in a cGMP environment a must; prefer clinical or commercial API experience.

Demonstrated ability to work effectively with all staff levels and disciplines a must.

Excellent verbal and written communication skills required.

ProvencGMP experience in a Manufacturing environment required. cGMP experience in development and validation in solid phase synthesis, chromatography, UF, or freeze-drying desired.

Formal training or proven experience with Continuous Improvement tools such as Lean Six Sigma and Root Cause Analysis required. Active leadership in a continuous improvement roll-out preferred.