Surmasis - Manufacturing Manager | M - F | Pay Based on Experience - Katecho

PRIMARY DUTIES AND RESPONSIBILITIES

1. Manages and oversees new product launch, post-approval changes and routine commercial manufacturing activities.
2. Oversees and plans product needs to ensure timely supply. Assist in preparation schedules and coordination of manufacturing activities.
3. Trains and manages the clean room personnel on relevant production processes and quality systems related to 21 CFR 210/211 and Part 820.
4. Technical leadership of Surmasis products with emphasis in equipment management, process, and manufacturing activities.
5. Manages team of manufacturing operators and manufacturing technicians.
6. Provides senior management the visibility of manufacturing floor concerns related to process, product, personnel, procedure, and production performance.
7. Assists Engineering department with writing/reviewing batch records and protocols for manufacturing of drug products.
8. Writes /reviews development and validation technical reports.
9. Works with Quality to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements.
10. First level of escalation for real time technical decisions in line with regulations and Surmasis procedures.
11. Ensures that products manufactured for Surmasis adhere to quality standards.
12. Performs the department review and approval of the following GMP documentation as it relates to the department: Batch Record Reviews, Manufacturing Investigations (Deviations), Validation Plans, Protocols and Reports, Standard Operating Procedures, CAPAs, and any associated compliance records.
13. Escalates quality issues to management for resolution and maintain the flow of products and documents to meet site objectives.
14. Supports the development and execution of policies, procedures, standards, and guidelines related to technical areas (Production, Validation, New Formulation Introduction, Root Cause Analysis, Process Trending, Risk Assessment, etc.).
15. Drives Quality Management System assignments (CAPA, Deviation, Change Control, GMP tasks) to on-time closure as assigned.
16. Collaborates in data analysis and report creation on metrics and key performance indicators.
17. Regular and reliable attendance is an essential function of this job. Punctuality and regular attendance are crucial for efficient plant operations, safety and morale.

SECONDARY DUTIES AND RESPONSIBILITIES

1. Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
2. High level of proficiency in problem solving, creativity, independent thought, and sound judgment.
3. Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
4. Training and mentoring of other members of the organization.
5. Strong performance history of consistently meeting and exceeding expectations.
6. Other duties and responsibilities may be assigned as required.

AUTHORITY

1. Take necessary action required to remedy product quality problems; such as quarantining product or shutting down production, etc.
2. Determine and request necessary resources (personnel, equipment, supplies, etc.) to effectively run the Quality Department within the manufacturing floor.
3. Hire, reward, review, discipline, and terminate personnel in the Quality Department according to company policy and applicable legal requirements.
4. Works together with other members of the management team to manage the overall direction of Surmasis.

QUALIFICATIONS

BS degree in an engineering or scientific position with at least five years of experience in an Operations or Engineering/Technical position. A minimum of five years of pharmaceutical or related industry experience, including late-stage development, process validation and commercial pharmaceutical cGMP manufacturing environments. Prior experience in working at a contract manufacturing organization is a plus.

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.

While performing the duties of this job, the employee is frequently required to stand, walk, sit, and operate a computer. Specific vision abilities required by this job include close vision and distance vision.

WORK ENVIRONMENT

Office environment with business casual dress. May require business attire.

• Full Benefits: Medical, Dental, Vision, Short-Term Disability (STD), Long-Term Disability (LTD), and Life Insurance options
• 401(k) Retirement Plan
• Paid Time Off (PTO) awarded immediately
• 7 paid holidays per year, including New Year’s Day, Memorial Day, 4th of July, Labor Day, Thanksgiving (Thursday & Friday), and Christmas Day