Production Manager at SOFIE

Job Description: Production Manager, Radiopharmaceutical Contract Manufacturing, NJ5
Title: Production Manager
Location: NJ5-Totowa, New Jersey
Department: Radiopharmaceutical Contract Manufacturing
Training Curriculum: ID TCU.XXX

Overview:

The Production Manager for Radiopharmaceutical Contract Manufacturing at NJ5 is responsible for
overseeing the Pharmaceutical Production Chemists and Aseptic Cleaning Technicians, ensuring timely manufacture and
delivery of all diagnostic and therapeutic radiopharmaceutical finished product to meet customer expectations. The
Production Manager will be responsible for overseeing the site’s production related activities within aseptic and GMP
areas such as cleaning, manufacturing campaigns for various products, and coordinating/scheduling both resources and
materials for production. Following SOFIE's master records, SOPs, and QMS requirements, and following cGMP
guidelines, the Production Manager will ensure that these radiopharmaceuticals are in full compliance with all regulatory
requirements, including 21 CFR 211/212, EudraLex Volume 4, and all other applicable regulations for drug manufacturing.
Essential Duties and Responsibilities
▪ Lead and implement the transfer of established manufacturing processes, records, and procedures for new
radiopharmaceuticals, either directly from customer or from SOFIE development group, or the SOFIE production
team.
▪ Schedule and supervise clinical and commercial manufacturing activities, focusing on full compliance with industry
requirements. Lead by example by fully understanding and participating in manufacturing activities as needed.
▪ Manage implementation, validation, organization, and participation in the production of routine patient dose
manufacturing activities for various radiopharmaceutical drug products.
▪ Manage and supervise the RCM production and cleaning team (including shift leads and supervisors) beginning
with the transition of radiopharmaceuticals in development to clinical manufacturing and through commercial
manufacturing.
▪ Conduct performance review for the direct reports and or indirect reports as assigned. Track performance through
regular 1:1s and staff meetings.
▪ Develops and maintains working relationships with employees at all levels. Manage current and newly hired
personnel training process and ensures training for direct reports meets expectations as defined in job specific
training matrices.Ensure aseptic operations by the production team members comply with internal procedures (example: gowning,
cleaning/sanitation, sterility, environmental monitoring), accepted industry practice and regulatory guidance.
Assure completeness, accuracy, traceability, and compliance of the site utility and facility monitoring methods and
records. Provide support to site Microbiologists and QA, as necessary.
▪ Review and approve clinical dose manufacturing plans, final drug product labels, reagents, manufacturing batch
records, and associated EM data. Properly organize and securely maintain cGMP production documents until
archived by QA. Keep facility and manufacturing SOPs up to date and ensure no copies of obsoleted documents
are held by the production team members.
▪ Work with SOFIE's QA, Regulatory, and EH&S teams to ensure SOFIE's standards are continuously reflected in
all new radiopharmaceutical products and contribute in the generation of regulatory documentation required for
new radiopharmaceuticals, including Standard Operating Procedures (SOPs), development and validation
Protocols, and Master Batch Records.
▪ Oversee the participation of the production team in the installation, qualification, and maintenance of the facility
production equipment. Executes approved protocols to validate manufacturing processes in coordination with
project managers. Maintain individual qualification requirements and training for entering ISO classified areas.
▪ Demonstrate proficiency in industry radiation safety procedures. Responsible for tracking radiation exposure of
production personnel and seeing that principles of ALARA are maintained. Maintain a clean and safe working
environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.
▪ Provide oversight to the materials utilized in the manufacturing process and ensure that raw materials,
components, containers, closures, packaging, and labeling are inspected, qualified, and meet acceptance criteria
before use.
▪ Lead exception document initiation and investigation for manufacturing processes [Deviation, OOS, Action/Alert
Level Notifications]. Ensure that scientifically sound root causes are identified. Initiate and Implement CAPA plans. Evaluate effectiveness of the CAPA plans through reporting and trending. Ensure SOFIE's Change Control
procedure is followed as required.
▪ Monitor site production performance and manage departmental metrics by collecting key performance indicators.
Collaborate cross functionally to discuss operations, issues/concerns, innovative ideas, and continuous quality
improvements. Keep departmental costs within the budget and determine ways to reduce production costs using
Lean tools.
▪ Ability to work various shifts and weekends required. Perform routine production synthesis as needed.
▪ Write reports, presentations, and other documentation summarizing data. Coordinate the Radiopharmaceutical
Contract Manufacturing team's activities to reach defined objectives.
▪ Liaise with our contract partners (e.g., biotech and pharma). Effectively communicate with customers, vendors,
and other internal sites.
▪ Perform other duties as assigned.

Qualifications:

▪ Bachelor’s degree in a scientific field is required with 10+ years of experience in radiopharmaceutical /
pharmaceutical drug product manufacturing and production equipment management (qualification,
troubleshooting and maintenance) required. Master’s degree with 7+ years of experience is preferred.
▪ Three to five years of people management experience required.
▪ Familiarity with radiation protection and safe handling of radioactive materials is required. Experience in radiation
safety is highly preferred.
▪ Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and
procedure manuals required.
▪ Experience in cGMP manufacturing environment is highly preferred. Knowledge of cGMP requirements, aseptic
process (cleanroom environment), and equipment qualification is required.
▪ Efficient in the use of MS Office Suite required.
▪ Excellent organizational skills required. Knowledge of Lean Six Sigma preferred.
▪ Cross functional communication skills in addition to collaboration and troubleshooting