Supervisor, Manufacturing - 2nd Shift - Aseptic Filling , GMP
Morrisville, NC 
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Posted 9 days ago
Job Description


Free Healthcare Option | Bonus Program | 401(k) with Match | College Loan Forgiveness
Core Values: Trustworthy, Relentless, Accountable, Collaborative, Customer-Focused, and Skilled

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

Job Summary:

The Supervisor, Manufacturing is accountable for driving results in a fast-paced environment by leading daily manufacturing operations on second shift, including facility/equipment/component preparation, formulation, and aseptic filling. The Supervisor, Manufacturing works directly with performance and engagement of manufacturing technicians who operate autoclaves, depyrogenation ovens, aseptic filling machines and other equipment for manufacturing operations. This leader is accountable for performing duties in accordance with Standard Operating Procedures (SOP) and driving the performance management, training and development and continuous improvement of the team. In addition to overseeing manufacturing personnel, this hands-on leader should have functional capability to perform the essential functions and activities alongside the manufacturing associates.

On-Site Expectations:

  • 100% on-site position.
  • 2nd Shift: Monday-Friday 3:00pm-12:00am

Responsibilities:

  • Performs duties in accordance with Standard Operating Procedures (SOPs).
  • Develops internal working relationships across business units.
  • Leads internal investigations and works cross-functionally with other departments toward solutions.
  • Clearly and effectively communicates with technicians, management, and clients as needed.
  • Troubleshoots technical issues within the department.
  • Monitor's manufacturing personnel performance to meet output requirements for the department.
  • Maintains personnel timekeeping and time off request to ensure uninterrupted operations of the department.
  • Maintains and prioritizes personnel training steps.
  • Monitors personnel progress within the department.
  • Provides ongoing coaching and feedback to direct reports and updates to management.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • Responsible for the selection, training and development, coaching/mentoring, engagement, retention, and performance management of a high performing team to meet the current and evolving needs of the site.
  • Directly supervises team of 4-12 direct reports.
  • Participates in the hiring process of other employees.
  • Makes hiring decisions of other employees.
  • Schedules and reviews the work of other employees.
  • Ensures accuracy and relevance of assigned training curriculum.
  • Drives timely completion of training for employees to meet regulatory requirements.
  • Coaches, mentors and develops other employees.
  • Prepares and delivers performance evaluations of other employees.
  • Makes recommendation of disciplinary actions of other employees.
  • Other duties as assigned.

Qualifications:

  • Bachelor's degree required, engineering preferred.
  • Two (2) years or more of hands on working experience in a regulated (cGMP) environment.
  • Prior experience with Drug Product manufacturing required.

Knowledge, Skills, and Abilities:

  • Knowledge of cGMP, SOPs, CAPAs and manufacturing required.
  • Knowledge of pharmaceutical manufacturing and review of batch records preferred.
  • Excellent communications, problem solving, organizational skills and ability to handle confidential documents required.
  • Knowledge of basic computer skills, including Microsoft office and windows-based system required.
  • Ability to train operators preferred.

Travel Expectations:

  • Up to 5% domestic travel.

Physical Demands and Work Environment:

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 required to frequently stand; sit; walk; talk or hear; and reach with hands and arms. The employee is required some of the time to use hands to finger, handle or feel; and climb or balance. The employee is required to occasionally stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may frequently work near moving mechanical parts; fumes or airborne particles; and outdoor weather conditions.

About Us:

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle. Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision, and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.

Diversity and Inclusion:

Alcami is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
2 years
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