Manages and coordinates the activities of Sterile and Non- Sterile operations.
Interaction with Amityville Site Management in establishment and ensuring compliance with policies, budgets (departmental and capital), goals and objectives, and regulatory guidelines (pharmaceutical, safety and financial).
The duties include providing site leadership, guidance, and personnel development from both administrative and technical base.
Interface with external organizations such as the FDA, DEA, Contract Auditors, OSHA, EPA, and others to ensure compliance with current regulations.
Schedules production activities with the VP of Operations, according to supply chain demand. Oversees all day-to-day activities in the manufacturing departments.
Lead and support filling and packaging equipment modifications and upgrades for automated process efficiency, regulatory compliance and replacement of obsolescent equipment, controls and systems.
Provide leadership and support for continuing process improvement efforts for Manufacturing and Packaging. This shall include the initiation of Capital Projects, which benefit the line efficiency and/or productivity; along with project justification analysis, program preparation, project implementation, cost tracking, scheduling control and completion/closing of all projects on time and within budget.
Enhance the management and operation skills within the operations departments; provide technical resources to departments within the organization regarding filling and packaging equipment improvement based upon the departmental systems used to facilitate the workload; represent and foster harmonious relationships both inter and intra-departmentally.
Manages the following departments: Compounding (Non-sterile), Packaging (Non-sterile), and Sterile.
Strong written and verbal communication skills.
Oversees the re certification of aseptic manufacturing.
Perform (in conjunction with the QA department) investigations for OOS results within the manufacturing department.
Develops departmental Standard Operating Procedures.
Develops cost reduction plans.
Measures performance and suggest improvements of process.
Conducts interviewing process for new departmental employees.
Participates in plant budgeting.
Directly manages employees in the manufacturing departments. Carries out responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems. Responsibilities include interviewing, hiring, training, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
Bachelor of Science degree with a minimum of ten years related experience in the pharmaceutical environment, with sufficient training and knowledge to perform all required duties.
Minimum of 5 years of management experience.
Ability to meet attendance standards
Hands on experience required to trouble shoot projects.
Have a thorough knowledge in FDA and cGMP guideline.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. Additional physical requirements include the ability to hear accurately the spoken word with moderate office noise (or plant noise).
Mental requirements include:
Ability to apply deductive reasoning and understand complicated issues.
Ability to receive instructions and follow work rules and company policies.
Ability to follow safety and security practices.
Ability to meet deadlines and effectively deal with office stress.
Ability to accurately communicate ideas, facts and technical information.
Maintain confidentiality of certain information.