MARKET COMPETITIVE WAGES

COMPREHENSIVE BENEFITS PACKAGE STARTING DAY ONE

Position Summary

The Manufacturing Technician II is accountable for results in a fast-paced environment and is responsible for manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician II operates manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician II employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician II works collaboratively to support other manufacturing areas as required. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies for the role.

Essential Functions

• Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
• Performs applicable manufacturing techniques and technologies per SOPs and cGMPs.
• Performs manufacturing technologies and operation of manufacturing and material handling equipment.
• Documents activities in real time on controlled documentation and legibly, per SOPs and cGMPs.
• Performs in-process testing, weight checks, component counting and basic math calculations.
• Performs cleaning of rooms, tools and equipment.
• Provides training to entry-level Manufacturing Technicians.
• Assists with other manufacturing areas as required.
• This position will be required to supervise, handle, or process hazardous waste under Resource and Conservation guidelines promulgated under 40 CFR 262.177(a)(7), Personnel Training. This includes completion of initial and annual RCRA training and documented as required in Alcami records. This training also includes familiarity with emergency response procedures, emergency equipment, and emergency systems.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Manufacturing Technologies for Sterile Liquids:

• Equipment and component preparation and sterilization
• Compounding
• Aseptic filling
• Capping

Manufacturing Technologies for Solid Oral Dosage:

• Blending
• Granulation
• Compression
• Encapsulation
• Coating
• Other specialized manufacturing technologies

Education and Experience

• High school diploma with a minimum of 2 years of relevant experience required. 2-5 years of experience is preferred.
• cGMP or prior work experience in a regulated environment preferred.
• Prior pharmaceutical or CDMO experience preferred.

Alcami Non-Negotiables

• Consistently demonstrates honesty and integrity through personal example.
• Follows all safety policies and leads by example a safety first culture.
• Produces high quality work product with a focus on first time right.
• Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Ability to perform basic math calculations.
• Ability to read and comprehend detailed written instructions required.
• Ability to move materials throughout the facility using appropriate methods and equipment required.
• Proficiency in basic computing skills required.
• Awareness of or prior experience with cGMP practices and procedures preferred.

Decision Making and Supervision Required

• Applies job skills, company policies and SOPs to complete a variety of tasks.
• Receives general instructions on routine work, detailed instructions on new projects or assignments.

Travel Requirements

• Up to 5% domestic travel.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered 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 regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.