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Title: Manager, Manufacturing
Location: Pleasant Prairie, WI
Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.
Nexus Pharmaceuticals, Inc. is looking to recruit a Manager of Manufacturing. The Manager of Manufacturing will be instrumental in leading and overseeing the manufacturing needs related efforts associated with the design, construction, commissioning/ qualification and sustainable operation of a new, state-of-the-art, aseptic manufacturing facility. In concert with Nexus’s philosophy, this role is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients.
- Assists in overseeing the organization's GMP manufacturing processes
- Influences decisions on manufacturing equipment purchases, maintenance, layout and initial/routine qualification and actively participates in critical FAT/SAT exercises
- Provides comprehensive review and assessment of facility and equipment design and build documents to ensure compliance with current Good Manufacturing Practices (cGMP) as well as current best industry practices
- Develops, monitors and evaluates workflow and production methods and makes recommendations for process improvements
- Oversees staffing, scheduling and training for production
- Ensures manufacturing performance and quality goals are met
- Provides support for the qualification and validation of manufacturing related processes (e.g. sterilization, cleaning, product/process, etc.)
- Prepares and trains production staff
- Assists in the transfer of products and processes from contract manufacturing sites to the Nexus facility
- Manages departmental sub-functions (e.g. component and equipment preparation, formulation, filling, and lyophilization)
- Responsible for facility and equipment sanitization and cleaning functions
- Assist in designing and acquiring equipment to implement a robust formulation and filling operation
- Other duties as assigned
Skills and Abilities:
- Previous manufacturing experience including isolator technology, lyophilization, inspection and demonstrated proficiency in acting as a technical lead required
- Proven managerial experience with demonstrated success in communicating, leading, and motivating others to succeed required; experience building teams and developing succession plans is highly desirable
- Must be a strategic, innovative driver of change with strong technical skills
Education or Experience:
- Bachelor’s Degree in a science, engineering or business discipline is required
- Minimum of 7-10 years of relevant work experience in an aseptic, FDA regulated manufacturing environment - GMP pharma required
- Minimum of 5-7 years supervising others is required
- 5-30% Travel required for this role
- Low (less than 50%) physical effort includes sitting, and operating computers
- Position requires Low to Moderate (25%) exertion including standing/walking for extended periods of time
- Lifting/carrying more than 15 and up to 25 pounds
- Working in mechanical areas where basic personal protective equipment (PPE) (glasses, gloves, ear protection) is worn as applicable
DISCLAIMER: The list under Role Responsibilities is not exhaustive, but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.
EEOC Statement: Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.