Manufacturing Associate III

About the Company

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 offer formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create process designs tailored to our clients’ products.

With operations spanning the globe and featuring a multicultural team, BioTechnique is passionate about bringing together talented individuals to form something truly special. We believe in coaching and developing the next generation of industry leaders, offering tools for growth and a compensation structure that rewards your contributions.

About the Role

This position is responsible for performing a variety of complex tasks under general guidance, in accordance with manufacturing instructions and current GMP/ISO requirements as defined in FDA and EU regulations. The role involves routine and critical manufacturing operations, including aseptic and non-aseptic filling, equipment preparation, cleaning, dissolution, and formulation activities. The individual may also support other departments such as engineering, warehouse, and facilities.

Responsibilities

• Maintain certification for aseptic gowning and demonstrate proper aseptic technique.
• Perform equipment preparation, including CIP (Clean-in-Place) and SIP (Steam-in-Place) operations.
• Execute manufacturing instructions for compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs.
• Adhere to verbal instructions and written procedures when operating production equipment.
• Accurately complete all required production documentation, ensuring compliance with Good Documentation Practices (GDP).
• Perform room sanitization activities to maintain controlled environment conditions.
• Identify, escalate, and document deviations from normal operations; participate in investigations as needed.
• Support commissioning and validation activities, as well as routine and critical operations.
• Assist engineering, warehouse, and facilities departments to build cross-functional skills.
• 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 for equipment and components.
• Maintain responsibility for floor inventory and communicate schedule changes to the Supervisor.
• 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 teams to identify root causes and implement corrective actions.
• Assist the Supervisor, Engineer, and/or Facilities team with investigations; communicate quality issues to Supervisor and QA.
• Interact with cross-functional support teams such as Quality Assurance, Quality Control, Engineering, R&D, and Validation.
• Assist with training Manufacturing Associate I’s and II’s.

Requirements

• 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 proficiency 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 verbal and written communication skills.
• Self-motivated with the ability to complete multiple floor activities effectively and compliantly.
• 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 make balanced decisions.
• Positive attitude and strong interpersonal skills.

Benefits

• Medical, Dental, and Vision: PSC pays 100% of 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) with company matching.
• Paid Time Off (PTO), Sick Time, and Paid Holidays.
• Education Assistance.
• Pet Insurance.
• Fitness Benefits, including membership discounts at qualifying gyms (e.g., Anytime Fitness, 24-Hour Fitness).
• Financial Perks and Discounts.