Alcohol and drug counselor serp_jobs.h1.location_city

Drug Substance Manager

Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earning our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.

This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substances, drug products, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.

The ideal candidate for this role will be an energetic leader with strong interpersonal, leadership, collaboration skills, and has demonstrated the ability to meet immediate business objectives even through adversity. This role will support drug substance manufacturing in regulated, clean room environments complying with current Good Manufacturing Practices in the form of project management and ultimately shop floor leadership.

Key Responsibilities

Accountability | Project Support

• First-line operations supervisor with a team of individual contributor production direct reports
• Supports project team as operations leader through start-up, qualification through licensure, and ramp-up of the facility
• Leads and provides input into continuous improvement opportunities

Accountability | Operational Leadership

Compliance - Creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business

Supply / Support Tier - Exercise judgment and decision making to ensure a quality product is reliably produced while managing cost

Continuous Improvement - Accountable for developing a Company Production System (CPS) and continuous improvement culture while achieving CPS Targets and business results for the Shift(s)

Financial Stewardship Accountable for meeting the Shift(s) operating budget and continuously reducing cost

People Management Creating and sustaining a highly engaged workforce through the utilization of Company Leadership Behaviors and Inclusion

Education

High School Diploma AND at least Six (6) years in a manufacturing, technical, support, or Military role.

OR

Bachelor's degree in a technical field AND at least four (4) years in a manufacturing, technical, support, or Military role.

Bachelor's degree and two (2) years of experience in a direct GMP, biotechnology, and manufacturing setting.

Required Experience and Skills

Ability to develop and lead others

Ability to be flexible and understand the risk

Continuous improvement

Conflict resolution

Leadership style adaptive; high-performance coaching; a servant leader

Successfully maintain Aseptic Gowning qualifications (Aseptic gowning includes all skin and hair covered).

Candidate must pass a TB Blood and Chest X-Ray prior to start date.

Preferred Experience and Skills

Minimum two years in relevant manufacturing or processing (aseptic / sterile, bulk, solid oral dosage, packaging, etc.)

Demonstrated knowledge of Lean / Six Sigma

Demonstrated experience of interacting with the site, divisional or regulatory audits

Schedule Requirements

The position is for 2nd Shift - 2pm - 10 : 30pm - Overtime required upon request

Residents of Colorado