Manufacturing Manager

Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women’s health. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development. In addition, Sebela Women’s Health has two next generation intra-uterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth.

Our culture is characterized by a high degree of urgency, open dialogue and collaborative discussion across all levels of the team, a willingness to challenge the “traditional” approach, and shared ownership of the organization we are building and of our results. We are all willing to step in and do whatever is needed on any given day, regardless of the title we hold. We strive to create a positive, collaborative, inclusive work environment in which all employees can learn, develop and grow.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• The ability to direct manufacturing efforts and meet the directives and goals established by the VP of Manufacturing Operations. Communicates issues and results to the VP.
• In conjunction with the safety committee, manage plant safety to comply with OSHA requirements. Monitor manufacturing plant safety to regulations, establish and implement safety measures as needed, and train staff on applicable safety procedures.
• Develop operational excellence and continuous improvement paradigms through quality systems.
• Work cross functionally with Quality Assurance to establish and perform corrective actions.
• Troubleshoot manufacturing issues to maintain the quality of the product and maximize efficiency.
• Establish resolutions for manufacturing; manage the resolutions with Quality Assurance, and implement corrective actions (CAPA management).
• Perform or assign batch record revisions and deviation resolution. Verify or complete cGMP documentation and batch records accurately.
• Monitor and/or perform training of manufacturing staff and completion of training modules.
• Ensure manufacturing efficiencies through proper scheduling and planning. Ensures the delegation of staging of material and personnel, and proper logistics.
• Manage the requisition of materials, movement of inventory, and account for inventory. Coordinate material with materials management and purchasing.
• Ensure and/or verify equipment runs to meet product specifications. Write or update SOPs and batch records to ensure proper operating procedures.
• Monitor the equipment performance during packaging or manufacturing and perform inspections as needed.
• Perform start up documentation for packaging and manufacturing of product and perform control checks (if applicable).
• Verify the cleaning and proper maintenance of equipment and rooms, managing progress with the maintenance staff.
• Write deviations, determine root causes for issues and develop sound corrective actions.
• Write and execute Installation Qualifications, Operational Qualifications, Performance Qualifications, Cleaning Validation and Process Validation documentation.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in Pharmaceutical Manufacturing. The requirements listed below are representative of the knowledge, skills and/or abilities required.

• Bachelor’s degree with 2-5 years’ experience and/or Associates Degree and 5-7 years’ supervisory experience in a manufacturing environment and /or high school diploma or technical school and ten plus years of incremental supervisory experience in a pharmaceutical/biotechnology manufacturing environment.

• Exceptional technical writing, review and analytical skills.
• Knowledge of good documentation practices and cGMPs.
• Must have strong ability to organize and manage multiple tasks in a fast-paced environment
• Verbal and written communication skills. Must be able to read, write, and converse in English.