Manager, Technical Operations (Finance)

MANAGER, TECHNICAL OPERATIONS

SUMMARY: Manages the day-to-day technical operations support for Cardiogen-82 Generator manufacturing. Position ensures the successful implementation and completion of technical projects, product investigations or product changes, which typically involve collaboration with other departments, divisions and companies. Such projects must meet corporate goals, scheduled timelines and cost objectives. Some projects will not be product specific but help drive company initiatives.

ESSENTIALDUTIES AND RESPONSIBILITIES:

• Proficient knowledge of products, contract manufacturer's or supplier's processes, including pharmaceutical validation requirements and component sourcing.
• Leads CMO and supplier's manufacturing teams to identify and qualify subcontractors and alternate suppliers.
• Manages activities to ensure supply of product.
• Support quality system requirements via the change control process, CAPAs, and field complaint investigations.
• Position is responsible for the development of actions required to:

• • Maintain or improve manufacturing process.
  • Identify and support the implementation of new processes associated with product testing.
  • Facilitate various projects in support of company initiatives.

• Drive and demonstrate compliance to agency regulations, guidance and standard operation procedure regarding Process Validation and Risk Management.
• Generate, review and or approve technical documents.
• Other activities may be assigned as required by management.

SECONDARYDUTIES AND RESPONSIBILITIES:N/A

SUPERVISORY RESPONSIBILITIES: N/A

CORE COMPETENCIES : To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the core competencies required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Demonstrated working experience in a radiopharmaceutical environment.
• Candidate must be highly motivated and passionate about managing the manufacturing operations aspects of a portfolio of products; while demonstrating strong documentation, oral, and interpersonal communication skills.
• Contributes to overall achievement by accomplishing related tasks and demonstrating characteristics that exemplify team building and support.
• Can work independently as well as in a team-oriented environment. Ability to conform shifting priorities, demands, and timelines.
• Demonstrated problem solving skills are important.
• This position has full responsibility and authority to make necessary decisions and/or take action, which is required to carry out job duties.

EDUCATION and EXPERIENCE:

• Bachelor's degree in life sciences, preferred
• 10 years of experience with sterile/non-sterile pharmaceutical drug and device manufacturing validation.
• Computer proficiency in Microsoft Office suite.
• Working knowledge of FDA/EU cGMP regulations (Pharma/Aseptic).

CERTIFICATES LICENSES, REGISTRATIONS: N/A

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel may be required.

WORK ENVIRONMENT : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a hybrid position.
CORE RELATIONSHIPS:

• Quality Assurance, Regulatory, Legal, Research, Marketing, Suppliers