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Pipeline Operations Manager
5 months ago
Interns must be local to York, PA. While internships are full-time during academic breaks (i.e. Summer 2023) interns are required to be able to continue interning part-time hours, on-site, in York, PA throughout the academic semesters.
The work we do at BioTechnique has never been more important and we are looking for talented candidates to join us. We re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people s lives. Join BioTechnique and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We re proud to cultivate a culture that will fuel your passion, energy, and drive. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At BioTechnique, you determine what s possible.
BioTechnique is a highly potent sterile injectable and clinical oncolytics manufacturing company dedicated to providing cytotoxic and high potency sterile injectable fill-finish services. BioTechnique s project management and client services staff work closely with our clients to meet all manufacturing needs. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and optional lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team s expertise to work with our clients to create a process design for their product that suits their needs.
Our goal is to skyrocket our clients success, and you can be a part of our team s achievements. Employing a global team of skilled professional and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech 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. Our goal is to provide you 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
Manufacturing Interns are responsible for performing a variety of complex tasks under team guidance and in accordance with the current GMP requirements and standards. With 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.
- Maintain and adhere to safe work habits and all applicable safety procedures and guidelines.
- Assist in the execution of manufacturing instructions to perform equipment preparation, compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs.
- Strong adherence to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes all appropriate production documentation.
- Learn how to identify, escalate, and documents events that deviate from normal operation; participate as needed in investigations. Assist in the introduction of manufacturing schemes into the GMP manufacturing facility.
- Assist with the formulation and validation of new processes with the assistance of the tech transfer group
- Contribute to the execution of all routine and critical operations as well as commissioning and validation activities, as assigned. Learn how to revise and author Standard Operating Procedures (SOPs)/Batch Records.
- Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, form preps, batch records, etc.).
- Ensure sanitization and sterilization practices (build, clean, sanitize and sterilize equipment and components to support production operations).
- Recommend/Implement process changes/improvements or safety/ergonomic improvements.
- Perform room sanitization activities to maintain controlled environment conditions.
- Learn how to initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause and implement appropriate corrective actions.
- Assist supervisor/engineer/facilities with investigations and communicate any quality issues/concerns to Supervisor and QA. Interacts with cross functional support teams, such as Quality Assurance, Quality Control, Engineering, R&D, Validation, etc.
- Additional duties as required
Requirements
- Enrolled in an accredited Bachelor of Science or Arts Degree Program .
- Strong drive to learn.
- Excellent attention to detail.
- Strong analytical and problem-solving skills.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Strong time management skills to manage multiple priorities.
- Proficient in Microsoft Office Applications
Enrolled in an accredited Bachelor of Science or Arts Degree Program . Strong drive to learn. Excellent attention to detail. Strong analytical and problem-solving skills. Demonstrates excellent verbal, written, and interpersonal communication skills. Strong time management skills to manage multiple priorities. Proficient in Microsoft Office Applications