Bristol, Pennsylvania

Kelly Services is actively recruiting for a Bioprocessing Manufacturing Associate for a temp-to-hire opportunity in Bristol, PA.  

The work schedule is typically M-F from 9a-5p but flexibility is needed due to manufacturing needs/schedule. (Less than 10% of occasional weekend work may be required.)

Responsibilities of the Manufacturing Associate includes: 

  • Performing large-scale chemistry processes for cGMP manufacturing projects.
  • Performs functions related to the development and processing of drug substances, APIs and intermediates ensuring product compliance and multiple tasks that ultimately provide Good Manufacturing Practices and on time delivery to the customer.
  • Must be able to communicate production status, communicate problems to proper personnel and understand how it affects other aspects of the operation.
  • Will work in a highly collaborative and fast-paced environment, and will be directly involved in the cGMP manufacture. This includes the hands-on execution of chromatographic purifications, lyophilization, evaporation, crystallization as well as authoring of relevant documentation (process development reports, batch records, and SOPs), and perform in-process analytical characterization (HPLC, UPLC, LC-MS, NMR, etc.) of products.
  • Will perform Manufacturing activities including:
    • Perform a variety of complex tasks in accordance with CGMP, CGDP, SOPs, and Batch Records
    • Batch Documentation/Record Generation
    • Materials sampling, staging, dispensing, and return
    • Equipment and Room set-up, operation, and cleaning
    • Use of appropriate personal safety equipment and engineering controls
    • In-process inspection and sampling
    • Support investigational and quality systems activities.
    • Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment.
    • Participate in continuous improvement activities
    • Interface and consult with Analytical, Quality Control and Quality Assurance.
    • Provide detailed observations, analyze data and interpret results
    • Communicates these results to staff and upper management
    • Initiate deviations, assist in assessing product quality impact and assists with proposals for Corrective and Preventive Actions (CAPAs)
    • Ensure the proper set-up and operation of processes and equipment
    • Write, review, SOPs, Master Batch Record, Specifications, and other applicable cGMP documentation for Manufacturing
    • Prepare technical reports, batch summaries, protocols, batch records, specifications, and quantitative analyses
    • Ensures proper execution of Master Batch Records, standard operating procedures, and validation protocols.
    •  Ensure completion of equipment logs and batch record.
    • Ensures cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s)
    • Ensures accuracy of Standard Operating Procedures (SOP’s).
    • Train on and understand all policy and procedures including Regulatory, Safety, SOPs, Work Instructions, etc.

Required Experience and Skills:

  • Bachelor's degree in Chemistry or related field preferred.  
  • Minimum of 4 years’ experience in a GMP pharmaceutical environment including experience in manufacturing of small molecules. 
  • Direct hands-on experience with large scale extractions, crystallizations, evaporations and lyophilizations.
  • Experience with cGMP manufacturing operations and GxP principles.
  • Understanding and application of cGMP requirements.
  • Adheres to quality standards set by regulations and policies and procedures.
  • Understanding of common chemical reactions and approaches.
  • Experience with organic and synthetic chemistry principles.
  • Have a strong working knowledge and understanding of cGMP compliance and how they apply to responsibilities.
  • Ability to follow detailed instructions and to maintain accurate records.
  • Ability to safely operate production equipment in accordance with established practices.
  • Possesses advanced technical skills, time management and communication competencies, and a commitment to innovation and efficiency.
  • Strong communication and problem solving skills.
  • Team-oriented with the flexibility to adapt to changing work priorities.
  • Willingness to work flexible hours, including weekends, as needed.
  • Ability to stand for extended periods of time, and lift heavy objects.

 



Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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Bristol, Pennsylvania

Why Kelly - Since 2011 we have placed over 16,000 Veterans

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Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

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Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

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