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Sr. Manufacturing Tech

Company: Alcami Corporation
Location: Morrisville
Posted on: November 19, 2021

Job Description:

Think Different. Do Different. Be Different.

Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, 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, accelerated professional growth and the opportunity to be part of something different.



Comprehensive Benefits Package Starting Day One

  • paid out upon hire and in two additional installments. Internal candidates are not eligible for sign on bonusPosition Summary

    The Senior Manufacturing Technician 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 Senior Manufacturing Technician 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 Senior Manufacturing Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Senior Manufacturing Technician demonstrates proficiency in all department procedures, trains and coaches other technicians, and provides work instruction and oversees daily work assignments in the absence of the supervisor as needed. The Senior Manufacturing Technician interacts with customers as needed. 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.
    • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
    • Performs and oversees applicable manufacturing techniques and technologies per SOPs and cGMPs.
    • Performs and oversees 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.
    • Demonstrates proficiency in all department procedures and trains and coaches other technicians.
    • Provides work instruction and oversees daily work assignments in the absence of the supervisor as needed.
    • Assists with other manufacturing areas as required.Manufacturing Technologies For Sterile Liquids
      • Equipment and component preparation and sterilization
      • Compounding
      • Aseptic filling
      • Capping
      • Visual inspectionEducation And Experience
        • High school diploma or GED with 5 years of related experience required.
        • cGMP or prior work experience in a regulated environment required.
        • Prior pharmaceutical or CDMO experience required. 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.
              • Ability to train, coach and develop others required.
              • Prior experience with cGMP practices and procedures required.
              • Proficiency in aseptic processing and manufacturing operations using filling machines, filtration equipment, autoclaves, and semi-automatic inspection machines
              • Ability to develop and optimize processes, procedures, and the agility to change directions when requiredDecision 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.

                    What We Offer You
                    • Competitive salary with career advancement opportunities
                    • Bonus plan
                    • Medical, dental and vision coverage from day one
                    • 401(k) with company match
                    • Company paid vacation, holiday and sick-leave
                    • Voluntary benefits including short & long-term disability, life, accident, critical illness insurancesDiversity And Inclusion

                      Alcami values diversity and we are c ommitted to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

                      As part of our effort to provide and maintain a safe and healthful workplace, Alcami Corporation requires new hires to be fully vaccinated against COVID-19. Individuals are considered fully vaccinated 2 weeks after their second dose of the Pfizer or Moderna vaccine, or 2 weeks after a single-dose of the Johnson & Johnson vaccine. Individuals seeking an exemption from this requirement for medical or religious reasons should contact HR to complete a request for accommodation form.
                      ..... click apply for full job details

Keywords: Alcami Corporation, Cary , Sr. Manufacturing Tech, Other , Morrisville, North Carolina

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