Manufacturing Associate III

Job Description

Job Description

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

The Experience

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.

At BioTechnique, it’s about more than just a job—it’s about your career and your future.

Your Role

This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMP/ISO requirement and standards as defined in FDA and EU applicable Regulations. With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in aseptic and non-aseptic filling, equipment prep, cleaning dissolution and formulation activities. The individual may provide support in other departments within the company, including but not limited to, engineering, warehouse and facilities.

Core Responsibilities:

• Maintain certification for aseptic gowning and demonstrate the ability to perform all duties using proper aseptic technique.
  
• Perform equipment preparation, including CIP (Clean-in-Place) and SIP (Steam-in-Place) operations, to prepare equipment for use.
  
• Execute manufacturing instructions to perform compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs.
  
• Strongly adhere to verbal instructions and written procedures when operating production equipment and performing processing steps.
  
• Accurately complete all required production documentation, ensuring forms, logbooks, form preparations, and batch records are complete, reviewed, and meet Good Documentation Practices (GDP).
  
• Perform room sanitization activities to maintain controlled environment conditions.
  
• Identify, escalate, and document events that deviate from normal operations; participate in investigations as needed; assist in introducing new manufacturing schemes into the GMP manufacturing facility.
  
• Execute routine and critical operations, as well as commissioning and validation activities, as assigned.
  
• Support the engineering, warehouse, and facilities departments to build cross-functional skills, as required.
  
• Revise and author Standard Operating Procedures (SOPs) and Batch Records.
  
• Assist with the formulation and validation of new processes in partnership with the tech transfer group.
  
• Ensure sanitization and sterilization practices are followed, including building, cleaning, sanitizing, and sterilizing equipment and components to support production operations.
  
• Maintain responsibility for floor inventory and communicate schedule changes to the Supervisor, as needed.
  
• Perform additional duties as assigned.
  

Additional Level III Responsibilities

• Lead teams to complete manufacturing activities.
  
• Initiate deviations or investigations of varying complexity, working with cross-functional departments to identify root cause and implement appropriate corrective actions.
  
• Assist the Supervisor, Engineer, and/or Facilities team with investigations; communicate quality issues or concerns to the Supervisor and QA; interact with cross-functional support teams such as Quality Assurance, Quality Control, Engineering, R&D, and Validation.
  
• Assist with training of Manufacturing Associate I’s and II’s.

• Bachelor’s Degree in a Life Sciences or Liberal Arts field, or equivalent experience.
  
• 5-7 years of professional manufacturing experience in an aseptic, FDA-regulated pharmaceutical facility.
  
• Ability to manage floor activities in the absence of the Supervisor.
  
• Experience in reviewing and creating controlled documents.
  
• Experience with sterile injectable drug products and well versed in aseptic technique.
  
• Familiarity with formulation, filling, primary packaging, and aseptic processing.
  
• Willingness to work extended shifts and a variable schedule when required.
  
• Skilled in MS Office/Excel tools.
  
• Excellent communication skills, verbal and written.
  
• Self-motivatedl with the ability to complete multiple floor activities in an effective and compliant manner.
  
• Strong attention to detail, organizational skills, and commitment to quality.
  
• Proven ability to plan and prioritize complex activities.
  
• Strong analytical skills and mechanical aptitude to identify risks and prepare balanced decisions.
  
• Positive attitude and strong interpersonal skills.
  

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  
• 401(k) and 401(k) matching
  
• PTO, Sick Time, and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
  
• Financial Perks and Discounts

Equal Opportunity Employment Statement

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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