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Biopharmaceutical Production Associate II

2 months ago

Milford, Connecticut, United States Rentschler Biopharma Full time

Company Overview

Rentschler Biopharma stands as a prominent global contract development and manufacturing organization (CDMO) specializing in biopharmaceuticals. Our facilities provide comprehensive solutions, encompassing bioprocess development and production, alongside consulting services such as project management and regulatory compliance.

As a family-owned enterprise, we take pride in our diverse workforce of approximately 1100 employees from 25 different nationalities. Our collective passion drives us to empower clients in their mission to assist patients suffering from serious or rare diseases. Through our commitment and expertise, we translate medical research into exceptional biopharmaceuticals, contributing significantly to the global accessibility of vital therapies. To support our sustainable growth, we are expanding our team and invite you to join us on this remarkable journey, shaping the future of biopharmaceutical manufacturing.

Key Responsibilities

  • Execute operations related to various manufacturing processes, which may include commercial scale products, development studies, clinical scale, or validation activities.
  • Operate manufacturing equipment to carry out different production steps effectively.
  • Initiate new revisions for operational procedures as necessary.
  • Demonstrate proficiency in aseptic techniques while working within a Biological Safety Cabinet (BSC).
  • Monitor and document batch parameters, ensuring accurate computer data entry.
  • Complete relevant documentation in accordance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) guidelines.
  • Troubleshoot process-related issues and respond to alarms, providing necessary information for unplanned events.
  • Manage the ordering, receiving, and distribution of supplies within the production area.
  • Facilitate training sessions for team members, demonstrating procedures and scheduling departmental activities.
  • Communicate effectively with external stakeholders, including auditors and global colleagues.
  • Engage in Continuous Improvement Teams to enhance operational efficiency.
  • Perform additional duties as assigned, particularly during production processing.
  • Possess knowledge of laboratory and pharmaceutical production equipment, including autoclaves, process tanks, chromatography systems, and analytical instruments.
  • Utilize standard troubleshooting methodologies for problem-solving.

Qualifications

  • High school diploma with 4+ years of relevant experience, or an associate degree in Life Sciences/Engineering; Biotech Certificate preferred.
  • Bachelor's degree typically requires 2+ years of related experience.
  • Proficient in Microsoft Office applications, including Outlook, Word, and Excel.
  • Strong mathematical skills, capable of working with both metric and U.S. measurement standards.
  • Adept at following detailed written instructions with effective verbal and written communication skills.
  • Ability to produce clear and grammatically correct documentation.
  • Competent in authoring technical procedures and creating necessary forms.
  • Strong interpersonal skills, able to collaborate effectively within a team environment.
  • Willingness to meet scheduling requirements, including shifts, weekends, holidays, and potential overtime.

Working Conditions

  • Personal Protective Equipment (PPE) must be utilized as required.
  • Physical demands may include lifting up to 25 lbs.
  • Manufacturing tasks necessitate remaining on feet for extended periods.
  • Ability to push buffer containers ranging from 50L to 200L.
  • Capability to sit for durations of 2 to 3 hours.
  • Work in a cleanroom environment, adhering to hygiene standards and wearing specialized garments.

Physical Requirements

  • Compliance with PPE requirements.
  • Ability to lift up to 25 lbs.
  • Regularly remain on feet during manufacturing operations.