Location: Buena, NJ
The Aseptic Process Manager will be responsible for required functions to support Aseptic Manufacturing Operations to ensure the sterility of Teligent Pharma Inc’s products. This person will ensure that all activities in the Aseptic Area are performed following FDA regulations, in compliance with all cGMP’s, SOP’s, Company Policy, and batch record procedures.
- Ensure the quality of all Sterile product.
- Maintain cGMP’s in the Sterile production areas.
- Work directly with the Microbiology Department to address all environmental concerns and proactively prevent reoccurrences.
- Key participant in inspections and audits by internal and external agencies.
- Responsible for Aseptic technique of all Sterile employees. Develop and ensure training for Sterile employees.
- Review, edit, and generate SOP’s as required.
- Assist with the editing and improvement of batch records.
- Owner of the media fill program.
- Owner of the site gowning program.
- Owner of departmental non-conformities.
- Create and Improve Sterile Manufacturing processes.
- Assist on the selection of the aseptic processing and/or sterilization process for new products, and the sites for execution.
- Stay current on new regulatory expectations for aseptic and TS manufacturing and ensure site compliance.
- Involved in the selection of new manufacturing operations (to include aseptic processing manufacturing sites, contract sterilization, contract laboratories, and third-party manufacturers).
- Provide guidance about the manufacturing site regarding the control of environmental monitoring.
- Involved in due diligence and provide technical support for sterile or aseptic products and provide technical SME support.
- Identifies the microbiological controls needed for the components or raw materials coming into the manufacturing sites.
- Input for the design of critical water & air systems and the design of controlled environments and cleanliness control strategies.
- Maintain close involvement/alignment with the Product Development organization to develop technical competencies for future products.
- Maintain close involvement/alignment with the manufacturing sites, with a pro-active scan from a sterility risks standpoint and drive remediation, if required.
- Work directly with Quality Control (Microbiology and Chemistry), Quality Assurance and Supply Chain for receiving, testing and release of raw materials, components and other materials to be used for the manufacturing of Sterile products.
- Maintain a clean and safe work environment.
- Monitor equipment for necessary maintenance, improvements, or upgrades.
- Assume other activities and responsibilities as directed.
- Minimum Bachelor’s degree in a science or technical degree (Master’s degree preferred).
- 3-5 years supervisory experience in a cGMP batch manufacturing environment preferred.
- 5-10 years’ experience in aseptic production and media fill programs is required.
- Excellent computer and math skills.
- Experience with isolators and autoclaves preferred.
- Self-starter with strong analytical and reasoning abilities.
- Participative management type – advocates team concept.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Ability to establish credibility and be decisive, but able to recognize and support the organization’s preferences and priorities.
- Good communication skills, written and verbal.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
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.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs